title: 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.
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 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.
authors.affiliation: Department of Internal Medicine and Systemic Pathology, Medical Angiology Section, University of Catania, Catania, Italy. ssignore@unict.it
authors.forename: Salvatore Santo
authors.initials: SS
authors.lastname: Signorelli
authors.forename: Pasquale
authors.initials: P
authors.lastname: Fatuzzo
authors.forename: Francesco
authors.initials: F
authors.lastname: Rapisarda
authors.forename: Sergio
authors.initials: S
authors.lastname: Neri
authors.forename: Margherita
authors.initials: M
authors.lastname: Ferrante
authors.forename: Gea
authors.initials: G
authors.lastname: Oliveri Conti
authors.forename: Roberto
authors.initials: R
authors.lastname: Fallico
authors.forename: Luigi
authors.initials: L
authors.lastname: Di Pino
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Pennisi
authors.forename: Gabriella
authors.initials: G
authors.lastname: Celotta
authors.forename: Anzaldi
authors.initials: A
authors.lastname: Massimiliano
mesh_terms: 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
chemical_list: D000447:Aldehydes; D009566:Nitrates; D009573:Nitrites; D010919:Placebos; C003223:propionylcarnitine; D008315:Malondialdehyde; C027576:4-hydroxy-2-nonenal; D002331:Carnitine; D010100:Oxygen