Briefs

Summary: Merck's three-year APPROVe study resulted in an increased relative risk for confirmed thrombotic cardiovascular events beginning after 18 months of treatment in patients taking VIOXX compared with those taking placebo. Those results were reported in September 2004. At that time, Merck voluntarily withdrew VIOXX from the market. Merck then announced it would follow patients for one year after they came off treatment.

Now, Merck has released those results, which reveal that in the off-drug follow-up period there was not a statistically significant difference in the risk of confirmed thrombotic cardiovascular events in patients who have previously taken VIOXX compared with those who had previously taken placebo. The off-drug follow-up analysis included patients regardless of when they discontinued study therapy. In the analysis of each patient's four-year data (that combined data from the on-drug period and the off-drug period regardless of when patients discontinued study therapy), the difference in the risk of confirmed thrombotic cardiovascular events between groups initially observed in the on-drug period of the study remained statistically significant.

Here is the rest of the story.