CardioExchange Archive

March 17th, 2011

Meta-Analysis Suggests Worse Outcomes For Rosiglitazone Compared To Pioglitazone

Larry Husten, PHD

There are no long-term trials directly comparing rosiglitazone and pioglitazone. In an article published in BMJ, Yoon Kong Loke and colleagues performed a systematic review and meta-analysis of 16 observational studies with more than 800,000 thiazolidinedione users in an attempt to assess the relative cardiovascular effects of the two drugs. When compared with pioglitazone, rosiglitazone was […]

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September 26th, 2010

Avandia: Lessons Learned and Unanswered Questions

Harlan M. Krumholz, MD, SM

The following is republished from Pharmalot, a widely read site that provides commentary on the pharmaceutical industry and related litigation. What should we make of the decisions on Avandia yesterday? There remains some controversy about the risk, but the concerns were sufficient, given the therapeutic alternatives, to bring about action. The Europeans decided to suspend sales […]

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July 26th, 2010

Questions for Sanjay Kaul about TIDE and Avandia

Sanjay Kaul, MD and Harlan M. Krumholz, MD, SM

CardioExchange’s editor-in-chief Harlan Krumholz discussed the TIDE trial on email with Sanjay Kaul, who was a member of the FDA’s advisory panel last week on Avandia. Here is a lightly edited version of their exchange. Krumholz: What is your response to the FDA announcement that it has placed TIDE on a “partial clinical hold”? Do you […]

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July 22nd, 2010

Lessons Learned from 2 Avandia Panels

Larry Husten, PHD

In a perspective published online in the New England Journal of Medicine, Clifford Rosen, who was the chair of the 2007 FDA Advisory Panel that allowed rosiglitazone (Avandia) to remain on the market and also a member of the panel that met last week, writes about “lessons learned” from the extraordinary series of events involving […]

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July 21st, 2010

FDA Halts New Enrollment in TIDE

Larry Husten, PHD

The FDA has halted new enrollment in TIDE (Thiazolidinedione Intervention with Vitamin D Evaluation), the controversial Avandia safety study, by placing the study on “partial clinical hold.” Patients already enrolled in the trial will continue to participate. The FDA said in a statement that it had instructed GlaxoSmithKline to “update investigators, institutional review boards (IRBs) and ethics committees […]

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