Intravenous Treatment of Chronic Peripheral Occlusive Arterial Disease: A Double-Blind,Placebo-Controlled,Randomized,Multicenter Trial of Pentoxifylline

Abstract

A multicenter, prospective, pla cebo-controlled, double-blind trial was conducted to investigate the effi cacy of intravenous infusion therapy with pentoxifylline over fourteen days in patients suffering from angio graphically confirmed chronic pe ripheral 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 am poules) or 15 mL of a 0.9% NaCl so lution in 250 mL of 5% laevulose, administered over three hours twice daily. The main efficacy parameters were treadmill-assessed initial claudi cation distance (ICD) and absolute claudication distance (ACD). Base line 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 im provement (p < 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.

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