Posts Tagged ‘rosiglitazone’

March 12th, 2014

Clinical Trials For Diabetes Drugs Need To Consider Heart Failure

Is heart failure the missing 800 pound gorilla in diabetes trials? That’s the argument proposed by a group of  prominent cardiovascular and diabetes researchers. It was long believed that by virtue of their glucose-lowering properties diabetes drugs would confer substantial cardiovascular benefits. That belief is no longer widely held, however, and the FDA now requires cardiovascular […]

November 25th, 2013

FDA Removes Restrictions on Avandia

In a remarkable climax to a long-running drama, the FDA today lifted major restrictions on rosiglitazone (Avandia, GlaxoSmithKline). The drug has been the subject of  intense criticism and controversy since the 2007 publication of the famous Nissen meta-analsysis that first raised the possibility that the blockbuster diabetes drug might increase the risk of heart attack and cardiovascular death. The FDA said its […]

October 7th, 2013

Selections from Richard Lehman’s Literature Review: October 7th

This week’s topics include several papers on the CV safety of diabetes drugs, a follow-up report from the WHI on hormone therapy, clopidogrel and smoking, and more.

September 5th, 2013

Rosiglitazone Revisited


Richard G. Bach discusses his study group’s observational analysis of data from the BARI 2D trial regarding outcomes associated with rosiglitazone.

September 2nd, 2013

Cardiovascular Outcome Studies in Diabetes Drugs Finally Arrive

Large trials of two diabetes drugs show that they appear to be safe, but do not improve CV outcomes.

June 7th, 2013

FDA Advisory Panel Backs Looser Restrictions on Avandia

After two days of deliberation an FDA advisory panel has recommended that the severe restrictions (REMS) placed on rosiglitazone (Avandia, GlaxoSmithKline [GSK]) be modified. The vote constitutes a modest revival in fortune for the embattled drug and its maker after many years of controversy and bad news. Only 5 panel members voted to continue the current severe restrictions. […]

June 4th, 2013

With One Big Exception FDA Reviewers Back More Benign View of Avandia Trial

The FDA has 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 by […]

May 29th, 2013

Report on the RECORD Trial Released

An independent re-adjudication of the RECORD trial has confirmed the trial’s original finding that rosiglitazone does not increase cardiovascular risk. But critics of the trial and the drug are unlikely to be appeased by the new result. The re-adjudication of RECORD will be the subject of an extraordinary 2-day FDA advisory committee meeting next week on […]

May 24th, 2013

Spinning RECORD: Battle Over Rosiglitazone Heats up Two Weeks Before Crucial FDA Meeting

Battle lines are being drawn two weeks before a highly unusual two-day FDA advisory committee meeting to discuss the contentious diabetes drug rosiglitazone (Avandia, GlaxoSmithKline [GSK]). This will be the second time an FDA panel has wrestled with the fate of the drug and expectations have been that the discussion will once again be heated. But at […]

April 13th, 2013

FDA Schedules Another 2-Day Avandia Advisory Panel

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 April 15, 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 […]