Intravenous pentoxifylline for the treatment of chronic critical limb ischaemia. The European Study Group.

Abstract

To investigate the safety and efficacy of intravenous pentoxifylline infusion therapy, 600 mg twice daily for up to 21 days, for the management of patients with chronic critical limb ischaemia (CLI). A prospective, randomised, double-blind, placebo-controlled, parallel-group, multicentre trial. County and university hospitals in six European countries. A total of 314 patients suffering from CLI were enrolled: 157 patients were allocated to each treatment. Patients were reviewed after 7 days of treatment and continued in the study for up to a further 14 days if their condition had not deteriorated. Rest pain (assessed by pain score and visual analogue scale), sleep disturbances and analgesic consumption were measured. Both intention-to-treat and per protocol analyses showed significantly positive results in favour of pentoxifylline over placebo. Severity of rest pain was consistently and significantly lower as shown by the results of the pre-infusion pain scores (p = 0.007), pain visual analogue scales (p < 0.001) and scores describing rest pain-related sleep disturbances (p = 0.003). Treatment response was not influenced by the presence of diabetes mellitus or by eligibility for surgery. These results justify the use of intravenous pentoxifylline infusion therapy for the management of rest pain in patients with CLI.