Prevalence of patient with low intensity pain symptom severity states during treatment with Rofecoxib and Ibuprofen for osteoarthritis

Aim of study: To examine the prevalence of low intensity symptom severity states in patients taking placebo, rofecoxib 12.5 mg once daily, rofecoxib 25 mg once daily, or ibuprofen 800 mg three times daily using a post-hoc definition of low pain intensity states (BLISS Index) based on the WOMAC Index. Methods: Two 6-week, double-blind, parallel-group, placebocontrolled, ibuprofen-comparator studies were conducted to measure the efficacy of rofecoxib in patients with knee or hip osteoarthritis. These studies employed a flare design requiring a minimum level of symptoms at entry following discontinuation of prior analgesics. The WOMAC Pain subscale (100 mm visual analog scale) was used as the pain measure. In separate analyses, WOMAC pain subscale scores from each patient were compared to five thresholds of pain:%5 mm, %10 mm, %15 mm, %20 mm, and %25 mm. The percent of patients with BLISS states (1) on average over 6 weeks, (2) at any time during the study, and (3) at week 6 was computed for each treatment group and threshold. The treatment group percentages were compared using Fisher’s exact test. Results: During the study, patients received placebo (N Z 143), rofecoxib 12.5 mg (N Z 461), rofecoxib 25 mg (N Z 459), or ibuprofen (N Z 465). For each pain threshold and treatment group, the percent of patients with BLISS states at any time (e.g., 50% for rofecoxib 25 mg) exceeded the percentage at week 6 (e.g., 40% for rofecoxib 25 mg) which, in turn, exceeded the percentage with BLISS states on average (e.g., 32% for rofecoxib 25 mg). The percentages of patients in the active treatment groups with BLISS states on average were significantly different than observed in the placebo group at the%15 mm threshold (8–11% points vs placebo, P ! 0.01), %20 mm level (10–15% points, P ! 0.01), and %25 mm level (14–17% points, P ! 0.001). Significant differences between the active treatments and placebo were also observed at the %10 mm threshold (8–9% points, P ! 0.05) for measurements at week 6 and at the%10 (12–14% points, P !0.001) and%5 mm thresholds (5–7% points, P ! 0.05) for patients with BLISS states at any time. Conclusion: These measures of BLISS states differentiate all three active treatment groups from placebo and further confirm, at an individual patient level, the clinical benefit of rofecoxib in the treatment of osteoarthritis. Furthermore, they provide information on the prevalence of patients achieving low (%15 mm, %20 mm, %25 mm), and very low (%5 mm, %10 mm) pain severity states.