Avandia May Be Finished

Why use Avandia that increases cardiovascular risk, when Actos is available that appears to reduce such risks. Two new reports published last week in the Journal of the American Medical Association, confirm the prior studies that Avandia does increase cardiac risks. One of the new studies, co-authored by Dr. Steven Nissen of the Cleveland Clinic, found that a rival drug called Actos appears to actually protect patients from heart attacks, strokes, and death. Actos, lowered the combined risk of heart attacks, stroke, and death by 18%, according to the Nissen team’s latest findings. It was Nissen who published an influential study in May that first identified an increased risk of heart attack for patients taking GlaxoSmithKline’s Avandia (BusinessWeek, 6/1/07).

That initial analysis came under fierce attack by Glaxo and some physicians because it was a so-called meta-analysis, which combines the results of many disparate studies. But the second of the two new studies published in JAMA confirms Nissen’s earlier findings on Avandia. While also a meta-analysis, the study by a team from Wake Forest University is seen as more rigorous, as it draws from four studies that followed more than 14,000 patients for a year or more. The Wake Forest researchers found that Avandia increased the risk of heart attack by 42%, while Nissen’s earlier survey found a 43% increased risk.

Glaxo said in a statement Sept. 11 that the conclusions of the most recent JAMA studies "do not confirm a difference in the safety profile of Avandia (rosiglitazone) and Actos (pioglitazone)." The statement said the two studies "do not yield data robust enough to guide doctors in selecting appropriate diabetes treatments for their patients."

Nissen disagrees. "It does not make sense to give a patient Avandia when you have another drug that [lowers insulin resistance] and is safer," Nissen tells BusinessWeek, noting that heart disease is the leading cause of death for diabetics. "Why give them a drug that raises the risk?" Nissen, who was one of the first doctors to sound the alarm about heart attack risks from the Merck painkiller Vioxx, says he thinks the Food & Drug Administration will now come under tremendous pressure to remove Avandia from the market.