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Review
. 2023 Mar 10;58(2):125-133.
doi: 10.1093/alcalc/agac070.

Sodium Oxybate for Alcohol Dependence: A Network Meta-Regression Analysis Considering Population Severity at Baseline and Treatment Duration

Affiliations
Review

Sodium Oxybate for Alcohol Dependence: A Network Meta-Regression Analysis Considering Population Severity at Baseline and Treatment Duration

Julien Guiraud et al. Alcohol Alcohol. .

Abstract

Aims: The estimated effect of sodium oxybate (SMO) in the treatment of alcohol dependence is heterogeneous. Population severity and treatment duration have been identified as potential effect modifiers. Population severity distinguishes heavy drinking patients with <14 days of abstinence before treatment initiation (high-severity population) from other patients (mild-severity population). Treatment duration reflects the planned treatment duration. This study aimed to systematically investigate the effect of these potential effect moderators on SMO efficacy in alcohol-dependent patients.

Methods: Network meta-regression allows for testing potential effect modifiers. It was selected to investigate the effect of the above factors on SMO efficacy defined as continuous abstinence (abstinence rate) and the percentage of days abstinent (PDA). Randomized controlled trials for alcohol dependence with at least one SMO group conducted in high-severity and mild-severity populations were assigned to a high-severity and mild-severity group of studies, respectively.

Results: Eight studies (1082 patients) were retained: four in the high-severity group and four in the mild-severity group. The high-severity group was associated with larger SMO effect sizes than the mild-severity group: abstinence rate risk ratio (RR) 3.16, P = 0.004; PDA +26.9%, P < 0.001. For PDA, longer treatment duration was associated with larger SMO effect size: +11.3% per extra month, P < 0.001. In the high-severity group, SMO showed benefit: abstinence rate RR 2.91, P = 0.03; PDA +16.9%, P < 0.001. In the mild-severity group, SMO showed benefit only in PDA for longer treatment duration: +23.9%, P < 0.001.

Conclusions: In the retained studies with alcohol-dependent patients, high-severity population and longer treatment duration were associated with larger SMO effect sizes.

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Figures

Fig. 1
Fig. 1
Definitions of alcohol-dependent subpopulations according to van den Brink et al. (2018). DRL: drinking risk level see Supplementary Table S1; early abstainers: patients with > 14 consecutive days of abstinence before treatment initiation; early reducers: patients who reduce their alcohol consumption to a low or medium DRL prior to treatment initiation.
Fig. 2
Fig. 2
Flow diagram of study selection.
Fig. 3
Fig. 3
Network plot of efficacy studies in abstinence rate. SMO: sodium oxybate. Nodes represent the interventions in the network and lines show the available direct comparisons between pairs of interventions, e.g. SMO vs. placebo. The size of the nodes corresponds to the number of participants assigned to each treatment. The thickness of the line and the reported number both indicate the number of trials evaluating the specific comparison.

References

    1. Addolorato G, Lesch O-M, Maremmani I et al. (2020) Post-marketing and clinical safety experience with sodium oxybate for the treatment of alcohol withdrawal syndrome and maintenance of abstinence in alcohol-dependent subjects. Expert Opin Drug Saf 19:159–66. - PubMed
    1. van den Brink W, Aubin H-J, Bladstrom A et al. (2013) Efficacy of as-needed nalmefene in alcohol-dependent patients with at least a high drinking risk level: results from a subgroup analysis of two randomized controlled 6-month studies. Alcohol Alcohol 48:570–8. - PMC - PubMed
    1. van den Brink W, Sørensen P, Torup L et al. (2014) Long-term efficacy, tolerability and safety of nalmefene as-needed in patients with alcohol dependence: a 1-year, randomised controlled study. J Psychopharmacol 28:733–44. - PubMed
    1. van den Brink W, Addolorato G, Aubin H-J et al. (2018) Efficacy and safety of sodium oxybate in alcohol-dependent patients with a very high drinking risk level. Addict Biol 23:969–86. - PubMed
    1. Caputo F, Addolorato G, Lorenzini F et al. (2003) Gamma-hydroxybutyric acid versus naltrexone in maintaining alcohol abstinence: an open randomized comparative study. Drug Alcohol Depend 70:85–91. - PubMed

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