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Previous Volume 352:1092-1102 March 17, 2005 Number 11 Next

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ABSTRACT

Background Selective inhibition of cyclooxygenase-2 (COX-2) may be associated with an increased risk of thrombotic events, but only limited long-term data have been available for analysis. We report on the cardiovascular outcomes associated with the use of the selective COX-2 inhibitor rofecoxib in a long-term, multicenter, randomized, placebo-controlled, double-blind trial designed to determine the effect of three years of treatment with rofecoxib on the risk of recurrent neoplastic polyps of the large bowel in patients with a history of colorectal adenomas.

Methods A total of 2586 patients with a history of colorectal adenomas underwent randomization: 1287 were assigned to receive 25 mg of rofecoxib daily, and 1299 to receive placebo. All investigator-reported serious adverse events that represented potential thrombotic cardiovascular events were adjudicated in a blinded fashion by an external committee.

Results A total of 46 patients in the rofecoxib group had a confirmed thrombotic event during 3059 patient-years of follow-up (1.50 events per 100 patient-years), as compared with 26 patients in the placebo group during 3327 patient-years of follow-up (0.78 event per 100 patient-years); the corresponding relative risk was 1.92 (95 percent confidence interval, 1.19 to 3.11; P=0.008). The increased relative risk became apparent after 18 months 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 infarctions and ischemic cerebrovascular events 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 (hazard 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 mortality was similar in the two groups.

Conclusions Among patients with a history of colorectal adenomas, the use of rofecoxib was associated with an increased cardiovascular risk.

Source Information

From the Department of Gastrointestinal Medicine and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (R.S.B.); the Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill (R.S.S.); Merck Research Laboratories, West Point, Pa. (H.Q., J.A. Bolognese, B.O., K.H., C.L.); the Department of Pathology, Mount Sinai Hospital, Toronto (R.R.); the Department of Surgery, University of Birmingham, Birmingham, United Kingdom (D.M.); the Department of Medicine, Clinic University Hospital, Zaragoza, Spain (A.L.); the Department of Medicine, Tufts–New England Medical Center, Boston (M.A.K.); and the Departments of Medicine and Community and Family Medicine, Dartmouth Medical School, Hanover, N.H. (J.A. Baron).

This article was published at www.nejm.org on February 15, 2005.

Address reprint requests to Dr. Bresalier at the Department of Gastrointestinal Medicine and Nutrition, University of Texas M.D. Anderson Cancer Center, 1515 Holcombe Blvd., Houston, TX 77030-4009, or at rbresali{at}mdanderson.org.

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