A META-ANALYSIS OF ANALGESIC EFFICACY OF ROFECOXIB 50 MG FROM 13 CLINICAL STUDIES

Background: Acute pain is a common complaint in the rheumatology setting. Rofecoxib, a selective cyclooxygenase (COX)-2 inhibitor has demonstrated efficacy in the treatment of acute pain in several studies, with efficacy similar to conventional nonsteroidal anti-inflammatory drugs and superior to selected opioid comparators.Objectives: To assess the overall analgesic efficacy of a single dose of rofecoxib 50 mg based on a meta-analysis of similarly designed acute pain studies.Methods: For inclusion in the meta-analysis, patients were required to have been treated with a single oral dose of rofecoxib 50 mg when they experienced moderate or severe pain after surgical extraction of at least two third molars (a well-validated and widely-used acute pain model); the study design involved patient randomization, double-blinding, and matching placebo; and efficacy data were available from individual patients. The overall analgesic effect was determined by patient global assessment at 24 hours based on responders (excellent, very good, good) versus non-responders (poor, fair). Total pain relief over 8 hours (TOPAR8), the time-weighted sum of pain relief scores, ranging from 0 (no relief) to 4 (complete relief), during the first 8 hours was also analyzed. The TOPAR8 scores ranged from 0 to 32.Results: Thirteen studies, involving patients treated with rofecoxib 50 mg (N=1329) or placebo (N=568) were included in the analysis. Patient characteristics were similar between rofecoxib and placebo in each study. Overall, about 60% were females, mean age was 21 years, and 68% had moderate pain at baseline. Based on patient global assessment at 24 hours, 72% of rofecoxib-treated patients were responders compared with 16% of placebo-treated patients (P<0.001). Results of rofecoxib versus placebo by TOPAR8 (17.4 vs 4.4, P<0.001) confirmed the robust overall analgesic efficacy of rofecoxib.Conclusion: In this meta-analysis involving over 1300 patients treated with a single dose of rofecoxib 50 mg, approximately three of every four patients experienced a good, very good, or excellent response even 24 hours after the dose of rofecoxib. The overall sustaineded analgesic efficacy of rofecoxib shown in global patient-reported endpoints is consistent with desired characteristics of analgesics used in the treatment of acute pain.Citation: , volume , supplement , year 2003, page Session: Psychology, measurements and management of pain