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A Journal on Angiology

Official Journal of the International Union of Angiology, the International Union of Phlebology and the Central European Vascular Forum
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International Angiology 2001 March;20(1):58-65


language: English

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

Kieffer E., Bahnini A., Mouren X. *, Gamand S. **

From the Hôpital Pitié-Salpétrière, Paris, * Hôpital de la Croix Saint Simon, Paris, ** Lipha SA, Lyon, France


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.

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