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A Double-Blind, Placebo-Controlled Study of the Effects of Policosanol in Patients with Intermittent Claudication

Rosa Más, PhD

Juan Roca, MD

Lilia Fernández

José Illnait, MD

Julio César Fernández

Eugenio Selman, MD

Rosa Más, PhD

Center of Natural Products National Center for Scientific Research PO Box 6880 or 6990, Cubanacán Havana City, Cuba

This study was undertaken to evaluate the efficacy and tolerability of policosanol, a new cholesterol-lowering drug with concomitant antiplatelet effects, in patients with inter mittent claudication. After a baseline period of 6 weeks, 62 patients were randomized to receive, under double-blind conditions, either placebo (31 patients) or policosanol (31), 10 mg twice daily. Walking distances in a treadmill (constant speed 3.2 km/hr, slope 10°) were assessed before and after 6 months of treatment. Both groups were similar at randomization. Policosanol increased significantly (p<0.01) the initial claudication distance from 132.5 ±13.5 m (baseline) to 205.7 ±36.3 m (after therapy) and the absolute claudication distance (p<0.0001) from 229.5 ±22.0 m to 365.4 _±46.9 m; meanwhile both variables remained unchanged in the placebo group (p<0.05). The reduction of lower limb symptoms showed a greater benefit in the policosanol group. There was no significant change in either group in the ankle/arm pressure ratio. The treatment was well tolerated. There were 10 discontinuations (seven placebo, three poli- cosanol) from the study. Six withdrawals occurred because of adverse events (AE); all were in placebo patients. There were five serious vascular AEs in the placebo group but none in the policosanol group (p<0.05). Overall, 12/31 (38.7%) placebo patients and 3/31 (9.7%) policosanol patients experienced AEs after randomization, which showed a lesser incidence of AEs in the policosanol group (p<0.01). The present study demon strates a beneficial effect of policosanol in patients with intermittent claudication.

Angiology, Vol. 50, No. 2, 123-130 (1999)
DOI: 10.1177/000331979905000205


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