APPROVe study: Vioxx users not at more CV risk

US drug major Merck & Co says that an off-drug follow-up of Vioxx (rofecoxib) patients from the APPROVe study, which led to the painkiller being withdrawn from the market, showed no statistically-significant difference in the risk of confirmed thrombotic cardiovascular events in patients who had received the drug versus those on placebo.

The firm noted that, in these analyses, the data were insufficient to conclude that there was an increased relative risk of confirmed thrombotic cardiovascular events following discontinuation of therapy. In 2003, Vioxx netted Merck $2.5 billion but the drug major pulled it off the market after initial data from the APPROVe study found that it increased relative risk of heart attacks and strokes after 18 months (Marketletter October 4, 2004).