Monday, May 15, 2006

Vioxx: Is Risk Reduced After Use Ends?

My Friday May 12, 2006 post referred to data released May 11, 2006 by Merck. The same day and the next, headlines touted different conclusions.

The battle that now lays ahead is from the APPROVe study. The study found that patients taking Vioxx during the first three years of the study had a 92% higher risk of stroke and heart attack than those taking an inactive placebo pill.

The "preliminary" data released indicates that in the year after stopping Vioxx, 1,721 patients had a 74% higher stroke/heart attack risk. During that year, 28 patients who had taken Vioxx -- and 16 patients who had taken placebo pills -- had a stroke or heart attack. Most of these events were strokes.

According to various Merck employees' statement, the difference is not statistically significant, meaning it could be a chance finding. Merck says this means there isn't any risk to people who stop taking Vioxx -- at least, no scientifically proven risk.

According to a report on however:This is not so. Steve Nissen, MD, interim chairman of the department of cardiovascular medicine at The Cleveland Clinic has said: "What this means is the relative risk of an event with Vioxx, even after the drug was stopped, was very similar to the risk while taking the drug."

"It has profound implications for patients. It means that patients who previously took Vioxx must be followed closely and must be made aware of their increased risk."

Another doctor said, "I would say the numbers are small, but they suggest an ongoing risk from Vioxx in those who stopped taking it. There appears to be this same increase in risk as seen while taking the drug. While the difference is not statistically significant, it is concerning." (Per Michael Farkouh, MD).

"This suggests Vioxx has more than a [blood-clot-promoting] effect," he says. "It suggests more is going on with this drug than we thought. I would say it is possible it causes persistent damage to the arteries."

You can read more from this well done report by going here.