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

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

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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.

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Acknowledgements

This study was funded by Sigma-Tau, Italy.

LAC in Diabetic Neuropathy Study Group (Italy): Prof. F. Angeleri (Università degli Studi, Ancona), Prof. R. Badino (Ospedale S. Corona, Pietra Ligure), Dr F. Bellavere (Ospedale Civile, Padova), Prof. G. Cazzato (Ospedale Cattinara, Trieste), Dr C.A. De Fanti (Ospedali Riuniti, Bergamo), Prof. T. Di Perri (Università degli Studi, Siena), Dr F. Galeone (Ospedale Civile, Pescia), Dr A. Giustina (Università degli Studi, Brescia), Prof. R. Lucchi (Ospedale Estense, Modena), Dr M. Mantero (Ospedale Civile, Savona), Prof. C. Morocutti (Policlinico Umberto I, Roma), Dr C. Noacco (Ospedale Civile, Udine), Dr F. Orio (Ospedale Civile, Eboli), Dr A. Parente (Ospedali Riuniti, Foggia), Prof. F. Piccoli (Università degli Studi, Palermo), Dr I. Sacco (Ospedale S. Carlo), Dr P. Simone (Ospedale Casa Sollievo della Sofferenza, S. Giovanni Rotondo, Foggia), Dr C. Teodonio (Ospedale S. Giovanni-Addolorata, Roma), Dr A. Venezia (Ospedali Riuniti, Matera), Prof. D. Zerbi (Ospedale S. Carlo Borromeo, Milano).

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Authors and Affiliations

  1. Department of Neurology, Ospedale Civile, Via Tre Martiri 140, I-45100, Rovigo, Italy

    Domenico De Grandis

  2. Neurology Unit, Bufalini Hospital, Cesena, Italy

    Chiara Minardi

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  1. Domenico De Grandis
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  2. Chiara Minardi
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Correspondence to Domenico De Grandis.

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De Grandis, D., Minardi, C. Acetyl-L-Carnitine (Levacecarnine) in the Treatment of Diabetic Neuropathy. Drugs R&D 3, 223–231 (2002). https://doi.org/10.2165/00126839-200203040-00001

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