Published in:
01-03-2006 | Original Research Article
A Randomised, Controlled Clinical Trial Evaluating Changes in Therapeutic Efficacy and Oxidative Parameters after Treatment with Propionyl L-Carnitine in Patients with Peripheral Arterial Disease Requiring Haemodialysis
Authors:
Professor Salvatore Santo Signorelli, Pasquale Fatuzzo, Francesco Rapisarda, Sergio Neri, Margherita Ferrante, Gea Oliveri Conti, Roberto Fallico, Luigi Di Pino, Giuseppe Pennisi, Gabriella Celotta, Massimiliano Anzaldi
Published in:
Drugs & Aging
|
Issue 3/2006
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Abstract
Objective
We explored the efficacy of intravenous therapy with propionyl L-carnitine in patients with both peripheral arterial disease (PAD) and chronic renal insufficiency requiring haemodialysis.
Methods
The trial was a randomised, double-blind, placebo-controlled trial. Sixty-four patients on haemodialysis (32 per treatment arm) with chronic renal insufficiency and PAD were assigned to receive either intravenous propionyl L-carnitine 600mg or placebo 3 times weekly for 12 months. The main outcome measures were the ankle/brachial index (ABI), plasma malondialdehyde (MDA) and 4-hydroxynonenal (4-HNE) concentrations, and the plasma nitrite/nitrate ratio (NO2/NO3); these were measured at baseline and at 6 and 12 months.
Results
Significant increases in ABI were observed in the propionyl L-carnitine group, whereas in the placebo group the reverse trend was seen. In patients treated with propionyl L-carnitine, significant progressive decreases were seen in plasma MDA, 4-HNE and the NO2/NO3 ratio from baseline. In the placebo-treated group, only weakly significant or no differences were seen.
Conclusion
Intravenous administration of propionyl L-carnitine to haemodialysis patients with PAD improves both haemodynamic flow and the oxidative profile.