Naftidrofuryl for intermittent claudication: meta-analysis based on individual patient data

doi:10.1136/bmj.b603

Published 10 March 2009, doi:10.1136/bmj.b603
Cite this as: BMJ 2009;338:b603

Research

Naftidrofuryl for intermittent claudication: meta-analysis based on individual patient data

T De Backer, clinical cardiologist¹^,2, R Vander Stichele, research fellow¹, P Lehert, professor of statistics³, L Van Bortel, professor of clinical pharmacology¹^,2

¹ Heymans Institute of Pharmacology, Ghent University, Ghent, Belgium, ² Department of Cardiovascular Disease, University Hospital Ghent, Belgium, ³ Department of Statistics, Facultes Universitaires Catholiques de Mons, Leuven Academy, Mons, Belgium

Correspondence to: T De Backer Department of Cardiovascular Disease, University Hospital Ghent, De Pintelaan 185, 9000 Ghent, Belgium tine.debacker{at}Ugent.be

Objective To assess the efficacy of naftidrofuryl compared withplacebo in treating the symptoms of intermittent claudication.

Design Meta-analysis based on individual patient data.

Data sources Medline, International Pharmaceutical Abstracts,Embase, Science Citation Index, and the Cochrane trial registers.Reference lists of retrieved articles were checked. Authorsand companies were approached for additional information andindividual patient data.

Inclusion criteria Double blind, randomised controlled trialsin patients with intermittent claudication receiving oral naftidrofurylor placebo and with pain-free walking distance as primary outcome.

Data collection Individual patient data were collected fromelectronic data or from case report forms and checked for integrity.

Analysis All randomised patients were analysed following theintention to treat principle. Efficacy was assessed by the ratioof geometric mean of the relative improvement in pain-free walkingdistance after use of naftidrofuryl compared with placebo. Inthe analysis of responders, therapeutic success was definedas an improvement of walking distance at baseline by at least50%.

Results In total, 1266 patients were randomised (1083 in themain analysis). The ratio of relative improvement in pain-freewalking distance after use of naftidrofuryl compared with placebowas 1.37 (95% confidence interval 1.27 to 1.49). The differencein response rate was 22.3% (95% confidence interval 17.1% to27.6%) and the number needed to treat for relief of symptomsduring six months of treatment was 4.48 (95% confidence interval3.62 to 5.85).

Conclusion This meta-analysis of individual patient data providesevidence that naftidrofuryl has a clinically meaningful effectcompared with placebo in improving walking distance in patientswith intermittent claudication.

© Backer et al 2009
This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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