Abstract | OBJECTIVES: This study was performed to identify a target population of claudicants for propionyl- L-carnitine treatment. BACKGROUND: Previous studies suggest that the efficacy of propionyl- L-carnitine in intermittent claudication is greater in patients with severe functional impairment than in those with mild walking disability. METHODS: After run-in, 485 claudicant patients were randomized to placebo or propionyl- L-carnitine (1 g bid, p.o.) and then stratified on the basis of maximal walking distance (cutoff point 250 m) and maximal walking distance variability (cutoff point 25%). Treatment lasted 12 months. Walking capacity was assessed by treadmill and quality of life by a questionnaire exploring various aspects of daily life. RESULTS: In the target population, that is, patients who at baseline walked < or = 250 m and showed a maximal walking distance variability < or = 25%, per-protocol analysis showed that the effect of propinyl- L-carnitine was significantly greater than that with placebo for both maximal walking distance and initial claudication distance (ICD). In the intention-to-treat population, maximal walking distance increased by 62 +/- 14% on propionyl- L-carnitine and by 46 +/- 9% (p < 0.05) on placebo, while no difference between treatments was observed for ICD. The beneficial effect of propionyl- L-carnitine was confirmed when data of the target population were pooled with those of patients who at baseline walked < or = 250 m and showed a > 25% maximal walking distance < 50% variability. Actually, maximal walking distance increased by 98 +/- 16% in the propionyl- L-carnitine group and by only 54 +/- 10% in the placebo group (p < 0.01). The corresponding values for ICD were 99 +/- 21% and 51 +/- 8% (p < 0.05). For patients with baseline maximal walking distance > 250 m, no difference between treatments was observed. CONCLUSIONS: Claudicants with maximal walking distance < or = 250 m benefited from the use of propionyl- L-carnitine, with improvement in walking distance and quality of life. However, patients with mild functional impairment (i.e., walking distance > 250 m) showed no response to propionyl- L-carnitine.
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Authors | G Brevetti, C Diehm, D Lambert |
Journal | Journal of the American College of Cardiology
(J Am Coll Cardiol)
Vol. 34
Issue 5
Pg. 1618-24
(Nov 01 1999)
ISSN: 0735-1097 [Print] United States |
PMID | 10551714
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Cardiotonic Agents
- propionylcarnitine
- Carnitine
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Topics |
- Cardiotonic Agents
(therapeutic use)
- Carnitine
(analogs & derivatives, therapeutic use)
- Double-Blind Method
- Europe
- Female
- Humans
- Intermittent Claudication
(drug therapy)
- Male
- Middle Aged
- Prospective Studies
- Quality of Life
- Treatment Outcome
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