Effects of ethaverine hydrochloride on the walking tolerance of patients with intermittent claudication.

The effect of ethaverine hydrochloride on exercise tolerance of patients with intermittent claudication was evaluated in a double-blind, placebo-controlled study conducted at three sites. Forty-five patients with symptoms of occlusive arterial insufficiency of the lower extremities were randomly assigned to receive ethaverine 200 mg or placebo four times daily. The patients were evaluated biweekly for 12 weeks with treadmill claudication tests, patient and investigator assessments of symptom severity, and reports of adverse reactions. Doppler ankle/brachial pressure ratios were recorded for 26 patients. Walking tolerance improved for patients in both groups during the course of the study. Increases in distance-to-claudication were significantly greater for patients receiving ethaverine after 6, 8, 10, and 12 weeks of therapy. Ankle/brachial pressure index after exercise was unchanged in both groups. Incidence of adverse reactions was similar for the two groups. Although patients were generally unaware of any improvement in symptoms, the investigators judged significant relief of claudication among those receiving ethaverine compared to those receiving placebo. It was concluded that ethaverine safely increased distance-to-claudication in patients with intermittent claudication.