Naftidrofuryl can enhance the quality of life in patients with intermittent claudication

Background: Using a disease specific questionnaire, the CLAU-S, we undertoo k a double blind, placebo controlled study in patients with intermittent cl audication to determine whether the increase in the pain-free walking dista nce, previously demonstrated with naftidrofuryl, is reflected as an improve ment in the patients' quality of life Patients and methods: 287 patients, with stable intermittent claudication f ar at least 3 months were entered into the study. Following an initial one month placebo run-in, patients were randomised to either naftidrofuryl, at a dosage of 200 mg three times daily or matching placebo, for 6 months. All patients completed the self-administered CLAU-S questionnaire which is div ided into 6 dimensions, before the start of treatment, at 3 and 6 months. S tatistical analysis was undertaken on an intention-to-treat (ITT) basis whi ch included all patients know to have taken at feast one dose of the drug a nd to have provided key data on at least one occasion after baseline. For e ach of the CLAU-S dimensions the two groups were compared with respect to d ifference between the initial and final values. Results: 255 patients (133 naftidrofuryl, 122 placebo) were eligible for th e ITT analysis. Significant improvements, in favour of the active medicatio n, were seen for the dimensions "daily living", "pain", "disease specific a nxiety" and "mood". A multivariate analysis of covariance, which took into account such factors as initial score, age and sex confirmed the global sup eriority of naftidrofuryl (p = 0.004). Conclusions: In this placebo controlled study, using a disease specific que stionnaire, naftidrofuryl has been shown to significantly improve several a spects of the quality of life of patients with intermittent claudication.