Abstract | INTRODUCTION:
Celecoxib is an effective treatment for pain associated with osteoarthritis. There are differences in patient demographics among ethnic groups, with Asian populations typically smaller in body size. As a consequence, there may be a perception that celecoxib is less effective, or has poorer tolerability in Asian patients. METHODS: This analysis compares data from two multicenter, randomized, double-blind, placebo-controlled, active-comparator trials of celecoxib for the treatment of osteoarthritis of the knee: one study in Asian patients and the other in a mixed population comprised mostly of non-Asian patients (from which Asian patients were excluded for this analysis). Each trial was of similar design, with patients randomized 2:2:1 to 6 weeks treatment with celecoxib 200 mg once daily, active comparator ( naproxen 500 mg twice daily or ibuprofen 800 mg three times daily), or placebo. The primary efficacy endpoint in each trial was the change from baseline to week 6 in the Patient's Assessment of Arthritis Pain, as measured on a visual analog scale. RESULTS: In total, 329 patients were included in the efficacy analysis, 179 in the Asian study and 150 in the non-Asian study. The Asian population was significantly older and smaller in body size (P < 0.0001). There was no significant difference between the Asian and non-Asian populations in change in pain score (95% confidence interval) at study endpoint with celecoxib [-1.1 (-7.7, 5.5); P = 0.7400] or placebo [-5.2 (-14.8, 4.4); P = 0.2870]. There were also no notable differences in safety outcomes between populations. CONCLUSIONS: Due to the smaller size of some Asian patients with OA, physicians may be tempted to decrease the dose of celecoxib below the therapeutic range recognized by regulatory authorities; these data suggest that dose changes are not necessary. FUNDING: Pfizer Inc.
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Authors | Andri Lubis, Wei Wang, Graça Lima, Rana Fayyad, Chris Walker |
Journal | Pain and therapy
(Pain Ther)
Vol. 6
Issue 2
Pg. 235-242
(Dec 2017)
ISSN: 2193-8237 [Print] New Zealand |
PMID | 28921415
(Publication Type: Journal Article)
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