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Acetyl-L-carnitine (levacecarnine) in the treatment of diabetic neuropathy. A long-term, randomised, double-blind, placebo-controlled study.

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 (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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  • Authors+Show Affiliations

    ,

    Department of Neuroscience, Ospedale Civile, Rovigo, Italy. ddegrandis@iol.it

    Source

    Drugs in R&D 3:4 2002 pg 223-31

    MeSH

    Acetylcarnitine
    Adolescent
    Adult
    Aged
    Diabetic Neuropathies
    Double-Blind Method
    Female
    Humans
    Male
    Middle Aged
    Neural Conduction
    Pain Measurement
    Statistics, Nonparametric

    Pub Type(s)

    Clinical Trial
    Comparative Study
    Journal Article
    Multicenter Study
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    12455197

    Citation

    De Grandis, Domenico, and Chiara Minardi. "Acetyl-L-carnitine (levacecarnine) in the Treatment of Diabetic Neuropathy. a Long-term, Randomised, Double-blind, Placebo-controlled Study." Drugs in R&D, vol. 3, no. 4, 2002, pp. 223-31.
    De Grandis D, Minardi C. Acetyl-L-carnitine (levacecarnine) in the treatment of diabetic neuropathy. A long-term, randomised, double-blind, placebo-controlled study. Drugs R D. 2002;3(4):223-31.
    De Grandis, D., & Minardi, C. (2002). Acetyl-L-carnitine (levacecarnine) in the treatment of diabetic neuropathy. A long-term, randomised, double-blind, placebo-controlled study. Drugs in R&D, 3(4), pp. 223-31.
    De Grandis D, Minardi C. Acetyl-L-carnitine (levacecarnine) in the Treatment of Diabetic Neuropathy. a Long-term, Randomised, Double-blind, Placebo-controlled Study. Drugs R D. 2002;3(4):223-31. PubMed PMID: 12455197.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Acetyl-L-carnitine (levacecarnine) in the treatment of diabetic neuropathy. A long-term, randomised, double-blind, placebo-controlled study. AU - De Grandis,Domenico, AU - Minardi,Chiara, PY - 2002/11/29/pubmed PY - 2003/5/13/medline PY - 2002/11/29/entrez SP - 223 EP - 31 JF - Drugs in R&D JO - Drugs R D VL - 3 IS - 4 N2 - 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 (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. SN - 1174-5886 UR - https://www.unboundmedicine.com/medline/citation/12455197/full_citation L2 - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&amp;PAGE=linkout&amp;SEARCH=12455197.ui DB - PRIME DP - Unbound Medicine ER -