Loading…
Long-Term Safety and Efficacy of Deutetrabenazine in Younger and Older Patients With Tardive Dyskinesia
•What is the primary question addressed by this study?This post hoc analysis of a long-term open-label extension study evaluated the efficacy and safety of treatment with deutetrabenazine in younger (
Saved in:
| Published in: | The American journal of geriatric psychiatry 2022-03, Vol.30 (3), p.360-371 |
|---|---|
| Main Authors: | , , , , , , |
| Format: | Article |
| Language: | English |
| Subjects: | |
| Citations: | Items that this one cites Items that cite this one |
| Online Access: | Get full text |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| cited_by | cdi_FETCH-LOGICAL-c428t-51d81cbf869e003444a327e458dbb394d6d8797620fedbe9733b5e2472882fa63 |
|---|---|
| cites | cdi_FETCH-LOGICAL-c428t-51d81cbf869e003444a327e458dbb394d6d8797620fedbe9733b5e2472882fa63 |
| container_end_page | 371 |
| container_issue | 3 |
| container_start_page | 360 |
| container_title | The American journal of geriatric psychiatry |
| container_volume | 30 |
| creator | Sajatovic, Martha Finkbeiner, Stacy Wilhelm, Amanda Barkay, Hadas Chaijale, Nayla Gross, Nicholas Gordon, Mark Forrest |
| description | •What is the primary question addressed by this study?This post hoc analysis of a long-term open-label extension study evaluated the efficacy and safety of treatment with deutetrabenazine in younger ( |
| doi_str_mv | 10.1016/j.jagp.2021.08.003 |
| format | article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2572213969</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S1064748121004243</els_id><sourcerecordid>2641594976</sourcerecordid><originalsourceid>FETCH-LOGICAL-c428t-51d81cbf869e003444a327e458dbb394d6d8797620fedbe9733b5e2472882fa63</originalsourceid><addsrcrecordid>eNp9kUuLFDEUhYMozjj6B1xIwI2bKvOqVArcyMz4gIYRbBFXIZXctCm7Uz1JaqD99abt0YULV7mL75zcew5CzylpKaHy9dROZrNvGWG0JaolhD9A57QTXdMzKh7WmUjR9ELRM_Qk54kQIgcpHqMzLjpKOefnaLOa46ZZQ9rhz8ZDOWATHb72PlhjD3j2-AqWAiWZEaL5GSLgEPG3eYkbSL_Zm62r0ydTAsSS8ddQvuO1SS7cAb465B9VkoN5ih55s83w7P69QF_eXa8vPzSrm_cfL9-uGiuYKk1HnaJ29EoOUO8RQhjOehCdcuPIB-GkU_3QS0Y8uBGGnvOxAyZ6phTzRvIL9Orku0_z7QK56F3IFrZbE2FesmZdzxjlgxwq-vIfdJqXFOt2mklBu0HUjyrFTpRNc84JvN6nsDPpoCnRxxr0pI816GMNmihd166iF_fWy7gD91fyJ_cKvDkBULO4C5B0tjU_Cy4ksEW7OfzP_xfXLJee</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2641594976</pqid></control><display><type>article</type><title>Long-Term Safety and Efficacy of Deutetrabenazine in Younger and Older Patients With Tardive Dyskinesia</title><source>ScienceDirect (Elsevier)</source><creator>Sajatovic, Martha ; Finkbeiner, Stacy ; Wilhelm, Amanda ; Barkay, Hadas ; Chaijale, Nayla ; Gross, Nicholas ; Gordon, Mark Forrest</creator><creatorcontrib>Sajatovic, Martha ; Finkbeiner, Stacy ; Wilhelm, Amanda ; Barkay, Hadas ; Chaijale, Nayla ; Gross, Nicholas ; Gordon, Mark Forrest</creatorcontrib><description>•What is the primary question addressed by this study?This post hoc analysis of a long-term open-label extension study evaluated the efficacy and safety of treatment with deutetrabenazine in younger (<55 years) and older (≥55 years) research study participants with tardive dyskinesia.•What is the main finding of this study?Long-term treatment with deutetrabenazine was associated with sustained improvements in total motor Abnormal Involuntary Movement Scale (AIMS) score, treatment success, and improved quality of life, and was well tolerated in both younger and older adults with tardive dyskinesia.•What is the meaning of the finding?Findings from this analysis may help inform clinicians how to manage tardive dyskinesia, particularly in patients ≥55 years of age.
To assess long-term safety and efficacy of deutetrabenazine in younger (<55 years) and older (≥55 years) adult participants with tardive dyskinesia (TD).
Three-year, single-arm, open-label extension (OLE) study enrolling participants who completed the 12-week, pivotal ARM-TD or AIM-TD studies.
Seventy-six centers in the United States and Europe.
A total of 337 participants with TD (119 younger and 218 older).
Deutetrabenazine was initiated at 12 mg/day and titrated once weekly by 6 mg/day using a response-driven dosing regimen until adequate dyskinesia control was reached or a clinically significant adverse event occurred.
This post hoc analysis assessed change and percent change from baseline in total motor Abnormal Involuntary Movement Scale (AIMS) score, response rates for ≥50% AIMS improvement, Clinical Global Impression of Change (CGIC), Patient Global Impression of Change (PGIC), and safety in younger and older participants with TD.
After 3 years of open-label treatment, mean deutetrabenazine dose was ∼39.5 mg/day in both groups. Mean±SE changes from baseline in total motor AIMS score were –6.7 ± 0.62 and –6.5 ± 0.47 in younger and older participants, respectively (percent changes: –61.4% ± 4.10% and –54.6% ± 3.01%); 76% of younger and 62% of older participants achieved ≥50% AIMS response. Most younger and older participants achieved treatment success per CGIC (67% and 76%) and PGIC (64% and 63%). Deutetrabenazine was generally well tolerated in both groups.
Deutetrabenazine treatment was associated with sustained improvements in total motor AIMS score, treatment success, and improved quality of life, and was well tolerated in younger and older adults with TD in this 3-year OLE study.</description><identifier>ISSN: 1064-7481</identifier><identifier>EISSN: 1545-7214</identifier><identifier>DOI: 10.1016/j.jagp.2021.08.003</identifier><identifier>PMID: 34511333</identifier><language>eng</language><publisher>England: Elsevier Inc</publisher><subject>Adrenergic Uptake Inhibitors - adverse effects ; Aged ; Clinical outcomes ; Clinical significance ; Deutetrabenazine ; Drug administration ; Drug therapy ; Dyskinesia ; efficacy ; elderly ; Geriatrics ; Humans ; Middle Aged ; Quality of Life ; safety ; tardive dyskinesia ; Tardive Dyskinesia - chemically induced ; Tardive Dyskinesia - complications ; Tardive Dyskinesia - drug therapy ; Tetrabenazine - adverse effects ; Tetrabenazine - analogs & derivatives ; Treatment Outcome</subject><ispartof>The American journal of geriatric psychiatry, 2022-03, Vol.30 (3), p.360-371</ispartof><rights>2021 The Authors</rights><rights>Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.</rights><rights>Copyright Elsevier Limited Mar 2022</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c428t-51d81cbf869e003444a327e458dbb394d6d8797620fedbe9733b5e2472882fa63</citedby><cites>FETCH-LOGICAL-c428t-51d81cbf869e003444a327e458dbb394d6d8797620fedbe9733b5e2472882fa63</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S1064748121004243$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>314,776,780,3536,27901,27902,45756</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/34511333$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Sajatovic, Martha</creatorcontrib><creatorcontrib>Finkbeiner, Stacy</creatorcontrib><creatorcontrib>Wilhelm, Amanda</creatorcontrib><creatorcontrib>Barkay, Hadas</creatorcontrib><creatorcontrib>Chaijale, Nayla</creatorcontrib><creatorcontrib>Gross, Nicholas</creatorcontrib><creatorcontrib>Gordon, Mark Forrest</creatorcontrib><title>Long-Term Safety and Efficacy of Deutetrabenazine in Younger and Older Patients With Tardive Dyskinesia</title><title>The American journal of geriatric psychiatry</title><addtitle>Am J Geriatr Psychiatry</addtitle><description>•What is the primary question addressed by this study?This post hoc analysis of a long-term open-label extension study evaluated the efficacy and safety of treatment with deutetrabenazine in younger (<55 years) and older (≥55 years) research study participants with tardive dyskinesia.•What is the main finding of this study?Long-term treatment with deutetrabenazine was associated with sustained improvements in total motor Abnormal Involuntary Movement Scale (AIMS) score, treatment success, and improved quality of life, and was well tolerated in both younger and older adults with tardive dyskinesia.•What is the meaning of the finding?Findings from this analysis may help inform clinicians how to manage tardive dyskinesia, particularly in patients ≥55 years of age.
To assess long-term safety and efficacy of deutetrabenazine in younger (<55 years) and older (≥55 years) adult participants with tardive dyskinesia (TD).
Three-year, single-arm, open-label extension (OLE) study enrolling participants who completed the 12-week, pivotal ARM-TD or AIM-TD studies.
Seventy-six centers in the United States and Europe.
A total of 337 participants with TD (119 younger and 218 older).
Deutetrabenazine was initiated at 12 mg/day and titrated once weekly by 6 mg/day using a response-driven dosing regimen until adequate dyskinesia control was reached or a clinically significant adverse event occurred.
This post hoc analysis assessed change and percent change from baseline in total motor Abnormal Involuntary Movement Scale (AIMS) score, response rates for ≥50% AIMS improvement, Clinical Global Impression of Change (CGIC), Patient Global Impression of Change (PGIC), and safety in younger and older participants with TD.
After 3 years of open-label treatment, mean deutetrabenazine dose was ∼39.5 mg/day in both groups. Mean±SE changes from baseline in total motor AIMS score were –6.7 ± 0.62 and –6.5 ± 0.47 in younger and older participants, respectively (percent changes: –61.4% ± 4.10% and –54.6% ± 3.01%); 76% of younger and 62% of older participants achieved ≥50% AIMS response. Most younger and older participants achieved treatment success per CGIC (67% and 76%) and PGIC (64% and 63%). Deutetrabenazine was generally well tolerated in both groups.
Deutetrabenazine treatment was associated with sustained improvements in total motor AIMS score, treatment success, and improved quality of life, and was well tolerated in younger and older adults with TD in this 3-year OLE study.</description><subject>Adrenergic Uptake Inhibitors - adverse effects</subject><subject>Aged</subject><subject>Clinical outcomes</subject><subject>Clinical significance</subject><subject>Deutetrabenazine</subject><subject>Drug administration</subject><subject>Drug therapy</subject><subject>Dyskinesia</subject><subject>efficacy</subject><subject>elderly</subject><subject>Geriatrics</subject><subject>Humans</subject><subject>Middle Aged</subject><subject>Quality of Life</subject><subject>safety</subject><subject>tardive dyskinesia</subject><subject>Tardive Dyskinesia - chemically induced</subject><subject>Tardive Dyskinesia - complications</subject><subject>Tardive Dyskinesia - drug therapy</subject><subject>Tetrabenazine - adverse effects</subject><subject>Tetrabenazine - analogs & derivatives</subject><subject>Treatment Outcome</subject><issn>1064-7481</issn><issn>1545-7214</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><recordid>eNp9kUuLFDEUhYMozjj6B1xIwI2bKvOqVArcyMz4gIYRbBFXIZXctCm7Uz1JaqD99abt0YULV7mL75zcew5CzylpKaHy9dROZrNvGWG0JaolhD9A57QTXdMzKh7WmUjR9ELRM_Qk54kQIgcpHqMzLjpKOefnaLOa46ZZQ9rhz8ZDOWATHb72PlhjD3j2-AqWAiWZEaL5GSLgEPG3eYkbSL_Zm62r0ydTAsSS8ddQvuO1SS7cAb465B9VkoN5ih55s83w7P69QF_eXa8vPzSrm_cfL9-uGiuYKk1HnaJ29EoOUO8RQhjOehCdcuPIB-GkU_3QS0Y8uBGGnvOxAyZ6phTzRvIL9Orku0_z7QK56F3IFrZbE2FesmZdzxjlgxwq-vIfdJqXFOt2mklBu0HUjyrFTpRNc84JvN6nsDPpoCnRxxr0pI816GMNmihd166iF_fWy7gD91fyJ_cKvDkBULO4C5B0tjU_Cy4ksEW7OfzP_xfXLJee</recordid><startdate>202203</startdate><enddate>202203</enddate><creator>Sajatovic, Martha</creator><creator>Finkbeiner, Stacy</creator><creator>Wilhelm, Amanda</creator><creator>Barkay, Hadas</creator><creator>Chaijale, Nayla</creator><creator>Gross, Nicholas</creator><creator>Gordon, Mark Forrest</creator><general>Elsevier Inc</general><general>Elsevier Limited</general><scope>6I.</scope><scope>AAFTH</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>4T-</scope><scope>K9.</scope><scope>7X8</scope></search><sort><creationdate>202203</creationdate><title>Long-Term Safety and Efficacy of Deutetrabenazine in Younger and Older Patients With Tardive Dyskinesia</title><author>Sajatovic, Martha ; Finkbeiner, Stacy ; Wilhelm, Amanda ; Barkay, Hadas ; Chaijale, Nayla ; Gross, Nicholas ; Gordon, Mark Forrest</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c428t-51d81cbf869e003444a327e458dbb394d6d8797620fedbe9733b5e2472882fa63</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Adrenergic Uptake Inhibitors - adverse effects</topic><topic>Aged</topic><topic>Clinical outcomes</topic><topic>Clinical significance</topic><topic>Deutetrabenazine</topic><topic>Drug administration</topic><topic>Drug therapy</topic><topic>Dyskinesia</topic><topic>efficacy</topic><topic>elderly</topic><topic>Geriatrics</topic><topic>Humans</topic><topic>Middle Aged</topic><topic>Quality of Life</topic><topic>safety</topic><topic>tardive dyskinesia</topic><topic>Tardive Dyskinesia - chemically induced</topic><topic>Tardive Dyskinesia - complications</topic><topic>Tardive Dyskinesia - drug therapy</topic><topic>Tetrabenazine - adverse effects</topic><topic>Tetrabenazine - analogs & derivatives</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Sajatovic, Martha</creatorcontrib><creatorcontrib>Finkbeiner, Stacy</creatorcontrib><creatorcontrib>Wilhelm, Amanda</creatorcontrib><creatorcontrib>Barkay, Hadas</creatorcontrib><creatorcontrib>Chaijale, Nayla</creatorcontrib><creatorcontrib>Gross, Nicholas</creatorcontrib><creatorcontrib>Gordon, Mark Forrest</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Docstoc</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><jtitle>The American journal of geriatric psychiatry</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Sajatovic, Martha</au><au>Finkbeiner, Stacy</au><au>Wilhelm, Amanda</au><au>Barkay, Hadas</au><au>Chaijale, Nayla</au><au>Gross, Nicholas</au><au>Gordon, Mark Forrest</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Long-Term Safety and Efficacy of Deutetrabenazine in Younger and Older Patients With Tardive Dyskinesia</atitle><jtitle>The American journal of geriatric psychiatry</jtitle><addtitle>Am J Geriatr Psychiatry</addtitle><date>2022-03</date><risdate>2022</risdate><volume>30</volume><issue>3</issue><spage>360</spage><epage>371</epage><pages>360-371</pages><issn>1064-7481</issn><eissn>1545-7214</eissn><abstract>•What is the primary question addressed by this study?This post hoc analysis of a long-term open-label extension study evaluated the efficacy and safety of treatment with deutetrabenazine in younger (<55 years) and older (≥55 years) research study participants with tardive dyskinesia.•What is the main finding of this study?Long-term treatment with deutetrabenazine was associated with sustained improvements in total motor Abnormal Involuntary Movement Scale (AIMS) score, treatment success, and improved quality of life, and was well tolerated in both younger and older adults with tardive dyskinesia.•What is the meaning of the finding?Findings from this analysis may help inform clinicians how to manage tardive dyskinesia, particularly in patients ≥55 years of age.
To assess long-term safety and efficacy of deutetrabenazine in younger (<55 years) and older (≥55 years) adult participants with tardive dyskinesia (TD).
Three-year, single-arm, open-label extension (OLE) study enrolling participants who completed the 12-week, pivotal ARM-TD or AIM-TD studies.
Seventy-six centers in the United States and Europe.
A total of 337 participants with TD (119 younger and 218 older).
Deutetrabenazine was initiated at 12 mg/day and titrated once weekly by 6 mg/day using a response-driven dosing regimen until adequate dyskinesia control was reached or a clinically significant adverse event occurred.
This post hoc analysis assessed change and percent change from baseline in total motor Abnormal Involuntary Movement Scale (AIMS) score, response rates for ≥50% AIMS improvement, Clinical Global Impression of Change (CGIC), Patient Global Impression of Change (PGIC), and safety in younger and older participants with TD.
After 3 years of open-label treatment, mean deutetrabenazine dose was ∼39.5 mg/day in both groups. Mean±SE changes from baseline in total motor AIMS score were –6.7 ± 0.62 and –6.5 ± 0.47 in younger and older participants, respectively (percent changes: –61.4% ± 4.10% and –54.6% ± 3.01%); 76% of younger and 62% of older participants achieved ≥50% AIMS response. Most younger and older participants achieved treatment success per CGIC (67% and 76%) and PGIC (64% and 63%). Deutetrabenazine was generally well tolerated in both groups.
Deutetrabenazine treatment was associated with sustained improvements in total motor AIMS score, treatment success, and improved quality of life, and was well tolerated in younger and older adults with TD in this 3-year OLE study.</abstract><cop>England</cop><pub>Elsevier Inc</pub><pmid>34511333</pmid><doi>10.1016/j.jagp.2021.08.003</doi><tpages>12</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1064-7481 |
| ispartof | The American journal of geriatric psychiatry, 2022-03, Vol.30 (3), p.360-371 |
| issn | 1064-7481 1545-7214 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_2572213969 |
| source | ScienceDirect (Elsevier) |
| subjects | Adrenergic Uptake Inhibitors - adverse effects Aged Clinical outcomes Clinical significance Deutetrabenazine Drug administration Drug therapy Dyskinesia efficacy elderly Geriatrics Humans Middle Aged Quality of Life safety tardive dyskinesia Tardive Dyskinesia - chemically induced Tardive Dyskinesia - complications Tardive Dyskinesia - drug therapy Tetrabenazine - adverse effects Tetrabenazine - analogs & derivatives Treatment Outcome |
| title | Long-Term Safety and Efficacy of Deutetrabenazine in Younger and Older Patients With Tardive Dyskinesia |
| url | http://sfxeu10.hosted.exlibrisgroup.com/loughborough?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-02T21%3A03%3A31IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Long-Term%20Safety%20and%20Efficacy%20of%20Deutetrabenazine%20in%20Younger%20and%20Older%20Patients%20With%20Tardive%20Dyskinesia&rft.jtitle=The%20American%20journal%20of%20geriatric%20psychiatry&rft.au=Sajatovic,%20Martha&rft.date=2022-03&rft.volume=30&rft.issue=3&rft.spage=360&rft.epage=371&rft.pages=360-371&rft.issn=1064-7481&rft.eissn=1545-7214&rft_id=info:doi/10.1016/j.jagp.2021.08.003&rft_dat=%3Cproquest_cross%3E2641594976%3C/proquest_cross%3E%3Cgrp_id%3Ecdi_FETCH-LOGICAL-c428t-51d81cbf869e003444a327e458dbb394d6d8797620fedbe9733b5e2472882fa63%3C/grp_id%3E%3Coa%3E%3C/oa%3E%3Curl%3E%3C/url%3E&rft_id=info:oai/&rft_pqid=2641594976&rft_id=info:pmid/34511333&rfr_iscdi=true |