Efficacy and tolerability of lumiracoxib versus placebo in patients with osteoarthritis of the hand.

OBJECTIVE This multicentre, randomized, double-blind, placebo-controlled parallel-group study was undertaken to investigate the efficacy, safety and tolerability of lumiracoxib (Prexige), a cyclooxygenase-2 selective inhibitor, in patients with primary osteoarthritis (OA) of the hand. METHODS The study randomized 594 patients aged > or = 18 years with symptomatic OA of the hand. Patients underwent a 3 to 7-day washout for previous nonsteroidal anti-inflammatory drugs and those with pain intensity > or = 40 mm on a 100 mm Visual Analogue Scale (VAS) in the target hand during the 24 hours prior to baseline and an increase in pain intensity of either > or = 20% or > or = 10 mm VAS since screening (whichever was greater) were randomized to lumiracoxib 200 mg once daily (od) (n=205), lumiracoxib 400 mg od (n=193) or placebo (n=196). The primary efficacy variable was overall OA pain intensity (VAS mm) in the target hand after 4 weeks of treatment. Safety and tolerability assessments were performed. RESULTS After 4 weeks of treatment, overall OA pain intensity in the target hand was significantly lower for patients treated with lumiracoxib compared with patients treated with placebo (both doses p<0.001). There was no significant difference between lumiracoxib doses in terms of the reduction in overall OA pain intensity. Lumiracoxib was well tolerated. The incidence of adverse events was similar for active treatment groups and placebo. CONCLUSIONS Lumiracoxib 200 and 400 mg od were effective and well tolerated treatments for OA of the hand. Lumiracoxib significantly improved overall OA pain intensity in the target hand versus placebo, with a tolerability profile similar to placebo.