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Propionyl-L-carnitine in intermittent claudication: double-blind, placebo-controlled, dose-titration, multicenter study
No full textPROPIONYL-L-CARNITINE IN INTERMITTENT CLAUDICATION - DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE TITRATION, MULTICENTER STUDY
No full textObjectives. The aim of this double-blind, placebo-controlled, dose titration, multicenter trial was to assess the efficacy and safety of propionyl-L-carnitine in intermittent claudication. Background. Human and animal studies indicate that propionyl-L-carnitine increases carnitine content and improves energy metabolism in the ischemic skeletal muscle. Methods. After a 2-week preliminary period to assess maximal walking distance, 245 patients were randomly assigned to receive propionyl-L-carnitine (n = 118) or placebo (n = 127). The initial oral dose of 500 mg twice daily was increased at 2-month intervals to 2 g/day and then to 3 g/day in patients showing improvement in treadmill performance <30% over baseline. Efficacy analysis was conducted for the 214 patients who completed the 24 weeks of treatment by comparing the effect of placebo and propionyl-L-carnitine on day 180. Results. Analysis of variance showed a significant improvement of 73 +/- 9% (mean +/- SE) in maximal walking distance with propionyl-L-carnitine (n = 99) compared with 46 +/- 6% for placebo (n = 115, p = 0.03). For distance walked at onset of claudication, propionyl-L-carnitine showed about double the improvement of placebo; however, the difference was not statistically significant. There were no changes in electrocardiographic and routine biochemical and hematologic tests that would indicate an adverse effect of propionyl-L-carnitine. Adverse events requiring drug discontinuation (II in the propionyl-L-carnitine group, 3 in the placebo group) were unrelated to study medication. The dose titration design of the study also provided information on the dose-response relation. Slightly less than 67% of patients were expected to improve their maximal walking distance by at least 30%, assuming 2 g/day of propionyl-L-carnitine (95% confidence interval 0.51 to 0.70). The response rate during the entire titration course was significantly in favor of propionyl-L-carnitine compared with placebo. Conclusions. Although the precise mode of therapeutic action requires clarification, propionyl-L-carnitine, at a dose of 1 to 2 g/day, appears to be effective and well tolerated, with minimal adverse effects
Propionyl-L-carnitine in intermittent claudication: double-blind, placebo-controlled, dose-titration, multicenter study
No full textEffect of propionyl-L-carnitine on quality of life in intermittent claudication
No full textA double-blind, dose titration study was designed to assess the efficacy of propionyl-l-carnitine in intermittent claudication. The effect on walking capacity was described in a previous article. This study reports on the effect on quality of life, assessed by the McMaster Health Index Questionnaire (MHIQ). After 24 weeks of treatment, the global MHIQ score did not show any difference from baseline in patients randomized to placebo (n = 102). Conversely, it increased from 0.59 +/- 0.12 to 0.64 +/- 0.12 in those taking propionyl-l-carnitine (n = 85). Analysis of variance showed a significant difference between treatments (p = 0.018). Stepwise multiple regression analysis identified baseline maximal walking capacity (cutoff point 250 m) as a predictor of treatment outcome. In patients walking <250 m, propionyl-L-carnitine significantly improved physical function (p = 0.027), emotional function (p = 0.002), and global MHIQ score (p = 0.002) compared with placebo. Also, for maximal walking capacity, group difference significantly favored propionyl-L-carnitine (p = 0.009). In patients with baseline maximal walking capacity greater than or equal to 250 m, propionyl-l-carnitine did not affect the MHIQ scores, nor improve walking performance. These data indicate that propionyl-l-carnitine exerts beneficial effects on quality of life and walking performance in patients with more severely limited walking capacity. (C) 1997 by Excerpta Medica Inc
Measurement of soluble adhesion molecules in primary Raynaud's phenomenon and in Raynaud's phenomenon secondary to connective tissue diseases.
No full textCarnitine-related alterations in patients with intermittent claudication. Indication for a focused carnitine therapy
No full textHigh Levels of adhesion molecules are associated with impaired endothelium-mediated vasodilation in patients with peripheral arterial disease
No full textExercise increases soluble adhesion molecules ICAM-1 and VCAM-1 in patients with intermitent claudication
No full textCarnitine-related alterations in patients with intermittent claudication: indication for a focused carnitine therapy.
No full textHigh Levels of adhesion molecules are associated with impaired endothelium-mediated vasodilation in patients with peripheral arterial disease
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