ANALGESIC EFFICACY AND TOLERABILITY OF LYSINE-CLONIXINATE VERSUS IBUPROFEN IN PATIENTS WITH GONARTHROSIS

Patients with pain due to gonarthrosis were treated in a randomized, s ingle-blind, controlled clinical trial between March 1990 and July 199 0 to examine the efficacy and tolerability of lysine-clonixinate compa red with ibuprofen, There were 160 patients from 12 centers who were t reated in randomized order for 4 weeks with lysine-clonixinate at leas t 125 mg, 1 tablet three times a day, or ibuprofen at least 400 mg, 1 tablet three times a day. The analgesic effect of the drug was measure d for pain during all-day activity, pain during movement, intensity an d duration of morning stiffness, limitation of movement, and amount of drug necessary to control pain. The mean value of intensity of pain, documented by the patient using a visual analog scale, significantly i mproved from 57.9 mm to 29.8 mm (48% improvement from baseline) in pat ients treated with lysine-clonixinate and from 59.2 mm to 32.1 mm (46% improvement from baseline) in patients treated with ibuprofen (P < 0. 001), The most distinct pain reduction occurred within the first 3 day s of treatment (21% for lysine-clonixinate and 17% for ibuprofen). The difference between treatment groups was not statistically significant (P = 0.4). All other efficacy parameters showed similar improvement, with slight advantages for most parameters in patients treated with ly sine-clonixinate. Results of laboratory measurements and assessment of adverse events showed good tolerability.