A randomized placebo-controlled trial comparing the efficacy of etoricoxib 30 mg and ibuprofen 2400 mg for the treatment of patients with osteoarthritis

• Published in: Osteoarthritis and cartilage Vol. 15; no. 12; pp. 1348 - 1356
• Main Authors: Puopolo, A., M.D, Boice, J.A., Ph.D, Fidelholtz, J.L., M.D, Littlejohn, T.W., M.D, Miranda, P., M.D, Berrocal, A., M.D, Ko, A., M.P.H, Cichanowitz, N., M.S.J, Reicin, A.S., M.D
• Format: Journal Article
• Language: English
• Published: England Elsevier Ltd 01-12-2007
• Subjects: Adult; Aged; Aged, 80 and over; COX-2; Cyclooxygenase Inhibitors - therapeutic use; Double-Blind Method; Etoricoxib; Female; Humans; Ibuprofen; Ibuprofen - therapeutic use; Male; Middle Aged; Osteoarthritis; Osteoarthritis - drug therapy; Pain Measurement; Placebos; Pyridines - therapeutic use; Rheumatology; Selective NSAID; Statistics as Topic; Sulfones - therapeutic use; Treatment Outcome; CHF; DVT; Etoricoxib; LS; WOMAC-PFS; VAS; Patient Global Assessment of Response to Therapy; American Rheumatism Association; ANCOVA; Western Ontario and McMaster's University Osteoarthritis Index; WOMAC-PS; Ibuprofen; IGADS; congestive heart failure; Investigator Global Assessment of Response to Therapy; Selective NSAID; AE; q.d; cyclooxygenase; VA; cerebrovascular accident; ARA; PGADS; MEDAL Multinational Etoricoxib and Diclofenac Arthritis Long-term, MITT; Traditional NSAIDs; least squares; WOMAC; Patient Global Assessment of Disease Status; Osteoarthritis; analysis of covariance; WOMAC Physical Function Subscale; IGART; COX-2; gastroprotective agents; once daily; OA; analysis of variance; ANOVA; visual analog; CV cardiovascular, CVA; GPAs; t.i.d; WOMAC Pain Subscale; PGART; CI; visual analog scale; COX; Investigator Global Assessment of Disease Status; deep vein thrombosis; adverse experience; confidence interval; three times daily; Traditional nonsteroidal anti-inflammatory drugs; modified intention-to-treat
• ISSN: 1063-4584; 1522-9653
• DOI: 10.1016/j.joca.2007.05.022

Summary Objective We compared the efficacy of etoricoxib 30 mg to placebo and ibuprofen 2400 mg for the treatment of osteoarthritis (OA) of the hip and knee. Design In this 12-week, randomized, double-blind, placebo- and active-comparator-controlled trial, 548 patients (median age 63 years) with OA of the hip or knee were randomized to receive placebo, etoricoxib 30 mg q.d., or ibuprofen 800 mg t.i.d. Demonstration of etoricoxib's efficacy vs placebo and comparison of its efficacy to ibuprofen were assessed using three co-primary endpoints: Western Ontario and McMaster's University Osteoarthritis Index (WOMAC) Pain Subscale (WOMAC-PS); WOMAC Physical Function Subscale (WOMAC-PFS); and Patient Global Assessment of Disease Status (PGADS). Each primary endpoint utilizes a 0–100 mm visual analog scale. To demonstrate comparable efficacy of etoricoxib vs ibuprofen, the 95% confidence intervals (CIs) for the difference in the least squares (LS) mean change over 12 weeks for all three co-primary endpoints had to fall within ±10 mm. Safety and tolerability data were collected throughout the study. Results Mean baseline values for the three co-primary endpoints ranged from 62.52 to 70.14 mm. Both etoricoxib and ibuprofen demonstrated superior ( P ≤ 0.002) efficacy for all primary endpoints. The LS mean (mm) changes (95% CI) over 12 weeks for etoricoxib and ibuprofen, respectively, compared to placebo were given as follows: WOMAC-PS: −11.66 (−16.31, −7.01) and −7.62 (−12.30, −2.94); WOMAC-PFS: −10.15 (−14.74, −5.57) and −7.23 (−11.85, −2.61); PGADS: −11.65 (−16.81, −6.50) and −8.11 (−13.30, −2.92). The efficacy of etoricoxib 30 mg was comparable to ibuprofen 2400 mg. All treatments were similarly well tolerated. Conclusion Treatment with etoricoxib 30 mg q.d. provides superior efficacy vs placebo and comparable clinical efficacy vs ibuprofen 2400 mg (800 mg t.i.d.) for the treatment of OA of the hip and knee.