Propionyl-L-carnitine improves exercise performance and functional status in patients with claudication

William R. Hiatt, Judith G. Regensteiner, Mark A. Creager, Alan T. Hirsch, John P. Cooke, Jeffrey W. Olin, Georgij N. Gorbunov, Jeffrey Isner, Yurij V. Lukjanov, Mihail Sh Tsitsiashvili, Tatyana F. Zabelskaya, Antonino Amato

Research output: Contribution to journalArticlepeer-review

113 Scopus citations


PURPOSE: We tested the hypothesis that propionyl-L-carnitine would improve peak walking time in patients with claudication. Secondary aims of the study were to evaluate the effects of propionyl-L-carnitine on claudication onset time, functional status, and safety. SUBJECTS AND METHODS: In this double-blind, randomized, placebo-controlled trial, 155 patients with disabling claudication from the United States (n = 72) or Russia (n = 83) received either placebo or propionyl-L-carnitine (2g/day orally) for 6 months. Subjects were evaluated at baseline and 3 and 6 months after randomization with a graded treadmill protocol at a constant speed of 2 miles per hour, beginning at 0% grade, with increments in the grade of 2% every 2 minutes until maximal symptoms of claudication forced cessation of exercise. Questionnaires were used to determine changes in functional status. RESULTS: At baseline, peak walking time was 331 ± 171 seconds in the placebo group and 331 ± 187 seconds in the propionyl-L-carnitine group. After 6 months of treatment, subjects randomly assigned to propionyl-L-carnitine increased their peak walking time by 162 ± 222 seconds (a 54% increase) as compared with an improvement of 75 ± 191 seconds (a 25% increase) for those on placebo (P <0.001). Similar improvements were observed for claudication onset time. Propionyl-L-carnitine treatment significantly improved walking distance and walking speed (by the Walking Impairment Questionnaire), and enhanced physical role functioning, reduced bodily pain, and resulted in a better health transition score (by the Medical Outcome Study SF-36 Questionnaire). The incidence of adverse events and study discontinuations were similar in the two treatment groups. CONCLUSIONS: Propionyl-L-carnitine safely improved treadmill exercise performance and enhanced functional status in patients with claudication.

Original languageEnglish
Pages (from-to)616-622
Number of pages7
JournalAmerican Journal of Medicine
Issue number8
StatePublished - 1 Jun 2001
Externally publishedYes


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