AN EVALUATION OF PATIENTS WITH SEVERE INTERMITTENT CLAUDICATION AND THE EFFECT OF TREATMENT WITH NAFTIDROFURYL

A randomized placebo-controlled study was undertaken in 188 patients w ith severe intermittent claudication attending two vascular clinics in Manchester and Liverpool. After a 4-week run-in period, patients rece ived active or placebo treatment for 24 weeks. Patients were assessed on a treadmill prior to the 4-week run-in period, at randomization, an d at 8, 16, and 24 weeks. Outcome was measured in terms of change in p ain-free walking distance, maximum walking distance, and pressure indi ces. In this severe claudication population, in which the patients pre sented with a mean pain-free walking distance of 60 m, an intention-to -treat analysis demonstrated that the outcome in the naftidrofuryl-tre ated group was significantly better than in the group receiving placeb o (p = 0.045). Additionally, 7% of patients in the naftidrofuryl group deteriorated compared with 22% in the placebo group (p = 0.005). Of t he various risk factors that were recorded during the study-smoking ha bits, the presence of hypertension, diabetes, obesity, and duration of illness-only duration of illness had a significant influence on outco me. Maximum walking distances alone were not significantly influenced by treatment, but the use of a combined index of pain-free walking dis tance, maximum walking distance, and pressure indices to record succes s or failure confirmed a significant treatment effect(p = 0.047). A hi gher incidence of minor gastrointestinal symptoms was recorded in the naftidrofuryl-treated group. Treatment with naftidrofuryl was shown to prevent or slow the deterioration observed in a group of patients wit h severe claudication over a 24-week period.