MedWorm: Avandia

  Follow-up of Phase I Trial of Adalimumab and Rosiglitazone in FSGS: III. Report of the FONT Study Group

Antifibrotic therapy for a defined period of time may be a viable strategy to preserve kidney function in patients with resistant focal segmental glomerulosclerosis. BMC Nephrology (Source: Medscape Nephrology Headlines)

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  Toluene diisocyanate (TDI) regulates haem oxygenase-1/ferritin expression: implications for toluene diisocyanate-induced asthma

In this study of toluene diisocyanate (TDI)-OA, we found identical findings with increased transferrin and decreased ferritin levels in the serum of patients with TDI-OA. To elucidate whether diisocyanate suppresses FTL synthesis directly, we tested the effect of TDI on the FTL synthesis in A549 cells, a human airway epithelial cell line. We found that haem oxygenase-1 as well as FTL was suppressed by treatment with TDI in dose- and time-dependent manners. We also found that the synthesis of other anti-oxidant proteins such as thioredoxin-1, glutathione peroxidase, peroxiredoxin 1 and catalase were suppressed by TDI. Furthermore, TDI suppressed nuclear translocation of Nrf2 through suppressing the phosphorylation of mitogen-activated protein kinases (MAPKs); extracellular-regulated kinase ...

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  The investigation of Mitogen-Activated Protein kinase Phosphatase-1 as a potential pharmacological target in non-small cell lung carcinomas, assisted by non-invasive molecular imaging

Conclusion: The induction of MKP-1 could significantly suppress the proliferative and metastatic abilities of NSCLC both in vitro and in vivo. Therefore, MKP-1 could be considered as a potential therapeutic target in NSCLC therapy and PPARgamma agonists could be explored for combined chemotherapy. (Source: BMC Cancer)

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  Clinical Trial Summary: Assessment on the Prevention of Progression by Rosiglitazone on Atherosclerosis in Diabetes Patients With Cardiovascular History (APPROACH)

The goal of the trial was to evaluate treatment with rosiglitazone compared with glipizide among patients with type 2 diabetes. (Source: Cardiosource)

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  Entering and Exiting the Medicare Part D Coverage Gap: Role of Comorbidities and Demographics

CONCLUSIONS  Certain chronically ill MAPD enrollees are at high risk of gap entry and exposure to unsubsidized medication costs. Clinically vulnerable populations should be counseled on how to best manage costs through drug substitution or discontinuation of specific, non-essential medications. Content Type Journal ArticleCategory Original ArticleDOI 10.1007/s11606-010-1300-6Authors Susan L. Ettner, David Geffen School of Medicine at UCLA Division of General Internal Medicine and Health Services Research, Department of Medicine 911 Broxton Plaza Los Angeles CA 90024 USANeil Steers, David Geffen School of Medicine at UCLA Division of General Internal Medicine and Health Services Research, Department of Medicine 911 Broxton Plaza Los Angeles CA 90024 USAO. Kenrik Duru,...

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  FXR activation reverses insulin resistance and lipid abnormalities and protects against liver steatosis in Zucker (fa/fa) obese rats [Research Articles]

In this study, we investigated the effect of FXR activation by 6-ethyl-chenodeoxycholic acid, (6E-CDCA, 10 mg/kg) on insulin resistance and liver and muscle lipid metabolism in fa/fa rats and compared its activity with rosiglitazone (10 mg/kg) alone or in combination with 6E-CDCA (5 mg/kg each). In comparison to lean (fa/+), fa/fa rats on a normal diet developed insulin resistance and liver steatosis. FXR activation protected against body weight gain and liver and muscle fat deposition and reversed insulin resistance as assessed by insulin responsive substrate-1 phosphorylation on serine 312 in liver and muscles. Activation of FXR reduced liver expression of genes involved in fatty acid synthesis, lipogenesis, and gluconeogenesis. In the muscles, FXR treatment reduced free fatty acid synth...

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  Different Effects of Thiazolidinediones on Cardiovascular Risk in Patients with Type 2 Diabetes Mellitus: Pioglitazone versus Rosiglitazone.

This article will review the differential effects of pioglitazone and rosiglitazone on cardiovascular risk factors and outcomes, as well as the potential differences between them. Based upon available evidence, pioglitazone has a beneficial effect on cardiovascular disease. By contrast, it seems that rosiglitazone increases cardiovascular risk. The difference in lipid profile may be the main factor accounting for the superiority of pioglitazone in reducing cardiovascular risk. PMID: 20210732 [PubMed - as supplied by publisher] (Source: Current Drug Safety)

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  Rosiglitazone reduces a wide range of proinflammatory profiles in synovial fibroblast SW982 under spheroid culture.

Authors: Song JS, Kim CH, Heo JY, Cho YS Rosiglitazone (RSG) has been known to play a role in the modulation of inflammatory responses. Therefore, we sought to elucidate the underlying molecular mechanism by which RSG regulates the development of rheumatoid arthritis. Firstly, we examined the preventive effect of RSG on the inflammatory mediators induced by spheroid culture of synovial sarcoma SW982. Expression of proinflammatory cytokines under spheroid culture was more elevated than that under monolayer culture while RSG abolished inflammatory responses. The upregulation of inflammation-related genes by spheroid culture was closely associated with NFkappaB (NFkappaB) activation. Also, activation of p38 and c-Jun N-terminal kinase (JNK) by spheroid culture was abrogated with RSG treat...

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  Glaxo Could Face $6bn Avandia Liability, Says UBS

(Source: PharmaManufacturing.com)

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  Sokolove Blasts GlaxoSmithKline Over Avandia Recall

James Sokolove, Chairman of Sokolove La today blasted GlaxoSmithKline over reports of a potential recall of popular diabetes drug Avandia. (PRWeb Mar 3, 2010) Read the full story at http://www.prweb.com/releases/2010/03/prweb3648864.htm (Source: PRWeb: Medical Pharmaceuticals)

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  MHRA safety update on Rosiglitazone (Avandia, Avandamet) in the treatment of type 2 diabetes

Following a Europe-wide review of the cardiovascular safety of Rosiglitazone (Avandia, Avandamet), the MHRA have updated the drug's safety profile when used on its own or in combination with insulin, finding that the balance of risks and benefits of rosiglitazone remain favourable in its licensed indications. Further information can be found by following the link below. MHRA Rosiglitazone profile (Source: Society for Endocrinology)

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  Cedars-Sinai Heart Institute Cardiologist Sanjay Kaul, M.D. Co-Authors Statement On Safety Of Diabetes Drugs

A Cedars-Sinai Heart Institute cardiologist co-authored the joint science advisory issued by the American Heart Association and the American College of Cardiology that calls for close monitoring of patients taking certain blood sugar-lowering drugs. Sanjay Kaul, M.D. co-authored the advisory about drugs called thiazolidinediones (TZDs) such as pioglitazone (Actos) or Rosiglitazone (Avandia)... (Source: Diabetes News From Medical News Today)

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  Cedars-Sinai Heart Institute Cardiologist Sanjay Kaul, M.D. Co-Authors Statement On Safety Of Diabetes Drugs

A Cedars-Sinai Heart Institute cardiologist co-authored the joint science advisory issued by the American Heart Association and the American College of Cardiology that calls for close monitoring of patients taking certain blood sugar-lowering drugs. Sanjay Kaul, M.D. co-authored the advisory about drugs called thiazolidinediones (TZDs) such as pioglitazone (Actos) or Rosiglitazone (Avandia)... (Source: Health News from Medical News Today)

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  Hepatic Effects of Rosiglitazone in Rats with the Metabolic Syndrome

In this study, we characterized the hepatic effects of rosiglitazone in fructose-enriched diet rats. Rats were randomly divided into three groups. One group was maintained on standard rat chow diet for 6 weeks, whereas the other two groups were given fructose-enriched diet for 6 weeks. Four weeks after the initiation of fructose-enriched diet, one of the fructose-enriched diet groups was also given rosiglitazone (10 mg/kg/day) for an additional 2 weeks. Rosiglitazone administration to the fructose-enriched diet rats was associated with decreases in the following parameters: blood pressure ([minus]17%), plasma triglycerides ([minus]62%), hepatic total lipids ([minus]19%), hepatic triglycerides ([minus]61%), hepatic malondialdehyde ([minus]88%), glutathione reductase activity ([minus]84%). A...

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  GSK blasts Senate report, defends Avandia research

GlaxoSmithKline (GSK) has released a 30-page white paper refuting the U.S. Senate report concerning its diabetes drug Avandia failed “to present an accurate, balanced or complete view of the currently available information on Avandia (rosiglitazone).” (Source: Cardiovascular Business News)

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  Questions raised about ongoing Avandia studies

While health regulators in both Canada and the U.S. wrangle over what to do about the diabetes medication Avandia, some are raising concerns about why clinical studies are still recruiting patients to test the controversial drug. (Source: CTV Health)

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  Site-specific modulation of white adipose tissue lipid metabolism by oleoyl-estrone and/or rosiglitazone in overweight rats

In this study, we studied whether their effects on white adipose tissue [WAT] were due to a shared or synergistic mechanism of action. Combined effects of OE and rosiglitazone 10-day treatment on WAT lipid, cell mass/number, and the expression of key lipid metabolism and regulatory agents were studied using an adult male overweight rat model. OE decreased WAT cell mass and lipids, parameters not changed by rosiglitazone. The effects of OE and—specially—rosiglitazone were more marked in small-cell WAT (i.e., mesenteric and subcutaneous sites) than in larger cell WAT (retroperitoneal and perigonadal). OE decreased the expressions in WAT of lipogenic enzymes, lipoprotein lipase, PPARs, and SREBP1c, effects symmetrically reversed by rosiglitazone. OE showed no effects on hormone-sens...

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  Development of a rapid culture method to induce adipocyte differentiation of human bone marrow-derived mesenchymal stem cells.

In this study we optimized the culture conditions for adipocyte induction to achieve a shorter cultivation time for the induction of adipocyte differentiation in bone marrow-derived hMSCs. Briefly, we used a cocktail of dexamethasone, insulin, metylisobutylxanthine (DIM) plus a peroxisome proliferator-activated receptor gamma agonist, rosiglitazone (DIMRo) as a new adipogenic differentiation medium. We successfully shortened the period of cultivation to 7-8 days from 2-3 weeks. We also found that rosiglitazone alone was unable to induce adipocyte differentiation from hMSCs in vitro. However, rosiglitazone appears to enhance hMSC adipogenesis in the presence of other hormones and/or compounds, such as DIM. Furthermore, the inhibitory activity of TGF on adipogenesis could be investigated usi...

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  Rosiglitazone: accusations over cardiovascular safety

(Source: Reactions)

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  GlaxoSmithKline responds to US Senate Committee on Finance report on Avandia

GlaxoSmithKline (GSK) responded to the recently released Senate Committee on Finance's January 2010 "Staff Report on GlaxoSmithKline and the Diabetes Drug Avandia" (the "Staff Report") by releasing a White Paper. (Source: World Pharma News)

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  Effect of Rosiglitazone on Progression of Coronary Atherosclerosis in Patients With Type 2 Diabetes Mellitus and Coronary Artery Disease. The Assessment on the Prevention of Progression by Rosiglitazone on Atherosclerosis in Diabetes Patients With Cardiovascular History Trial.

Conclusions-Rosiglitazone did not significantly decrease the primary end point of progression of coronary atherosclerosis more than glipizide in patients with type 2 diabetes mellitus and coronary atherosclerosis. Clinical Trial Registration-http://www.clinicaltrials.gov. Unique Identifier: NCT00116831. PMID: 20194881 [PubMed - as supplied by publisher] (Source: Circulation)

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  Disparity Seen in Decline of Glitazone Use

Use of rosiglitazone in physicians' office-based treatment of diabetes patients fell 60%, while pioglitazone use showed just a 9% drop during a 16-month period that included three Food and Drug Administration advisories in 2007 about the drugs' cardiovascular risks. (Source: Family Practice News)

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  What’s Your Guidance for People Taking Avandia?

Some perspective on the diabetes drug, as the FDA prepares to consider its heart risks (Source: U.S. News - Health)

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  Health Buzz: CDC Panel Recommends Flu Vaccination for All

6 things Avandia users should know; Planned Parenthood responds to undercover ‘sting’ videos. (Source: U.S. News - Health)

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  Report hits out at GSK’s Avandia

Two US senators claim GlaxoSmithKline knew about a link between a diabetes drug and heart attack, and pressured doctors to withdraw concerns (Source: Chemistry World | Latest News)

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  Chronic Peroxisome Proliferator-activated Receptor {gamma} (PPAR{gamma}) Activation of Epididymally Derived White Adipocyte Cultures Reveals a Population of Thermogenically Competent, UCP1-containing Adipocytes Molecularly Distinct from Classic Brown Adipocytes [Cell Biology]

The recent insight that brown adipocytes and muscle cells share a common origin and in this respect are distinct from white adipocytes has spurred questions concerning the origin and molecular characteristics of the UCP1-expressing cells observed in classic white adipose tissue depots under certain physiological or pharmacological conditions. Examining precursors from the purest white adipose tissue depot (epididymal), we report here that chronic treatment with the peroxisome proliferator-activated receptor agonist rosiglitazone promotes not only the expression of PGC-1 and mitochondriogenesis in these cells but also a norepinephrine-augmentable UCP1 gene expression in a significant subset of the cells, providing these cells with a genuine thermogenic capacity. However, although functional...

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  GlaxoSmithKline Fires Back in Defense of Rosiglitazone

In its response, the company states it has been "proactive in investigating the safety data" of rosiglitazone and is critical of the Senate report that ignores other data, including DREAM, ADOPT, and RECORD. Heartwire (Source: Medscape Today Headlines)

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  FDA Offers Docs Guidance on Rosiglitazone as Safety Review Nears Completion

The FDA is recommending that patients continue taking the diabetes medication rosiglitazone, unless told otherwise by their physicians, as the agency continues to look at the risks and benefits of using rosiglitazone to treat type 2 diabetes. Meanwhile, the Senate Committee on Finance and drug manufacturer GlaxoSmithKline, or GSK, are debating the safety of the drug. (Source: AAFP Health of the Public)

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  6 Things You Should Know About Avandia

Controversy over the drug is swirling again. What should you do if you’re taking it? (Source: U.S. News - Health)

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  GlaxoSmithKline fires back in defense of rosiglitazone

In its response, the company states it has been "proactive in investigating the safety data" of rosiglitazone and is critical of the Senate report that ignores other data, including DREAM, ADOPT, and... For complete story visit theheart.org. (Source: theHeart.org)

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  Glaxo Calls Congressional Report Incomplete

GlaxoSmithKline disputes a congressional report suggesting rosiglitazone (Avandia) be pulled from the market, charging that the assessment "fails to present an accurate, balanced, or complete view" of data on the diabetes drug. (Source: MedPage Today Cardiovascular)

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  Rosiglitazone Increases Myocardial Glucose Metabolism in Insulin-Resistant Cardiomyopathy

The connection between insulin resistance (IR) and heart failure (HF) is well recognized (). Insulin resistance has repeatedly been demonstrated to be a strong predictor of the development of HF and to predict a poor prognosis in patients with HF. The mechanism by which IR contributes to the pathogenesis of HF is unclear, but it likely involves the balance between the utilization of free fatty acids (FFAs) and glucose as an energy substrate in the myocardium. Glucose is a more efficient fuel source than FFAs and is therefore preferentially used under conditions of stress, such as HF. In states of IR, this compensatory switch is inhibited, leading to decreased cardiac efficiency (). (Source: Journal of the American College of Cardiology)

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  Bradykinin and high glucose promote renal tubular inflammation

Conclusions. In conclusion, HG stimulates tubular proinflammatory, profibrotic and angiogenic signals, which is partly mediated through BK via MAPK signalling and partly through PKC independent of BK. The potential therapeutic role of complementary B2KR blockade and PPAR- activation deserves clinical investigation. (Source: Nephrology Dialysis Transplantation)

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  AVANDAMET (Rosiglitazone Maleate And Metformin Hydrochloride) Tablet, Film Coated [GlaxoSmithKline LLC]

Updated Date: Feb 25, 2010 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

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  AVANDIA (Rosiglitazone Maleate) Tablet, Film Coated [Physicians Total Care, Inc.]

Updated Date: Feb 25, 2010 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

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  GlaxoSmithKline Response to Senate Report Adds to Controversy Over Avandia

On Wednesday, Feb. 24th, 2010, GlaxoSmithKline (GSK) issued a response to the recent Senate Finance Committee's "Staff Report on GlaxoSmithKline and the Diabetes Drug Avandia". The report had stated that GSK, the manufacturer of Avandia, (rosiglitazone) did not warn patients that the drug was potentially deadly, when cardiovascular events and deaths were first brought to light. In their response, GSK says, "The Senate Finance Committee's January 2010 Staff Report on GlaxoSmithKline and the Diabetes Drug Avandia" ("Staff Report") does not present an accurate, balanced, or complete view of the currently available information on Avandia® (rosiglitazone maleate). Further, the Staff Report mischaracterizes and distorts the efforts that GlaxoSmithKline LLC ("GSK") took to continue to monitor th...

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  Experts Debate Future of Rosiglitazone in the Wake of Critical Senate Report

After the release of the Senate report last weekend, experts had varying opinions on the future of the drug. Some, including FDA officials, called for it to be pulled from the market, while others felt rosiglitazone still had a role in select patients. Overall, though, most felt the evidence favors pioglitazone when choosing one of the TZDs. Heartwire (Source: Medscape Today Headlines)

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  Cardiology Groups Stand by Embattled Diabetes Drug (CME/CE, with audio)

There's not good enough reason to pick pioglitazone (Actos) over rosiglitazone (Avandia), despite controversy on cardiac safety, according to the American Heart Association and American College of Cardiology. (Source: MedPage Today Cardiovascular)

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  Experts debate future of rosiglitazone in the wake of critical Senate report

After the release of the Senate report last weekend, experts had varying opinions on the future of the drug. Some, including FDA officials, called for it to be pulled from the market, while others... For complete story visit theheart.org. (Source: theHeart.org)

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  Safety Review of Avandia (Rosiglitazone)

Source: Food and Drug Administration Related MedlinePlus Page: Diabetes (Source: MedlinePlus Health News)

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  GlaxoSmithKline Responds to US Senate Committee on Finance Report on Avandia

RESEARCH TRIANGLE PARK, N.C., Feb. 24 (HSMN NewsFeed) -- Today, GlaxoSmithKline (NYSE: GSK) responded to the recently released Senate Committee on Finance's January 2010 "Staff Report on GlaxoSmithKline and the Diabetes Drug Avandia" (the &quo... Biopharmaceuticals, EndocrinologyGlaxoSmithKline, Avandia, rosiglitazone, diabetes (Source: HSMN NewsFeed)

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  GlaxoSmithKline responds to US Senate Committee on Finance report on Avandia

Today, GlaxoSmithKline (GSK) responded to the recently released Senate Committee on Finance’s January 2010 “Staff Report on GlaxoSmithKline and the Diabetes Drug Avandia” (the “Staff Report”) by releasing a White Paper. (Source: GSK news)

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  American Heart Association/American College Of Cardiology Joint Science Advisory: AHA/ACC Issue Advisory On Diabetes Drugs And Heart Risk

The data are inconclusive on heart risks from a class of blood sugar-lowering drugs called thiazolidinediones (TZDs) such as pioglitazone (Actos) or rosiglitazone (Avandia), but the medications should be used with close monitoring from healthcare providers according to a joint science advisory from the American College of Cardiology and the American Heart Association. The advisory is published online in both Circulation: Journal of the American Heart Association and Journal of the American College of Cardiology. The U.S... (Source: Health News from Medical News Today)

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  American Heart Association/American College Of Cardiology Joint Science Advisory: AHA/ACC Issue Advisory On Diabetes Drugs And Heart Risk

The data are inconclusive on heart risks from a class of blood sugar-lowering drugs called thiazolidinediones (TZDs) such as pioglitazone (Actos) or rosiglitazone (Avandia), but the medications should be used with close monitoring from healthcare providers according to a joint science advisory from the American College of Cardiology and the American Heart Association... (Source: Cardiovascular / Cardiology News From Medical News Today)

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  Pharmacodynamic Effects of Rosiglitazone in Nondiabetic Patients with Metabolic Syndrome

Conclusion. Rosiglitazone had beneficial effects on adiponectin concentrations without significantly affecting other components of the metabolic syndrome phenotype. Additional studies that further elucidate the time course of thiazolidinedione pharmacodynamic effects, along with their effects on cardiovascular end points, are warranted in nondiabetic patients with metabolic syndrome. (Source: Pharmacotherapy: Official Journal of the American College of Clinical Pharmacy)

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  Statement From The American Heart Association Following Senate Report On Avandia

The US Senate Finance Committee has released a report, which followed a two-year inquiry into the safety of the diabetes drug Avandia (rosiglitazone), and the possibility of an increased incidence of adverse cardiovascular events. The American Heart Association encourages patients to consult with their physicians on any matters concerning risk factors for heart disease and stroke, such as diabetes. Take-away messages for patients with diabetes: -- Focus on glycemic (blood sugar) control keeping your HbA1c levels below 7... (Source: Health News from Medical News Today)

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  Statement From The American Heart Association Following Senate Report On Avandia

The US Senate Finance Committee has released a report, which followed a two-year inquiry into the safety of the diabetes drug Avandia (rosiglitazone), and the possibility of an increased incidence of adverse cardiovascular events... (Source: Cardiovascular / Cardiology News From Medical News Today)

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  Avandia analysis: Authors with financial conflicts draw more positive conclusions

An analysis of over 202 papers discussing the potential MI risks of rosiglitazone shows that almost half of authors had ties to the diabetes-drug industry and that those with ties were more likely to... For complete story visit theheart.org. (Source: theHeart.org)

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  FDA Reviews Avandia Safety Data

From UPI Science News (February 23, 2010) The U.S. Food and Drug Administration says it is reviewing data from a long-term study concerning possible cardiovascular risks with the drug Avandia. The FDA’s announcement follows a Saturday report... (Source: Drugs.com - Pharma News)

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  Avandia Fallout Could Hit Triangle

[The News And Observer, Raleigh, N.C.] From News & Observer (Raleigh, NC) (February 23, 2010) Feb. 23--The firestorm over the safety of GlaxoSmithKline’s diabetes drug Avandia could hurt profit at one of... (Source: Drugs.com - Pharma News)

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  Avandia (rosiglitazone): FDA reviewing a large, long-term clinical study on possible risks for cardiovascular outcomes with use of rosiglitazone

Avandia (rosiglitazone): Ongoing Review of Cardiovascular Safety Audience: Endocrinology, cardiology healthcare professionals, patients ROCKVILLE, Md., Feb. 22, 2010-FDA notified healthcare professional and patients that it is reviewing the primary... (Source: Drugs.com - Pharma News)

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  Pull Rosiglitazone, FDA Reviewers Urge

WASHINGTON --Two FDA reviewers have recommended that the diabetes drug rosiglitazone (Avandia) be pulled from the market because of its link to major cardiac events. Drugmaker GSK insists the product is safe. (Source: MedPage Today Cardiovascular)

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  Senate, FDA Reports Increase Concerns About Controversial Diabetes Drug

"Hundreds of people taking Avandia, a controversial diabetes medicine, needlessly suffer heart attacks and heart failure each month, according to confidential government reports that recommend the drug be removed from the market ... ," The New York Times reports. "The internal F.D.A. reports are part of a fierce debate within the agency over what to do about Avandia, manufactured by GlaxoSmithKline." Some within the agency think the drug should be withdrawn because "they believe there is a safer alternative... (Source: Health News from Medical News Today)

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  Senate, FDA Reports Increase Concerns About Controversial Diabetes Drug

"Hundreds of people taking Avandia, a controversial diabetes medicine, needlessly suffer heart attacks and heart failure each month, according to confidential government reports that recommend the drug be removed from the market ... ," The New York Times reports. "The internal F.D.A... (Source: Cardiovascular / Cardiology News From Medical News Today)

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  GlaxoSmithKline deliberately hid evidence of Avandia harm, says Senate report

This report also accuses the FDA of betraying the public trust, explaining that FDA bureaucrats intentionally dismissed safety concerns found by the agency's own scientists.The report says that Big Pharma's drugs "put public safety at risk because the FDA has been too cozy with drug makers and has been regularly outmaneuvered by companies that have a financial interest in downplaying or under-exploring potential safety risks." Sales of Avandia were $3.2 billion (yes, billion) in 2006.According to a statistical analysis in the report, if all the diabetics currently taking Avandia were put on a "safer" drug, it would avert 500 heart attacks and 300 cases of heart failure every month in the United States alone. Presently, hundreds of thousands of Americans are still taking this drug, and hund...

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  FDA: No Decision on Whether to Pull Diabetes Drug Avandia Off the Market

Title: FDA: No Decision on Whether to Pull Diabetes Drug Avandia Off the MarketCategory: Health NewsCreated: 2/22/2010 6:10:00 PMLast Editorial Review: 2/23/2010 (Source: MedicineNet Chronic Pain General)

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  FDA: No Decision on Whether to Pull Diabetes Drug Avandia Off the Market

Title: FDA: No Decision on Whether to Pull Diabetes Drug Avandia Off the MarketCategory: Health NewsCreated: 2/22/2010 6:10:00 PMLast Editorial Review: 2/23/2010 (Source: MedicineNet Heart General)

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  FDA: No Decision on Whether to Pull Diabetes Drug Avandia Off the Market

Title: FDA: No Decision on Whether to Pull Diabetes Drug Avandia Off the MarketCategory: Health NewsCreated: 2/22/2010 6:10:00 PMLast Editorial Review: 2/23/2010 (Source: MedicineNet Diabetes General)

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  FDA: No Decision on Whether to Pull Diabetes Drug Avandia Off the Market

Title: FDA: No Decision on Whether to Pull Diabetes Drug Avandia Off the MarketCategory: Health NewsCreated: 2/22/2010 6:10:00 PMLast Editorial Review: 2/23/2010 (Source: MedicineNet Senior Health General)

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  FDA: No new conclusions on Glaxo's Avandia yet

WASHINGTON (Reuters) - The U.S. Food and Drug Administration is reviewing data on possible heart risks with GlaxoSmithKline Plc's diabetes drug Avandia but has not reached any new conclusions, the agency said on Monday. (Source: Reuters: Health)

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  FDA Faces Pressure to Pull Avandia

The FDA told doctors that patients taking the diabetes drug Avandia should stay on it unless their doctors say otherwise. (Source: WSJ.com: Health)

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  FDA Drug Safety Communication: Ongoing review of rosiglitazone and cardiovascular safety

Source: FDA Area: News The U S Food and Drug Administration has announced that it is still reviewing data from a large, long-term clinical study on possible cardiovascular risks with rosiglitazone.   The clinical study, called the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycaemia in Diabetes or RECORD study was designed to evaluate the cardiovascular safety of rosiglitazone. Once the FDA completes its review of the data from the RECORD study, the agency will present the totality of new and existing cardiovascular safety data on rosiglitazone at a joint public meeting of the Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees in July 2010. At that meeting, the Advisory Committee will provide an updated assessment...

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  FDA Reviewing Avandia Cardiovascular Safety

The U.S. Food and Drug Administration has informed health care professionals that the organization is currently reviewing cardiovascular safety data associated with rosiglitazone (Avandia), a type 2 diabetes drug, from the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes study as well as from other recently published safety analyses. (Source: Modern Medicine)

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  Effects of PPARgamma ligands on TGF-beta1-induced epithelial-mesenchymal transition in alveolar epithelial cells

Conclusions: RGZ and CGZ inhibited profibrotic changes in TGF-beta1-stimulated A549 cells independently of inhibition of Smad phosphorylation. Their inhibitory effects on changes in collagen I and E-cad, but not N-cad or CTGF, appeared to be PPARgamma-dependent. Further studies are required to unravel additional mechanisms of inhibition of TGF-beta1 signalling by thiazolidinediones and their implications for the contribution of EMT to lung fibrosis. (Source: Respiratory Research)

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  Diabetes patients should not stop taking Avandia, FDA says

But "we feel that it is time for a thorough evaluation of all the cardiovascular risks with that drug," says Center for Drug ... (Source: USATODAY.com Health)

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  A Face-Off on the Safety of a Drug for Diabetes

In 2007, a cardiologist recorded a meeting with four executives of GlaxoSmithKline to warn them that the diabetes drug Avandia raised the risk of heart attacks. (Source: NYT > Health)

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  No New Conclusions on Glaxo's Avandia Yet: FDA

The U.S. Food and Drug Administration is reviewing data on possible heart risks with GlaxoSmithKline Plc's diabetes drug Avandia but has not reached any conclusions, the agency said on Monday. Source: Reuters Health Related MedlinePlus Topics: Diabetes, Drug Safety (Source: MedlinePlus Health News)

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  Senate probe of Avandia heats up

The U.S. Senate Committee on Finance sent a blistering letter on Feb. 18 to the FDA questioning the agency’s actions regarding the diabetes drug rosiglitazone (Avandia, GlaxoSmithKline). (Source: Cardiovascular Business News)

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  No new conclusions on Glaxo's Avandia yet: FDA

WASHINGTON (Reuters) - The U.S. Food and Drug Administration said on Monday it is reviewing data on possible heart risks with GlaxoSmithKline Plc's controversial diabetes drug, Avandia, but has not reached any conclusions yet. (Source: Reuters: Health)

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  Avandia (rosiglitazone): Ongoing Review of Cardiovascular Safety

FDA is reviewing data from a large, long-term clinical study on possible risks for cardiovascular outcomes associated with use of rosiglitazone. (Source: FDA MedWatch)

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  Health Buzz: FDA Report Advises Avandia Be Pulled From the Market

‘Stuffed’ suggests how food industry can battle obesity; protect your heart with a happiness project. (Source: U.S. News - Health)

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  New Senate Report Puts Avandia Safety in Spotlight Again

A new senate report has rekindled debate about the cardiovascular safety of GlaxoSmithKline's diabetes agent, rosiglitazone (Avandia), stating that there are "serious health risks" associated with the drug. It also severely condemns company tactics and criticizes the FDA's role in events. Heartwire (Source: Medscape Today Headlines)

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  Drug's heart risks "known to maker"

A report has claimed that the risk of heart attacks carried by diabetes medication Avandia was known of by its manufacturer years before the evidence concerned was made public. (Source: Pharmacy Europe)

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  Diabetes Drug Avandia Linked To Heart Risks

The diabetes drug Avandia caused 83,000 heart attacks between 1999 and 2007, the FDA says. (Source: WDSU.com - Health)

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  New senate report puts Avandia safety in spotlight again

A new senate report has rekindled debate about the cardiovascular safety of GlaxoSmithKline's diabetes agent, rosiglitazone (Avandia), stating that there are "serious health risks" associated with... For complete story visit theheart.org. (Source: theHeart.org)

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  Baucus, Grassley Release Finance Committee Report on Diabetes Drug Avandia, Express Concern About FDA?s Role in Protecting Patients in Ongoing Avandia Study

WASHINGTON, Feb. 20, 2010-- – Senator Max Baucus, Chairman of the Committee on Finance, and Senator Chuck Grassley, Ranking Member, today released a committee report based on a twoyear inquiry of the diabetes drug Avandia. The senators also... (Source: Drugs.com - Pharma News)

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  Rosiglitazone Should Be Removed from the Market, Some FDA Staff Advise

(Source: Physician's First Watch current issue)

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  Senate Report: Avandia Maker Knew of Cardiac Risks

From Associated Press (February 21, 2010) NEW YORK -- A Senate report said Saturday that drug maker GlaxoSmithKline knew of possible heart attack risks tied to Avandia, its diabetes medication,... (Source: Drugs.com - Pharma News)

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  US Senate questions regulators on GSK drug

Lawmakers demand the FDA explain why it permitted the pharmaceutical group to proceed with a clinical trial of diabetes drug Avandia in spite of knowledge of higher cardiac risks (Source: FT.com - Drugs and Healthcare)

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  Is Diabetes Drug Avandia Safe? Senate Reports Claim It’s A Killer

Popular Type 2 diabetes drug Avandia is being investigated by the FDA as a possible cause of thousands of heart attacks. Read more about the senate's allegations and the drug company's rebuttal. (Source: Diabetes1 Articles)

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  Is Diabetes Drug Avandia Safe? Senate Reports Claim It's A Killer

Popular Type 2 diabetes drug Avandia is being investigated by the FDA as a possible cause of thousands of heart attacks. Read more about the senate's allegations and the drug company's rebuttal. (Source: Diabetes1 Articles)

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  Diabetes sufferers warned that widely-used drug Avandia can cause heart disease and death

U.S. senators said the makers of Avandia, British firm GlaxoSmithKline, knew it carried a higher risk of heart attack than a rival medicine but had tried to keep evidence of the risk from the public. (Source: the Mail online | Health)

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  GSK rejects conclusions of Senate Committee on Finance Staff Report on Avandia

The Staff Report of the Senate Committee on Finance draws conclusions on the safety of Avandia (rosiglitazone) that are based on analyses that are not consistent with the rigorous scientific evidence supporting the safety of the drug. (Source: World Pharma News)

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  Rosiglitazone Inhibits Cell Proliferation by Inducing G1 Cell Cycle Arrest and Apoptosis in ADPKD Cyst-Lining Epithelia Cells

Abstract: Abnormal proliferation is an important pathological feature of autosomal dominant polycystic kidney disease (ADPKD). Many drugs inhibiting cell proliferation have been proved to be effective in slowing the disease progression in ADPKD. Recent evidence has suggested that peroxisome proliferator-activated receptor [gamma] (PPAR[gamma]) ligands have anti-neoplasm effects through inhibiting cell growth and inducing cell apoptosis in various cancer cells. In the present study, we examined the expression of PPAR[gamma] in human ADPKD kidney tissues and cyst-lining epithelial cell line, and found that the expression of PPAR[gamma] was greater in ADPKD kidney tissues and cyst-lining epithelial cell line than in normal kidney tissues and human kidney cortex (HKC) cell line. Rosiglitazone ...

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  Avandia Still on the Market Despite Cardiac Deaths

After ongoing observational studies on the safety of the type 2 diabetes drug, rosiglitazone (Avandia), the FDA issued a statement today that says, for now, rosiglitazone will stay on the market, at least until all the results of all the studies are in, most likely in July of this year. The results will be presented at a public meeting at that time. This announcement follows major news stories of this past weekend, which brought to light a confidential report on rosiglitazone by a U.S. Senate investigatory committee. In that report, according to ABC News, Glaxo Smith Kline, the manufacturer of rosiglitazone did not warn patients that Avandia was potentially deadly, when cardiovascular events and deaths were first brought to light. According to the NY Times, rosiglitazone has been linked to...

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  Reviewers urge Glaxo's Avandia come off market

WASHINGTON (Reuters) - Two U.S. drug safety reviewers have recommended that GlaxoSmithKline PLC's diabetes drug Avandia be pulled from the market after concluding it is more dangerous to the heart than a rival medicine, according to documents released on Saturday. (Source: Reuters: Health)

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  Report: GlaxoSmithKline Knew Avandia's Risks

A Senate report said Saturday that drug maker GlaxoSmithKline knew of possible heart attack risks tied to Avandia, its diabetes medication, years before such evidence became public. The report was released on the heels of an article in The New York Times saying that confidential government reports show diabetes patients would suffer 500 fewer heart attacks and 300 fewer cases of heart congestion each month if they took a similar pill named Actos instead of Avandia. (Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire)

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  GSK rejects conclusions reported in The New York Times story on Avandia

GlaxoSmithKline (GSK) rejects the conclusions about the safety of Avandia (rosiglitazone) reported in the February 20, 2010, New York Times story. (Source: World Pharma News)

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  Video: Diabetes Drug a Heart Risk

A new Senate report blames the diabetes drug Avandia for thousands of heart attacks. As Kimberly Dozier reports, calls to remove the deadly drug from the market have gone unheeded. (Source: Health News: CBSNews.com)

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  Report: Avandia, heart attacks linked

The diabetes drug Avandia is linked with tens of thousands of heart attacks, and drugmaker GlaxoSmithKline worked to keep the risks from the public, a Senate committee report says. (Source: CNN.com - Health)

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  U.S. reviewers urge Glaxo's Avandia come off market

WASHINGTON (Reuters) - Two U.S. drug safety reviewers have recommended that GlaxoSmithKline PLC's diabetes drug Avandia be pulled from the market because it is more dangerous to the heart than a rival medicine, according to documents released Saturday. (Source: Reuters: Health)

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  U.S. Senate report: Avandia maker knew of cardiac risks

A U.S. Senate report says that drug maker GlaxoSmithKline knew of possible heart attack risks tied to Avandia, its diabetes medication, years before such evidence became public. (Source: CTV Health)

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  Diabetes drug linked to heart attacks

WASHINGTON, Feb. 20 (UPI) -- The U.S. Senate Finance Committee released a 334-page report Saturday showing a link between the Type 2 diabetes drug Avandia and thousands of heart attacks. (Source: Health News - UPI.com)

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  GSK rejects conclusions of Senate Committee on Finance Staff Report on Avandia

The Staff Report of the Senate Committee on Finance draws conclusions on the safety of Avandia (rosiglitazone) that are based on analyses that are not consistent with the rigorous scientific evidence supporting the safety of the drug. (Source: GSK news)

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  Senate report ties diabetes drug to heart attacks

The diabetes drug Avandia is linked with tens of thousands of heart attacks, and drugmaker GlaxoSmithKline knew of the risks for years but worked to keep them from the public, a Senate committee report released Saturday says. (Source: CNN.com - Health)

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  GSK rejects conclusions reported in The New York Times story on Avandia

GlaxoSmithKline (GSK) rejects the conclusions about the safety of Avandia (rosiglitazone) reported in the February 20, 2010, New York Times story. (Source: GSK news)

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  Report Says 'Avandia' Maker Knew of Heart Attack Risks

NEW YORK (AP) — A Senate report said Saturday that drug maker GlaxoSmithKline knew of possible heart attack risks tied to Avandia, its diabetes medication, years before such evidence became public. Sen. Max Baucus, chairman of the Senate Finance... (Source: OrlandoSentinel: Medical Research)

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  Research Ties Diabetes Drug to Heart Woes

Government reports concluded that hundreds of people taking Avandia suffered heart attacks and heart failure, but some said the drug should remain available. (Source: NYT > Health)

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  Research Ties Diabetes Drug to Heart Woes

Government reports concluded that hundreds of people taking Avandia suffered heart attacks and heart failure, but some said the drug should remain available. (Source: NYT)

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  Senate report says Avandia maker GlaxoSmithKline knew of heart attack risks

NEW YORK (AP) — A Senate report said Saturday that drug maker GlaxoSmithKline knew of possible heart attack risks tied to Avandia, its diabetes medication, years before such evidence became public. Sen. Max Baucus, chairman of the Senate Finance... (Source: OrlandoSentinel: Medical Research)

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  Controversial Diabetes Drug Harms Heart, U.S. Concludes

Government reports concluded that hundreds of people taking Avandia suffered heart attacks and heart failure, but some said the drug should remain available. (Source: NYT)

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  GSK Rejects Conclusions Of Senate Committee On Finance Staff Report On Avandia

The Staff Report of the Senate Committee on Finance draws conclusions on the safety of Avandia (rosiglitazone) that are based on analyses that are not consistent with the rigorous scientific evidence supporting the safety of the drug. (Source: Pharmaceutical Online News)

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  Controversial Diabetes Drug Harms Heart, U.S. Concludes

Government reports concluded that hundreds of people taking Avandia suffered heart attacks and heart failure, but some said the drug should remain available. (Source: NYT > Health)

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  FDA reports says Avandia can hurt heart: report

WASHINGTON (Reuters) - Confidential U.S. government reports recommend that GlaxoSmithKline Plc's diabetes drug Avandia be pulled from the market because it can hurt the heart, The New York Times reported on Friday. (Source: Reuters: Health)

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  Cardiomyocyte-derived adiponectin is biologically active in protecting against myocardial ischemia-reperfusion injury

Adiponectin (APN) has traditionally been viewed as an adipocyte-specific endocrine molecule with cardioprotective effects. Recent studies suggest that APN is also expressed in cardiomyocytes. However, biological significances of this locally produced APN remain completely unknown. The aim of this study was to investigate the pathological and pharmacological significance of cardiac-derived APN in cardiomyocyte pathology. Adult cardiomyocytes from wild-type littermates (WT) or gene-deficient mice were pretreated with vehicle (V) or rosiglitazone (RSG) for 6 h followed by simulated ischemia-reperfusion (SI/R, 3 h/12 h). Compared with WT cardiomyocytes, myocytes from APN knockout (APN-KO) mice sustained greater SI/R injury, evidenced by greater oxidative/nitrative stress, caspase-3 activity, a...

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  Early exposure of the pregestational intrauterine and postnatal growth-restricted female offspring to a peroxisome proliferator-activated receptor-{gamma} agonist

Prenatal nutrient restriction with intrauterine growth restriction (IUGR) alters basal and glucose-stimulated insulin response and hepatic metabolic adaptation. The effect of early intervention with insulin-sensitizing peroxisome proliferator-activated receptor agonists was examined in the metabolically maladapted F1 pregestational IUGR offspring with a propensity toward pregnancy-induced gestational diabetes. The effect of rosiglitazone maleate [RG; 11 µmol/day from postnatal day (PN) 21 to PN60] vs. placebo (PL) on metabolic adaptations in 2-mo-old F1 female rats subjected to prenatal (IUGR), postnatal (PNGR), or pre- and postnatal (IUGR + PNGR) nutrient restriction was investigated compared with control (CON). RG vs. PL had no effect on body weight or plasma glucose concentrations...

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  Rosiglitazone Add-On in Treatment of Depressed Patients with Insulin Resistance: a Pilot Study

Dr. Rasgon and colleagues in the Department of Psychiatry at Stanford University have completed a pilot study examining the potential mood-improving effects of add-on treatment with an insulin-sensitizing agent (rosiglitazone) in depressed patients with biomarkers of insulin resistance. Results of the 12-week prospective study showed significant improvement in depression severity. These findings suggest the potential novel use for an insulin sensitizing agent in the treatment of depressive disorders. (Source: TheScientificWorldJOURNAL: Newly published articles.)

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  Thiazolidinediones alter growth and epithelial cell integrity, independent of PPAR{gamma} and MAPK activation, in mouse M1 Cortical Collecting Duct Cells.

Authors: Nasrallah R, Clark J, Corinaldi J, Paris G, Miura P, Jasmin BJ, Hebert RL Peroxisome proliferator-activated receptor (PPAR)-gamma is highly expressed in the collecting duct (CD), yet little is known about the effects of PPARgamma ligands, thiazolidinediones (TZDs), on CD cell structure and function. M1 mouse cortical CD cells were treated with 5 muM troglitazone (TRO) and rosiglitazone (ROSI). First growth was measured by thymidine and H(3)-leucine incorporation, as well as analysis of cyclin D1 and the CDK inhibitor p27 by Western blot. H(3)-thymidine incorporation was reduced by 56 and 24% by TRO and ROSI at 6 hours, and H(3)-leucine by 21 and 10%. A similar growth inhibition was also observed after 24 hours for thymidine, but leucine was reduced by 48 and 24% respectively. ...

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  Involvement of adiponectin-SIRT1-AMPK signaling in the protective action of rosiglitazone against alcoholic fatty liver in mice

The development of alcoholic fatty liver is associated with reduced adipocyte-derived adiponectin levels, decreased hepatic adiponectin receptors, and deranged hepatic adiponectin signaling in animals. Peroxisomal proliferator-activated receptor- (PPAR-) plays a key role in the regulation of adiponectin in adipose tissue. The aim of the present study was to test the ability of rosiglitazone, a known PPAR- agonist, to reverse the inhibitory effects of ethanol on adiponectin expression and its hepatic signaling, and to attenuate alcoholic liver steatosis in mice. Mice were fed modified Lieber-DeCarli ethanol-containing liquid diets for 4 wk or pair-fed control diets. Four groups of mice were given a dose of either 3 or 10 mg·kg body wt–1·day–1 of rosiglitazone with ...

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  Diabetes Drugs Avandia, Actos Tied to Fractures in Women

Title: Diabetes Drugs Avandia, Actos Tied to Fractures in WomenCategory: Health NewsCreated: 2/15/2010 12:10:00 PMLast Editorial Review: 2/16/2010 (Source: MedicineNet Chronic Pain General)

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  Diabetes Drugs Avandia, Actos Tied to Fractures in Women

Title: Diabetes Drugs Avandia, Actos Tied to Fractures in WomenCategory: Health NewsCreated: 2/15/2010 12:10:00 PMLast Editorial Review: 2/16/2010 (Source: MedicineNet Diabetes General)

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  Diabetes Drugs Avandia, Actos Tied to Fractures in Women

Title: Diabetes Drugs Avandia, Actos Tied to Fractures in WomenCategory: Health NewsCreated: 2/15/2010 12:10:00 PMLast Editorial Review: 2/16/2010 (Source: MedicineNet Senior Health General)

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  Diabetes Drugs Avandia, Actos Tied to Fractures in Women

Title: Diabetes Drugs Avandia, Actos Tied to Fractures in WomenCategory: Health NewsCreated: 2/15/2010 12:10:00 PMLast Editorial Review: 2/16/2010 (Source: MedicineNet Womens Health General)

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  Diabetes Drugs Avandia, Actos Tied to Fractures in Women

Title: Diabetes Drugs Avandia, Actos Tied to Fractures in WomenCategory: Health NewsCreated: 2/15/2010 12:10:00 PMLast Editorial Review: 2/16/2010 (Source: MedicineNet Arthritis General)

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  Heme oxygenase-1/p21WAF1 mediates peroxisome proliferator-activated receptor-γ signaling inhibition of proliferation of rat pulmonary artery smooth muscle cells

This study addressed this issue. The PPAR[gamma] agonist rosiglitazone dose-dependently stimulated heme oxygenase (HO)-1 expression in PASMCs, 5 [mu]m rosiglitazone inducing a 12.1-fold increase in the HO-1 protein level. Cells pre-exposed to rosiglitazone showed a dose-dependent reduction in proliferation in response to serotonin; this was abolished by pretransfection of cells with sequence-specific small interfering RNA against HO-1. In addition, rosiglitazone stimulated p21WAF1 expression in PASMCs, a 2.34-fold increase in the p21WAF1 protein level being achieved with 5 [mu]m rosiglitazone; again, this effect was blocked by knockdown of HO-1. Like loss of HO-1, loss of p21WAF1 through siRNA transfection also reversed the inhibitory effect of rosiglitazone on PASMC proliferation triggere...

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  Pioglitazone was associated with lower risk for adverse cardiovascular events than rosiglitazone in older patients.

Authors: PMID: 20157125 [PubMed - in process] (Source: Annals of Internal Medicine)

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  Diabetes Drugs Avandia, Actos Tied to Fractures in Women

Those over 65 at greatest risk from thiazolidinedione use, study indicates Source: HealthDay Related MedlinePlus Topics: Diabetes, Diabetes Medicines, Fractures (Source: MedlinePlus Health News)

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  Rosiglitazone: Anasarca in an elderly patient: case report

(Source: Reactions)

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  Pharmacological correction of a defect in PPAR-γ signaling ameliorates disease severity in Cftr-deficient mice

Pharmacological correction of a defect in PPAR-γ signaling ameliorates disease severity in Cftr-deficient mice Nature Medicine 16, 313 (2010). doi:10.1038/nm.2101 Authors: Gregory S Harmon, Darren S Dumlao, Damian T Ng, Kim E Barrett, Edward A Dennis, Hui Dong & Christopher K Glass Cystic fibrosis is caused by mutations in the cystic fibrosis transmembrane conductance regulator (encoded by Cftr) that impair its role as an apical chloride channel that supports bicarbonate transport. Individuals with cystic fibrosis show retained, thickened mucus that plugs airways and obstructs luminal organs as well as numerous other abnormalities that include inflammation of affected organs, alterations in lipid metabolism and insulin resistance. Here we show that colonic epithelial cells and w...

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  Safety Review of Avandia (Rosiglitazone)

Description: FDA offers advice to people who take the diabetes drug Avandia (rosiglitazone) while the agency continues to review data on possible heart-related risks associated with the drug. (Source: FDA Consumer Updates)

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  Peroxisome proliferator-activated receptors gamma reverses hepatic nutritional fibrosis in mice and suppresses activation of hepatic stellate cells in vitro.

In conclusion, the present study shows that MCD diet-induced fibrosing steatohepatitis can be reversed by overexpression of PPARgamma. It is likely that PPARgamma reverses fibrosis by reducing HSCs proliferation, inducing cell cycle arrest and apoptosis. PMID: 20156580 [PubMed - as supplied by publisher] (Source: The International Journal of Biochemistry and Cell Biology)

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  RECORD Confirms Climb in HF Risk With Rosiglitazone

The secondary finding from the controversial trial is consistent with an interim analysis conducted several years ago. Heartwire (Source: Medscape Today Headlines)

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  RECORD confirms climb in HF risk with rosiglitazone

The secondary finding from the controversial trial is consistent with an interim analysis conducted several years ago. For complete story visit theheart.org. (Source: theHeart.org)

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  NHS Evidence expert commentary on study investigating risk of cardiovascular complications with oral antidiabetes drugs.

This study had reported that sulfonylureas had a relatively unfavourable risk profile compared with metformin for all outcomes examined, whilst pioglitazone was associated with reduced all cause mortality compared with metformin, and a favourable risk profile compared to rosiglitazone.   According to the commentary by the clinical lead for NHS Evidence-diabetes "this study sheds more light on these new drugs highlighting the benefits of pioglitazone which is shown to have a significantly lower risk of all cause mortality. Pioglitazone is due to come off patent in around 12 month's time, after which it is likely to drop in price, making it a similar cost to sulfonylurea. When this happens national ... (Source: NeLM - News)

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  Effect of chronic treatment with Rosiglitazone on Leydig cell steroidogenesis in rats: in vivo and ex vivo studies

Conclusion: The results revealed that the Leydig cells from rosiglitazone-treated rats showed significant reduction in testosterone production under basal, hCG/dbcAMP- or 22 (R)-OH-C/pregnenolone-induced conditions, although increased labeling of StAR and P450scc was detected in these cells by immunocytochemistry. The ultrastructural study suggested that the lower levels of testosterone produced by these cells could be due to mitochondrial damage induced by rosiglitazone. (Source: Reproductive Biology and Endocrinology)

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  Association between rosiglitazone use and decline in renal function in patients with type 2 diabetes mellitus.

Conclusion: The use of rosiglitazone may be associated with a decline of renal function in patients with T2DM. Further studies are needed to better quantify the risk-benefit trade-offs associated with rosiglitazone therapy. PMID: 20155725 [PubMed - as supplied by publisher] (Source: Journal of Nephrology)

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  A Macrophage Sterol-Responsive Network Linked to Atherogenesis.

Authors: Becker L, Gharib SA, Irwin AD, Wijsman E, Vaisar T, Oram JF, Heinecke JW Cholesteryl ester accumulation by macrophages is a critical early event in atherogenesis. To test the hypothesis that sterol loading promotes foam cell formation and vascular disease by perturbing a network of interacting proteins, we used a global approach to identify proteins that are differentially expressed when macrophages are loaded with cholesterol in vivo. Our analysis revealed a sterol-responsive network that is highly enriched in proteins with known physical interactions, established roles in vesicular transport, and demonstrated atherosclerotic phenotypes in mice. Pharmacologic intervention with a statin or rosiglitazone and use of mice deficient in LDL receptor or apolipoprotein E implicated t...

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  eNOS plays a major role in adiponectin synthesis in adipocytes.

This study was undertaken to test the hypothesis that endothelial NO synthase (eNOS) plays an important role in adiponectin synthesis by producing NO and enhancing mitochondrial function in adipocytes. We examined the effects of eNOS knockdown on adiponectin synthesis in 3T3L1 adipocytes, and also examined plasma adiponectin levels and the mitochondria in adipose tissue of eNOS knockout (eNOS(-/-)) mice with and without chronic administration of a NO donor. In cultured 3T3L1 adipocytes, eNOS siRNA decreased rosiglitazone-induced adiponectin secretion, which was associated with decreases in mitochondrial proteins and biogenesis factors. Plasma adiponectin concentrations were reduced in adult eNOS(-/-) mice, compared to age-matched wild-type mice. Mitochondrial contents in adipose tissue wer...

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  Heart failure and rosiglitazone: results from RECORD trial

Source: Eur Heart J Area: News Analysis of data from the RECORD trial of rosiglitazone in patients with type 2 diabetes found an increased risk of heart failure in the rosiglitazone group compared to the control group: the relative risk was roughly doubled.   The thiazolidinedione anti-diabetic drugs (glitazones) are associated with an increased risk of heart failure, however there has been considerable debate over the magnitude of this adverse effect for the two available drugs. The RECORD trial was intended to determine whether the effect of rosiglitazone treatment on overall cardiovascular mortality and morbidity was different to that of an active control. It included heart failure (HF) as a pre-specified outcome, collected prospectively and adjudicated according to accepted c...

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  [HDL Cholesterol Reduction during Rosiglitazone and Fenofibrate Treatment in a Type 2 Diabetes Mellitus Patient with Dyslipidemia.]

Authors: Im M, Kim M, Lee JK, Chang YH, Lee DY, Hong SI, Lee YY, Hong YJ Thiazolidinediones (TZD), which are widely used as insulin sensitizers, and fibrates, which are lipid-lowering drugs, are used in the treatment of dyslipidemia that commonly accompanies diabetes. Several reports suggest elevated levels of high-density lipoprotein (HDL) cholesterol, but the paradoxical reduction of HDL cholesterol level during single or combined TZD and fibrate therapies has been occasionally reported. Herein, we report a case of paradoxical decrease in HDL cholesterol and apolipoprotein A-1 levels during rosiglitazone and fenofibrate treatment for the first time in Korea. The patient was a 56-yr-old man presenting with type 2 diabetes mellitus and dyslipidemia. His HDL cholesterol and apolipoprote...

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  Rosiglitazone Reduces Plasma Levels of Inflammatory and Hemostatic Biomarkers and Improves Global Endothelial Function in Habitual Heavy Smokers Without Diabetes Mellitus or Metabolic Syndrome.

CONCLUSION: Rosiglitazone significantly reduces plasma levels of inflammatory and hemostatic biomarkers, and restores global endothelial dysfunction, independently from insulin sensitization, in healthy smokers. PMID: 20206835 [PubMed - as supplied by publisher] (Source: J Formos Med Assoc)

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  Follow-up of phase I trial of adalimumab and rosiglitazone in FSGS: III. Report of the FONT study group

Conclusion: Nearly 50% of patients with resistant FSGS who receive novel antifibrotic agents may have a legacy effect with delayed deterioration in kidney function after completion of therapy. Based on this proof-of-concept preliminary study, we recommend long-term follow-up of patients enrolled in clinical trials to ascertain a more comprehensive assessment of the efficacy of experimental treatments. (Source: BMC Nephrology)

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  Does Choice of Antidiabetes Therapy Influence Macrovascular Outcomes?

Abstract  Despite a clear epidemiologic relationship between hemoglobin A1c levels and the risk of cardiovascular (CV) disease in patients with type 2 diabetes mellitus (T2DM), prospective studies examining the benefit of intensive glucose lowering in reducing CV events have yielded conflicting results. Controversy over the choice of antidiabetic therapy for lowering macrovascular events has existed for nearly four decades, beginning with the potential risk of increased CV mortality with sulfonylurea use. Although sulfonylureas were subsequently felt to be safe, a more recent controversy was raised as to whether rosiglitazone use was associated with an increased risk of CV events. Additionally, early positive results for metformin in reducing macrovascular events have not be...

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  Stretch reduces nephrin expression via an angiotensin II-AT1-dependent mechanism in human podocytes: effect of rosiglitazone

Increased glomerular permeability to proteins is a characteristic feature of diabetic nephropathy (DN). The slit diaphragm is the major restriction site to protein filtration, and the loss of nephrin, a key component of the slit diaphragm, has been demonstrated in both human and experimental DN. Both systemic and glomerular hypertension are believed to be important in the pathogenesis of DN. Human immortalized podocytes were subjected to repeated stretch-relaxation cycles by mechanical deformation with the use of a stress unit (10% elongation, 60 cycles/min) in the presence or absence of candesartan (1 µM), PD-123319 (1 µM), and rosiglitazone (0.1 µM). Nephrin mRNA and protein expression were assessed using quantitative real-time PCR, immunoblotting, and immunofluorescenc...

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  Changes in glitazone use among office based physicians, in the united states, 2003-2009.

Conclusions: The combined effect of scientific publications, advisories, and media exposure was associated with a substantial decrease in rosiglitazone use. Despite a class-level FDA advisory, pioglitazone use was not similarly affected. PMID: 20103549 [PubMed - as supplied by publisher] (Source: Diabetes Care)

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  Effects of peroxisome proliferator-activated receptor γ agonists on Na+ transport and activity of the kinase SGK1 in epithelial cells from lung and kidney

Conclusions and implications: Our results do not support the view that PPAR[gamma] agonists stimulate epithelial Na+ absorption or alter the control of cellular SGK1 activity. It is therefore likely that other mechanisms are involved in PPAR[gamma]-mediated fluid retention, and a better understanding of these mechanisms may help with the identification of patients likely to develop oedema or heart failure when treated with these drugs. (Source: British Journal of Pharmacology)

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  Effect of Triiodothyronine on Adiponectin Expression and Leptin Release by White Adipose Tissue of Normal Rats

Horm Metab ResDOI: 10.1055/s-0029-1246118AbstractPrevious studies have shown that alterations in thyroid status may lead to changes in serum leptin and adiponectin, both in humans and rodents. The mechanisms, especially for adiponectin, are unclear. In the present study, we investigated the effect of triiodothyronine (T3) on the expression of adiponectin mRNA and the release of leptin and adiponectin by white adipose tissue (WAT) explants obtained from epididymal (visceral) or inguinal (subcutaneous) depots from normal rats. We also analyzed the effects of other known regulators of adiponectin and leptin release, such as rosiglitazone and dexamethasone. T3 acted directly at rat WAT explants in a depot-specific manner and in a unique fashion to each hormone. T3 was able to inhibit leptin re...

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  Insights on distinct pathways of thiazolidinediones (PPAR[gamma] ligand)-promoted apoptosis in TRAIL-sensitive or -resistant malignant urothelial cells

Thiazolidinediones, including rosiglitazone and troglitazone, are insulin-sensitizing drugs and high-affinity ligands for the peroxisome proliferator-activated receptor [gamma] (PPAR[gamma]). Apart from their antidiabetic activity, these molecules possess antitumor properties. We investigated their potential apoptotic effects on RT4 (derived from a well-differentiated Grade I papillary tumor) and T24 (derived from an undifferentiated Grade III carcinoma) bladder cancer cells. Rosiglitazone induced G2/M or G0/G1 phase cell cycle arrest in RT4 and T24 cells, respectively. Only troglitazone triggered apoptosis via extrinsic and intrinsic pathways in both cell lines. Interestingly, rosiglitazone amplified TRAIL-induced apoptosis in TRAIL-sensitive RT4 cells or let TRAIL-resistant T24 cells to ...

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  Molecular characterization and functional analysis of porcine macrophage migration inhibitory factor (MIF) gene.

We report here the molecular characterization of porcine MIF gene, which resides on chromosome 14q21.3 and encodes 114 amino acids. Porcine MIF mRNA was found to be highly expressed in stomach, to a lesser extent in spleen, and at the lowest levels in skeletal muscle and heart. To gain further insight into the functional regulation of MIF, we cloned the porcine MIF promoter and verified its functionality using luciferase reporter assay. In NIH 3T3 cells, the endogenous MIF mRNA level was up-regulated by rosiglitazone treatment in a dose-dependent manner, which was accompanied by a concurrent increase in peroxisome proliferator-activated receptor (PPAR)gamma2 transcription. Over-expression of porcine PPARgamma2 in NIH 3T3 cells could also up-regulate the transcription of MIF in the absence ...

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  Rosiglitazone alleviates the persistent fibrotic phenotype of lesional skin scleroderma fibroblasts

Conclusion. Rosiglitazone may alleviate the extent of fibrosis in dcSSc. (Source: Rheumatology)

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  Hormone and pharmaceutical regulation of ASP production in 3T3-L1 adipocytes

Several studies have demonstrated increases in acylation stimulating protein (ASP), and precursor protein C3 in obesity, diabetes and dyslipidemia, however the nature of the regulation is unknown. To evaluate chronic hormonal and pharmaceutical mediated changes in ASP and potential mechanisms, 3T3-L1 adipocytes were treated with physiological concentrations of relevant hormones and drugs currently used in treatment of metabolic diseases for 48 h. Medium ASP production and C3 secretion were evaluated in relation to changes in adipocyte lipid metabolism (cellular triglyceride (TG) mass, non-esterified fatty acid (NEFA) release and real-time FA uptake). Chylomicrons increased ASP production (up to 411 ± 133% P < 0.05), while leptin, triiodothyronine, and [beta]-blockers atenolol and proprano...

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  In vivo effects of rosiglitazone in a human neuroblastoma xenograft

Authors: I Cellai, G Petrangolini, M Tortoreto, G Pratesi, P Luciani, C Deledda, S Benvenuti, C Ricordati, S Gelmini, E Ceni, A Galli, M Balzi, P Faraoni, M Serio & A Peri (Source: British Journal of Cancer AOP)

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  Rosiglitazone: Proptosis in an elderly patient: case report

(Source: Reactions)

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  AVANDAMET (Rosiglitazone Maleate And Metformin Hydrochloride) Tablet, Film Coated [Physicians Total Care, Inc.]

Updated Date: Jan 8, 2010 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

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  Rosiglitazone improves pancreatic mitochondrial function in an animal model of dysglycemia: role of the insulin-like growth factor axis

This study examined whether this effect is attributable to improved mitochondrial function in the pancreas and the potential involvement of the pancreatic insulin-like growth factor (IGF) axis in mediating this effect. Female Wistar rats were given either saline (vehicle) or nicotine (1 mg kg−1 day−1) during pregnancy and lactation. Following weaning, nicotine-exposed offspring were randomized to receive either vehicle or rosiglitazone (3 mg kg−1 day−1) until 26 weeks of age when serum and pancreas tissue were collected. The effect of rosiglitazone on nicotine-induced mitochondrial dysfunction was also examined in vitro. Fetal and neonatal nicotine exposure resulted in structural and functional mitochondrial deficits relative to saline contro...

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  The inhibitory effects of rosiglitazone on cardiac hypertrophy through modulating the renin-angiotensin system in diet-induced hypercholesterolemic rats

Cardiac hypertrophy is not only an adaptational state before heart failure but also is an independent risk factor for ischemia, arrhythmia, and sudden death. However, the direct effects of hypercholesterolemia on the myocardium and mechanisms are not completely understood. It has been demonstrated that peroxisome proliferator-activated receptor-[gamma] (PPAR[gamma]) ligand agonists attenuate cardiac hypertrophy through anti-inflammatory effects. The present study investigated the effects of PPAR[gamma] agonists on hypercholesterolemia-dependent, renin-angiotensin-system-related cardiac hypertrophy. The findings showed that left ventricular hypertrophy, eminent cardiomyocyte hypertrophy, and lipid deposits in myocardium were observed in the rats fed a cholesterol-rich diet for 6 months, whi...

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  Cardiomyocyte-Derived Adiponectin is Biologically Active in Protecting Against Myocardial Ischemia/Reperfusion Injury.

Authors: Wang Y, Lau WB, Gao E, Tao L, Yuan Y, Li R, Wang X, Koch WJ, Ma XL Adiponectin (APN) has traditionally been viewed as an adipocyte-specific endocrine molecule with cardioprotective effects. Recent studies suggest that APN is also expressed in cardiomyocytes. However, biological significances of this locally produced APN remain completely unknown. The aim of this study was to investigate the pathologic and pharmacologic significance of cardiac-derived APN in cardiomyocyte pathology. Adult cardiomyocytes from wild type littermates (WT) or gene deficient mice were pre-treated with vehicle (V) or rosiglitazone (RSG) for 6 h followed by simulated ischemia/reperfusion (SI/R, 3h/12h). Compared to WT cardiomyocytes, myocytes from APN knockout (APN-KO) mice sustained greater SI/R injur...

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  Avandaryl (Rosiglitazone Maleate and Glimepiride) - updated on RxList

Avandaryl (Rosiglitazone Maleate and Glimepiride) drug description - FDA approved labeling for prescription drugs and medications at RxList (Source: RxList - New and Updated Drug Monographs)

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  LA Superior Court Appoints Steering Committee to Lead 3,000+ Avandia Lawsuits

The Avandia JCCP Plaintiffs' Steering Committee is charged with coordinating over 3000 cases filed in the State of California, and to act as liaison counsel for all plaintiffs' firms who have filed those cases, as well as to maintain close contact with all other lawfirms who have filed Avandia cases throughout the United States. To do that, the members must conduct all pretrial activity, including, but not limited to discovery, motions, science and anything else required by Judge Kuhl. Mr. Finson currently appointment as Chair of the MDL Avandia Stroke Science Committee, and active member of the MDL Avandia Science Committee, will allow the Steering Committee to conduct expert depositions with the tools necessary to do the best job for our clients. (PRWeb Dec 18, 2009) Read t...

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  PPAR alpha and PPAR gamma coactivation rapidly induces Egr-1 in the nuclei of the dorsal and ventral urinary bladder and kidney pelvis urothelium of rats.

Authors: Egerod FL, Svendsen JE, Hinley J, Southgate J, Bartels A, Brünner N, Oleksiewicz MB To facilitate studies of the rat bladder carcinogenicity of dual-acting PPAR alpha+gamma agonists, we previously identified the Egr-1 transcription factor as a candidate carcinogenicity biomarker and developed rat models based on coadministration of commercially available specific PPAR alpha and PPAR gamma agonists. Immunohistochemistry for Egr-1 with a rabbit monoclonal antibody demonstrated that male vehicle-treated rats exhibited minimal urothelial expression and specifically, no nuclear signal. In contrast, Egr-1 was induced in the nuclei of bladder, as well as kidney pelvis, urothelia within one day (2 doses) of oral dosing of rats with a combination of 8 mg/kg rosiglitazone and 200 m...

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