BACKGROUND: The efficacy and safety of naftidrofuryl were assessed in a double blind, placebo controlled, parallel group study, in patients presenting with intermittent claudication, according to the latest European guidelines. METHODS: The outpatients selected were of both sexes, aged 35 to 85, with moderately severe chronic, stable intermittent claudication and a pain-free (PFWD) and maximum walking distance (MWD) on the treadmill of between 100 and 300 metres. They received naftidrofuryl 200 mg tid or placebo for six months and were then assessed during a six-month follow-up period without treatment. The primary outcome measures were the pain-free walking distance and 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 demographic variables, risk factors and history of vascular disease. After six months of treatment, patients who received naftidrofuryl had a 92% im-provement of geometric pain-free walking distance versus 17% in the placebo group (p < 0.001) and an 83% improvement of geometric maximum walking distance versus 14% in the placebo group (p < 0.001). During the follow-up period without treatment, the walking distances of the patients in the naftidrofuryl group significantly decreased. The incidence of adverse events was similar in the two groups. CONCLUSIONS: This study demonstrated the efficacy of naftidrofuryl versus placebo in patients with intermittent claudication with a highly significant and clinically relevant difference and confirmed its good safety profile.
RCT Entities:
BACKGROUND: The efficacy and safety of naftidrofuryl were assessed in a double blind, placebo controlled, parallel group study, in patients presenting with intermittent claudication, according to the latest European guidelines. METHODS: The outpatients selected were of both sexes, aged 35 to 85, with moderately severe chronic, stable intermittent claudication and a pain-free (PFWD) and maximum walking distance (MWD) on the treadmill of between 100 and 300 metres. They received naftidrofuryl 200 mg tid or placebo for six months and were then assessed during a six-month follow-up period without treatment. The primary outcome measures were the pain-free walking distance and 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 demographic variables, risk factors and history of vascular disease. After six months of treatment, patients who received naftidrofuryl had a 92% im-provement of geometric pain-free walking distance versus 17% in the placebo group (p < 0.001) and an 83% improvement of geometric maximum walking distance versus 14% in the placebo group (p < 0.001). During the follow-up period without treatment, the walking distances of the patients in the naftidrofuryl group significantly decreased. The incidence of adverse events was similar in the two groups. CONCLUSIONS: This study demonstrated the efficacy of naftidrofuryl versus placebo in patients with intermittent claudication with a highly significant and clinically relevant difference and confirmed its good safety profile.