Fundamental prospective trial investigated drug in patients with recurrent colon polyps
The largest prospective trial ever examining the anti-inflammatory drug Vioxx as a chemoprevention agent found that the risk of developing a cardiovascular "event" - heart attacks and/or strokes - was almost double in patients who received the drug, compared to patients who took the placebo, according to a study out Feb. 15 on-line in The New England Journal of Medicine. The risk was first discovered and reported last September by the studys safety monitoring board and led to the shutdown of the colon cancer chemoprevention trial and subsequent withdrawal of the drug from the U.S. market.
The trial, known as APPROVe (Adenomatous Polyp Prevention on Vioxx), was the longest test yet of Vioxx as a chemoprevention agent, and was designed to determine whether the drug could prevent the re-growth of precancerous colon polyps in people who had already had polyps removed. The prospective chemoprevention study randomized 2,586 participants from 108 centers in 29 countries to receive either 25 mgs. of Vioxx daily or a placebo drug for three years, 2001-2004. The trial was stopped September 30, 2004 - approximately two months before its planned completion.
Laura Sussman | EurekAlert!
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