Adverse events associated with rofecoxib therapy: results of a large study in community-derived osteoarthritic patients.

OBJECTIVE

To evaluate the safety profile of rofecoxib, a selective cyclo-oxygenase-2 inhibitor, in patients with osteoarthritis who are receiving care in non-hospital practice settings.

DESIGN

All patients participating in a large 24-week, open-label, nonpharmacological intervention trial were given rofecoxib for painful osteoarthritis of the knee or hip. They started at a dose of 12.5mg once daily for the first month, with the option of increasing to 25mg daily thereafter, if needed for efficacy. Adverse events were closely monitored. We considered all adverse events that occurred during treatment and within 14 days of discontinuation of rofecoxib. PATIENT GROUP STUDIED: 2896 patients (861 males and 2035 females) were involved in the safety analysis. Their mean (SD) age was 66.8 (9.9) years, and 631 patients (21.8%) were aged >/=75 years. There were 913 patients (31.5%) with hypertension and 151 (5.2%) with diabetes mellitus at the start of the study; 78 patients (2.7%) had a prior medical history of angina and/or myocardial infarction. The mean (SD) duration of rofecoxib treatment was 139 (62) days.

RESULTS

A total of 519 patients (17.9%) discontinued rofecoxib. The main reasons for discontinuation were dyspepsia (4.4%), nausea (2.4%) and dizziness (2.1%). The annualised incidence rates (95% CI) of complicated and uncomplicated upper gastrointestinal ulcers, myocardial infarction, and stroke were 1.36 (0.76-2.23), 0.09 (0-0.50) and 0.45 (0.16-1.05), respectively.

CONCLUSION

This study conducted in conditions close to daily practice confirms that the use of rofecoxib is associated with a low rate of serious adverse events in patients with osteoarthritis.