Effect of propionyl-L-carnitine on a background of monitored exercise in patients with claudication secondary to peripheral artery disease.
OBJECTIVE
Exercise training is established for the treatment of peripheral artery disease; however the additional benefit of pharmacologic therapy with exercise has not been studied. This trial tested the hypothesis that propionyl-L-carnitine (PLC), in combination with monitored home-based exercise training, would improve treadmill peak walking time (PWT) over exercise training alone.


METHODS
Subjects with claudication were randomized to 6 months of therapy with PLC (2 g daily, n = 32) or matching placebo (n = 30). After supervised exercise instruction, all subjects performed exercise training sessions 3 times a week for 30 to 50 minutes/session and compliance was monitored by activity monitors and diary. Change in PWT was the primary outcome measure with other functional assessments predefined as secondary endpoints.


RESULTS
After 6 months of treatment, patients randomized to training and placebo had an increase in PWT of 218 ± 367 seconds, while those randomized to training plus PLC had an increase of 266 ± 243 seconds, P = .258. Across the total study cohort, the dose of exercise training (total number of minutes of exercise of at least moderate intensity) was correlated with the change in PWT (r = 0.259, P = .048), suggesting that the monitored exercise was effective in improving walking performance in both treatment arms.


CONCLUSIONS
In all subjects, the increase in PWT from baseline to month 6 was correlated with the amount of exercise training. However, although favoring PLC, the combination of exercise training and PLC did not result in a statistically significant benefit in peak treadmill performance or quality of life compared with exercise alone.
Hiatt
William R
WR
University of Colorado School of Medicine, Division of Cardiology and CPC Clinical Research, Aurora, Colorado 80045, USA. Will.Hiatt@UCDenver.edu
Creager
Mark A
MA
Amato
Antonino
A
Brass
Eric P
EP
D002316:Cardiotonic Agents / Q000494:pharmacology / Q000627:therapeutic use*; D002331:Carnitine / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use; D004311:Double-Blind Method; D005080:Exercise Test / Q000187:drug effects*; D005081:Exercise Therapy / Q000379:methods*; D005260:Female; D006801:Humans; D007383:Intermittent Claudication / Q000188:drug therapy* / Q000628:therapy; D008297:Male; D058729:Peripheral Arterial Disease / Q000188:drug therapy* / Q000628:therapy; D011788:Quality of Life; D016138:Walking / Q000502:physiology
D002316:Cardiotonic Agents; C003223:propionylcarnitine; D002331:Carnitine