In VIGOR, a study in 8076 patients (mean age 58; VIOXX (rofecoxib) n=4047,NAPROXEN n=4029) with a median duration of exposure of 9 months, the risk of developing a serious cardiovascular thrombotic event was significantly higher in patients treated with VIOXX (rofecoxib) 50 mg once daily (n=45) as compared to patients treated with NAPROXEN 500 mg twice daily (n=19). In VIGOR, mortality due to cardiovascular thrombotic events (7 vs 6, VIOXX (rofecoxib) vs NAPROXEN, respectively) was similar between the treatment groups. (See CLINICAL STUDIES, Special Studies, VIGOR, Other Safety Findings: Cardiovascular Safety.) In a placebo-controlled database derived from 2 studies with a total of 2142 elderly patients (mean age 75; VIOXX (rofecoxib) n=1067, placebo n=1075) with a median duration of exposure of approximately 14 months, the number of patients with serious cardiovascular thrombotic events was 21 vs 35 for patients treated with VIOXX (rofecoxib) 25 mg once daily versus placebo, respectively. In these same 2 placebo-controlled studies, mortality due to cardiovascular thrombotic events was 8 vs 3 for VIOXX (rofecoxib) versus placebo, respectively. The significance of the cardiovascular findings from these 3 studies (VIGOR and 2 placebo-controlled studies) is unknown. Prospective studies specifically designed to compare the incidence of serious CV events in patients taking VIOXX (rofecoxib) versus NSAID comparators or placebo have not been performed.
How did we miss the intensity of the medication's effects beyond the 45 of 4047 patients mentioned above? 45 of 4047 is bad enough, but it was even worse.
We physicians are gullible. Fifty percent of major medical advances are disproven within five years. We refer to post marketing reports to understand the effects of medications on a broader population than those initially studied.
We lost some patient trust with Vioxx and similar drugs. How do we get it back?