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:
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:

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

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

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

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:

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:

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

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