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Cardiovascular Events Associated with Rofecoxib in a Colorectal Adenoma Chemoprevention Trial

Cardiovascular Events Associated with Rofecoxib in a Colorectal Adenoma Chemoprevention Trial.

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Cardiovascular Events Associated with Rofecoxib in a Colorectal Adenoma Chemoprevention Trial

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  1. Cardiovascular Events Associated with Rofecoxib in a Colorectal Adenoma Chemoprevention Trial Robert S. Bresalier, M.D., Robert S. Sandler, M.D., Hui Quan, Ph.D., James A. Bolognese, M.Stat., Bettina Oxenius, M.D., Kevin Horgan, M.D., Christopher Lines, Ph.D., Robert Riddell, M.D., Dion Morton, M.D., Angel Lanas, M.D., Marvin A. Konstam, M.D., John A. Baron, M.D. and the Adenomatous Polyp Prevention on Vioxx (APPROVe) Trial Investigators N Engl J Med Volume 352;11:1092-1102 March 17, 2005

  2. Study Overview • In a clinical trial of chemoprevention for colorectal adenomas, the use of rofecoxib was found to be associated with a significantly increased risk of cardiovascular events, primarily myocardial infarctions and ischemic cerebrovascular events • Although rofecoxib has been removed from the market by the manufacturer, these data need to be carefully considered in making decisions about any future use of rofecoxib

  3. Enrollment, Randomization, and Outcomes Bresalier, R. et al. N Engl J Med 2005;352:1092-1102

  4. Baseline Characteristics of the Patients Bresalier, R. et al. N Engl J Med 2005;352:1092-1102

  5. Incidence of Adjudicated Thrombotic Adverse Events Bresalier, R. et al. N Engl J Med 2005;352:1092-1102

  6. Kaplan-Meier Estimates of the Cumulative Incidence of Confirmed Serious Thrombotic Events Bresalier, R. et al. N Engl J Med 2005;352:1092-1102

  7. Summary of Rates and Relative Risks of Confirmed Serious Thrombotic Events and the APTC End Point Bresalier, R. et al. N Engl J Med 2005;352:1092-1102

  8. Kaplan-Meier Estimates of the Cumulative Incidence of Investigator-Reported Congestive Heart Failure (CHF), Pulmonary Edema (PE), or Cardiac Failure (CF) Bresalier, R. et al. N Engl J Med 2005;352:1092-1102

  9. Incidence of Nonadjudicated Cardiovascular Adverse Events Bresalier, R. et al. N Engl J Med 2005;352:1092-1102

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

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