Abstract Details

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

Topic Movement Disorders

Presentation(s) S11 - Huntington's Disease, Tardive Dyskinesia, and Functional Movement Disorders (5:06 PM-5:18 PM)

Poster/Presentation
Number 009

Objective To assess the short- and long-term effects of deutetrabenazine treatment on weight and metabolic parameters in individuals treated for tardive dyskinesia (TD).

Background Deutetrabenazine, a novel vesicular monoamine transporter 2 (VMAT2) inhibitor, is approved by the FDA for treatment of TD in adults. Dopamine-receptor antagonists (DRAs) are associated with worsening of metabolic parameters, including weight gain, hyperlipidemia, and elevated blood glucose.

Design/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. The OLE enrolled 343 patients; no meaningful weight change was observed (mean change: 0.4 [0.4] kg at Week 54 and –0.5 [0.6] kg at Week 106). Across the studies, no meaningful changes were observed in triglyceride, cholesterol, or glucose levels.

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

Authors/Disclosures
Joohi Jimenez Shahed, MD (Icahn School of Medicine at Mount Sinai) PRESENTER	Dr. Jimenez Shahed has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Teva. Dr. Jimenez Shahed has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Medtronic. Dr. Jimenez Shahed has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. Dr. Jimenez Shahed has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amneal. Dr. Jimenez Shahed has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for BlueRock. Dr. Jimenez Shahed has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Treefrog. Dr. Jimenez Shahed has received personal compensation in the range of $500-$4,999 for serving as a Consultant for RebrAIn. Dr. Jimenez Shahed has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for BlueRock Therapeutics. Dr. Jimenez Shahed has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for PhotoPharmics. Dr. Jimenez Shahed has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Emalex. Dr. Jimenez Shahed has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biohaven. The institution of Dr. Jimenez Shahed has received research support from Amneal. The institution of Dr. Jimenez Shahed has received research support from Annovis. The institution of Dr. Jimenez Shahed has received research support from SAGE. The institution of Dr. Jimenez Shahed has received research support from Ono Pharmaceuticals. The institution of Dr. Jimenez Shahed has received research support from BlueRock. The institution of Dr. Jimenez Shahed has received research support from Neuron23. Dr. Jimenez Shahed has received personal compensation in the range of $0-$499 for serving as a Faculty with Movement Disorders Society. Dr. Jimenez Shahed has received personal compensation in the range of $500-$4,999 for serving as a Faculty with ��ɫ��. Dr. Jimenez Shahed has received personal compensation in the range of $500-$4,999 for serving as a Grant Reviewer with Parkinson Foundation.
	No disclosure on file
Karen E. Anderson	Ms. Anderson has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for teva. Ms. Anderson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for AskBio. The institution of Ms. Anderson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for novartis. The institution of Ms. Anderson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche Biogen. Ms. Anderson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurocrine. The institution of Ms. Anderson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Ms. Anderson has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for neurocrine. Ms. Anderson has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Medscape. Ms. Anderson has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for atheneum. Ms. Anderson has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for GLG. Ms. Anderson has received personal compensation in the range of $500-$4,999 for serving as a scientific advisor with CHDI.
Hubert H. Fernandez, MD, FAAN (Center for Neurological Restoration, Cleveland Clinic)	Dr. Fernandez has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. Dr. Fernandez has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amneal. Dr. Fernandez has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Intrance. Dr. Fernandez has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Fernandez has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie. Dr. Fernandez has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Elsevier. Dr. Fernandez has received publishing royalties from a publication relating to health care. Dr. Fernandez has received personal compensation in the range of $10,000-$49,999 for serving as a Steering Committee/Advisory Committee Member with Parkinson Study Group.
Stewart A. Factor, DO, FAAN (Emory University School of Medicine)	Dr. Factor has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Neurocrine. Dr. Factor has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Factor has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Takeda. The institution of Dr. Factor has received research support from Biohaven. The institution of Dr. Factor has received research support from Neurocrine. The institution of Dr. Factor has received research support from Supernus. The institution of Dr. Factor has received research support from Sun Pharmaceuticals Advanced Research Company. The institution of Dr. Factor has received research support from Aspen. The institution of Dr. Factor has received research support from RHO. Dr. Factor has received publishing royalties from a publication relating to health care. Dr. Factor has received publishing royalties from a publication relating to health care. Dr. Factor has received publishing royalties from a publication relating to health care. Dr. Factor has received publishing royalties from a publication relating to health care.
Robert A. Hauser, MD, MBA, FAAN (Movement Disorders Center)	Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Kyowa Kirin Pharmaceuticals. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Neurocrine Biosciences. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for NeuroDerm. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Revance Therapeutics. Dr. Hauser has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Supernus Pharma. Dr. Hauser has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Abbvie. Dr. Hauser has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Amneal. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Regenxbio. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Forsee Pharmaceuticals. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for KiefeRx. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Mitsubishi Tanabe. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Intrance. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Zambon. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Truebinding. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Serina Therapeutics. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Nano PharmaSolutions. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for HanAll. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cerevel. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sorridi Therapeutics. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Conterra Pharma. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Clario. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Theravance. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Photopharmics. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Cerevance. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for NDP Pharmaceuticals. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Stoparkinson. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Inhibikase. The institution of Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Stoparkinson. The institution of Dr. Hauser has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Photopharmics. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amneal . Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Kyowa Kirin. Dr. Hauser has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Neurocrine Biosciences. Dr. Hauser has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Supernus. Dr. Hauser has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Abbvie. Dr. Hauser has stock in Inhibikase. Dr. Hauser has stock in Axial Therapeutics. Dr. Hauser has stock in Enterin. The institution of Dr. Hauser has received research support from Annovis Bio, Inc.. The institution of Dr. Hauser has received research support from Inhibikase Therapeutics. The institution of Dr. Hauser has received research support from AbbVie, Inc.. The institution of Dr. Hauser has received research support from Biogen MA. The institution of Dr. Hauser has received research support from Cavion, Inc.. The institution of Dr. Hauser has received research support from Cerevance Beta, Inc.. The institution of Dr. Hauser has received research support from Cerevel Therapeutics. The institution of Dr. Hauser has received research support from Enterin, Inc.. The institution of Dr. Hauser has received research support from Genentech. The institution of Dr. Hauser has received research support from Global Kinetics Corporation. The institution of Dr. Hauser has received research support from Hoffman-La Roche Inc. The institution of Dr. Hauser has received research support from Michael J. Fox Foundation for Parkinson's Research. The institution of Dr. Hauser has received research support from National Parkinson's Foundation. The institution of Dr. Hauser has received research support from Neuroderm. The institution of Dr. Hauser has received research support from Sage Therapeutics. The institution of Dr. Hauser has received research support from Scion NeuroStim. The institution of Dr. Hauser has received research support from UCB BioPharma. The institution of Dr. Hauser has received research support from UCB. The institution of Dr. Hauser has received research support from Amneal Pharmaceuticals. The institution of Dr. Hauser has received research support from Motric Bio, Inc.. The institution of Dr. Hauser has received research support from Sun Pharma Advanced Research Company. The institution of Dr. Hauser has received research support from Teva Branded Pharmaceuticals. The institution of Dr. Hauser has received research support from Truebinding, Inc.. Dr. Hauser has received intellectual property interests from a discovery or technology relating to health care.
Maria Wieman, MPH	No disclosure on file
Mark F. Gordon, MD, FAAN (Teva Pharmaceuticals)	Dr. Gordon has received personal compensation for serving as an employee of Teva. Dr. Gordon has stock in Teva.
	No disclosure on file

��ɫ����

��ɫ����

��ɫ��

��ɫ��