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

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< or =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.

Moxifloxacin versus cephalexin in the treatment of uncomplicated skin infections.

The efficacy and safety of oral moxifloxacin (400 mg once daily, 7 days) versus cephalexin (500 mg three times daily, 7 days) were compared in a prospective, multicentre, randomised, double-blind trial in 401 adults with uncomplicated skin infections. Clinical outcome was evaluated in 351 patients. Moxifloxacin proved to be as effective as cephalexin both clinically (90% versus 91%, respectively) and bacteriologically in eradicating the most frequently isolated pathogen Staphylococcus aureus (92% and 93%, respectively). Moxifloxacin was more effective than cephalexin in eliminating Streptococcus spp. (90% and 82%, respectively). Drug-related adverse events were comparable in both treatment groups with the most frequently reported being nausea in the moxifloxacin-treated patients and headache in the cephalexin-treated patients. Medication was discontinued due to unwanted reactions in 3% of the moxifloxacin- and 4% of the cephalexin-treated patients. Moxifloxacin, 400 mg once daily for 7 days, is as safe and effective as cephalexin 500 mg three times daily for 7 days in the treatment of uncomplicated skin infections.