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[PMID]:28320223
[Au] Autor:Hauser RA; Factor SA; Marder SR; Knesevich MA; Ramirez PM; Jimenez R; Burke J; Liang GS; O'Brien CF
[Ad] Endereço:From the Departments of Neurology and Molecular Pharmacology and Physiology, University of South Florida, Tampa; the Department of Neurology, Emory University, Atlanta; the Department of Psychiatry, University of California, Los Angeles; University Hills Clinical Research, Irving, Tex.; the Departme
[Ti] Título:KINECT 3: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial of Valbenazine for Tardive Dyskinesia.
[So] Source:Am J Psychiatry;174(5):476-484, 2017 May 01.
[Is] ISSN:1535-7228
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:OBJECTIVE: Tardive dyskinesia is a persistent movement disorder induced by dopamine receptor blockers, including antipsychotics. Valbenazine (NBI-98854) is a novel, highly selective vesicular monoamine transporter 2 inhibitor that demonstrated favorable efficacy and tolerability in the treatment of tardive dyskinesia in phase 2 studies. This phase 3 study further evaluated the efficacy, safety, and tolerability of valbenazine as a treatment for tardive dyskinesia. METHOD: This 6-week, randomized, double-blind, placebo-controlled trial included patients with schizophrenia, schizoaffective disorder, or a mood disorder who had moderate or severe tardive dyskinesia. Participants were randomly assigned in a 1:1:1 ratio to once-daily placebo, valbenazine at 40 mg/day, or valbenazine at 80 mg/day. The primary efficacy endpoint was change from baseline to week 6 in the 80 mg/day group compared with the placebo group on the Abnormal Involuntary Movement Scale (AIMS) dyskinesia score (items 1-7), as assessed by blinded central AIMS video raters. Safety assessments included adverse event monitoring, laboratory tests, ECG, and psychiatric measures. RESULTS: The intent-to-treat population included 225 participants, of whom 205 completed the study. Approximately 65% of participants had schizophrenia or schizoaffective disorder, and 85.5% were receiving concomitant antipsychotics. Least squares mean change from baseline to week 6 in AIMS dyskinesia score was -3.2 for the 80 mg/day group, compared with -0.1 for the placebo group, a significant difference. AIMS dyskinesia score was also reduced in the 40 mg/day group (-1.9 compared with -0.1). The incidence of adverse events was consistent with previous studies. CONCLUSIONS: Once-daily valbenazine significantly improved tardive dyskinesia in participants with underlying schizophrenia, schizoaffective disorder, or mood disorder. Valbenazine was generally well tolerated, and psychiatric status remained stable. Longer trials are necessary to understand the long-term effects of valbenazine in patients with tardive dyskinesia.
[Mh] Termos MeSH primário: Antipsicóticos/efeitos adversos
Transtornos do Humor/tratamento farmacológico
Transtornos Psicóticos/tratamento farmacológico
Esquizofrenia/tratamento farmacológico
Discinesia Tardia/tratamento farmacológico
Tetrabenazina/análogos & derivados
Valina/análogos & derivados
[Mh] Termos MeSH secundário: Escala de Movimento Involuntário Anormal
Adulto
Idoso
Antipsicóticos/uso terapêutico
Relação Dose-Resposta a Droga
Método Duplo-Cego
Quimioterapia Combinada
Feminino
Seres Humanos
Masculino
Meia-Idade
Discinesia Tardia/diagnóstico
Tetrabenazina/efeitos adversos
Tetrabenazina/uso terapêutico
Resultado do Tratamento
Valina/efeitos adversos
Valina/uso terapêutico
[Pt] Tipo de publicação:CLINICAL TRIAL, PHASE III; COMPARATIVE STUDY; JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Antipsychotic Agents); 54K37P50KH (valbenazine); HG18B9YRS7 (Valine); Z9O08YRN8O (Tetrabenazine)
[Em] Mês de entrada:1706
[Cu] Atualização por classe:170619
[Lr] Data última revisão:
170619
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170322
[St] Status:MEDLINE
[do] DOI:10.1176/appi.ajp.2017.16091037



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