Intravenous treatment of chronic peripheral occlusive arterial disease: a double-blind, placebo-controlled, randomized, multicenter trial of pentoxifylline

Abstract

A multicenter, prospective, placebo-controlled, double-blind trial was conducted to investigate the efficacy of intravenous infusion therapy with pentoxifylline over fourteen days in patients suffering from angiographically confirmed chronic peripheral occlusive arterial disease, Fontaine stage II, with at least a six-month history. After a washout phase of one week, the patients received in accordance with a randomization scheme either an i.v. infusion of 300 mg of pentoxifylline (15 mL ampoules) or 15 mL of a 0.9% NaCl solution in 250 mL of 5% laevulose, administered over three hours twice daily. The main efficacy parameters were treadmill-assessed initial claudication distance (ICD) and absolute claudication distance (ACD). Baseline testing revealed a mean ICD of 131 m in the pentoxifylline group and 126 m in the placebo cohort; mean ACD values were 239 m and 225 m respectively. The group of patients treated with pentoxifylline (n = 75) displayed a significantly greater improvement (p less than 0.0001) in ICD (+70%) and ACD (+60%) than the placebo group did (+33%) and 32%, respectively) (n = 79). The infusions were well tolerated in both groups.