Elsevier

Mayo Clinic Proceedings

Volume 74, Issue 11, November 1999, Pages 1095-1105
Mayo Clinic Proceedings

Original Article
Treatment of Osteoarthritis With Celecoxib, a Cyclooxygenase-2 Inhibitor: A Randomized Controlled Trial

https://doi.org/10.4065/74.11.1095Get rights and content

Objective

To compare the efficacy and safety of celecoxib, a cyclooxygenase-2 (COX-2) inhibitor, with those of naproxen, a nonsteroidal anti-inflammatory drug (NSAID), and placebo in the treatment of osteoarthritis of the knee.

Methods

In this multicenter, randomized, double-blind, placebo-controlled trial, 1003 patients with symptomatic osteoarthritis of the knee were randomly assigned to receive celecoxib at doses of 50, 100, or 200 mg twice a day; naproxen, 500 mg twice a day; or placebo for 12 weeks. Patients were evaluated with standard measures of efficacy 2 to 7 days after discontinuing previous NSAID or analgesic therapy and after 2, 6, and 12 weeks of treatment with the study drug.

Results

Celecoxib treatment led to significant improvement in the signs and symptoms of osteoarthritis as determined by all efficacy measures. Significant pain relief occurred within 2 days of the initiation of treatment, and maximum anti-inflammatory and analgesic activity, evident within 2 weeks, was sustained throughout the 12-week study. All celecoxib doses were efficacious compared with placebo, although the 50-mg twice-daily dosage regimen was minimally effective. The higher doses of celecoxib (100 and 200 mg twice a day) were similarly efficacious, and the magnitude of improvement observed with these dosing regimens was comparable to that seen with naproxen at a dose of 500 mg twice a day. All doses of celecoxib and naproxen were well tolerated.

Conclusion

COX-2 inhibition with celecoxib is an effective approach for the treatment of osteoarthritis, as seen by clinical improvement in signs and symptoms comparable to treatment with naproxen.

Section snippets

Study Population

Male and female outpatients aged 18 years or older were eligible to participate if they fulfilled the American College of Rheumatology clinical criteria for a diagnosis of primary OA of the knee and were in a functional class of I, II, or III.20, 21 Patients were required to have symptomatic OA as evidenced by a defined worsening of the signs and symptoms of the disease following discontinuation of treatment with NSAIDs or other analgesic medications or to have met other criteria if the patient

Patient Characteristics

A total of 1003 patients were enrolled in the trial. No significant differences between the 5 treatment groups were detected with respect to demographic characteristics or measures of OA disease activity at baseline (Table 1). More than 70% of the patients evaluated their condition as poor or very poor in the patient's and physician's global assessments following withdrawal from an NSAID and other analgesic therapy. The study was completed by 569 (57%) patients. Reasons for early

Discussion

The results of this large, randomized, double-blind, placebo-controlled trial show the clinical efficacy of celecoxib, an anti-inflammatory/analgesic agent that primarily inhibits COX-2 and does not inhibit COX-1 at therapeutic doses, in patients with OA of the knee. Treatment with celecoxib for a period of 12 weeks was associated in a dose-related fashion with a reduction in the signs and symptoms of OA as shown by several measures of efficacy. The magnitude of improvement observed with

Acknowledgments

The following investigators participated in this trial: John L. Baldwin, MD, Bellevue, Wash; Herbert S. B. Baraf, MD, Wheaton, Md; Scott W. Baumgartner, MD, Spokane, Wash; Anthony Bohan, MD, JD, MHA, Newport Beach, Calif; Milan L. Brandon, MD, San Diego, Calif; Francis X. Burch, MD, San Antonio, Tex; Michael C. Burnette, MD, Tampa, Fla; Barbara A. Caciolo, MD, St Louis, Mo; Jacques R. Caldwell, MD, Gainesville, Fla; Stanley B. Cohen, MD, Dallas, Tex; Selwyn A. Cohen, MD, Trumbull, Conn; Francis

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