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Clinical Trial
. 2003 Apr 1;114(5):359-64.
doi: 10.1016/s0002-9343(03)00010-x.

Effects of simvastatin on walking performance and symptoms of intermittent claudication in hypercholesterolemic patients with peripheral vascular disease

Affiliations
Clinical Trial

Effects of simvastatin on walking performance and symptoms of intermittent claudication in hypercholesterolemic patients with peripheral vascular disease

Sergio Mondillo et al. Am J Med. .

Abstract

Purpose: To analyze the effects of short-term therapy with simvastatin on walking performance in hypercholesterolemic patients with peripheral vascular disease.

Methods: Eighty-six patients with peripheral arterial disease (Fontaine stage II), intermittent claudication, and total cholesterol levels >220 mg/dL were enrolled in a randomized, placebo-controlled, double-blind study. Forty-three patients were assigned to simvastatin (40 mg/d); the remaining 43 patients were assigned to placebo treatment. All patients underwent an exercise test and clinical examination, and completed a self-assessment questionnaire at 0, 3, and 6 months. Pain-free and total walking distance, resting and postexercise ankle-brachial indexes, and questionnaire scores were determined at each follow-up.

Results: At 6 months, the mean pain-free walking distance had increased 90 meters (95% confidence interval [CI]: 64 to 116 meters; P <0.005) more in the simvastatin group than in the placebo group. Similar results were seen for the total walking distance (mean between-group difference in the change, 126 meters; 95% CI: 101 to 151 meters; P <0.001), and for the ankle-brachial index at rest (mean, 0.09; 95% CI: 0.06 to 0.12; P <0.01) and after exercise (mean, 0.19; 95% CI: 0.14 to 0.24; P <0.005). There was also a greater improvement in claudication symptoms among patients treated with simvastatin. The effects on walking performance, ankle-brachial indexes, and questionnaire scores had also been significant at 3 months.

Conclusion: High-dose short-term therapy with simvastatin may improve walking performance, ankle-brachial pressure indexes, and symptoms of claudication in hypercholesterolemic patients with peripheral vascular disease.

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