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The Effects of Naftidrofuryl on Quality of Life

  • Section 2: Diagnosis of Vascular Disease and Treatment Outcome
  • Published:
Disease Management & Health Outcomes

Summary

The primary aim of treatment in patients with intermittent claudication is symptomatic improvement. This is usually determined by the change in walking distance to onset of pain measured on a treadmill. However, a more appropriate measure of treatment efficacy, especially from the point of view of patients, would be the effect on health-related quality of life. A specific instrument, the Claudication Scale (CLAU-S), has been developed in Germany and validated in Germany, France, the UK and Belgium. The CLAU-S is a multidimensional questionnaire that measures daily living, pain, complaints, social life, disease-specific anxiety, and mood.

A multicentre randomised placebo-controlled study evaluated the effect of oral naftidrofuryl 600mg daily for 6 months on health-related quality of life of patients with peripheral arterial obstructive disease and intermittent claudication (stage II). 328 patients with a perceived walking distance of less than 500 metres entered a 1-month placebo washout period; 250 with an ankle brachial index of <0.90 were randomised. 234 patients (117 in each group) were eligible for the intention-to-treat analysis. Both treatment groups were well matched demographically and with respect to the initial CLAU-S dimensions. The difference between the final and baseline values constituted the main measure for each dimension. The increase in the CLAU-S was generally greater in patients treated with naftidrofuryl than in placebo recipients. The difference was significant for daily living (p=0.004), pain frequency (p=0.002), pain intensity (p < 0.001) and, to a lesser extent, for social life (p=0.049). A multivariate test confirmed that, globally, naftidrofuryl had a better effect (p < 0.01).

This study is, to our knowledge, the first placebo-controlled study to demonstrate a significant improvement in the perceived quality of life of claudicants.

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Liard, F., Benichou, A.C., Gamand, S. et al. The Effects of Naftidrofuryl on Quality of Life. Dis-Manage-Health-Outcomes 2 (Suppl 1), 71–78 (1997). https://doi.org/10.2165/00115677-199700021-00014

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  • DOI: https://doi.org/10.2165/00115677-199700021-00014

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