DOUBLE-BLIND, CONTROLLED, MULTICENTER STUDY OF INDOBUFEN VERSUS PLACEBO IN PATIENTS WITH INTERMITTENT CLAUDICATION

The objective of the study was to evaluate the efficacy and safety of indobufen compared with placebo in the treatment of moderately severe intermittent claudication. The study consisted of a four-week single-b lind, placebo-controlled run-in phase, followed by a six-month double- blind randomized treatment period. A total of 302 patients were alloca ted to treatment with either placebo (154 patients) or indobufen (148) 200 mg twice daily. The results of the overall intention-to-treat ana lysis of the study population showed statistically significant superio rity of indobufen over placebo after six months for both the initial ( ICD) and absolute claudication distances (ACD). The ICD before treatme nt with indobufen or placebo averaged 137.9 +/- 68.2 and 136.6 +/- 63. 2 m (mean +/- SD), respectively. After six months' treatment with acti ve drug or placebo, this parameter reached 227.9 +/- 174.4 and 153.1 /- 86.8 m (mean +/- SD), respectively (p<0.01). Similar results were o btained on ACD. The reduction of lower limb symptoms also suggested a greater clinical benefit in the indobufen-treated patients. There was no significant change in either group in the ankle/arm pressure ratio at the end of treatment. Adverse events of any type were reported by 1 8 patients (12.2 %) in the indobufen group and by 11 patients (7.2 %) in the placebo group. The mechanism whereby the drug is effective in t his clinical condition could be related to both its antiplatelet and h emorheologic effects.