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The effects of valbenazine on tardive dyskinesia in older and younger patients.

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Title: The effects of valbenazine on tardive dyskinesia in older and younger patients.
Authors: Sajatovic, Martha (AUTHOR), Alexopoulos, George S. (AUTHOR), Burke, Joshua (AUTHOR), Farahmand, Khodayar (AUTHOR), Siegert, Scott (AUTHOR)
Source: International Journal of Geriatric Psychiatry. Jan2020, Vol. 35 Issue 1, p69-79. 11p. 4 Charts, 2 Graphs.
Subjects: Tardive dyskinesia, Older patients, Older people, Young adults, Adverse health care events
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. [ABSTRACT FROM AUTHOR]
Copyright of International Journal of Geriatric Psychiatry is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Database: Psychology and Behavioral Sciences Collection
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DbLabel: Psychology and Behavioral Sciences Collection
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PubType: Academic Journal
PubTypeId: academicJournal
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  Label: Title
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  Data: The effects of valbenazine on tardive dyskinesia in older and younger patients.
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  Data: &lt;searchLink fieldCode=&quot;AR&quot; term=&quot;%22Sajatovic%2C+Martha%22&quot;&gt;Sajatovic, Martha&lt;/searchLink&gt; (AUTHOR)&lt;br /&gt;&lt;searchLink fieldCode=&quot;AR&quot; term=&quot;%22Alexopoulos%2C+George+S%2E%22&quot;&gt;Alexopoulos, George S.&lt;/searchLink&gt; (AUTHOR)&lt;br /&gt;&lt;searchLink fieldCode=&quot;AR&quot; term=&quot;%22Burke%2C+Joshua%22&quot;&gt;Burke, Joshua&lt;/searchLink&gt; (AUTHOR)&lt;br /&gt;&lt;searchLink fieldCode=&quot;AR&quot; term=&quot;%22Farahmand%2C+Khodayar%22&quot;&gt;Farahmand, Khodayar&lt;/searchLink&gt; (AUTHOR)&lt;br /&gt;&lt;searchLink fieldCode=&quot;AR&quot; term=&quot;%22Siegert%2C+Scott%22&quot;&gt;Siegert, Scott&lt;/searchLink&gt; (AUTHOR)
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  Data: &lt;searchLink fieldCode=&quot;JN&quot; term=&quot;%22International+Journal+of+Geriatric+Psychiatry%22&quot;&gt;International Journal of Geriatric Psychiatry&lt;/searchLink&gt;. Jan2020, Vol. 35 Issue 1, p69-79. 11p. 4 Charts, 2 Graphs.
– Name: Subject
  Label: Subjects
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  Data: &lt;searchLink fieldCode=&quot;DE&quot; term=&quot;%22Tardive+dyskinesia%22&quot;&gt;Tardive dyskinesia&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;DE&quot; term=&quot;%22Older+patients%22&quot;&gt;Older patients&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;DE&quot; term=&quot;%22Older+people%22&quot;&gt;Older people&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;DE&quot; term=&quot;%22Young+adults%22&quot;&gt;Young adults&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;DE&quot; term=&quot;%22Adverse+health+care+events%22&quot;&gt;Adverse health care events&lt;/searchLink&gt;
– Name: Abstract
  Label: Abstract
  Group: Ab
  Data: &lt;bold&gt;Objective: &lt;/bold&gt;To evaluate the effects of once-daily valbenazine (40 or 80&#160;mg/d) in older and younger adults with tardive dyskinesia (TD).&lt;bold&gt;Methods: &lt;/bold&gt;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&#160;years or older and younger than 55&#160;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 [&quot;very much improved&quot; or &quot;much improved&quot;]). Safety assessments included treatment-emergent adverse events (TEAEs).&lt;bold&gt;Results: &lt;/bold&gt;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&#160;years or older (80&#160;mg/d, 39.7% [P&#160;&lt;&#160;.001]; 40&#160;mg/d, 28.6% [P&#160;&lt;&#160;.01]; placebo, 9.7%); younger than 55&#160;years (80&#160;mg/d, 39.5% [P&#160;&lt;&#160;.001]; 40&#160;mg/d, 20.0% [P&#160;&gt;&#160;.05]; placebo, 10.8%). The percentage of participants with CGI-TD response was also higher with valbenazine versus placebo: 55&#160;years or older (80&#160;mg/d, 41.3% [P&#160;&lt;&#160;.01]; 40&#160;mg/d, 30.2% [P&#160;&gt;&#160;.05]; placebo, 19.4%); younger than 55&#160;years (80&#160;mg/d, 39.5% [P&#160;&lt;&#160;.05]; 40&#160;mg/d, 35.3% [P&#160;&lt;&#160;.05]; placebo, 18.5%). Responses at week 48 (end of long-term treatment, combined doses) were as follows: 55&#160;years or older (AIMS, 70.7%; CGI-TD, 82.8%); younger than 55&#160;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.&lt;bold&gt;Conclusions: &lt;/bold&gt;Valbenazine improved TD and was generally well tolerated in older and younger adults. [ABSTRACT FROM AUTHOR]
– Name: AbstractSuppliedCopyright
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  Data: &lt;i&gt;Copyright of International Journal of Geriatric Psychiatry is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites without the copyright holder&#39;s express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.&lt;/i&gt; (Copyright applies to all Abstracts.)
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RecordInfo BibRecord:
  BibEntity:
    Identifiers:
      – Type: doi
        Value: 10.1002/gps.5218
    Languages:
      – Code: eng
        Text: English
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      Pagination:
        PageCount: 11
        StartPage: 69
    Subjects:
      – SubjectFull: Tardive dyskinesia
        Type: general
      – SubjectFull: Older patients
        Type: general
      – SubjectFull: Older people
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      – SubjectFull: Young adults
        Type: general
      – SubjectFull: Adverse health care events
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      – TitleFull: The effects of valbenazine on tardive dyskinesia in older and younger patients.
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            NameFull: Sajatovic, Martha
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            NameFull: Alexopoulos, George S.
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            NameFull: Burke, Joshua
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            NameFull: Farahmand, Khodayar
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            NameFull: Siegert, Scott
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              Text: Jan2020
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              Value: 35
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            – TitleFull: International Journal of Geriatric Psychiatry
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