A randomized trial of iloprost in patients with intermittent claudication.
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 microg, 100 microg, or 150 microg 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 microg, 100 microg, and 150 microg 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.
Creager
Mark A
MA
Department of Medicine, Division of Cardiology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA. mcreager@partners.org
Pande
Reena L
RL
Hiatt
William R
WR
D000284:Administration, Oral; D000368:Aged; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D016285:Iloprost / Q000009:adverse effects / Q000627:therapeutic use*; D007383:Intermittent Claudication / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D008297:Male; D010431:Pentoxifylline / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016491:Peripheral Vascular Diseases / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D011788:Quality of Life; D020127:Recovery of Function; D017211:Treatment Failure; D014481:United States; D014665:Vasodilator Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016138:Walking
D010975:Platelet Aggregation Inhibitors; D014665:Vasodilator Agents; D016285:Iloprost; D010431:Pentoxifylline