Treatment of Acute Lumbosacral Back Pain with Diclofenac Resinate

Abstract

A 2-week multicentre, double-blind, randomised trial was conducted to evaluate the efficacy and tolerability of diclof enac resinate, a new galenic formulation of diclofenac, versus piroxicam, an established analgesic/anti-inflammatory agent, in patients suffering from acute lumbosacral back pain. Adult male or female patients complaining of moderate to severe pain at rest/on movement were treated with either diclofenac resinate 75mg twice daily or piroxicam 20mg once daily for up to 14 days; the latter group received piroxicam 40 mg/day for the first 2 days. In the 132 patients eligible for efficacy analyses (66 in each treatment group), both drugs led to comparable and clinically significant reductions in mean pain scores commencing after 3 days of treatment. Tests for spinal flexion also showed considerable improvement, as did functional capability, with no significant differences being observed between diclofenac and piroxicam. Overall evaluations of efficacy by the investigators and the patients revealed a positive response rate in 78.8 and 81.8%, respectively, in patients treated with diclofenac compared with 83.3 and 87.7%, respectively, for piroxicam. The incidence of adverse effects, most frequently gastrointestinal, was 19.7% for diclofenac resinate and 18.2% for piroxicam. The results of this controlled study show that diclofenac at a daily dosage of 150mg has efficacy similar to piroxicam 20mg with a loading dose regimen of 40mg for the symptomatic management of acute lumbosacral back pain.