MedWorm: Byetta

  Amylin & Friends Brace for Diabetes Review (AMLN, LLY, ALKS)

Amylin Pharmaceuticals, Inc. (NASDAQ: AMLN) has a big event on deck this week.  This Friday, March 12, is its Prescription Drug User Fee Act (PDUFA) action date for an FDA panel to issue a recommendation on Byetta as the the first once a week treatment for Type II diabetes.  The date had been moved due to recent weather closures in February in and around Washington D.C. Analysts are mixed on the stock with BMO cutting its rating last week, but there were two positive calls from Credit Suisse and Jesup & Lamont. Options are elevated today, but not overly active.  The open interest of stock options is also large enough that the $20 synthetic options straddle would imply that shares have to rise above $24.70 or drop below $15.30 to be profitable. Byetta is already sold with Eli Lilly &...

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  Improvement of Postprandial Endothelial Function after a Single Dose of Exenatide in Individuals with Impaired Glucose Tolerance and Recent Onset Type 2 Diabetes Mellitus.

Conclusions: Exenatide ameliorates postprandial endothelial dysfunction after a high-fat meal. PMID: 20200309 [PubMed - as supplied by publisher] (Source: Diabetes Care)

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  Once-Weekly GLP-1 Agonists: How Do They Differ from Exenatide and Liraglutide?

This article summarizes the physiologic effects of GLP-1; the effects of the already marketed GLP-1 analogues for daily dosing, exenatide and liraglutide; and reviews the presently published data (with emphasis on clinical pharmacokinetics, efficacy, and safety) on GLP-1 agonists, which currently are in development and intended for once-weekly dosing: albiglutide/albugon, CJC-1131, CJC-1134-PC, exenatide once weekly, and taspoglutide. Content Type Journal ArticleDOI 10.1007/s11892-010-0102-xAuthors Mikkel Christensen, University of Copenhagen Diabetes Research Division, Department of Internal Medicine F, Gentofte Hospital Niels Andersens Vej 65 2900 Hellerup DenmarkFilip K. Knop, University of Copenhagen Diabetes Research Division, Department of Internal Medicine F, Gentofte Hosp...

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  Recalls and Safety Alerts: Kidney Impairment with Byetta

To help clinicians weigh the benefits and risks of the diabetes drug Byetta (exenatide), FDA is requiring that information about the risk of renal impairment be added to the drug's labeling. From April 2005 to October 2008, FDA received 78... (Source: Food and Drug Adminstration (FDA): Patient Safety News)

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  Exenatide Once Weekly New Drug Application Review Extended By FDA Due To Weather-Related Closure

Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) confirmed that the U.S. Food and Drug Administration (FDA) has set a new Prescription Drug User Fee Act (PDUFA) action date of March 12 for its review of the exenatide once weekly new drug application (NDA). The revised action date is the result of the FDA's decision to allow five additional days for its review of pending regulatory applications following the agency's recent five-day weather-related closure... (Source: Health News from Medical News Today)

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  Exenatide Once Weekly New Drug Application Review Extended By FDA Due To Weather-Related Closure

Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) confirmed that the U.S. Food and Drug Administration (FDA) has set a new Prescription Drug User Fee Act (PDUFA) action date of March 12 for its review of the exenatide once weekly new drug application (NDA)... (Source: Diabetes News From Medical News Today)

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  Alkermes drug application put on ice

The snow storms that slammed the mid-Atlantic region this month shut down government agencies around Washington, D.C., long enough for the U.S. Food and Drug Administration to delay its review of Alkermes Inc.’s new drug application for diabetes therapy exenatide. (Source: bizjournals.com Health Care:Biotechnology headlines)

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  BYETTA (Exenatide) Injection [Physicians Total Care, Inc.]

Updated Date: Feb 24, 2010 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

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  A Novel Antihypertensive Effect of Exenatide, a GLP-1 Agonist.

Authors: Dandona P, Chaudhuri A, Dhindsa S PMID: 20154655 [PubMed - in process] (Source: American Journal of Hypertension)

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  NICE issues preliminary recommendations (ACD) on liraglutide for type 2 diabetes

Source: NICE Area: News NICE has been asked to produce guidance on the use of liraglutide for the treatment of type 2 diabetes mellitus in the NHS in England and Wales.  The Appraisal Committee has issued an Appraisal Consultation Document (ACD), which includes the following preliminary recommendations:   . Liraglutide 1.2 mg daily in triple therapy regimens (in combination with metformin and a sulfonylurea, or metformin and a thiazolidinedione) is recommended as an option for the treatment of people with type 2 diabetes mellitus, only if used as described for exenatide in 'Type 2 diabetes: the management of type 2 diabetes' (NICE clinical guideline 87); this applies when control of blood glucose remains or becomes inadequate (HbA1c ? 7.5%, or other higher level agreed ...

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  News From the FDA

The Food and Drug Administration has approved liraglutide as a once-daily injection for the treatment of type 2 diabetes. Liraglutide, a human glucagonlike peptide 1 (GLP-1) receptor agonist that promotes glucose-dependent insulin secretion, will be marketed by Novo Nordisk under the name Victoza. It was licensed for use in combination with diet, exercise, and certain other glucose-lowering medications, but not as initial therapy. The first drug in this class, exenatide (Byetta, Amylin/Eli Lilly), was approved in 2005. (Source: Internal Medicine News)

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  Exenatide Versus Glibenclamide in Patients with Diabetes

Diabetes Technology & Therapeutics Mar 2010, Vol. 12, No. 3: 233-240. (Source: Diabetes Technology)

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  Horizon scanning: Diabetes drug - taspoglutide - shows positive results in trials

Source: PharmaTimes Area: News PharmaTimes reports that the once weekly glucagon-like peptide-1 (GLP-1) analogue taspoglutide has shown positive results in five phase III trials and the company have suggested that it could be a valuable treatment for people with type 2 diabetes. The drug is licensed to Roche from Ipsen. The phase III trials (called T-emerge trials) found that taspoglutide met the primary end-points of reduction in blood glucose (no further detail in PharmaTimes story). The trials compared the drug with current standards of care including: insulin glargine, sitagliptin and exenatide. According to the PharmaTimes report, taspoglutide was generally well tolerated and the most frequently reported adverse events were nausea and vomiting - common adverse effects for this class ...

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  Exenatide and weight loss

Conclusion: Further research on the effects of exenatide treatment on energy intake and expenditure are recommended to better understand the mechanisms through which exenatide causes weight loss. (Source: Nutrition)

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  Positive impact of exenatide on BP, weight ‘warrants further study’

The diabetes drug exenatide is associated with reductions in systolic blood pressure (BP) and body weight, a randomized clinical trial has found. (Source: MedWire News - Diabetes)

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  Combination of exenatide and insulin in type 2 diabetes: a retrospective case series observation

No Abstract. (Source: Practical Diabetes International)

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  Population Pharmacokinetics of Liraglutide, a Once-Daily Human Glucagon-Like Peptide-1 Analog, in Healthy Volunteers and Subjects With Type 2 Diabetes, and Comparison to Twice-Daily Exenatide.

Authors: Watson E, Jonker DM, Jacobsen LV, Ingwersen SH The once-daily human glucagon-like peptide-1 (GLP-1) analog, liraglutide, was recently shown to provide improved glycemic control in subjects with type 2 diabetes (T2D) compared with exenatide. The aim of this work is to estimate the population pharmacokinetics of liraglutide and make a comparison to the pharmacokinetic profile of exenatide. Pharmacokinetic data from 5 published studies of subcutaneous and intravenous administration of liraglutide to healthy volunteers (HV) and subjects with T2D were used to develop a population pharmacokinetic model in NONMEM. Exenatide data came from a published study in T2D. Liraglutide pharmacokinetics were adequately described using a 1-compartment model with sequential zero-and first-order a...

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  Positive impact of exenatide on BP, weight ‘warrants further study’

The diabetes drug exenatide is associated with reductions in systolic blood pressure (BP) and body weight, a randomized clinical trial has found. (Source: MedWire News - Hypertension)

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  Corrections

In the article, “Premeal Exenatide Improved Postprandial Endothelial Function” (January 2010, p. 21), the study was done by Dr. Peter Reaven, not Dr. Gerald Reaven. In a supplement supported by Daiichi-Sankyo (Case Study: Management Decisions in a Comorbid Patient With Type 2 Diabetes Having Primary Hyperlipidemia, January 2010, p. 11) the names of the American College of Endocrinology and the American Association of Clinical Endocrinologists were incorrect. (Source: Clinical Endocrinology News)

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  Effect of exenatide on heart rate and blood pressure in subjects with type 2 diabetes mellitus: a double-blind, placebo-controlled, randomized pilot study

Background: Cardiovascular effects of glucose-lowering agents are of increasing interest. Our aim was to assess the effects of the glucagon-like peptide-1 receptor agonist exenatide on heart rate (HR) and blood pressure (BP) in subjects with type 2 diabetes mellitus (T2DM). Methods: In this double-blind, placebo-controlled trial, subjects with T2DM on metformin and/or a thiazolidinedione were randomized to receive exenatide (5mcg for 4 weeks followed by 10mcg) or placebo BID for 12 weeks. Heart rate and BP were assessed with 24-hour ambulatory BP monitoring. The primary measure was change from baseline in mean 24-hour HR. Results: Fifty-four subjects (28 exenatide, 26 placebo) were randomized and comprised the intent-to-treat population. Baseline values (exenatide and placebo) were (mean +...

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  Byetta LAR Will Become Decision Resources' New Clinical Gold Standard In 2013 For The Treatment Of Type 2 Diabetes

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that Amylin/Eli Lilly/Alkermes' Byetta LAR earns Decision Resources' proprietary clinical gold standard status in 2013 for the treatment of type 2 diabetes following its approval for the indication in 2010. Byetta LAR has competitive advantages over currently available and emerging drugs in efficacy and delivery... (Source: Health News from Medical News Today)

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  Byetta LAR Will Become Decision Resources' New Clinical Gold Standard In 2013 For The Treatment Of Type 2 Diabetes

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that Amylin/Eli Lilly/Alkermes' Byetta LAR earns Decision Resources' proprietary clinical gold standard status in 2013 for the treatment of type 2 diabetes following its approval for the indication in 2010... (Source: Diabetes News From Medical News Today)

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  Benefit-Risk Assessment of Exenatide in the Therapy of Type 2 Diabetes Mellitus

(Source: Drug Safety)

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  Lack of preservation of insulin gene expression by a Glucagon-Like Peptide 1 agonist or a Dipeptidyl Peptidase 4 inhibitor in an in vivo model of glucolipotoxicity

Conclusions: Neither a GLP-1 agonist nor a DPP-4 inhibitor, at doses that do not alter blood glucose levels, prevented the inhibition of insulin gene expression in this in vivo model of glucolipotoxicity. (Source: Diabetes Research and Clinical Practice)

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  FDA warns Lilly, Amylin over Byetta marketing violations

The FDA has sent a letter notifying Amylin Pharmaceuticals and Eli Lilly, which co-market Byetta (exenatide) injection, that the company representatives improperly promoted the diabetes drug on June 10 and June 11, 2009, at the 91st Endocrine Society’s annual meeting held in Washington, D.C. (Source: Cardiovascular Business News)

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  Exenatide is associated with significantly lower medical costs than insulin glargine

(Source: PharmacoEconomics and Outcomes News)

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  exenatide, Byetta

Title: exenatide, ByettaCategory: MedicationsCreated: 7/8/2005Last Editorial Review: 1/7/2010 (Source: MedicineNet Diabetes General)

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  exenatide, Byetta

Title: exenatide, ByettaCategory: MedicationsCreated: 7/8/2005Last Editorial Review: 1/7/2010 (Source: MedicineNet Senior Health General)

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  FDA requests new safety studies on exenatide (Byetta®)

Source: Reuters Health News Area: News According to a Reuters report, the US FDA has requested additional safety studies to ensure the benefits of exenatide (Byetta®) outweigh the risk of inflammation of the pancreas and acute renal failure.   A letter posted on the Agency's website notes that it has 'determined that post-marketing requirements are needed to assess the risk of acute pancreatitis, including fatal and non-fatal haemorrhagic or necrotizing pancreatitis, and the risk of thyroid neoplasms'.  Please see the link below for details. (Source: NeLM - News)

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  Premeal Exenatide Improved Postprandial Endothelial Function

Major Findings: Premeal exenatide injections significantly improved postprandial serum triglyceride levels and endothelial function in patients with impaired glucose tolerance or type 2 diabetes. (Source: Clinical Endocrinology News)

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  Exenatide and Kidney Function [Health Agencies Update]

(Source: JAMA)

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  Drugs Not Linked to β-Cell Improvement in Diabetes

The use of insulin, exenatide, and the immunosuppressant daclizumab doesn't lead to improved function of surviving β-cells in patients with long-standing type 1 diabetes, according to research published in the December issue of Diabetes Care. (Source: Modern Medicine)

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  Practical Use of Exenatide and Pramlintide for the Treatment of Type 2 Diabetes

Type 2 diabetes is a progressive disease that affects more than 20.8 million Americans. Traditional antihyperglycemic therapy can cause weight gain and hypoglycemia in this population. Research shows that type 2 diabetic patients have low levels of glucagon-like peptide-1 and amylin. This discovery led to the creation of 2 newer agents, exenatide and pramlintide. Exenatide, a glucagon-like peptide-1 agonist, stimulates insulin secretion, suppresses glucagon secretion, and slows gastric motility. Transient nausea is the most common side effect, which can be minimized with slow titration. Weight loss associated with exenatide is between 0.9 and 2.8 kg. Hypoglycemia occurs more frequently when exenatide is used with a sulfonylurea. There are some case reports of pancreatitis in patients takin...

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  Effects of Exenatide on Systolic Blood Pressure in Subjects With Type 2 Diabetes.

ConclusionsThese results support the need for a prospective, randomized, controlled study of BP changes during exenatide treatment in patients with hypertension and type 2 diabetes.American Journal of Hypertension 2009; doi:10.1038/ajh.2009.245. PMID: 20019672 [PubMed - as supplied by publisher] (Source: American Journal of Hypertension)

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  Exenatide Once Weekly Provided Superior Glucose Control Compared to BYETTA in DURATION-5 Study

SAN DIEGO, INDIANAPOLIS, and CAMBRIDGE, Mass., Dec. 15 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (NASDAQ:AMLN) , Eli Lilly and Company (NYSE:LLY) and Alkermes, Inc. (NASDAQ:ALKS) today announced positive results from a head-to-head... (Source: Drugs.com - Clinical Trials)

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  Berkshire Priorities Committee policy statement on exenatide in the treatment of type 2 diabetes

Source: Berkshire Priorities Committees Area: News The Berkshire Priorities Committee has reviewed the evidence for exenatide in the management of type 2 diabetes following the publication of NICE guidelines on the use of newer agents for blood glucose control in type 2 diabetes (May 2009, guideline 87). The committees are satisfied that funding for exenatide should be considered within its licensed indications in line with the NICE recommendations. The statement can be downloaded from the link below. (Source: NeLM - News)

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  BYETTA (Exenatide) Injection [Amylin Pharmaceuticals, Inc.]

Updated Date: Dec 3, 2009 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

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  Role of the incretin pathway in the pathogenesis of type 2 diabetes mellitus

Nutrient intake stimulates the secretion of the gastrointestinal incretin hormones, glucagon-like peptide–1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), which exert glucose-dependent insulinotropic effects and assist pancreatic insulin and glucagon in maintaining glucose homeostasis. GLP-1 also suppresses glucose-dependent glucagon secretion, slows gastric emptying, increases satiety, and reduces food intake. An impaired incretin system, characterized by decreased responsiveness to GIP and markedly reduced GLP-1 concentration, occurs in individuals with type 2 diabetes mellitus (T2DM). The administration of GLP-1 improves glycemic control, but GLP-1 is rapidly degraded by the enzyme dipeptidyl peptidase–4 (DPP-4). Exenatide, a DPP-4–resistant exendin-4 ...

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  Exenatide Gains Indication For Type 2 Monotherapy

The approved indication for exenatide was expanded with the Food and Drug Administration's approval of the glucagon-like peptide-1 (GLP-1) receptor agonist as monotherapy, as an adjunct to diet and exercise in adults with type 2 diabetes, the manufacturer announced. (Source: Clinical Endocrinology News)

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  Pharmacologic management of the older patient with type 2 diabetes mellitus.

Conclusions: Overall, there is a scarcity of data regarding the use of pharmacologic agents in older adults with T2DM, and clinical guidance is largely based on data obtained from younger populations. The selection of appropriate drug regimens for these patients remains challenging. PMID: 20129254 [PubMed - as supplied by publisher] (Source: The American Journal of Geriatric Pharmacotherapy)

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  Clinical Studies of Liraglutide, a Novel, Once-Daily Human Glucagon-Like Peptide-1 Analog for Improved Management of Type 2 Diabetes Mellitus

Pharmacotherapy 29(12, part 2): 43S-54S Abstract Liraglutide, a new glucagon-like peptide-1 (GLP-1)-receptor agonist with 97% homology to human GLP-1, can be administered once/day independent of meals in patients with type 2 diabetes mellitus. Clinical trials have demonstrated its efficacy in controlling hyperglycemia, helping patients achieve hemoglobin A1c level goals; in facilitating weight loss, and in improving indexes of beta-cell function when used alone or in combination with metformin, glimepiride, or rosiglitazone. These studies also suggest that liraglutide may be associated with modest improvements in systolic blood pressure. Data from a comparative trial of liraglutide and insulin glargine have suggested that liraglutide provides greater glycemic control with less weight gain,...

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  The Intersection of Safety and Adherence: New Incretin-Based Therapies in Patients with Type 2 Diabetes Mellitus

Pharmacotherapy 29(12, part 2): 55S-67S Abstract One of the challenges facing health care providers in the treatment of patients with type 2 diabetes mellitus is maintaining the balance between achieving hemoglobin A1c targets while simultaneously minimizing adverse events--most notably hypoglycemia and weight gain--that may negatively affect adherence to therapy and thus treatment outcomes. Incretin-based treatments, such as glucagon-like peptide-1 (GLP-1)-receptor agonists and dipeptidyl peptidase-4 (DPP-4) inhibitors, are the newest class of therapies for the management of patients with type 2 diabetes. Data from clinical trials in which liraglutide, exenatide, saxagliptin, or sitagliptin were employed as monotherapy or added to ongoing antidiabetic treatment indicate that the incretin-...

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  FDA Byetta (exenatide) Associated with Risk of Renal Failure

FDA notified healthcare professionals of revisions to the prescribing information for Byetta (exenatide) to include information on post-marketing reports of altered kidney function, including acute renal failure and insufficiency. Byetta, an incretin-mimetic, is approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. © Nephrology Now editors for Nephrology Now, 2009. | Permalink | Add comment! | Add to del.icio.us Post tags: (Source: Nephrology Now)

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  BYETTA (Exenatide) Injection [Amylin Pharmaceuticals, Inc.]

Updated Date: Nov 19, 2009 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

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  Insulin sensitizers in nonalcoholic fatty liver disease and steatohepatitis: Current status.

Authors: Stein LL, Dong MH, Loomba R Nonalcoholic fatty liver disease (NAFLD), first described in 1980, is now recognized as one of the most common causes of elevated liver enzymes and chronic liver disease in Western countries. The incidence of NAFLD in both adults and children is rising, in conjunction with the burgeoning epidemics of obesity and type 2 diabetes mellitus. NAFLD often coexists with other sequelae of the metabolic syndrome: central obesity, type 2 diabetes, hypertension, and hyperlipidemia. NAFLD encompasses a spectrum of pathologic liver diseases ranging from simple hepatic steatosis to a predominant lobular necro-inflammation, with or without centrilobular fibrosis (called nonalcoholic steatohepatitis or NASH). NASH can progress to cirrhosis, decompensated liver dise...

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  A recombinant polypeptide extends the in vivo half-life of peptides and proteins in a tunable manner

Authors: Volker Schellenberger, Chia-wei Wang, Nathan C Geething, Benjamin J Spink, Andrew Campbell, Wayne To, Michael D Scholle, Yong Yin, Yi Yao, Oren Bogin, Jeffrey L Cleland, Joshua Silverman & Willem P C Stemmer Increasing the in vivo residence times of protein therapeutics could decrease their dosing frequencies. We show that genetic fusion of an unstructured recombinant polypeptide of 864 amino acids, called XTEN, to a peptide or protein provides an apparently generic approach to extend plasma half-life. Allometric scaling suggests that a fusion of XTEN to the exenatide peptide should increase exenatide half-life in humans from 2.4 h to a projected time of 139 h. We confirmed the biological activity of the exenatide-XTEN fusion in mice. As extended stability might exacerbate und...

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  A Comparison of Costs among Patients with Type 2 Diabetes Mellitus Who Initiated Therapy with Exenatide or Insulin Glargine

(Source: Applied Health Economics and Health Policy)

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  Insulin-releasing and metabolic effects of small molecule GLP-1 receptor agonist 6,7-dichloro-2-methylsulfonyl-3-N-tert-butylaminoquinoxaline.

Authors: Irwin N, Flatt PR, Patterson S, Green BD Much recent attention has focused on the GLP-1 receptor as a potential target for antidiabetic drugs. Enzyme resistant GLP-1 mimetics such as exenatide are now employed for the treatment of type 2 diabetes, but must be administered by injection. The present study has examined and compared the in vitro and in vivo metabolic actions of a small molecule GLP-1 receptor agonist 6,7-dichloro-2-methylsulfonyl-3-N-tert-butylaminoquinoxaline (DMB), with native GLP-1, exenatide and liraglutide. DMB significantly stimulated in vitro insulin secretion from BRIN BD11 cells but with decreased molar potency compared to native GLP-1 or related mimetics. Administration of DMB in combination with glucose to mice significantly (P<0.05) decreased the ov...

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  Byetta (Exenatide Injection) - updated on RxList

Byetta (Exenatide Injection) drug description - FDA approved labeling for prescription drugs and medications at RxList (Source: RxList - New and Updated Drug Monographs)

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  Byetta label changed to include renal failure warnings

(Source: Reactions)

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  Effects of exenatide on circulating glucose, insulin, glucagon, cortisol and catecholamines in healthy volunteers during exercise

Conclusions/interpretation  In non-diabetic participants given exenatide, blood glucose concentrations rise rather than fall during aerobic exercise with an associated greater catecholamine response. Content Type Journal ArticleCategory Short CommunicationDOI 10.1007/s00125-009-1579-1Authors E. Y. H. Khoo, Nottingham University Hospitals Department of Diabetes and Endocrinology Queens Medical Centre Campus, Derby Road Nottingham NG7 2UH UKJ. Wallis, University of Nottingham School of Biomedical Sciences Nottingham UKK. Tsintzas, University of Nottingham School of Biomedical Sciences Nottingham UKI. A. Macdonald, University of Nottingham School of Biomedical Sciences Nottingham UKP. Mansell, Nottingham University Hospitals Department of Diabetes and Endocrinology Queens ...

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  Intarcia Therapeutics, Inc. Presents Positive Results from Two Studies of ITCA 650 for the Treatment of Type 2 Diabetes at the Ninth Annual Diabetes Technology Meeting

ITCA 650 induces potent reductions of HbA1c and body weight after 4 week treatment; ITCA 650 delivers up to 12 months of exenatide therapy from a single DUROS device HAYWARD, Calif., Nov. 6 /PRNewswire/ -- Intarcia Therapeutics, Inc. delivered two... (Source: Drugs.com - Clinical Trials)

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  FDA to revise prescribing information for exenatide, sitagliptin

The US Food and Drug Administration has approved drug label revisions for the GLP-1 agonist exenatide to incorporate information obtained from post-marketing reports of acute renal failure and insufficiency experienced by some patients taking the drug. (Source: MedWire News - Diabetes)

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  FDA Approves Revisions to Prescribing Information for Diabetes Medications

The FDA has approved revisions to the prescribing information for the injectable diabetes medication exenatide and the diabetes drug sitagliptin phosphate because of concerns about, respectively, renal problems and pancreatitis caused by the medications. (Source: AAFP Clinical Care and Research)

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  FDA Working to Revise Prescribing Information for Diabetes Medications

The FDA is revising the prescribing information for the injectable diabetes medication exenatide and the oral diabetes drug sitagliptin phosphate following reports of renal problems associated with exenatide use, as well as reports linking sitagliptin use with pancreatitis. (Source: AAFP Clinical Care and Research)

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  FDA: Diabetes drug Byetta tied to kidney problems

People with type 2 diabetes who are taking the blood-sugar-lowering drug Byetta may be at increased risk for kidney problems, including kidney failure, the U.S. Food and Drug Administration reported this week. (Source: CNN.com - Health)

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  Health News of the Day

is a daily summary made from the selected links I post on Twitter. It is in a bullet points format with links to the original sources which include 350 RSS feeds that produce about 2,500 items per day:FDA Issues Warning for Diabetes Drug Byetta about possible kidney problems, including renal failure http://bit.ly/1UOjwB"Who are the sleepiest people in the US?" Source: Morbidity and Mortality Weekly Report http://bit.ly/4djMWPX-rays showed 78 different items of cutlery in a 52-year-old woman's stomach http://bit.ly/4iojkQMayo Clinic: 10 great health foods for eating well http://bit.ly/sGLgF"Hospitals with hospitalists have an easier time recruiting subspecialists" http://bit.ly/WapWE and http://bit.ly/G85PLSleep Changes with Aging http://bit.ly/4CPzGJWhat drug is best for initial treatment...

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  FDA expands exenatide use; warns of renal-failure risk

The FDA has issued a warning about exenatide the same day the agency approved its first-line use along with diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus. (Source: theHeart.org)

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  FDA expands exenatide use; warns of renal-failure risk

The FDA has issued a warning about exenatide the same day the agency approved its first-line use along with diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus. For complete story visit theheart.org. (Source: theHeart.org)

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  FDA Approves Exenatide for First-Line Use; Warns of Renal Failure Risk

The FDA has issued a warning about exenatide the same day the agency approved its first-line use along with diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus. Medscape Medical News (Source: Medscape Today Headlines)

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  FDA Issues Warning for Diabetes Drug

Reports of kidney problems for those using Byetta prompted action Source: HealthDay Related MedlinePlus Topics: Diabetes Medicines, Drug Safety (Source: MedlinePlus Health News)

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  Exenatide Label Updated to Highlight Kidney Risks

(Source: Physician's First Watch current issue)

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  Amylin Pharmaceuticals And Eli Lilly And Company Statement On FDA's BYETTA(R) (Exenatide) Injection Update

Amylin Pharmaceuticals, Inc., (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) issued the following statement in response to the U.S. Food and Drug Administration (FDA) update on BYETTA® (exenatide) injection. "The FDA update issued today aligns with the BYETTA label approved last week. (Source: Health News from Medical News Today)

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  FDA approves exenatide (Byetta®) as monotherapy for type 2 diabetes

Source: BioSpace Area: News According to BioSpace, the FDA has approved an additional indication for exenatide (Byetta®), as monotherapy along with diet and exercise to improve glycaemic control in adults with type 2 diabetes. Previously, it was approved for use only in patients who were also taking metformin and/or sulphonylureas and had not achieved adequate glycaemic control on maximal doses of these therapies [it is currently licensed for this indication only in the UK].   The approval of this additional indication was based on a clinical study which found that patients with type 2 diabetes who were unable to achieve glycaemic control through diet and exercise alone had a reduction in HbA1c by 0.7% with 5mcg exenatide and 0.9% with 10mcg exenatide [no additional details give...

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  US label of exenatide (Byetta®) revised to include post-marketing reports of altered kidney function

Source: FDA Area: News The US FDA has notified healthcare professionals of revisions to the prescribing information for exenatide (Byetta®) to include information on post-marketing reports of altered kidney function, including acute renal failure and insufficiency.   Exenatide is approved in the US as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus.  A total of 78 reports of altered kidney function (62 cases of acute renal failure and 16 cases of renal insufficiency) in patients receiving treatment with exenatide have been received by the FDA between April 2005 and October 2008 (nearly 7 million prescriptions for exenatide were dispensed in this time period).  Some cases occurred in patients with pre-existing kidney ...

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  FDA Warns Exenatide Could Cause Kidney Problems

The U.S. Food and Drug Administration has revised the label of the type 2 diabetes drug exenatide (Byetta) to provide information about possible kidney function problems, including kidney failure, according to a Nov. 2 press release issued by the agency. (Source: Modern Medicine)

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  Amylin Pharmaceuticals and Eli Lilly and Company Statement on FDA's Byetta (Exenatide) Injection Update

SAN DIEGO and INDIANAPOLIS, Nov. 2, 2009 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc., (NASDAQ:AMLN) and Eli Lilly and Company (NYSE:LLY) today issued the following statement in response to the U.S. Food and Drug Administration (FDA)... (Source: Drugs.com - Pharma News)

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  Byetta (exenatide) - Altered kidney function, including acute renal failure/renal insufficiency, in patients on Byetta

ROCKVILLE, Md., Nov. 2, 2009--FDA notified healthcare professionals of revisions to the prescribing information for Byetta (exenatide) to include information on post-marketing reports of altered kidney function, including acute renal failure... (Source: Drugs.com - Pharma News)

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  Byetta (exenatide) - Renal Failure

Cases of altered kidney function, including acute renal failure and renal insufficiency, in patients using Byetta. (Source: FDA MedWatch)

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  FDA: Byetta Label Revised to Include Safety Information on Possible Kidney Problems

The U.S. Food and Drug Administration today acted on new safety information about possible kidney function problems, including kidney failure, in patients taking Byetta (exenatide), a drug used to treat Type 2 diabetes. (Source: Food and Drug Administration)

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  FDA Okays Diabetes Drug for First-Line Use, Adds Warning

WASHINGTON (MedPage Today) -- The FDA expanded the indication and prescribing language for the type 2 diabetes drug exenatide (Byetta). (Source: MedPage Today Cardiovascular)

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  Byetta Approved for Expanded Use as First-Line Treatment for Type 2 Diabetes

SAN DIEGO and INDIANAPOLIS, Oct. 30, 2009 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. and Eli Lilly and Company today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for Byetta (exenatide)... (Source: Drugs.com - New Drug Approvals)

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  FDA: Byetta Label Revised To Include Safety Information On Possible Kidney Problems

The U.S. Food and Drug Administration today acted on new safety information about possible kidney function problems, including kidney failure, in patients taking Byetta (exenatide), a drug used to treat Type 2 diabetes. (Source: Pharmaceutical Online News)

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  Byetta (exenatide) - Renal Failure

Audience: Endocrine and nephrology healthcare professionals FDA notified healthcare professionals of revisions to the prescribing information for Byetta (exenatide) to include information on post-marketing reports of altered kidney function,... (Source: Drugs.com - FDA MedWatch Alerts)

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  FDA gives Byetta nod as stand-alone diabetes treatment

The FDA has approved an expanded indication for Amylin Pharmaceuticals and Eli Lilly’s Byetta (exenatide) injection for use as a stand-alone medication (monotherapy) along with diet and exercise, to improve glycemic control in adults with type 2 diabetes. (Source: Cardiovascular Business News)

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  FDA approves Byetta as stand-alone diabetes treatment, with caveats

The FDA has approved an expanded indication for Amylin Pharmaceuticals and Eli Lilly’s Byetta (exenatide) injection for use as a stand-alone medication (monotherapy) along with diet and exercise, to improve glycemic control in adults with type 2 diabetes. (Source: Cardiovascular Business News)

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  Exenatide: Acute pancreatitis: case report

(Source: Reactions)

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  BYETTA Approved For Expanded Use As First-Line Treatment For Type 2 Diabetes

Amylin Pharmaceuticals, Inc., (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for BYETTA® (exenatide) injection. BYETTA is now approved for use as a stand-alone medication (monotherapy) along with diet and exercise to improve glycemic control in adults with type 2 diabetes. (Source: Health News from Medical News Today)

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  Phase III study of once weekly GLP-1 analogue taspoglutide vs. exenatide meets primary endpoint

Source: BioSpace Area: News Ipsen and Roche have announced the results of the first phase III clinical study using taspoglutide, the first human once weekly glucagon-like peptide-1 (GLP-1) analogue. The T-EMERGE 2 study is an open-label, 24-week non-inferiority study involving 1189 patients, randomised into three active arms (subcutaneous weekly taspoglutide 10mg or 20mg, and subcutaneous twice-daily exenatide 10mcg, as add-on to metformin, a thiazolidinedione [TZD], or metformin and a TZD). All patients continue into long-term extension of the study, The study demonstrated superiority versus exenatide in HbA1c reduction and the most frequently reported adverse events among taspoglutide and exenatide treated patients were nausea and vomiting (No other data were available from the press re...

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  First Phase III clinical trial of Roche's weekly taspoglutide meets primary end-point of change in HbA1c

Roche today announced that headline results from its Phase III study, T-emerge 2 (subcutaneous weekly taspoglutide versus subcutaneous twice-daily exenatide, as add-on to metformin, a thiazolidinedione [TZD], or metformin and a TZD), showed that the trial met its primary endpoint of change in HbA1c. Superiority versus exenatide was demonstrated. (Source: Roche Investor Update)

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  First Phase III clinical trial of Roche`s weekly taspoglutide meets primary end-point of change in HbA1c

Roche today announced that headline results from its Phase III study, T-emerge 2 (subcutaneous weekly taspoglutide versus subcutaneous twice-daily exenatide, as add-on to metformin, a thiazolidinedione [TZD], or metformin and a TZD), showed that the trial met its primary endpoint of change in HbA1c. Superiority versus exenatide was demonstrated. (Source: Roche Investor Update)

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  New Study Results Show That Patients Have Higher Treatment Satisfaction With Liraglutide Compared to Exenatide

MONTREAL, Oct. 22 /CNW/ - New data on patient treatment satisfaction from the LEAD(TM) 6 trial presented on the 22nd October at the 20th World Diabetes Congress (International Diabetes Federation) shows that patients have higher overall... (Source: Drugs.com - Clinical Trials)

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  Weekly exenatide demonstrates QOL superiority in T2DM

(Source: PharmacoEconomics and Outcomes News)

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  Exenatide and sitagliptin appear to carry no higher risk of acute pancreatitis than metformin or glibenclamide [glyburide]

(Source: Reactions)

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  Albiglutide is effective and well tolerated for treatment of Type 2 diabetes

The long-acting glucagon-like peptide-1 receptor agonist albiglutide can reduce glycated hemoglobin levels as effectively as exenatide in patients with inadequately controlled Type 2 diabetes, report researchers. (Source: MedWire News - Diabetes)

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  Effects of Exenatide Alone and in Combination with Daclizumab on Beta Cell Function in Long-Standing Type 1 Diabetes Mellitus.

Conclusions - In long-standing type 1 diabetes, which remains an active autoimmune disease even decades after its onset, surviving beta-cells secrete insulin in a physiologically regulated manner. However, the combination of intensified insulin therapy, exenatide, and daclizumab did not induce improved function of these remaining beta-cells. PMID: 19808924 [PubMed - as supplied by publisher] (Source: Diabetes Care)

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  Merck Blockbuster Diabetes Drug: Januvia Linked to Pancreatitis

(NaturalNews) U.S. health officials said on Friday they suspect Merck`s blockbuster diabetes drug Januvia to be linked to pancreatitis, a potentially fatal condition marked by serious inflammation of the pancreas. As might be expected, Merck company officials disputed the connection.According to the Food and Drug Administration, 88 cases of acute pancreatitis had been reported since the drug`s approval in 2006 through February of this year by users of the drug and a related product Janumet, including two cases of hemorrhagic or necrotizing pancreatitis. The agency "believes there may be an association" with the drug, since 19 of the patients developed the condition soon after taking Januvia and more than half saw the condition disappear after they discontinued taking it.The FDA further rec...

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  Use of exenatide does not increase risk for acute pancreatitis

Treatment of Type 2 diabetics with the glucagon-like peptide 1 analogue exenatide does not significantly increase the risk for acute pancreatitis compared with other antidiabetic drugs, report researchers. (Source: MedWire News - Diabetes)

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  [Correspondence] Adverse events in diabetes drug trial

The LEAD-6 trial (July 4, p 39) presents safety data less transparently than efficacy data. The rate of serious adverse events with liraglutide was twice that with exenatide, but confidence intervals and p values are omitted, by contrast with the efficacy outcomes. The definition of serious adverse events included mortality and hospital admissions, but neither is described. These data should be supplied. (Source: LANCET)

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  [Correspondence] Adverse events in diabetes drug trial – Authors' reply

Christoph Pechlaner raises concerns that there were no statistical comparisons for the incidence of serious adverse events (liraglutide 12/235 [5·1%]; exenatide 6/232 [2·6%]). The study was not powered to investigate differences between treatment groups in terms of adverse events. We have, however, done a post-hoc analysis to address the concern over serious adverse events. An odds ratio was calculated by use of a cumulative logit model with severity levels (severe, moderate, mild, none) as ordinal categorical response variables. There was no significant difference between the serious adverse events for liraglutide and exenatide: odds ratio 2·03 (95% CI 0·75–5·51, p=0·16). Similar analyses by use of the χ2 test and Fisher's exact test showed no significant difference between the s...

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  EASD: No Extra Risk of Acute Pancreatitis Seen with Exenatide (CME/CE)

VIENNA (MedPage Today) -- Acute pancreatitis was not more common with exenatide (Byetta) use compared with other drugs for type 2 diabetes, researchers said here. (Source: MedPage Today Product Alert)

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  Study: Exenatide Aids Weight Loss in Nondiabetic Patients

WASHINGTON — Exenatide helps increase weight loss in obese nondiabetic patients who also are following a diet and exercise program, study results suggest. Dr. Michael Trautmann, a researcher at Eli Lilly & Co., and his colleagues conducted a double-blind, placebo-controlled study of 152 patients with a mean body mass index of 39.6 kg/m2. The patients' average age was 46 years, and 82% were women. The average hemoglobin A1c was 5.5%. One-quarter of the patients had impaired glucose tolerance, and average blood pressure was 120/76 mm Hg. (Source: Ob.Gyn. News)

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  Diabetes Drug Could Cause Pancreatic Cancer

(NaturalNews) The popular diabetes drug sitagliptin (marketed as Januvia) may increase the risk of pancreatic cancer, according to study conducted by researchers from the University of California-Los Angeles and published in the journal Diabetes."Type 2 diabetes is a lifelong disease -- people often take the same drugs for many years, so any adverse effect that could over time increase the risk for pancreatic cancer would be a concern," said lead researcher Peter Butler. "A concern here is that the unwanted effects of this drug on the pancreas would likely not be detected in humans unless the pancreas was removed and examined."Previous research has suggested that the diabetes drug Byetta might increase the risk of pancreatic inflammation (pancreatitis), a known risk factor for pancreatic c...

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  Alkermes Announces Amylin and Lilly Will Present More than 20 Studies for Exenatide at EASD 2009

SAN DIEGO & INDIANAPOLIS & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sep 24, 2009 - Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) will unveil data from more than 20 studies at the 45th... (Source: Drugs.com - Clinical Trials)

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  Versartis Presents Preclinical Data For Novel Type 2 Diabetes Drug

Versartis, Inc. today presented preclinical data demonstrating the potential for monthly dosing of its lead product, VRS-859 (exenatide-XTEN), for the treatment of type 2 diabetes. The data were presented by Jeffrey Cleland, Ph.D., Founder and Chief Executive Officer of Versartis, at the IBC Protein Engineering & Design Conference in San Diego. (Source: Health News from Medical News Today)

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  New insights into the role of cAMP in the production and function of the incretin hormone glucagon-like peptide-1 (GLP-1).

Authors: Yu Z, Jin T The proglucagon gene (gcg) encodes both glucagon and glucagon-like pepetide-1 (GLP-1), produced in pancreatic alpha cells and intestinal endocrine L cells, respectively. The incretin hormone GLP-1 stimulates insulin secretion and pro-insulin gene transcription. GLP-1 also enhances pancreatic beta-cell proliferation, inhibits cell apoptosis, and has been utilized in the trans-differentiation of insulin producing cells. A long-term effective GLP-1 receptor agonist, Byetta, has now been developed as the drug in treating type II diabetes and potentially other metabolic disorders. The expression of gcg and the production of GLP-1 can be activated by the elevation of the second messenger cyclic AMP (cAMP). Recent studies suggest that in addition to protein kinase A (PKA)...

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  Intarcia Therapeutics, Inc. Commences Enrollment Of ITCA 650 Phase 2 Study In Type 2 Diabetes

Intarcia Therapeutics, Inc. announced the start of enrollment for a phase 2 study comparing its proprietary drug candidate ITCA 650 (DUROS continuous delivery of exenatide) with Byetta, an FDA-approved twice-daily injection form of exenatide. (Source: Health News from Medical News Today)

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  Real-world data confirm exenatide efficacy for Type 2 diabetes

Results of a “real-world,” observational study indicate that exenatide treatment is associated with similar reductions in glycated hemoglobin, weight, blood pressure, and lipids to those achieved with the drug in registration clinical trials. (Source: MedWire News - Diabetes)

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  Intarcia Therapeutics, Inc. Commences Enrollment Of ITCA 650 Phase 2 Study In Type 2 Diabetes

Intarcia Therapeutics, Inc. today announced the start of enrollment for a phase 2 study comparing its proprietary drug candidate ITCA 650 (DUROS continuous delivery of exenatide) with Byetta, an FDA-approved twice-daily injection form of exenatide. (Source: Pharmaceutical Online News)

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  The European Exenatide study of long-term exenatide vs. glimepiride for type 2 diabetes: rationale and patient characteristics

Conclusion: Patients included in the EUREXA study had early failure of glucose control with metformin and presented typical features of type 2 diabetes: overweight/obesity and high prevalence of lipid abnormalities and CVD. In this population, the effects of exenatide vs. glimepiride will be evaluated over at least 2.5 years. (Source: Diabetes, Obesity and Metabolism)

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  Biochemical and histological effects of exendin-4 (exenatide) on the rat pancreas

Conclusions/interpretation  Although the use of exendin-4 in rats is associated with decreased weight gain, lower insulin resistance and lower leptin levels than in control animals, extended use of exendin-4 in rats leads to pancreatic acinar inflammation and pyknosis. This raises important concerns about the likelihood of inducing acute pancreatitis in humans receiving incretin mimetic therapy. Content Type Journal ArticleCategory ArticleDOI 10.1007/s00125-009-1515-4Authors J. S. Nachnani, University of Missouri Kansas City Division of Gastroenterology and Hepatology 2411 Holmes Street Kansas City MO 64108 USAD. G. Bulchandani, University of Missouri Kansas City Division of Gastroenterology and Hepatology 2411 Holmes Street Kansas City MO 64108 USAA. Nookala, Universi...

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  Is liraglutide or exenatide better in type 2 diabetes?

Expert Opinion on Pharmacotherapy , Early Online. (Source: Expert Opinion: Expert Opinion on Pharmacotherapy: Table of Contents)

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  Six-month outcomes on A1C and cardiovascular risk factors in patients with type 2 diabetes treated with exenatide in an ambulatory care setting

This study evaluated changes in clinical effectiveness measures of patients with type 2 diabetes initiating exenatide therapy in a real-world setting.Methods: Eligible patients identified in the General Electric (GE) electronic medical record (EMR) research database from 1 January 2000 through 31 December 2007 were [ge]18 years old with type 2 diabetes. Patients had prescription orders in the previous 395 days for metformin, a sulfonylurea, or a thiazolidinedione as monotherapy or in combination, and had at least 6 months of follow-up activity. Baseline clinical measures were documented from 45 days prior up to 15 days after exenatide initiation and follow-up measures documented at 6 months ± 45 days.Results: A total of 1709 patients were identified for study inclusion. The overall mean A...

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  Exenatide trumps insulin glargine in cost effectiveness

(Source: PharmacoEconomics and Outcomes News)

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  Exenatide of benefit in insulin-treated Type 2 diabetes patients

The addition of exenatide to insulin-based therapy is associated with improved glycemic control, less weight gain, and reduced prandial insulin requirements for treatment periods of up to 27 months, researchers report. (Source: MedWire News - Diabetes)

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  Evaluation of exenatide vs. insulin glargine in type 2 diabetes: cost-effectiveness analysis in the German setting

Conclusions: Exenatide was projected to be associated with similar clinical outcomes and increased costs compared with insulin glargine. Analysis of cost-effectiveness from a third-party perspective suggests that exenatide is likely to represent good value for money in the German setting. (Source: Diabetes, Obesity and Metabolism)

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  Patients' preference for subsequent therapy following secondary failure of metformin and sulphonylurea

We surveyed 205 type 2 diabetic patients with glycated haemoglobin 7.5-10.0% on maximum metformin and sulphonylurea to determine their choice for further glycaemic therapy. In all, 54.6% of patients requested pioglitazone, 21.9% basal insulin, and 23.4% preferred exenatide. South Asians generally preferred non-injectables, and more overweight patients preferred exenatide.Despite physician preference for insulin, most patients prefer additional oral agents over injectables. Copyright © 2009 John Wiley & Sons, Ltd. (Source: Practical Diabetes International)

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  Exenatide May Aid Weight Loss in Nondiabetic Patients

WASHINGTON — Exenatide helps increase weight loss in obese nondiabetic patients who also are following a diet and exercise program, recent study results suggest. Dr. Michael Trautmann, a researcher at Eli Lilly & Co., and his colleagues conducted a double-blind, placebo-controlled study of 152 patients with a mean body mass index of 39.6 kg/m2. The patients' average age was 46 years, and 82% were women. The average hemoglobin A1c was 5.5%. One-quarter of the patients had impaired glucose tolerance, and average blood pressure was 120/76 mm Hg. (Source: Family Practice News)

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  Exenatide Aids Weight Loss In Nondiabetic Patients

WASHINGTON — Exenatide helps increase weight loss in obese nondiabetic patients who also are following a diet and exercise program, recent study results suggest. Dr. Michael Trautmann, a researcher at Eli Lilly & Co., and his colleagues conducted a double-blind, placebo-controlled study of 152 patients with a mean body mass index of 39.6 kg/m2. The patients’ average age was 46 years, and 82% were women. The average hemoglobin A1c was 5.5%. (Source: Cardiology News)

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  Exenatide Aids Weight Loss in Nondiabetics

Washington — Exenatide helps increase weight loss in obese nondiabetic patients who also are following a diet and exercise program, recent study results suggest. Dr. Michael Trautmann, a researcher at Eli Lilly & Co., and his colleagues conducted a double-blind, placebo-controlled study of 152 patients with a mean body mass index of 39.6 kg/m2. The patients' average age was 46 years, and 82% were women. The average hemoglobin A1c was 5.5%. One-quarter of the patients had impaired glucose tolerance, and average blood pressure was 120/76 mm Hg. (Source: Clinical Endocrinology News)

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  Exenatide efficacy and safety: a systematic review

Conclusions In subjects with poorly controlled diabetes, exenatide was associated with a reduction in HbA1c that was similar to introducing another oral agent or insulin. Weight loss may be an advantage with exenatide. Long-term studies in diverse and unselected populations are needed to clarify the benefit vs. harm profile of this drug. (Source: Diabetic Medicine)

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  CLARIFICATION: Exenatide aids weight loss in nondiabetic patients

Read the full story on MD Consult: CLARIFICATION: Exenatide aids weight loss in nondiabetic patients (Source: MD Consult: News: Top Stories)

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  Liraglutide in type 2 diabetes: from pharmacological development to clinical practice.

Authors: Rossi MC, Nicolucci A The novel drug class of GLP-1 analogues is extremely promising, since existing evidence suggests they can address many of the unmet needs of diabetes treatment, i.e., long-term efficacy, low risk of hypoglycemia, cardiovascular protection, weight loss, long-term safety and tolerability. Besides the already available exenatide, liraglutide is expected to arrive soon on the market. It is a human GLP-1 analogue with high homology (97%) to native hormone. A comprehensive phase III evaluation consisting of six randomized clinical trials--the "Liraglutide Effect and Action Diabetes (LEAD) program"--was recently completed, involving 6500 people seen in 600 sites in 41 countries worldwide. Aim of the LEAD program was to evaluate efficacy and safety of liraglutide...

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  Exenatide and liraglutide: different approaches to develop GLP-1 receptor agonists (incretin mimetics) – preclinical and clinical results

The GLP-1 analogues exenatide and liraglutide stimulate insulin secretion and inhibit glucagon output in a glucose-dependent manner, slow gastric emptying and decrease appetite. The injectable glucagon-like peptide-1 (GLP-1) receptor agonist exenatide significantly improves glycaemic control, with average reductions in HbA1c of about 1.0% point, fasting plasma glucose of about 1.4mmoll−1, and causes a weight loss of approximately 2–3kg after 30 weeks of treatment. The adverse effects are transient nausea and vomiting. The long-acting once-daily human GLP-1 receptor agonist liraglutide reduces HbA1c by about 1.0–2.0% point, weight by 1–3kg and seems to have fewer gastrointestinal side effects than exenatide. The final place of the GLP-1 receptor agonists in the diabetes treatment al...

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  Liraglutide: A Once-Daily Incretin Mimetic for the Treatment of Type 2 Diabetes Mellitus (September)(CE).

CONCLUSIONS: Once-daily administration may provide a therapeutic advantage for liraglutide over twice-daily exenatide, with similar improvements in A1C and body weight observed when liraglutide was compared with exenatide. The glucose-dependent mechanism of insulin release with GLP-1 agonist therapy holds potential clinical significance in the management of postprandial hyperglycemic excursions, with minimal risk of hypoglycemia. PMID: 19638470 [PubMed - as supplied by publisher] (Source: The Annals of Pharmacotherapy)

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  Exenatide Once Weekly Provided Superior Glucose Control Compared To Lantus in Head-to-Head DURATION-3 Study

Significant Reductions in Weight and Fewer Reports of Hypoglycemia Compared to Lantus Also Observed SAN DIEGO & INDIANAPOLIS & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jul 20, 2009 - Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company... (Source: Drugs.com - Clinical Trials)

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  Exenatide Once Weekly Provided Superior Glucose Control Compared To Lantus(R) In Head-to-Head DURATION-3 Study

Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced positive results from a study comparing subjects randomized to either exenatide once weekly or Lantus® (insulin glargine). (Source: Health News from Medical News Today)

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  A cardiologic approach to non-insulin antidiabetic pharmacotherapy in patients with heart disease

Classical non-insulin antihyperglycemic drugs currently approved for the treatment of type 2 diabetes mellitus (T2DM) comprise five groups: biguanides, sulfonylureas, meglitinides, glitazones and alpha-glucosidase inhibitors. Novel compounds are represented by the incretin mimetic drugs like glucagon like peptide-1 (GLP-1), the dipeptidyl peptidase 4 (DPP-4) inhibitors, dual peroxisome proliferator-activated receptors (PPAR) agonists (glitazars) and amylin mimetic drugs. We review the cardiovascular effects of these drugs in an attempt to improve knowledge regarding their potential risks when treating T2DM in cardiac patients. Metformin may lead to lethal lactic acidosis, especially in patients with clinical conditions that predispose to this complication, such as recent myocardial infarct...

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  Exenatide: Pancreatitis: case report

(Source: Reactions)

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  Exenatide: Pancreatitis: case report.

Page: 15 (Source: Reactions Weekly)

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  The Potential of Albiglutide, a Long-Acting GLP-1 Receptor Agonist, in Type 2 Diabetes: A Randomized Controlled Trial Exploring Weekly, Biweekly, and Monthly Dosing.

Conclusions - Weekly albiglutide administration significantly improved glycemic control and elicited weight loss in type 2 diabetes patients, with a favorable safety/tolerability profile. PMID: 19592625 [PubMed - as supplied by publisher] (Source: Diabetes Care)

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  Endothelial dysfunction induced by triglycerides is not restored by exenatide in rat conduit arteries ex vivo.

In conclusion, exenatide could neither confer any acute protective effects against triglyceride-induced endothelial dysfunction nor exert any significant vasorelaxant actions in this model of rat conduit arteries ex vivo. PMID: 19595708 [PubMed - as supplied by publisher] (Source: Regulatory Peptides)

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  New Drug Application For Exenatide Once Weekly Accepted For Review By FDA

Amylin Pharmaceuticals, Inc., (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) announced that the New Drug Application (NDA) for exenatide once weekly has been accepted for review by the U.S. Food and Drug Administration (FDA). (Source: Health News from Medical News Today)

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  FDA will review Amylin’s exenatide application

Amylin Pharmaceuticals, Eli Lilly and Co., and Alkermes Inc. said the Food and Drug Administration will review their new drug application for a once-weekly formulation of the diabetes drug exenatide. (LLY) (ALKS) (Source: bizjournals.com Health Care:Industry Regulation headlines)

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  FDA will review Amylin’s exenatide application

Amylin Pharmaceuticals, Eli Lilly and Co., and Alkermes Inc. said the Food and Drug Administration will review their new drug application for a once-weekly formulation of the diabetes drug exenatide. (LLY) (ALKS) (Source: bizjournals.com Health Care:Physician Practices headlines)

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  FDA will review Amylin’s exenatide application

Amylin Pharmaceuticals, Eli Lilly and Co., and Alkermes Inc. said the Food and Drug Administration will review their new drug application for a once-weekly formulation of the diabetes drug exenatide. (LLY) (ALKS) (Source: bizjournals.com Health Care:Health Insurance headlines)

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  FDA will review Amylin’s exenatide application

Amylin Pharmaceuticals, Eli Lilly and Co., and Alkermes Inc. said the Food and Drug Administration will review their new drug application for a once-weekly formulation of the diabetes drug exenatide. (LLY) (ALKS) (Source: bizjournals.com Health Care:Pharmaceuticals headlines)

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  FDA will review Amylin’s exenatide application

Amylin Pharmaceuticals, Eli Lilly and Co., and Alkermes Inc. said the Food and Drug Administration will review their new drug application for a once-weekly formulation of the diabetes drug exenatide. (LLY) (ALKS) (Source: bizjournals.com Health Care:Biotechnology headlines)

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  FDA will review Amylin’s exenatide application

Amylin Pharmaceuticals, Eli Lilly and Co., and Alkermes Inc. said the Food and Drug Administration will review their new drug application for a once-weekly formulation of the diabetes drug exenatide. (LLY) (ALKS) (Source: bizjournals.com Health Care:Hospitals headlines)

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  ABCD position statement on incretin mimetics and DPP-4 inhibitors -2009

The Association of British Clinical Diabetologists (ABCD) currently recommends a limited place for exenatide and the gliptins in obese type 2 diabetes. Exenatide requires careful patient selection and continued specialist support, particularly to avoid initiation in individuals at risk of pancreatitis or for those who are already on insulin therapy. Hypoglycaemic and weight reduction efficacy may vary depending on baseline levels of HbA1c and body mass index. Continuation of therapy beyond six months should be determined by changes in weight and/or HbA1c. Gliptins should be reserved for less obese, less hyperglycaemic cases than those considered for exenatide, assuming normal hepatorenal function, and where sulphonylureas and glitazones are inappropriate. Gliptin therapy should only contin...

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  [Articles] Liraglutide once a day versus exenatide twice a day for type 2 diabetes: a 26-week randomised, parallel-group, multinational, open-label trial (LEAD-6)

Unlike most antihyperglycaemic drugs, glucagon-like peptide-1 (GLP-1) receptor agonists have a glucose-dependent action and promote weight loss. We compared the efficacy and safety of liraglutide, a human GLP-1 analogue, with exenatide, an exendin-based GLP-1 receptor agonist. (Source: LANCET)

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  Exenatide advantages mostly related to weight loss

Results from a meta-analysis show that exenatide treatment achieves similar reductions in glycated hemoglobin to insulin therapy, but has potential additional weight-loss benefits. (Source: MedWire News - Diabetes)

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  Investigational Drug Bests Exenatide in Glucose Control

NEW ORLEANS — Patients with type 2 diabetes who were treated with once-daily liraglutide experienced significantly greater improvements in glycemic control, compared with patients who were treated with twice-daily exenatide, results from an open-label, multicenter trial showed. (Source: Family Practice News)

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  Managing type 2 diabetes: new policy and interventions.

Authors: Gillibrand W, Holdich P, Covill C This paper presents a critical discussion of the recent developments in diabetes services and concurrent patient care, which have a significant impact on the way that community nurses provide care to people with diabetes. The current prevalence and rising incidence of type 2 diabetes is discussed, mentioning how this trend will impact on community nursing practice. New interventions and management guidelines are presented and discussed, with a focus on patient-centred care as the main driver for these changes. New pharmacological interventions (Byetta(R)) and biochemical outcome measures are discussed which will have an impact on patient care, delivered by nurses working in the community. PMID: 19597379 [PubMed - in process] (Source: Briti...

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  Clinical application of incretin-based therapy: therapeutic potential, patient selection and clinical use.

This article examines clinical trial data and accepted algorithms with a view toward elucidating the application of these agents in routine clinical practice. We propose a systematic approach to treatment, addressing (1) patient selection, (2) optimal treatment combinations, and (3) timing and guidance for both initiation and intensification of therapy. The GLP-1 receptor agonists, for example, could be particularly beneficial in patients whose weight significantly increases cardiovascular risk. Early use of these agents may be effective in preventing diabetes in those at risk, or in halting or retarding disease progression in patients with frank diabetes. Additional clinical investigation will be required to test such hypotheses. Given the ever-increasing incidence of diabetes worldwide, ...

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  Liraglutide Lowered HbA1c More Than Exenatide

NEW ORLEANS — Patients with type 2 diabetes who were treated with once-daily liraglutide experienced significantly greater improvements in glycemic control, compared with patients who took twice-daily exenatide, results from an open-label, multicenter trial showed. (Source: Clinical Endocrinology News)

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  Exenatide added to insulin therapy: a retrospective review of clinical practice over two years in an academic endocrinology outpatient setting.

Conclusion: In this retrospective review of patients with T2DM treated in an outpatient setting, the addition of exenatide to insulin-based therapy was associated with reductions in mean HbA(1c), weight, and prandial insulin requirements for treatment periods of up to 27 months, and in total insulin requirements for treatment periods of up to 12 months. PMID: 19695400 [PubMed - in process] (Source: Clinical Therapeutics)

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  Stabilizing effect of exenatide in a patient with C-peptide-negative diabetes mellitus

Conclusions This patient with features of both Type 1 and Type 2 diabetes benefited greatly from exenatide with insulin therapy. The improvement seen in glycaemic control could not be attributable to enhanced insulin secretion but could be as a result of a combination of the other incretin effects (postprandial glucagon suppression, delayed gastric emptying and weight loss secondary to increased satiety) all improving insulin sensitivity, reducing insulin dose and smoothing control. (Source: Diabetic Medicine)

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  Effects of Exenatide on Plasma Glucose and Insulin Concentrations in Alpacas

Exenatide is a degradation-resistant glucagon-like peptide 1 agonist used in the treatment of diabetes mellitus. It enhances the insulin response to hyperglycemia. Because of a poor insulin response, adult camelids are susceptible to hyperglycemia from stress, glucose administration, or energy metabolism disorders. Insulin often is administered to decrease plasma glucose concentration, but this approach has disadvantages such as the risk of hypoglycemia. Noninsulin medications targeting the incretin hormone pathway, such as exenatide, are providing alternate treatment options. Exenatide will decrease plasma glucose and increase insulin concentrations in alpacas. Six healthy adult alpacas. After food was withheld for 8 hours, alpacas were given, on subsequent days in a randomly determined o...

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  Diabetes Experts Sound Caution Over Extended Role Of New Drugs, UK

MEDICAL experts have cautioned against indiscriminate use of new classes of medication for Britain's increasing number of people with diabetes - saying the drug advances needed "careful adoption" to meet their full treatment potential. The Association of British Clinical Diabetologists (ABCD) explored the safety and effectiveness of one new therapy in particular - exenatide - as part of a unique research project. (Source: Diabetes News From Medical News Today)

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  Versartis Focusing On Extending Half Life Of Drugs For Metabolic And Endocrine Diseases

Versartis, Inc., a new company developing novel biologics with enhanced properties for patients with metabolic diseases, published abstracts for preclinical data on its two product candidates, VRS-859 (exenatide-rPEG) and VRS-808 (glucagon-rPEG), at the American Diabetes Association Scientific Sessions annual meeting beginning today in New Orleans. (Source: Health News from Medical News Today)

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  Clinical Trial Summary: Liraglutide Effect and Action in our Diabetes (LEAD-6)

The goal of the trial was to evaluate treatment with the glucagon-like peptide-1 (GLP-1) receptor agonist liraglutide compared with exenatide among patients with type 2 diabetes. (Source: Cardiosource)

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  When Added To Diet And Exercise, Exenatide Promotes Weight Loss

In combination with diet and exercise, the diabetes drug exenatide helped nondiabetic, obese individuals lose over three times more weight than those receiving a placebo, or dummy treatment, for 6 months. The results of the new study were presented at The Endocrine Society's 91st Annual Meeting in Washington, D.C. (Source: Health News from Medical News Today)

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  Diabetes Drug Byetta May Aid Weight Loss in Obese Patients

Title: Diabetes Drug Byetta May Aid Weight Loss in Obese PatientsCategory: Health NewsCreated: 6/12/2009 7:00:00 AMLast Editorial Review: 6/12/2009 (Source: MedicineNet Diabetes General)

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  Diabetes Drug Byetta May Aid Weight Loss in Obese Patients

Title: Diabetes Drug Byetta May Aid Weight Loss in Obese PatientsCategory: Health NewsCreated: 6/12/2009 7:00:00 AMLast Editorial Review: 6/12/2009 (Source: MedicineNet Liver General)

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  Diabetes Drug Byetta May Aid Weight Loss in Obese Patients

Title: Diabetes Drug Byetta May Aid Weight Loss in Obese PatientsCategory: Health NewsCreated: 6/12/2009 7:00:00 AMLast Editorial Review: 6/12/2009 (Source: MedicineNet Weight Management General)

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  Results from LEAD 6 study published online

The Lancet publishes direct comparison study between liraglutide and exenatide (Source: Pharmacy Europe)

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  Exenatide promotes weight loss when added to diet and exercise

(The Endocrine Society) In combination with diet and exercise, the diabetes drug exenatide helped nondiabetic, obese individuals lose over three times more weight than those receiving a placebo, or dummy treatment, for 6 months. The results of the new study will be presented Thursday at the Endocrine Society's 91st Annual Meeting in Washington, D.C. (Source: EurekAlert! - Medicine and Health)

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  New Drug Taken Once Daily Shows Promise for Type 2 Diabetes

In this study of 464 people whose type 2 diabetes was poorly controlled with standard drug therapy, liraglutide was compared to exenatide, currently the only approved GLP-1 diabetes drug in the U.S. “We demonstrated that liraglutide administered once daily was associated with greater blood glucose lowering, identical weight loss, less hypoglycaemia, less persistent nausea as well as blood pressure lowering, and a modest benefit on blood lipid levels,” Buse said. Estimates from the World Health Organization indicate that worldwide more than 170 million people have diabetes, of which type 2 diabetes accounts for about 90% of all cases. Prevalence is predicted to continue growing, fueled by rising rates of obesity. (Source: Diabetes News from dLife.com)

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  The Lancet publishes direct comparison study between liraglutide and exenatide

COPENHAGEN, June 9, 2009--Today, The Lancet published online the results of the LEAD™ 6 study, a direct comparison between two products in a new class of diabetes treatments, the GLP-1 receptor agonists. Results show that patients treated with... (Source: Drugs.com - Clinical Trials)

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