The effect of naftidrofuryl on intermittent claudication: a meta-analysis.

A meta-analysis was performed on four clinical trials, conducted during 1980-1989 in France (two trials) and in the Federal Republic of Germany (two trials). Altogether, 596 patients with peripheral arterial occlusive disease (Fontaine's classification stage II) entered these four multicenter studies. Four hundred fifty-two patients completed the trials, 241 were treated with 600 mg naftidrofuryl orally per day and 211 were given a placebo. The studies were of a double-blind parallel design and lasted for 3 or 6 months. Inclusion and exclusion criteria were comparable, as were the experimental methods used. Occasionally, differences in study design and methods were observed. Risk factors were recorded in three of the four studies. The outcome criterion of pain-free walking distance was studied for the four trials together and showed a significant improvement in the active drug tested group, following both 3- and 6-month duration of treatment. The type of treatment, the severity of the disease, the existence of blood lipid disorders, and smoking were found to be the predictive factors associated with the evolution of pain-free walking distance during 3 months. The meta-analysis confirms the beneficial effect of naftidrofuryl in treating peripheral arterial occlusive disease.