Conclusions In this controlled trial LAAM induced QTc-prolongation in a higher degree than methadone. More patients with borderline prolonged and prolonged QTc-intervals were observed in the LAAM than in the methadone treatment group (n = 7 vs. There was no statistically significant change in QTc-dispersion 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. No clinical cardiac complications were observed in either group. Results Complete ECG data sets could be obtained in 53 patients (31 LAAM-group, 22 methadone-group. QTc-intervals were classified according to CPMP-guidelines. Mean values as well as individual changes compared to baseline parameters were evaluated.
These ECG recordings were analysed with respect to QTc-values and QTc-dispersion. 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. 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. 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. Thus a reappraisal of LAAM has been demanded. However, recent studies and meta-analyses underline the clinical advantages of LAAM with respect to the reduction of heroin use. Levo-α-acetylmethadol ( LAAM induced QTc-prolongation - results from a controlled clinical trialĭirectory of Open Access Journals (Sweden)įull Text Available 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. Buprenorphine is associated with less QTc prolongation than levomethadyl or methadone and may be a safe alternative. The levomethadyl and methadone groups were significantly more likely to manifest a QTc greater than 470 or 490 milliseconds (28% for the levomethadyl group vs 23% for the methadone group vs 0% for the buprenorphine group P methadone group ) compared with the buprenorphine group (2% of subjects P methadone remained fixed over at least 8 weeks, the QTc continued to increase progressively over time (P =. Baseline QTc was similar in the 3 groups.
The prespecified end points were a QTc greater than 470 milliseconds in men (or >490 milliseconds in women), or an increase from baseline in QTc greater than 60 milliseconds. Patients were randomized to receive treatment with levomethadyl, methadone, or buprenorphine (hereinafter, levomethadyl, methadone, and buprenorphine groups, respectively). Analyses were limited to the 154 patients with a normal baseline QTc = (QT/ radical R-R) who had at least 1 subsequent in-treatment electrocardiogram. We analyzed 12-lead electrocardiograms collected at baseline and every 4 weeks from 165 opioid-addicted participants in a 17-week randomized double-blind clinical trial of equally effective doses of levomethadyl, methadone, and buprenorphine at a major referral center. To compare the effects of 3 known hERG-associated channel blockers on the corrected QT (QTc), we conducted a randomized, controlled trial of opioid-addicted subjects. Each blocks the human ether-a-go-go-related gene (hERG)-associated channel in vitro and represents a risk for QT prolongation. Levomethadyl acetate, methadone hydrochloride, and buprenorphine hydrochloride are equally effective treatments for opioid dependence. Wedam, Erich F Bigelow, George E Johnson, Rolley E Nuzzo, Paul A Haigney, Mark C P QT-interval effects of methadone, levomethadyl, and buprenorphine in a randomized trial.
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