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Drugs in R&D
Published in: Drugs in R&D 4/2002

01-07-2002 | Original Research Article

Acetyl-L-Carnitine (Levacecarnine) in the Treatment of Diabetic Neuropathy

A Long-Term, Randomised, Double-Blind, Placebo-Controlled Study

Authors: Dr Domenico De Grandis, Chiara Minardi

Published in: Drugs in R&D | Issue 4/2002

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Abstract

Objective: To assess the efficacy and tolerability of acetyl-L-carnitine (levacecarnine; LAC) versus placebo in the treatment of diabetic neuropathy, mainly by evaluating the effects of treatment on electrophysiological parameters and pain symptoms.
Design: This was a multicentre (n = 20), randomised, double-blind, placebo-controlled, parallel-group study.
Patients: 333 patients meeting clinical and/or neurophysiological criteria for diabetic neuropathy were enrolled.
Interventions: Patients were randomised to treatment with LAC or placebo. LAC (or placebo) was started intramuscularly at a dosage of 1000 mg/day for 10 days and continued orally at a dosage of 2000 mg/day for the remainder of the study (355 days).
Main outcome parameters and results: The main efficacy parameter was the effect of treatment on 6- and 12-month changes from baseline in nerve conduction velocity (NCV) and amplitude in the sensory (ulnar, sural and median) and motor (median, ulnar and peroneal) nerves. The effect of treatment on pain was also evaluated by means of a visual analogue scale (VAS). Among the 294 patients with impaired electrophysiological parameters at baseline, those treated with LAC showed a statistically significant improvement in mean NCV and amplitude compared with placebo (p < 0.01). The greatest changes in NCV (at 12 months) were observed in the sensory sural nerve (+5.7 m/sec in the LAC group vs +1.0 m/sec in the placebo group), sensory ulnar nerve (+2.9 vs +0.1 m/sec, respectively) and motor peroneal nerve (+2.7 vs −0.2 m/sec), whereas the greatest changes in amplitude were recorded in the motor peroneal nerve (+2.2 vs +0.1 mV). After 12 months of treatment, mean VAS scores for pain were significantly reduced from baseline by 39% in LAC-treated patients (p < 0.0 vs baseline) compared with 8% in placebo recipients. LAC was well tolerated over the study period.
Conclusions: LAC was effective and well tolerated in improving neurophysiological parameters and in reducing pain over a 1-year period. LAC is, therefore, a promising treatment option in patients with diabetic neuropathy.
Footnotes
1
Use of tradenames is for product identification only and does not imply endorsement.
 
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Metadata
Title
Acetyl-L-Carnitine (Levacecarnine) in the Treatment of Diabetic Neuropathy
A Long-Term, Randomised, Double-Blind, Placebo-Controlled Study
Authors
Dr Domenico De Grandis
Chiara Minardi
Publication date
01-07-2002
Publisher
Springer International Publishing
Published in
Drugs in R&D / Issue 4/2002
Print ISSN: 1174-5886
Electronic ISSN: 1179-6901
DOI
https://doi.org/10.2165/00126839-200203040-00001

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