GLG News by Diabetologists that Treat Type II Diabetes (US)

Dan StrejaClinical Professor of MedicineUNIVERSITY OF CALIFORNIA, LOS ANGELES

Actos has little to worry about Avandia lawsuits

May 10, 2011

Analysis of:Glaxo May Settle 1,000 More Lawsuits Over Avandia, Patients’ Lawyer Says | www.bloomberg.com

The FDA has practically eliminated Avandia based on either an analysis considered by everybody faulty or on data that were never released to the public. Actos has a different cardiovascular safety profile and Takeda should not and probably will not settle any lawsuits concerning risk of heart attack.

Dan StrejaClinical Professor of MedicineUNIVERSITY OF CALIFORNIA, LOS ANGELES

Aspirin cuts heart attack but not strokes, but not in everybody

April 24, 2011

Analysis of:Aspirin cuts heart attacks, but not deaths or strokes: study | www.reuters.com

Aspirin is a great drug to take for prevention of heart attacks but is not for everybody: - In women aspirin prevents strokes but not heart attacks - In patients with diabetes and no heart disease it does not seem to work - In patients with poor circulation to the legs it is not strong enoughThe lack of prevention of death might be due to the fact that the patient studied had less heart attacks but did not oblige the investigators by dying for them. Given the right patient aspirin remains a great drug.

Dan StrejaClinical Professor of MedicineUNIVERSITY OF CALIFORNIA, LOS ANGELES

Analysis of most prescribed drugs is no surprise

April 24, 2011

Analysis of:What Drug Did Doctors Prescribe Most Last Year? | blogs.wsj.com

In times of cost constrains this is no concern. There are additional factors to explain the numbers, some of them related to FDA wisdom:-       Multiple new drug applications in metabolic area have been turned down-       Propoxiphene was withdrawn increasing dramatically the use of hydrocodone-       Atorvastatin is already generic in other countries Others are related to strategy of the Pharmaceuticals:-       Lipitor keeps the market share against simvastatin by issuing $4.00 coupons-       Advair and Plavix are heavily advertized directly to the consumer As fewer drugs are approved and many drugs are getting old the overall picture is a logical consequence.

William HaynesDirector of Clinical PharmacologyTHE UNIVERSITY OF IOWA

FDA Review of Contrave Indicates Skepticism on Cardiovascular Safety

December 3, 2010

Analysis of:FDA Briefing Document: Contrave from Orexigen Therapeutics | www.fda.gov

The release of the FDA briefing documents on Contrave (bupropion/naltrexone) highlights several areas of potential concern, including neuropsychiatric adverse events, seizures, and cardiovascular safety. Adverse events in each area were higher with Contrave and will be negatives for the committee and FDA. The most concerning issue is cardiovascular safety given increases relative to placebo in heart rate and BP, the similarity of the hemodynamic profile to sibutramine, and imbalanced CV events.

William HaynesDirector of Clinical PharmacologyTHE UNIVERSITY OF IOWA

Meridia SCOUT Results Will Impact Future Obesity Drug Approval

September 3, 2010

Analysis of:Effect of Sibutramine on Cardiovascular Outcomes in Overweight and Obese Subjects — NEJM | www.nejm.org

The SCOUT trial of the weight loss medication sibutramine (Meridia; Abbott) demonstrated a significant increase in cardiovascular events compared to placebo. In addition, blood pressure and heart rate were slightly but significantly higher in patients on sibutramine than placebo. The results of this trial will likely hurt the prospects for approval of weight loss medications that share similar cardiovascular effects such as Qnexa (Vivus) and Contrave (Orexigen, Takeda Pharmaceutical).

William HaynesDirector of Clinical PharmacologyTHE UNIVERSITY OF IOWA

FDA Viewpoint on Their Approval of Liraglutide

February 18, 2010

Analysis of:Weighing Risks and Benefits of Liraglutide — The FDA's Review of a New Antidiabetic Therapy | content.nejm.org

Several important themes emerge from this FDA authored article on the rationale for the approval of liraglutide from Novo (NVO). First, they acknowledge the need for new treatments for type 2 diabetes. Second, they are clearly willing to use post-marketing surveillance to assess rare side effects. Third, the FDA considers acute pancreatitis to be a class-related side effect of GLP-1 altering drugs . These themes have implications for the future review of other drugs for type 2 diabetes.

William HaynesDirector of Clinical PharmacologyTHE UNIVERSITY OF IOWA

EndoBarrier has Potential for Treatment of Obesity and Type 2 Diabetes Mellitus

November 30, 2009

Analysis of:Interim Data From A Clinical Trial Evaluating GI Dynamics' EndoBarrier™ Gastrointestinal Liner In Patients With Type 2 Diabetes | www.medicalnewstoday.com

Endoscopic placement of the EndoBarrier reduces weight by 14% and HBA1c by 1.5% after 24 weeks. While not reaching the magnitude of weight loss from bariatric surgery, these changes are impressive and substantially exceed those seen with pharmacologic monotherapy. If this efficacy is validated in future trials, and there are no safety issues, this approach could be useful for a large number of obese patients.

William HaynesDirector of Clinical PharmacologyTHE UNIVERSITY OF IOWA

New Meridia SCOUT Trial has Major Implications for Obesity Drug Development

November 23, 2009

Analysis of:FDA Ongoing Safety Review of Meridia | www.fda.gov

The recent FDA release of preliminary data from the first large-scale, randomized, cardiovascular outcome trial ever conducted for the treatment of obesity comes as a shock. While full data are not available (and the level statistical significance was not given), the fact that cardiovascular events increased rather than decreased with an obesity treatment that is at least moderately effective in reducing weight is an unwelcome surprise. Major changes in FDA review of new obesity drugs may occur.

William HaynesDirector of Clinical PharmacologyTHE UNIVERSITY OF IOWA

A flawed analysis that is unlikely to have as large an impact as financial pressure to prescribe generic simvastatin

December 5, 2008

Analysis of:Patients Taking Lipitor Had a Significantly Reduced Risk of Cardiovascular Events Compared with Patients Taking Simvastatin, New Observational Study Shows | pharmalive.com

This is an interesting analysis that may be scientifically flawed (because it was based on observational data that is subject to selection, medication compliance and comorbidity biases). It may encourage some prescribers to use Lipitor rather than simvastatin. However, that propensity may continue to be swamped by the administrative and financial pressure on prescribers and patients (from insurers and pharmacy benefit managers) to use generic statins.

William HaynesDirector of Clinical PharmacologyTHE UNIVERSITY OF IOWA

Ezetimibe may confer benefit on atherosclerosis

December 5, 2008

Analysis of:Effect of Statins Alone Versus Statins Plus Ezetimibe on Carotid Atherosclerosis in Type 2 Diabetes | content.onlinejacc.org

This analysis of a completed trial suggests that patients using statins plus ezetimibe to achieve an LDL of under 70, had better regression of atherosclerosis than patients with an LDL target of under 100. In addition, the ezetimibe plus statin group did just as well as a group that used statins alone (presumably in higher doses) to achieve the same LDL. This study suggests that there may indeed be a benefit from ezetimibe treatment, in contrast to the ENHANCE trial results (which were from a unique and aggressively treated population). Although from a retrospective and non randomized analysis, this may be the first ray of light for ezetimibe!

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