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

Author(s): Puopolo A, Boice JA, Fidelholtz JL, Littlejohn TW, Miranda P, Berrocal A, Ko A, Cichanowitz N, Reicin AS

Affiliation(s): Milford Emergency Associates, Milford, MA, United States.

Publication date & source: 2007-12, Osteoarthritis Cartilage., 15(12):1348-56. Epub 2007 Jul 16.

Publication type:

OBJECTIVE: We compared the efficacy of etoricoxib 30mg to placebo and ibuprofen 2400mg 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 30mg q.d., or ibuprofen 800mg 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 0-100mm 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 +/-10mm. Safety and tolerability data were collected throughout the study. RESULTS: Mean baseline values for the three co-primary endpoints ranged from 62.52 to 70.14mm. 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 30mg was comparable to ibuprofen 2400mg. All treatments were similarly well tolerated. CONCLUSION: Treatment with etoricoxib 30mg q.d. provides superior efficacy vs placebo and comparable clinical efficacy vs ibuprofen 2400mg (800mg t.i.d.) for the treatment of OA of the hip and knee.