Avandia Seems Associated With Increased Rate Of Heart Failure; Less Clear Whether Glaxo’s Diabetes Drug Causes Heart Attacks, Other Cardiovascular Problems

(Posted by Tom Lamb at DrugInjuryWatch.com)

In the July 5, 2007 edition of The New England Journal of Medicine (NEJM) there are several editorials of interest to those doctors and patients who are concerned about the heart safety of GlaxoSmithKline’s diabetes drug Avandia (rosiglitazone).

Before we get to the editorials, from the July 5 NEJM, a short item entitled "Rosiglitazone Evaluated for Cardiovascular Outcomes" provides a good overview of the situation at present:

Meta-analyses suggest that the thiazolidinedione [Avandia], used in the treatment of type 2 diabetes, may increase the risk of myocardial infarction and death from cardiovascular causes. This interim analysis of an ongoing noninferiority trial of rosiglitazone is inconclusive but does not exclude cardiotoxicity. Because patients with diabetes are already at high risk for cardiovascular disease, it is important that any potential cardiotoxicity of [Avandia] be reported.

A July 5, 2007 WebMD article, "Avandia Heart Risks May Be ‘Inconclusive’", provides additional details:

Today’s journal report comes from the interim results of a six-year Avandia study sponsored by GlaxoSmithKline. The interim results cover the study’s first 3.75 years. The data include 4,447 patients with type 2 diabetes in Europe and Australia who couldn’t adequately control their blood sugar with the diabetes drugs metformin or sulfonylurea.

Half of the patients took Avandia and a combination of metformin and sulfonylurea. For comparison, the other patients took the metformin-sulfonylurea drug combination without Avandia. The patients were 58 years old, on average. Apart from their diabetes, they were generally in good health.

The researchers included Philip Home, DM, DPhil, of England’s Newcastle Diabetes Centre and Newcastle University. They tracked the patients’ hospitalization or death from any cardiovascular problems.

The study shows no increased risk of heart attack or heart problems in general in patients taking Avandia, compared with those not taking Avandia. However, heart failure was 2.15 times more common in the Avandia group.

The several NEJM Avandia editorials appearing in the July 5 edition — all of which are accessible in full to the public without any need for registration or subscription — are:

• The Record on Rosiglitazone and the Risk of Myocardial Infarction, by Bruce M. Psaty and Curt D. Furberg
• Rosiglitazone — Continued Uncertainty about Safety, by Jeffrey M. Drazen, Stephen Morrissey, and Gregory D. Curfman
• Rosiglitazone and Cardiotoxicity — Weighing the Evidence, by David M. Nathan

In summary, researchers have not determined whether there is an association between Avandia and heart attacks.  As regards an association between Avandia and heart failure, however, the researcher found there to be more than twice as many heart failure cases in patients taking Avandia compared to patients taking other types of diabetes drugs.