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Effect of Deutetrabenazine on Metabolic Parameters in the Treatment of Tardive Dyskinesia

Published online by Cambridge University Press:  10 May 2021

Joohi Jimenez-Shahed
Affiliation:
Icahn School of Medicine at Mount Sinai, New York, NY, USA
Hadas Barkay
Affiliation:
Teva Pharmaceutical Industries Ltd., Netanya, Israel
Karen E. Anderson
Affiliation:
Georgetown University, Washington, DC, USA
Hubert H. Fernandez
Affiliation:
Cleveland Clinic, Cleveland, OH, USA
Stewart A. Factor
Affiliation:
Emory University, Atlanta, GA, USA
Robert A. Hauser
Affiliation:
University of South Florida, Parkinson’s Disease and Movement Disorders Center, Tampa, FL, USA
Maria Wieman
Affiliation:
Teva Pharmaceuticals, West Chester, PA, USA
Mark Forrest Gordon
Affiliation:
Teva Pharmaceuticals, West Chester, PA, USA
Juha-Matti Savola
Affiliation:
Teva Pharmaceuticals, Basel, Switzerland
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Abstract

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Background

Deutetrabenazine, a novel vesicular monoamine transporter 2 (VMAT2) inhibitor, is approved by the FDA for treatment of tardive dyskinesia (TD) in adults. Dopamine-receptor antagonists (DRAs) are associated with worsening of metabolic parameters, including weight gain, hyperlipidemia, and elevated blood glucose. This post hoc analysis assessed the short- and long-term effects of deutetrabenazine treatment on weight and metabolic parameters in individuals treated for TD.

Methods

Two 12-week, randomized placebo-controlled trials (RCTs) of deutetrabenazine for patients with TD evaluated either fixed dosing (AIM-TD; 12, 24, or 36 mg) or dose titration (ARM-TD; max dose, 48 mg/day). Patients completing ARM-TD or AIM-TD were included in an open-label extension (OLE) study, in which all patients underwent response-driven titration of deutetrabenazine from 12 mg/day up to a maximum total dose of 48 mg/day. Weight, body mass index (BMI), serum glucose, serum total cholesterol, and serum triglycerides were evaluated at baseline and during treatment in the RCTs and in the OLE.

Results

In the RCTs, 282 and 133 patients received deutetrabenazine or placebo. At baseline, 77% of patients used DRAs. At Week 12, no meaningful changes in weight were observed, with mean (standard error) weight changes of 0.9–1.2 (0.3–0.5) and 0.2 (0.3) kg in the deutetrabenazine and placebo groups, respectively, and mean BMI changes of 0.3–0.5 (0.1–0.2) and 0.1 (0.1) kg/m2. 337 patients were included in the analysis of the OLE study. No meaningful changes were observed in weight (mean change: 0.4 [0.4] kg at Week 54, –0.5 [0.6] kg at Week 106, and –1.1 [0.6] kg at Week 145) or BMI (mean change: 0.1 [0.2] kg/m2 at Week 54, –0.2 [0.2] kg/m2 at Week 106, and –0.3 [0.2] kg/m2 at Week 145). Across the studies, no meaningful changes were observed in triglyceride, cholesterol, or glucose levels.

Conclusion

Deutetrabenazine does not affect common metabolic parameters in patients with TD, even during long-term exposure.

Funding

Teva Pharmaceutical Industries Ltd., Petach Tikva, Israel

Type
Abstracts
Copyright
© The Author(s), 2021. Published by Cambridge University Press

Footnotes

Presenting Author: Joohi Jimenez-Shahed

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