Treatment of tardive dyskinesia with VMAT-2 inhibitors: a systematic review and meta-analysis of randomized controlled trials
Open accessAbstract
Aim: The aim of this study was to summarize the characteristics, efficacy, and safety of vesicular monoamine transporter-2 (VMAT-2) inhibitors for treating tardive dyskinesia (TD). Materials and methods: We conducted a literature search in PubMed, Cochrane Database, and ClinicalTrials.gov , screening for systematic reviews, meta-analyses or double-blind, randomized, placebo-controlled trials (DBRPCTs) reporting efficacy or safety data of VMAT-2 inhibitors (tetrabenazine, deutetrabenazine, and valbenazine) in patients with TD. A random effects meta-analysis of efficacy and safety data from DBRPCTs was performed. Results: Two acute, 12-week DBRPCTs with deutetrabenazine 12–48 mg/day (n=413) and 4 acute, 4–6-week double-blind trials with valbenazine 12.5–100 mg/day (n=488) were meta-analyzable, without meta-analyzable, high-quality data for tetrabenazine. Regarding reduction in total Abnormal Involuntary Movement Scale (AIMS) scores (primary outcome), both deutetrabenazine (k=2, n=413, standardized mean difference [SMD] =-0.40, 95% confidence interval [CI] =-0.19, -0.62, p <0.001; weighted mean difference (WMD) =-1.44, 95% CI =-0.67, -2.19, p <0.001) and valbenazine (k=4, n=421, SMD =-0.58, 95% CI =-0.26, -0.91, p <0.001; WMD =-2.07, 95% CI =-1.08, -3.05, p <0.001) significantly outperformed placebo. Results were confirmed regarding responder rates (≥50% AIMS total score reduction; deutetrabenazine: risk ratio [RR] =2.13, 95% CI =1.10, 4.12, p =0.024, number-needed-to-treat [NNT] =7, 95% CI =3, 333, p =0.046; valbenazine: RR =3.05, 95% CI =1.81, 5.11, p <0.001, NNT =4, 95% CI =3, 6, p <0.001). Less consistent results emerged from patient-rated global impression-based response ( p =0.15) and clinical global impression for deutetrabenazine ( p =0.088), and for clinical global impression change for valbenazine ( p =0.67). In an open-label extension (OLE) study of deutetrabenazine (≤54 weeks) and a dose-blinded valbenazine study (≤48 weeks), responder rates increased over time. With valbenazine, discontinuation effects were studied, showing TD symptom recurrence towards baseline severity levels within 4 weeks after valbenazine withdrawal. No increased cumulative or specific adverse (AEs) events versus placebo (acute trials) in extension versus acute trial data were observed. Conclusion: The 2 VMAT-2 inhibitors, valbenazine and deutetrabenazine, are effective in treating TD, both acutely and long-term, without concerns about increased risk of depression or suicide in the TD population. No head-to-head comparison among VMAT-2 inhibitors and no high-quality, meta-analyzable data are available for tetrabenazine in patients with TD. Keywords: tetrabenazine, deutetrabenazine, valbenazine, tardive dyskinesia, VMAT-2
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In most low- and middle-income countries, less than 1% of the health budget is spent on mental health.
“In most LMICs, less than 1% of the health budget is spent on mental health.310”
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- Authors
- Solmi, M., Pigato, G., Kane, J. M., & Correll, C.
- Affiliations
- University of Padua (IT)
- Azienda Ospedale - Università Padova (IT)
- Northwell Health (US)
- Corresponding author
- Correll, Christoph
- Venue
- Drug Design Development and Therapy
- Publisher
- Informa UK Limited
- Published
- 2018-05
- Volume
- Volume 12
- Pages
- 1215-1238
- ISSN
- 1177-8881 (ISSN-L)
- PMC
- PMC5958944
- OpenAlex
- W2801534436
- Cited by
- 88
- References
- 89
- Citations by year
- 2026: 7 · 2025: 16 · 2024: 15 · 2023: 6 · 2022: 6 · 2021: 11 · 2020: 11 · 2019: 15 · 2018: 1
- FWCI
- 1.44
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Drug Design Development and Therapy (publishedVersion, cc-by-nc)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Dove Medical Press (Taylor and Francis Group) (submittedVersion, cc-by-nc)
- Padua Research Archive (University of Padova) (submittedVersion)
- Funders
- Bristol-Myers Squibb
- Pfizer
- Teva Pharmaceutical Industries
- Sunovion
- Les Laboratories Pierre Fabre
- H. Lundbeck A/S
- Allergan
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
- Health Sciences › Medicine › Neurology › Parkinson's Disease Mechanisms and Treatments
- Health Sciences › Medicine › Neurology › Neurological disorders and treatments
- Keywords
- tardive dyskinesia, deutetrabenazine, valbenazine, tetrabenazine, treatment efficacy, drug safety, adverse events, antipsychotic-induced movement disorders, antiparkinsonian drugs, responder rate, number needed to treat, number needed to harm, placebo comparison
- MeSH terms
- Tardive Dyskinesia, Humans, Tetrabenazine, Antipsychotic Agents, Valine, Randomized Controlled Trials as Topic, Vesicular Monoamine Transport Proteins
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