Rofecoxib, a specific inhibitor of cyclooxygenase 2, with clinical efficacy comparable with that of diclofenac sodium - Results of a one-year, randomized, clinical trial in patients with osteoarthritis of the knee and hip

Objective. To compare the clinical efficacy of rofecoxib, a specific inhibi tor of cyclooxygenase 2 (COX-2), with that of diclofenac in patients with o steoarthritis (OA) and to evaluate the safety and tolerability of rofecoxib . Methods. We performed a randomized, double-blind, active comparator-control led trial in 784 adults with OA of the knee or hip. Patients were randomize d to 1 of 3 treatment groups: 12.5 mg of rofecoxib once daily, 25 mg of rof ecoxib once daily, and 50 mg of diclofenac 3 times daily. Clinical efficacy and safety were evaluated over a 1-year continuous treatment period. Resul ts. Rofecoxib at dosages of 12.5 and 25 mg demonstrated efficacy that was c linically comparable to that of diclofenac, as assessed by all 3 primary en d points according to predefined comparability criteria. Results from secondary end points were consistent with those of the primary end points. There were small statistical differences favoring diclofenac f or 2 of the end points. All treatments were well tolerated. Conclusion. Rofecoxib was well tolerated and provided efficacy that was cli nically comparable, according to predefined statistical criteria, to that o f 150 mg of diclofenac per day in this 1-year study. Specific inhibition of COX-2 provided therapeutic efficacy in OA.