ABSTRACT
BACKGROUND: Selective and nonselective nonsteroidal anti-inflammatory drugs (NSAIDs) are indicated for the treatment of juvenile idiopathic arthritis (JIA). However, the effect of NSAIDs on blood pressure (BP) in children has not been rigorously examined. METHODS: In this randomized, double-blind, multicenter, active-controlled, 6-week trial, the safety and efficacy of celecoxib (50 mg twice daily [bid] or 100 mg bid) or naproxen (7.5 mg/kg bid) was evaluated in patients aged 2-17 years with JIA. RESULTS: The least squares (LS) mean difference (celecoxib - naproxen) in change from baseline to week 6/final visit in systolic BP was 1.10 (90% confidence interval, -0.56, 2.76). No significant LS mean differences in diastolic BP relative to baseline were reported. Treatment-emergent adverse events occurred in 48% of patients in each treatment group. CONCLUSION: Both celecoxib and naproxen had no impact on BP, and both treatments had comparable safety profiles. Celecoxib, or naproxen, could be seen as suitable treatment options for pediatric patients with JIA.
ABSTRACT
OBJECTIVE: This 6-week, randomized, double-blind, parallel-group study compared the analgesic efficacy, tolerability and safety of celecoxib, naproxen and placebo in African Americans with osteoarthritis (OA) of the knee. METHODS: A total of 322 patients aged ≥ 45 years with OA of the knee in a flare state received 200 mg celecoxib orally once daily, 500 mg naproxen orally twice daily or placebo for 6 weeks. The primary endpoint was change from baseline in the Patient's Assessment of Arthritis Pain. RESULTS: Celecoxib was as effective as naproxen in reducing OA pain. Similar efficacy was observed in many of the secondary outcome measures. Celecoxib was well tolerated and demonstrated favorable upper gastro-intestinal tolerability. Improvements in outcome measures were numerically greater in the active treatment groups compared with the placebo group, but did not reach statistical significance. CONCLUSIONS: Celecoxib was as effective as naproxen in relieving OA pain in African Americans and was well tolerated. Few significant differences were observed between active treatments and placebo, possibly because of a strong placebo effect.
