cqvip:BACKGROUND: Selective inhibition of cyclooxygenase-2 (COX-2) may be associat ed with an increased risk of thrombotic events, but only limited long-term data have been available for analysis. We report on the cardiovascular outcomes asso ciated with the use of the selective COX-2 inhibitor rofecoxib in a long-term, multicenter, randomized,placebo-controlled, double-blind trial designed to de termine the effect of three years of treatment with rofecoxib on the risk of rec urrent neoplastic polyps of the large bowel in patients with a history of colore ctal adenomas.METHODS: A total of 2586 patients with a history of colorectal ade nomas underwent randomization: 1287 were assigned to receive 25 mg of rofecoxib daily, and 1299 to receive placebo. All investigator-reported serious adverse e vents that represented potential thrombotic cardiovascular events were adjudicat ed in a blinded fashion by an external committee. RESULTS: A total of 46 patient s in the rofecoxib group had a confirmed thrombotic event during 3059 patient-y ears of follow-up (1.50 events per 100 patient-years), as compared with 26 pat ients in the placebo group during 3327 patient-years of follow-up(0.78 event p er 100 patient-years); the corresponding relative risk was 1.92 (95 percent con fidence interval, 1.19 to 3.11; P=0.008). The increased relative risk became apparent after 18 m onths of treatment; during the first 18 months, the event rates were similar in the two groups.The results primarily reflect a greater number of myocardial infa rctions and ischemic cerebrovascular event s in the rofecoxib group. There was earlier separation (at approximately five months) between groups in the incidence of nonadjudicated investigator-reported congestive heart failure, pulmonary edema, or cardiac failure (hazar d ratio for the comparison of the rofecoxib group with the placebo group, 4.61 ; 95 percent confidence interval, 1.50 to 18.83). Overall and cardiovascular mor tality was similar in the two groups. CONCLUSIONS: Among patients with a history of colorectal adenomas, the use of rofecoxib was associated with an increased c ardiovascular risk.
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