The FDA today released a 538-page briefing document for an advisory panel meeting on Wednesday and Thursday that will reassess a key clinical trial and reconsider the fate of the now-tarnished former blockbuster diabetes drug rosiglitazone (Avandia, GlaxoSmithKline). (Click here for the FDA documents.) As reported last week, the re-adjudication of the RECORD safety trial performed…
With One Big Exception FDA Reviewers Back More Benign View Of Avandia Trial
June 3, 2013 by Leave a Comment
FDA Schedules Another 2 Day Avandia Advisory Panel
April 12, 2013 by Leave a Comment
Once again the controversial diabetes drug rosiglitazone (Avandia, GlaxoSmithKline) will be the subject of a 2 day FDA hearing. According to a meeting announcement scheduled to be published in the Federal Register on Monday, the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will meet on June 5 and June 6 to “discuss the results…
Cuban History Offers Important Lessons For Global Health Today
April 10, 2013 by 1 Comment
A large new study from Cuba shows the impressive benefits that can be achieved with weight loss and increased exercise. Much more ominously, the same study shows the dangers associated with weight gain and less exercise. In the study, published in BMJ, researchers took advantage of a “natural” experiment that occurred in Cuba as a result of a…
Amid Rising Tide Of Diabetes More Patients Reach Treatment Goals
February 15, 2013 by Leave a Comment
There’s a glimmer of good news amidst all the recent bad news about diabetes. Although the prevalence of diabetes has doubled over the last generation, more people today are reaching their treatment goals than in the past. New data from the National Health and Nutrition Examination Surveys (NHANES), published online today in Diabetes Care, show that…
CABG Highly Cost Effective In Diabetics With Multivessel Disease
January 2, 2013 by Leave a Comment
In November the main results of the FREEDOM trial showed that diabetics with multivessel disease do better with CABG than PCI. Now the findings of the trial’s cost-effectiveness study, published online in Circulation, demonstrate that CABG is also highly cost-effective when compared with PCI. Elizabeth Magnuson and colleagues found that although CABG initially cost nearly $9,000 more…
FREEDOM Lends Strong Support To CABG For Diabetics With Multivessel Disease
November 4, 2012 by 3 Comments
Editor’s note: The embargo on FREEDOM was lifted early after a press release was published by mistake.) Diabetics with multivessel disease do better with CABG than PCI, according to FREEDOM (Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease), a large NIH-sponsored study presented at the American Heart Assocation in Los…
ALTITUDE Autopsy Shows What Went Wrong With Aliskiren
November 3, 2012 by Leave a Comment
In its short lifespan the direct renin inhibitor aliskiren (a.k.a., Rasilez or Tekturna) rapidly declined from being a highly promising, first-of-its kind drug to a major failure. The death blow was struck last December with the early termination of the ALTITUDE trial, after the data and safety monitoring committee found an increased risk in patients taking aliskiren. Now the final results…
UK Study Casts Doubts On Value Of Type 2 Diabetes Screening
October 4, 2012 by Leave a Comment
The dramatic growth in type 2 diabetes has resulted in increased interest in screening programs. Now a new study published in the Lancet raises concerns that screening programs may not result in long-term improvement in outcomes. In the ADDITION-Cambridge study, investigators in the UK randomized general practices to either screening or no screening. The practices allocated to…
A Manhattan Project To End The Obesity Epidemic
September 12, 2012 by 3 Comments
A newly launched nonprofit organization, the Nutrition Science Initiative, will try to find an answer to the question, “What should we eat to be healthy?” NuSI is nothing if not ambitious: its goal is to seek “the end of fad diets and high obesity rates.” The founders of the organization, called NuSI (pronounced “new see”) for short, are Gary Taubes…
Reports From JUPITER And Taiwan: Benefits Of Statins Outweigh Risk Of Diabetes
August 9, 2012 by 1 Comment
Two new papers provide further evidence that statin usage is associated with an increased risk of diabetes, but both studies also find that the benefits of statins still outweigh the risks. In the first report, published in the Lancet, Paul Ridker and colleagues analyze data from the JUPITER trial, which compared rosuvastatin to placebo in…
AHA And ADA Cautiously Endorse Non-Nutritive Sweeteners
July 9, 2012 by 1 Comment
In a newly released scientific statement the American Heart Association and the American Diabetes Association offer a cautious endorsement of the use of non-nutritive sweeteners in the diet. But the statement notes that the products are not “magic bullets” and that there is no strong evidence demonstrating beneficial effects of the products. Sugar in the…
Linagliptin And Glimepiride Compared In Type Two Diabetes
June 29, 2012 by Leave a Comment
Sulfonylureas are often added to metformin to improve glycemic control, but at the known risk of increasing hypoglycemia and weight gain. In a report published in the Lancet, more than 1,500 patients with type 2 diabetes taking metformin were randomized to the addition of either linagliptin, a dipeptidyl peptidase-4 inhibitor or the sulfonylurea glimepiride. After two years…
Guest Post– Reality Check: The ORIGIN of Spin in a Randomized Trial
June 20, 2012 by 2 Comments
Editor’s Note: The following guest post is reprinted with permission from CardioExchange, the cardiology social media website published by the New England Journal of Medicine. Steven Coca is a nephrologist at the Yale School of Medicine. Reality Check: The ORIGIN of Spin in a Randomized Trial by Steven Coca, DO, MS In the ORIGIN randomized trial, involving about 12,500 people…
Is Chronic Kidney Disease A CHD Risk Equivalent?
June 19, 2012 by 1 Comment
A new study published in the Lancet provides new data about whether chronic kidney disease (CKD) should, like diabetes, be considered a coronary heart disease (CHD) risk equivalent. Marcello Tonelli and colleagues analyzed data from a population of 1.25 million people in Alberta, Canada. During a median followup of 4 years, 11,340 people were admitted to…
Transient Glucose Regulation Helps Prevent Progression To Diabetes In Prediabetics
June 9, 2012 by Leave a Comment
Prediabetics– people with impaired fasting glucose or impaired glucose tolerance– can reduce their high risk of progressing to diabetes if they achieve even a transient return to normal glucose regulation, according to results of the Diabetes Prevention Program Outcomes Study (DPPOS), presented at the American Diabetes Association meeting and published simultaneously online in the Lancet. Leigh…
Statins and Diabetes: Real Concern or Much Ado About Nothing?
March 5, 2012 by 6 Comments
Updated at 7 PM with a detailed comment at the bottom from C. Michael Minder of Johns Hopkins– In a New York Times Op-Ed piece on Monday, Eric Topol comments on last week’s announcement by the FDA that it was changing the label for statins. Topol focuses on the new warning that statins raise the risk…
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