A COX-2 inhibitor.
Increased risk of myocardial infarction in patients free of cardiac disease (0.4%) compared to naproxen (0.1%) in a 2000 randomized controlled study Vioxx Gastrointestinal Outcomes Research (VIGOR).
Adenomatous Polyp Prevention on Vioxx (APPROVe) trial terminated after analysis revealed a two-fold increased cardiovascular event risk in patients treated with 25 mg/d of rofecoxib for longer than 18 months compared with placebo with 1.5 vs 0.78 thrombotic events per 100 person-years.
3.5 per cent of patients without cardiovascular disease developed myocardial infarction or stroke compared to 1.9 per cent of controlled placebo patients resulting in the withdrawal of the drug from the market September 30, 2004.
Controlled studies show no difference in the incidence of myocardial infarction or stroke compared to placebo until more than a year of treatment.
Vioxx in Colorectal Cancer Therapy: Definition of Optimal Regime (VICTOR) trial utilized this drug vs a placebo as an adjuvant treatment for colorectal cancer, and found after a median of exposure of 7.4 months that there was an increased frequency of adverse cardiovascular events.
Suppresses the formation of prostaglandin I2 which is the predominant cyclooxygenase product in the endothelium which impairs platelet aggregation, prevents vascular proliferation of smooth muscle cells and causes vasodilation.
Does not inhibit thromboxane A2.
In a pooled analysis of 30 randomized, placebo-controlled trials of this agent and A combined enrollment of 20,152 subjects, rofecoxib was associated with a 35%-43% increased risk of cardiovascular thromboembolic adverse events or death (Ross JS).
In a prospective systematic evaluation involving 8076 patients, been shown to reduce clinically significant ulcers, ulcer complications and gastrointestinal bleeding significantly compared to naproxen.