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Titolo:
A new study demonstrates the efficacy of naftidrofuryl in the treatment ofintermittent claudication - Findings of the Naftidrofuryl Clinical Ischemia Study (NCIS)
Autore:
Kieffer, E; Bahnini, A; Mouren, X; Gamand, S;
Indirizzi:
Hop La Pitie Salpetriere, Paris, France Hop La Pitie Salpetriere Paris France Pitie Salpetriere, Paris, France
Titolo Testata:
INTERNATIONAL ANGIOLOGY
fascicolo: 1, volume: 20, anno: 2001,
pagine: 58 - 65
SICI:
0392-9590(200103)20:1<58:ANSDTE>2.0.ZU;2-2
Fonte:
ISI
Lingua:
ENG
Soggetto:
QUALITY-OF-LIFE; ARTERIAL OCCLUSIVE DISEASE; EXERCISE REHABILITATION; FUNCTIONAL STATUS;
Keywords:
intermittent claudication; peripheral vascular diseases, drug therapy; vasoactive agents;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Citazioni:
25
Recensione:
Indirizzi per estratti:
Indirizzo: Gamand, S LIPHA SA, 37 Rue St Romain, F-69008 Lyon, France LIPHA SA 37 RueSt Romain Lyon France F-69008 9008 Lyon, France
Citazione:
E. Kieffer et al., "A new study demonstrates the efficacy of naftidrofuryl in the treatment ofintermittent claudication - Findings of the Naftidrofuryl Clinical Ischemia Study (NCIS)", INT ANGIOL, 20(1), 2001, pp. 58-65

Abstract

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 enteredthe 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% improvement 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 inthe 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.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 27/09/20 alle ore 12:49:39