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Official Journal of the , the International Union of Phlebology and the
Indexed/Abstracted in: BIOSIS Previews, Current Contents/Clinical Medicine, EMBASE, PubMed/MEDLINE, Science Citation Index Expanded (SciSearch), Scopus
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D’Hooge D., Lehert P. *, Clement D. L. **
On behalf of the investigators of the NIQOL study: MERCK nv/sa, Overijse, Belgium
* Département d'Analyses Statistiques, Université de Mons, Mons, Belgium
** University Hospital, Gent, Belgium
Background. Using a disease specific questionnaire, the Claudication Scale (CLAU-S), we undertook a double blind, placebo controlled study in patients with intermittent claudication (IC) to determine whether the increase in the pain-free walking distance, previously demonstrated with naftidrofuryl, is reflected as an improvement in the patients’ quality of life.
Methods. Following an initial one month placebo run-in 235 patients, with stable IC for at least 3 months, were randomized to either naftidrofuryl (Praxilene®), at a dosage of 200 mg three times daily, or matching placebo, for 6 months. All patients completed the self-administered CLAU-S questionnaire which is divided into 6 dimensions, before the start of treatment, at 3 and at 6 months. Statistical analysis was undertaken on an intention-to-treat (ITT) basis which included all patients known to have taken at least one dose of the drug and to have provided key data on at least one occasion after baseline. For each of the CLAU-S dimensions the two groups were compared in respect to difference between the initial and final values.
Results. Two hundred and twenty patients (108 naftidrofuryl, 112 placebo) were eligible for the ITT analysis. Significant improvements, in favour of the active medication, were seen for the dimensions ‘Daily living’, ‘Pain’ and ‘Social life’ (all p<0.01). For the dimensions complaints, disease specific fears and mood, there were no significant differences between naftidrofuryl and placebo. A multivariate analysis of covariance, which took into account such factors as initial score, age and sex confirmed the global superiority of naftidrofuryl (p=0.047).
Conclusions. In this placebo controlled study, using a disease specific questionnaire, naftidrofuryl has been shown to significantly improve several aspects of the quality of life of patients with IC.