In a double blind, randomized multicenter study naftidrofuryl, a vasoactive substance, was compared with placebo in the treatment of 104 patients with chronic arterial occlusive disease. After a run-in period of four weeks the patients received either naftidrofuryl (600 mg daily) or placebo over 12 weeks. The pain-free and the total walking distances improved significantly in both groups. However, the difference in the improvement of the pain-free walking distance was significant (p less than 0.02) in favour of naftidrofuryl. There also was a difference in the improvement of the total walking distance in favour of naftidrofuryl which was not significant. The results indicate that naftidrofuryl has a beneficial effect on the symptoms and lengthens the painfree walking distance in patients with arterial occlusive disease.
The efficacy of naftidrofuryl ( Dusodril ) for treatment of stage II arterial occlusive disease was evaluated in a controlled multi-centre study in a total of 104 out-patients with angiographically documented localization of occlusion. The therapeutic effect was assessed over three months by measurements of walking distance using standardized treadmill conditions. Further parameters were venoocclusive plethysmography and Doppler ultrasonography measurement of pressures. The complaint-free walking distance increased significantly during daily application of 600 mg naftidrofuryl orally (n = 54) during the 12-week assessment period when compared to the placebo group (n = 50). Taking the intraindividual variability of 17.2 m in assessment of walking distance into account, the increase of painless walking of 93 m after treatment for 12 weeks in the active-drug group is considered the result of treatment-induced increased performance.
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