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