Deutetrabenazine Associated With Long-Term Improvements for Tardive Dyskinesia
Abnormal Involuntary Movement Scale scores were improved in both treatment groups with long-term deutetrabenazine treatment.
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NEW YORK – Deutetrabenazine (DTB) is associated with long-term improvements in abnormal movements for patients with tardive dyskinesia, per the results of a study presented at the 2018 American Psychiatric Association (APA) Annual Meeting, held May 5 to 9, 2018, in New York City.
Researchers developed an open-label safety study after 2 placebo-controlled, 12-week parent trials demonstrating the short-term efficacy and tolerability of DTB. Patients with tardive dyskinesia who had completed the DTB parent studies were eligible for the extension study after a 1-week washout period. Patients began the extension study at a baseline DTB dose of 12 mg/day, which was titrated during a 6-week period up to a maximum dose of 48 mg/day, based on dyskinesia control and individual tolerability.
Three site-rated efficacy measures were used: the Abnormal Involuntary Movement Scale (AIMS), the Clinical Global Impressions Scale (CGIC), and the Patients' Global Impression of Change Scale (PGIC), each of which has applicability in real-world clinical practice settings.
At the end of the parent studies, patients treated with DTB experienced greater mean (standard error) improvements in AIMS score (−5.0) compared with patients given placebo (−3.2). After long-term DTB treatment in the extension study, both groups experienced improvements in AIMS score (prior DTB, −7.9; prior placebo, −6.6). At the end of the parent studies, a greater proportion of patients in the DTB group experienced treatment success on the CGIC (DTB, 51%; placebo, 32%) and the PGIC (DTB, 46%; placebo, 33%).
At week 54 of the extension study, treatment success was similar across parent groups for both the CGIC (prior DTB, 66%; prior placebo, 68%) and the PGIC (prior DTB, 62%; prior placebo, 62%). Trial investigators also reported that DTB was generally well tolerated during the extension study.
Patients treated with DTB showed long-term improvements in abnormal movements per 3 site-rated efficacy measures, which may have applicability in clinical practice settings. These results underscore the DTB efficacy reported in previous 12-week double-blind trials (ARM-TD and AIM-TD).
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Anderson K, et al. Long-term improvements in site-rated outcomes with deutetrabenazine treatment in patients with tardive dyskinesia. Presented at: . American Psychiatric Association (APA) Annual Meeting; New York, NY; May 5-9. Abstract 139.