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.
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 600 mg 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 (NO(2)/NO(3)); 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 NO(2)/NO(3) ratio from baseline. In the placebo-treated group, only weakly significant or no differences were seen.


CONCLUSIONS
Intravenous administration of propionyl L-carnitine to haemodialysis patients with PAD improves both haemodynamic flow and the oxidative profile.
Signorelli
Salvatore Santo
SS
Department of Internal Medicine and Systemic Pathology, Medical Angiology Section, University of Catania, Catania, Italy. ssignore@unict.it
Fatuzzo
Pasquale
P
Rapisarda
Francesco
F
Neri
Sergio
S
Ferrante
Margherita
M
Oliveri Conti
Gea
G
Fallico
Roberto
R
Di Pino
Luigi
L
Pennisi
Giuseppe
G
Celotta
Gabriella
G
Massimiliano
Anzaldi
A
D000368:Aged; D000447:Aldehydes / Q000032:analysis; D002331:Carnitine / Q000031:analogs & derivatives* / Q000494:pharmacology; D004311:Double-Blind Method; D006801:Humans; D008315:Malondialdehyde / Q000032:analysis; D008875:Middle Aged; D009566:Nitrates / Q000378:metabolism; D009573:Nitrites / Q000378:metabolism; D010100:Oxygen / Q000378:metabolism; D016491:Peripheral Vascular Diseases / Q000188:drug therapy*; D010919:Placebos; D006435:Renal Dialysis / Q000379:methods*; D051437:Renal Insufficiency / Q000628:therapy
D000447:Aldehydes; D009566:Nitrates; D009573:Nitrites; D010919:Placebos; C003223:propionylcarnitine; D008315:Malondialdehyde; C027576:4-hydroxy-2-nonenal; D002331:Carnitine; D010100:Oxygen