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The effects of valbenazine on tardive dyskinesia in older and younger patients.
Int J Geriatr Psychiatry. 2020 01; 35(1):69-79.IJ

Abstract

OBJECTIVE

To evaluate the effects of once-daily valbenazine (40 or 80 mg/d) in older and younger adults with tardive dyskinesia (TD).

METHODS

Data were pooled from three 6-week, randomized, double-blind, placebo-controlled (DBPC) studies (KINECT [NCT01688037], KINECT 2 [NCT01733121], and KINECT 3 [NCT02274558]) and two long-term studies (KINECT 3 extension and KINECT 4 [NCT02405091]). Outcomes analyzed in older and younger participants (55 years or older and younger than 55 years, respectively) included Abnormal Involuntary Movement Scale (AIMS) response (threshold of greater than or equal to 50% improvement from baseline in total score [items 1 to 7]) and Clinical Global Impression of Change-Tardive Dyskinesia (CGI-TD) response (score 2 or less ["very much improved" or "much improved"]). Safety assessments included treatment-emergent adverse events (TEAEs).

RESULTS

At week 6 (end of DBPC treatment), the percentage of participants who met the AIMS response threshold was higher with valbenazine versus placebo in both subgroups: 55 years or older (80 mg/d, 39.7% [P < .001]; 40 mg/d, 28.6% [P < .01]; placebo, 9.7%); younger than 55 years (80 mg/d, 39.5% [P < .001]; 40 mg/d, 20.0% [P > .05]; placebo, 10.8%). The percentage of participants with CGI-TD response was also higher with valbenazine versus placebo: 55 years or older (80 mg/d, 41.3% [P < .01]; 40 mg/d, 30.2% [P > .05]; placebo, 19.4%); younger than 55 years (80 mg/d, 39.5% [P < .05]; 40 mg/d, 35.3% [P < .05]; placebo, 18.5%). Responses at week 48 (end of long-term treatment, combined doses) were as follows: 55 years or older (AIMS, 70.7%; CGI-TD, 82.8%); younger than 55 years (AIMS, 58.7%; CGI-TD, 72.3%). No significant differences between older and younger subgroups were found for AIMS or CGI-TD response. No new safety signals or TEAEs of clinical concern were found in older participants who received long-term treatment.

CONCLUSIONS

Valbenazine improved TD and was generally well tolerated in older and younger adults.

Authors+Show Affiliations

Departments of Psychiatry and of Neurology, University Hospitals Cleveland Medical Center, Cleveland, OH. Departments of Psychiatry and of Neurology, Case Western Reserve University School of Medicine, Cleveland, OH.Department of Psychiatry, Weill Cornell Medical College, New York, NY.Neurocrine Biosciences, Inc., San Diego, CA.Neurocrine Biosciences, Inc., San Diego, CA.Neurocrine Biosciences, Inc., San Diego, CA.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

31617235

Citation

Sajatovic, Martha, et al. "The Effects of Valbenazine On Tardive Dyskinesia in Older and Younger Patients." International Journal of Geriatric Psychiatry, vol. 35, no. 1, 2020, pp. 69-79.
Sajatovic M, Alexopoulos GS, Burke J, et al. The effects of valbenazine on tardive dyskinesia in older and younger patients. Int J Geriatr Psychiatry. 2020;35(1):69-79.
Sajatovic, M., Alexopoulos, G. S., Burke, J., Farahmand, K., & Siegert, S. (2020). The effects of valbenazine on tardive dyskinesia in older and younger patients. International Journal of Geriatric Psychiatry, 35(1), 69-79. https://doi.org/10.1002/gps.5218
Sajatovic M, et al. The Effects of Valbenazine On Tardive Dyskinesia in Older and Younger Patients. Int J Geriatr Psychiatry. 2020;35(1):69-79. PubMed PMID: 31617235.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The effects of valbenazine on tardive dyskinesia in older and younger patients. AU - Sajatovic,Martha, AU - Alexopoulos,George S, AU - Burke,Joshua, AU - Farahmand,Khodayar, AU - Siegert,Scott, Y1 - 2019/10/31/ PY - 2019/04/29/received PY - 2019/09/15/accepted PY - 2019/10/17/pubmed PY - 2020/11/12/medline PY - 2019/10/17/entrez KW - age KW - clinical trial KW - efficacy KW - older adults KW - safety KW - tardive dyskinesia KW - tolerability KW - valbenazine SP - 69 EP - 79 JF - International journal of geriatric psychiatry JO - Int J Geriatr Psychiatry VL - 35 IS - 1 N2 - OBJECTIVE: To evaluate the effects of once-daily valbenazine (40 or 80 mg/d) in older and younger adults with tardive dyskinesia (TD). METHODS: Data were pooled from three 6-week, randomized, double-blind, placebo-controlled (DBPC) studies (KINECT [NCT01688037], KINECT 2 [NCT01733121], and KINECT 3 [NCT02274558]) and two long-term studies (KINECT 3 extension and KINECT 4 [NCT02405091]). Outcomes analyzed in older and younger participants (55 years or older and younger than 55 years, respectively) included Abnormal Involuntary Movement Scale (AIMS) response (threshold of greater than or equal to 50% improvement from baseline in total score [items 1 to 7]) and Clinical Global Impression of Change-Tardive Dyskinesia (CGI-TD) response (score 2 or less ["very much improved" or "much improved"]). Safety assessments included treatment-emergent adverse events (TEAEs). RESULTS: At week 6 (end of DBPC treatment), the percentage of participants who met the AIMS response threshold was higher with valbenazine versus placebo in both subgroups: 55 years or older (80 mg/d, 39.7% [P < .001]; 40 mg/d, 28.6% [P < .01]; placebo, 9.7%); younger than 55 years (80 mg/d, 39.5% [P < .001]; 40 mg/d, 20.0% [P > .05]; placebo, 10.8%). The percentage of participants with CGI-TD response was also higher with valbenazine versus placebo: 55 years or older (80 mg/d, 41.3% [P < .01]; 40 mg/d, 30.2% [P > .05]; placebo, 19.4%); younger than 55 years (80 mg/d, 39.5% [P < .05]; 40 mg/d, 35.3% [P < .05]; placebo, 18.5%). Responses at week 48 (end of long-term treatment, combined doses) were as follows: 55 years or older (AIMS, 70.7%; CGI-TD, 82.8%); younger than 55 years (AIMS, 58.7%; CGI-TD, 72.3%). No significant differences between older and younger subgroups were found for AIMS or CGI-TD response. No new safety signals or TEAEs of clinical concern were found in older participants who received long-term treatment. CONCLUSIONS: Valbenazine improved TD and was generally well tolerated in older and younger adults. SN - 1099-1166 UR - https://www.unboundmedicine.com/medline/citation/31617235/The_effects_of_valbenazine_on_tardive_dyskinesia_in_older_and_younger_patients_ L2 - https://doi.org/10.1002/gps.5218 DB - PRIME DP - Unbound Medicine ER -