Avandia (Rosiglitazone) May Increase Risk of Cardiovascular Death

According to a meta-analysis by Steven Nissen, the chief of cardiology at the Cleveland Clinic, published in NEJM:

"Rosiglitazone was associated with a significant increase in the risk of myocardial infarction (MI) and with an increase in the risk of death from cardiovascular causes that had borderline significance. The study was limited by a lack of access to original source data, which would have enabled time-to-event analysis."

Avandia seemed to increase the risk of MI by 43 percent and cardiovascular death by 64 percent. Despite the limitations of the study, the findings are significant and there seems to be little rationale for prescribing rosiglitazone anymore.

A video recap from the WSJ health blog summarizes today's events:

Steven Nissen has a long track record as an early critic of the following medications:

- Merck’s Vioxx
- Bristol-Myers Squibb and Merck's Pargluva
- Johnson & Johnson’s Natrecor
- ADHD drugs

He wasn't named one of the 100 People Who Shape Our World by TIME for nothing.

For the record, I was never a big fan of Avandia, especially since I saw a small study in a 2003 issue of the Mayo Clinic Proceedings which showed that "thiazolidinediones can cause or exacerbate heart failure and pulmonary edema and should be avoided in patients with left ventricular dysfunction or chronic renal insufficiency."

In 2005, investigators from the Cleveland Clinic published their experience with using EMR to notify 11,699 patients on Vioxx within 24 hours of the medication withdrawal: Responding to the Rofecoxib Withdrawal Crisis: A New Model for Notifying Patients at Risk and Their Health Care Providers, Annals of Int Med. A similar system will likely be used to notify patients of the increased risk with Avandia.

There has been some discussion recently about the value of wikis for medical information. The Wikipedia entry about Avandia was updated with the new safety concerns about the drug at 4:48 PM and the full reference was added 2 hours later, as you can see from the revisions/history page. That was reasonably fast, I think.

As it has become customary, the medical blogosphere reviewed the news from a professional perspective in a timely fashion:

Not So Rosy. Medviews.

Rosiglitazone (Avandia) in perspective. Notes from Dr. RW.

Avandia and heart attack. Kevin, M.D.

Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes, NEJM.
Avandia: Video Recap, Jacob Goldstein, WSJ.
Cardiologist: Glaxo’s Diabetes Drug Raises Heart Risks, Jacob Goldstein, WSJ.
Thiazolidinedione-Associated Congestive Heart Failure and Pulmonary Edema. Mayo Clinic Proceedings, 2003.
Responding to the Rofecoxib Withdrawal Crisis: A New Model for Notifying Patients at Risk and Their Health Care Providers, Annals of Int Med, 2005.
Interview with Dr. C. Martin Harris on PHRs. eHealth, John Sharp, 06/2007.

Doctor Accused of Leak to Drug Maker. NYTimes, 01/2008.
The long Avandia endgame - The Lancet, 2011 http://goo.gl/qcMzN

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