In:
Psychiatry and Clinical Neurosciences, Wiley, Vol. 76, No. 11 ( 2022-11), p. 560-569
Abstract:
Valbenazine is approved in the US for treatment of tardive dyskinesia (TD); however, efficacy/safety data in Asian populations are lacking. We assessed the efficacy/safety of valbenazine in Japanese patients. Methods This phase II/III, multicenter, randomized, double‐blind, placebo‐controlled study (NCT03176771) included adult psychiatric patients with TD, who were randomly allocated to receive placebo or valbenazine (once‐daily 40‐ or 80‐mg) for a 6‐week, double‐blind period, after which the placebo group was switched to valbenazine for a 42‐week extension. The primary endpoint was change from baseline in Abnormal Involuntary Movement Scale (AIMS) total score at Week 6; clinical global impression of improvement of TD (CGI‐TD) was also assessed. Results Of 256 patients, 86, 85, and 85 were allocated to the 40‐mg valbenazine, 80‐mg valbenazine, and placebo groups, respectively. Least‐squares mean (95% confidence interval) change from baseline in AIMS score at Week 6 was −2.3 (−3.0 to −1.7) in the valbenazine 40‐mg group, −3.7 (−4.4 to −3.0) in the 80‐mg group, and −0.1 (−0.8 to 0.5) in the placebo group; both treatment groups showed statistically significant improvements vs. placebo. Patients switched to valbenazine at Week 6 showed similar improvements in AIMS scores, which were maintained to Week 48. Improvements in CGI‐TD scores were observed for both treatment groups vs. placebo. Incidence of adverse events was highest in the 80‐mg group; common events included nasopharyngitis, somnolence, schizophrenia worsening, hypersalivation, insomnia, and tremor. Conclusion The efficacy/safety profile of valbenazine was similar to that of previous clinical trials, supporting its use for TD treatment in Japanese patients.
Type of Medium:
Online Resource
ISSN:
1323-1316
,
1440-1819
Language:
English
Publisher:
Wiley
Publication Date:
2022
detail.hit.zdb_id:
2010264-1
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