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A randomized trial of iloprost in patients with intermittent claudication

Department of Medicine, Division of Cardiology, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA

Reena L Pande

Department of Medicine, Division of Cardiology, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA

William R Hiatt

Department of Medicine, University of Colorado School of Medicine, and the Colorado Prevention Center, Denver, CO, USA

Abstract

Prostanoids, which promote vasodilation and reduce platelet aggregation, have been proposed as candidate therapies for intermittent claudication due to peripheral arterial disease (PAD). However, studies of these medications have yielded inconsistent results. This study tested the hypothesis that iloprost, an oral prostacyclin analogue, would improve walking distance and quality of life in patients with intermittent claudication. The study was a multi-center, randomized, double-blind, placebo-controlled trial comparing three doses of oral iloprost (50 µg, 100 µg, or 150 µg twice daily), pentoxifylline, or placebo in 430 patients with intermittent claudication. The primary outcome measure was improvement in absolute claudication distance (ACD) after 6 months. Secondary outcomes included initial claudication distance and quality of life assessment. Placebo increased ACD by 3.3%, and iloprost increased peak ACD by 7.7%, 8.8% and 11.2% at the 50 µg, 100 µg, and 150 µg twice-daily doses, respectively (all insignificant relative to placebo). Pentoxifylline increased ACD by 13.9% relative to placebo (p = 0.039). Neither iloprost nor pentoxifylline enhanced quality of life. These results indicate that oral iloprost is not effective in improving exercise performance or quality of life in patients with PAD who have intermittent claudication.

Key Words: iloprost • intermittent claudication • pentoxifylline • peripheral arterial disease • randomized controlled trial

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