Levo-α-acetylmethadol (LAAM) induced QTc-prolongation - results from a controlled clinical trial





Professorship/Faculty: Professur für Pathopsychologie 
Author(s): Wieneke, H.; Conrads, H.; Wolstein, Jörg ; Breuckmann, F.; Gastpar, M.; Erbel, R.; Scherbaum, N.
Pages / Size: 7-12
Title of the Journal: European Journal of Medical Research
Language(s): English
Corporate Body: Deutsche AIDS-Gesellschaft
Publisher Information: London
Volume: 14
Issue: 7
Publisher Information: BioMed Central
Year of publication: 2009
Abstract: 
Background
Due to potential proarrhythmic side-effects levo-α-Acetylmethadol (LAAM) is currently not available in EU countries as maintenance drug in the treatment of opiate addiction. However, recent studies and meta-analyses underline the clinical advantages of LAAM with respect to the reduction of heroin use. Thus a reappraisal of LAAM has been demanded. The aim of the present study was to evaluate the relative impact of LAAM on QTc-interval, as a measure of pro-arrhythmic risk, in comparison to methadone, the current standard in substitution therapy.

Methods
ECG recordings were analysed within a randomized, controlled clinical trial evaluating the efficacy and tolerability of maintenance treatment with LAAM compared with racemic methadone. Recordings were done at two points: 1) during a run-in period with all patients on methadone and 2) 24 weeks after randomisation into methadone or LAAM treatment group. These ECG recordings were analysed with respect to QTc-values and QTc-dispersion. Mean values as well as individual changes compared to baseline parameters were evaluated. QTc-intervals were classified according to CPMP-guidelines.

Results
Complete ECG data sets could be obtained in 53 patients (31 LAAM-group, 22 methadone-group). No clinical cardiac complications were observed in either group. After 24 weeks, patients receiving LAAM showed a significant increase in QTc-interval (0.409 s ± 0.022 s versus 0.418 s ± 0.028 s, p = 0.046), whereas no significant changes could be observed in patients remaining on methadone. There was no statistically significant change in QTc-dispersion in either group. More patients with borderline prolonged and prolonged QTc-intervals were observed in the LAAM than in the methadone treatment group (n = 7 vs. n = 1; p = 0.1).

Conclusions
In this controlled trial LAAM induced QTc-prolongation in a higher degree than methadone. Given reports of severe arrhythmic events, careful ECG-monitoring is recommended under LAAM medication.
Keywords: LAAM, methadone, opiate addiction, cardiac arrhythmia, QTc-interval
DOI: 10.1186/2047-783X-14-1-7
Document Type: Article
URI: https://fis.uni-bamberg.de/handle/uniba/44810
Release date: 21. November 2018


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