Effects of Naftidrofuryl in Patients With Intermittent Claudication

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Abstract
In a randomized, double-blind, placebo-controlled study in patients with peripheral arterial occlusive dis ease stage IIb of Fontaine's classifica tion, the efficacy of naftidrofuryl, a vasoactive substance, was investi gated. Forty patients — 31 men and 9 women with an average age of 62.98 ± 10.65 years — were admitted to the study. All had a history of claudica tion for at least six months. The du ration of the trial was eighteen weeks. After a washout period of two weeks the patients received either two times 400 mg naftidrofuryl or two identical placebo tablets daily for eight weeks. Subsequently a cross over from verum to placebo and vice versa was carried out and the alter native medication was administered for another eight weeks. Clinical results were evaluated by measuring painfree and maximal walking distance by treadmill test at a speed of 3.2 km/h and an inclina tion of 12°. Systolic ankle pressure and brachial pressure were measured by Doppler ultrasound, and ankle/ arm pressure ratio was calculated. Treadmill test, Doppler ultrasound examination, and laboratory data analysis were performed at the begin ning of every study period, every four weeks during and at the end of the study. Results. The patients in both groups showed an initial homogeneity of age, risk factors, concomitant dis eases, walking distance, and Doppler indices. After eight weeks naftidro furyl resulted in a statistically signifi cant increase in painfree (p < 0.02) and maximal walking distance (p < 0.05). The placebo-treated group showed only a slight, statistically nonsignificant increase in both pain free and maximal walking distance. After crossover the administration of naftidrofuryl produced a further in crease in painfree walking distance (p < 0.05), whereas in the group crossed over to placebo, both pain free and maximal walking distance remained unchanged. Systolic ankle blood pressure and ankle/arm pres sure ratio showed no significant al terations in both groups within the study period. The authors conclude that naftidrofuryl is an efficient va soactive drug, which significantly im proves walking distance in patients with peripheral arterial occlusive dis ease stage IIb.