Gastrointestinal tolerability and effectiveness of rofecoxib versus naproxen in the treatment of osteoarthritis: a randomized, controlled trial

Article Abstract:

Background: Gastrointestinal (GI) toxicity mediated by dual cyclooxygenase (COX)-1 and COX-2 inhibition of nonsteroidal antiinflammatory drugs (NSAIDs) can cause serious alterations of mucosal integrity or, more commonly, intolerable GI symptoms that may necessitate discontinuation of therapy. Unlike NSAIDs, rofecoxib targets only the COX-2 isoform. Objective: To assess the tolerability of rofecoxib compared with naproxen for treatment of osteoarthritis. Design: Randomized, controlled trial. Setting: 600 office and clinical research sites. Patients: 5557 patients (mean age, 63 years) with a baseline diagnosis of osteoarthritis of the knee, hip, hand, or spine. Intervention: Rofecoxib, 25 mg/d, or naproxen, 500 mg twice daily. Use of routine medications, including aspirin, was permitted. Measurements: Discontinuation due to GI adverse events (primary end point) and use of concomitant medication to treat GI symptoms (secondary end point). Efficacy was determined by patient-reported global assessment of disease status and the Australian/Canadian Osteoarthritis Hand Index, as well as discontinuations due to lack of efficacy. Patients were evaluation at baseline and at weeks 6 and 12. Results: Rates of cumulative discontinuation due to GI adverse events were statistically significantly lower in the rofecoxib group than in the naproxen group (5.9% vs. 8.1%; relative risk, 0.74 [95% CI, 0.60 to 0.92]; P = 0.005), as were rates of cumulative use of medication to treat GI symptoms (9.1% vs. 11.2%; relative risk, 0.79 [CI, 0.66 to 0.96]; P = 0.014]). Subgroup analysis of patients who used low-dose aspirin (13%) and those who previously discontinued using arthritis medication because of GI symptoms (15%) demonstrated a relative risk similar to the overall sample for discontinuation due to GI adverse events (relative risk, 0.56 [CI, 0.31 to 1.01] and 0.53 [CI, 0.34 to 0.84], respectively). No statistically significant difference was observed between treatments for efficacy in treating osteoarthritis or for occurrence of other adverse events. Conclusions: In patients with osteoarthritis treated for 12 weeks, rofecoxib, 25 mg/d, was as effective as naproxen, 500 mg twice daily, but had statistically significantly superior GI tolerability and led to less use of concomitant GI medications. Benefits of rofecoxib in subgroup analyses were consistent with findings in the overall sample.

Evaluation, COX-2 inhibitors, Author Abstract

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Toward pharmacologic modification of joint damage in osteoarthritis

Article Abstract:

It may be possible to develop a drug that would treat the disease of osteoarthritis and not merely treat its symptoms. The current treatment for this crippling joint disease is limited to simple pain killers or surgical replacement of the joint. However, these drugs are frequently inadequate, and surgery is often delayed until the patient has spent many years in pain. Compounds that may warrant further research include nonsteroidal anti-inflammatory drugs (NSAIDS), heparinoids, and tetracyclines. Attempting clinical trials with these drugs may be feasible despite reservations in the community about long-term studies.

Care and treatment, Editorial, Knee, Joint diseases

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Gastrointestinal side effects of rofecoxib and naproxen

Article Abstract:

The COX-2 inhibitor rofecoxib appears to have fewer gastrointestinal side effects than the NSAID naproxen, according to a study of 5,557 patients. Both of these drugs are used to treat the pain of osteoarthritis. However, the study only lasted three months and many patients use these drugs intermittently for long periods of time.

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