Treatment of osteoarthritis with celecoxib, a cyclooxygenase-2 inhibitor: A randomized controlled trial

Objective: To compare the efficacy and safety of celecoxib, a cyclooxygenas e-2 (COX-2) inhibitor, with those of naproxen, a nonsteroidal anti-inflamma tory drug (NSAID), and placebo in the treatment of osteoarthritis of the kn ee. Methods: In this multicenter, randomized, double blind, placebo-controlled trial, 1003 patients with symptomatic osteoarthritis of the knee were rando mly assigned to receive celecoxib at doses of 50, 100, or 200 mg twice a da y; naproxen, 500 mg twice a day; or placebo for 12 weeks. Patients were eva luated with standard measures of efficacy 2 to 7 days after discontinuing p revious NSAID or analgesic therapy and after 2, 6, and 12 weeks of treatmen t with the study drug. Results: Celecoxib treatment led to significant improvement in the signs an d symptoms of osteoarthritis as determined by all efficacy measures. Signif icant pain relief occurred within 2 days of the initiation of treatment, an d maximum anti-inflammatory and analgesic activity, evident within 2 weeks, was sustained throughout the 12-week study. All celecoxib doses were effic acious compared with placebo, although the 50-mg twice-daily dosage regimen was minimally effective. The higher doses of celecoxib (100 and 200 mg twi ce a day) were similarly efficacious, and the magnitude of improvement obse rved with these dosing regimens was comparable to that seen with naproxen a t a dose of 500 mg twice a day. All doses of celecoxib and naproxen were we ll tolerated, Conclusion: COX-2 inhibition with celecoxib is an effective approach for th e treatment of osteoarthritis, as seen by clinical improvement in signs and symptoms comparable to treatment with naproxen.