A new study demonstrates the efficacy of naftidrofuryl in the treatment ofintermittent claudication - Findings of the Naftidrofuryl Clinical Ischemia Study (NCIS)

Background. The efficacy and safety of naftidrofuryl were assessed in a dou ble blind, placebo controlled, parallel group study, in patients presenting with intermittent claudication, according to the latest European guideline s. Methods. The outpatients selected were of both sexes, aged 35 to 85, with m oderately severe chronic, stable intermittent claudication and a pain-free (PFWD) and maximum walking distance (MWD) on the treadmill of between 100 a nd 300 metres. They received naftidrofuryl 200 mg tid or placebo for six mo nths and were then assessed during a six-month follow-up period without tre atment. The primary outcome measures were the pain-free walking distance an d maximum walking distance. Results. Of the 221 selected patients, 196 were randomised and 181 entered the intention-to-treat analysis. The two groups were well matched for demog raphic variables, risk factors and history of vascular disease. After six m onths of treatment, patients who received naftidrofuryl had a 92% improveme nt of geometric pain-free walking distance versus 17% in the placebo group (p <0.001) and an 83% improvement of geometric maximum walking distance ver sus 14% in the placebo group (p <0.001). During the follow-up period withou t treatment, the walking distances of the patients in the naftidrofuryl gro up significantly decreased. The incidence of adverse events was similar in the two groups. Conclusions. This study demonstrated the efficacy of naftidrofuryl versus p lacebo in patients with intermittent claudication with a highly significant and clinically relevant difference and confirmed its good safety profile.