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Avendia Fiasco

Major US Diabetes Study Partially Halted


08 February 2008

Diabetes Drug Avandia: Heart Risk?

Study Shows 43% More Heart Attacks With Avandia; Drugmaker Says Study Is Flawed
By Daniel J. DeNoon
 

May 21, 2007 The diabetes drug Avandia may increase a person's risk of heart attack and death due to heart disease, a new study warns.

Avandia maker GlaxoSmithKline says the study is flawed and that better data -- some already submitted to the FDA, some from an ongoing clinical trial -- show Avandia poses no significant risk to patients' heart health.

The FDA says that based on this "contradictory evidence about the risks in patients treated with Avandia," patients taking the drug -- especially those who have had heart attacks or who have underlying heart disease -- should talk with their doctors about whether to continue taking the drug.

The new warning comes from an analysis of publicly available, short-term clinical studies comparing Avandia to other diabetes treatments. It shows that Avandia increases heart attack risk by 43% -- and increases risk of death from heart disease by 64%.

However, the overall risk was small. Among the 15,560 Avandia patients there were 86 heart attacks and 39 deaths, compared with 72 heart attacks and 22 deaths among the 12,283 patients not taking Avandia.

"In susceptible patients, [Avandia] therapy may be capable of provoking myocardial infarction [heart attack] or death from cardiovascular causes after relatively short-term exposure," suggest study investigators Steven Nissen, MD, and Kathy Wolski, MPH. Nissen chairs the Cleveland Clinic's department of cardiovascular medicine; he is past president of the American College of Cardiology.

The Nissen/Wolski report will be published in The New England Journal of Medicine. The journal today made the report public under its early-release policy.

Avandia is sold by itself and, as Avandamet and Avandaryl, in pills that combine Avandia with other diabetes medications. The findings do not appear to immediately affect Actos (made by Takeda Pharmaceuticals), a diabetes drug in the same class as Avandia.

Avandia Benefit, Avandia Risk

The FDA in 1999 approved Avandia on the basis of clinical trials showing that the drug could reduce blood-sugar levels in people with type 2 diabetes. Diabetes has been linked to both microvascular problems (problems of tiny blood vessels) such as blindness, kidney failure, and loss of circulation in the extremities. It has also been linked to heart disease.

But none of the trials on which Avandia was approved showed that the drug actually prevented the greatest threats to people with diabetes: microvascular problems, heart disease, or heart death.

In a strongly worded editorial accompanying the study, University of Washington researcher Bruce M. Psaty, MD, PhD, says the Nissen study means there's no good reason for most patients to take Avandia.

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