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a University of Texas, Galveston
b Louisiana State University, New Orleans
c Pharmacia Corporation, Peapack, New Jersey
d Pharmacia Corporation, Skokie, Illinois
Seema D. Dedhiya, Pharmacia Corporation, 5200 Old Orchard Road, Skokie, IL 60077 E-mail: dedhiya_seema{at}hotmail.com.
Decision Editor: John E. Morley, MB, BCh
Background. This study evaluates the impact of celecoxib on functional status, health-related quality of life (HRQOL), and safety of elderly patients (
70 years) with osteoarthritis (OA) of the knee and/or hip.
Methods. Data were pooled from three prospective, randomized, multicenter, double-blind, parallel group trials, each having a 12-week treatment period. Multicenter studies were conducted in the United States and Canada. Data for patients diagnosed with active OA of the knee and/or hip in a flare state who were 70 years of age and older were included in the comparison of therapeutic doses of celecoxib or naproxen versus placebo (N = 768). Elderly patients from each of the three trials who were randomly assigned to groups treated with a placebo, 200 mg/day of celecoxib, 400 mg/day of celecoxib, or 1000 mg/day of naproxen were included in this analysis. The Western Ontario and McMaster Universities Osteoarthritis Index was used to measure functional status. The Short Form-36 was used as a general measure of HRQOL. Safety was assessed according to the incidence and type of adverse reactions as reported by the patients and the rate of withdrawal due to adverse events.
Results. At the end of the treatment period, patients in the celecoxib groups had significant improvement in both functional status and HRQOL in comparison with the placebo group. The effects of total daily doses of 200 mg of celecoxib, 400 mg of celecoxib, and 1000 mg of naproxen on functioning and HRQOL were not found to be significantly different from each other. The incidence of serious adverse events and withdrawal from the studies due to adverse events were similar in the celecoxib groups as they were in the placebo group. Overall, the naproxen group reported a significantly higher incidence of gastrointestinal adverse events than did the placebo and the 200-mg-daily celecoxib groups.
Conclusions. This study showed that celecoxib and naproxen significantly improved functional status and HRQOL in elderly patients compared with those treated with a placebo. Celecoxib-treated patients were also found to experience safety and tolerability similar to that of the placebo-treated patients.
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