Lancet study shows CV risks persisted one year after Vioxx was stopped

Patients on Merck & Co's Vioxx (rofecoxib) were at double the risk of suffering a heart attack, stroke or death at least a year after they stopped taking the painkiller, which was withdrawn from the market four years ago after it was linked with cardiovascular side effects (Marketletters passim). Published on October 14 in The Lancet on-line, the new analysis of the APPROVe study found that, in the year after the 2,587-patient trial was stopped, 34 people in the Vioxx arm demonstrated CV complications versus 18 in the placebo cohort. Commenting on the findings, Merck scientist Doug Watson noted that, as so few people suffered side effects, it is difficult to draw strong conclusions. Extended post-treatment cardiovascular follow-up data from 84% of participants found that, in total, 59 individuals had an Antiplatelet Trialists' Collaboration combined endpoint in the rofecoxib group vs 34 in the placebo arm (p=0.006). In the first year after cessation of treatment, there was a non-significant increase in the risks of APTC endpoints. The APTC hazard ratio did not substantially change over time.