A META-ANALYSIS OF ONSET OF ANALGESIC EFFICACY OF ROFECOXIB 50 MG FROM 11 CLINICAL STUDIES

Background: Rheumatology patients can develop acute pain in a variety of settings, such as a flare of an arthritic condition, in which fast pain relief is desired. Rofecoxib is a selective cyclooxygenase (COX)-2 inhibitor which has demonstrated rapid relief from acute pain in several studies.Objectives: To determine the rapidity and consistency of the onset of 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, the two-stopwatch method was to have been utilized to determine the time to onset; patients were treated with a single oral dose of rofecoxib 50 mg when they experienced moderate to 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 onset data were available from individual patients. Onset of analgesic efficacy was determined by time to confirmed perceptible pain relief (the time to perceptible pain relief for patients achieving meaningful pain relief), using the two-stopwatch method. The percent of patients achieving confirmed perceptible pain relief was also determined.Results: Eleven studies, involving 1219 patients treated with rofecoxib 50 mg were identified for the meta-analysis. Two studies were excluded from the meta-analysis since the two-stopwatch method was not used. Overall, 60% were females, mean age was 21 years, and 66% had moderate pain at baseline. The median time to confirmed perceptible pain relief was 34 minutes (95% CI, 31 to 38 minutes). Statistical tests of the hazard ratio did not detect significant heterogeneity across studies (P=0.126). The estimates of median time to confirmed perceptible pain relief in 10 of 11 studies were within 10 minutes of the combined estimate. Seventy seven percent of rofecoxib patients achieved confirmed perceptible pain relief.Conclusion: In this meta-analysis of 11 randomized, double-blind, placebo-controlled studies involving over 1200 patients, a single dose of rofecoxib 50 mg provided analgesic efficacy with consistent onset in approximately a half hour. The rapid onset of action demonstrated in this analysis supports the use of rofecoxib in the treatment of acute pain.Citation: , volume , supplement , year 2003, page Session: Psychology, measurements and management of pain