Long-Term Treatment With Extended-Release Methylphenidate Treatment in Children Aged 4 to <6 Years
To investigate long-term (12-month) safety and symptom control of extended-release methylphenidate (MPH-MLR) in children aged 4 to
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| Veröffentlicht in: | Journal of the American Academy of Child and Adolescent Psychiatry 2022-01, Vol.61 (1), p.80-92 |
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| container_title | Journal of the American Academy of Child and Adolescent Psychiatry |
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| creator | Childress, Ann C. Foehl, Henry C. Newcorn, Jeffrey H. Faraone, Stephen V. Levinson, Benjamin Adjei, Akwete L. |
| description | To investigate long-term (12-month) safety and symptom control of extended-release methylphenidate (MPH-MLR) in children aged 4 to |
| doi_str_mv | 10.1016/j.jaac.2021.03.019 |
| format | Article |
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A total of 90 children aged 4 to <6 years with attention-deficit/hyperactivity disorder (ADHD) were enrolled from 2 MPH-MLR studies. Treatment-emergent adverse events (TEAEs) and ADHD symptom control were assessed in the safety population (n = 89) and modeled with mixed model analyses.
Most TEAEs (89.9%) were rated by investigators as of mild or moderate severity. One serious AE was reported (unrelated to study drug). Ten children discontinued because of TEAEs. Two discontinued because of weight loss; no significant increase in the rate of underweight children from baseline to endpoint was observed. Overall, 18% lost weight and 18% reported decreased appetite. Weight and height z scores and obesity rates decreased significantly from baseline to endpoint. Insomnia was reported (9%); none of these children discontinued. Sleep quality did not change significantly. Hypertension was reported (6.7%); none of these children dropped out. Diastolic, but not systolic, blood pressure increased significantly during the follow-up. Control of ADHD symptoms was maintained throughout follow-up.
These data contribute to the understanding of the long-term safety of an extended-release stimulant in children 4 to <6 years of age. The observed risk of a TEAE-related discontinuation was ∼11%. TEAEs were not dose related, and most were of mild to moderate severity. Symptom control was maintained through the year-long study.
A 12-Month Open Label Safety Study of Aptensio XR® in Children Ages 4-5 Years Diagnosed With ADHD (EF004); https://clinicaltrials.gov; NCT02677519.</description><identifier>ISSN: 0890-8567</identifier><identifier>EISSN: 1527-5418</identifier><identifier>DOI: 10.1016/j.jaac.2021.03.019</identifier><identifier>PMID: 33892111</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>ADHD ; Attention Deficit Disorder with Hyperactivity - drug therapy ; Central Nervous System Stimulants - adverse effects ; Child ; Child, Preschool ; Delayed-Action Preparations ; Dose-Response Relationship, Drug ; Double-Blind Method ; Humans ; methylphenidate ; Methylphenidate - adverse effects ; preschool children ; safety ; Sleep Quality ; Treatment Outcome</subject><ispartof>Journal of the American Academy of Child and Adolescent Psychiatry, 2022-01, Vol.61 (1), p.80-92</ispartof><rights>2021 The Authors</rights><rights>Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c400t-75ddd16c7c73c9fd3655b09bd0ea3ddf3db1920f140e5551833a8ef8a80f66573</citedby><cites>FETCH-LOGICAL-c400t-75ddd16c7c73c9fd3655b09bd0ea3ddf3db1920f140e5551833a8ef8a80f66573</cites><orcidid>0000-0001-5772-7866 ; 0000-0001-5782-7891 ; 0000-0001-5154-4612 ; 0000-0001-8993-9337 ; 0000-0002-9217-3982 ; 0000-0003-0933-2717</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.jaac.2021.03.019$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>314,780,784,3548,27923,27924,45994</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33892111$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Childress, Ann C.</creatorcontrib><creatorcontrib>Foehl, Henry C.</creatorcontrib><creatorcontrib>Newcorn, Jeffrey H.</creatorcontrib><creatorcontrib>Faraone, Stephen V.</creatorcontrib><creatorcontrib>Levinson, Benjamin</creatorcontrib><creatorcontrib>Adjei, Akwete L.</creatorcontrib><title>Long-Term Treatment With Extended-Release Methylphenidate Treatment in Children Aged 4 to <6 Years</title><title>Journal of the American Academy of Child and Adolescent Psychiatry</title><addtitle>J Am Acad Child Adolesc Psychiatry</addtitle><description>To investigate long-term (12-month) safety and symptom control of extended-release methylphenidate (MPH-MLR) in children aged 4 to <6 years after treatment optimization.
A total of 90 children aged 4 to <6 years with attention-deficit/hyperactivity disorder (ADHD) were enrolled from 2 MPH-MLR studies. Treatment-emergent adverse events (TEAEs) and ADHD symptom control were assessed in the safety population (n = 89) and modeled with mixed model analyses.
Most TEAEs (89.9%) were rated by investigators as of mild or moderate severity. One serious AE was reported (unrelated to study drug). Ten children discontinued because of TEAEs. Two discontinued because of weight loss; no significant increase in the rate of underweight children from baseline to endpoint was observed. Overall, 18% lost weight and 18% reported decreased appetite. Weight and height z scores and obesity rates decreased significantly from baseline to endpoint. Insomnia was reported (9%); none of these children discontinued. Sleep quality did not change significantly. Hypertension was reported (6.7%); none of these children dropped out. Diastolic, but not systolic, blood pressure increased significantly during the follow-up. Control of ADHD symptoms was maintained throughout follow-up.
These data contribute to the understanding of the long-term safety of an extended-release stimulant in children 4 to <6 years of age. The observed risk of a TEAE-related discontinuation was ∼11%. TEAEs were not dose related, and most were of mild to moderate severity. Symptom control was maintained through the year-long study.
A 12-Month Open Label Safety Study of Aptensio XR® in Children Ages 4-5 Years Diagnosed With ADHD (EF004); https://clinicaltrials.gov; NCT02677519.</description><subject>ADHD</subject><subject>Attention Deficit Disorder with Hyperactivity - drug therapy</subject><subject>Central Nervous System Stimulants - adverse effects</subject><subject>Child</subject><subject>Child, Preschool</subject><subject>Delayed-Action Preparations</subject><subject>Dose-Response Relationship, Drug</subject><subject>Double-Blind Method</subject><subject>Humans</subject><subject>methylphenidate</subject><subject>Methylphenidate - adverse effects</subject><subject>preschool children</subject><subject>safety</subject><subject>Sleep Quality</subject><subject>Treatment Outcome</subject><issn>0890-8567</issn><issn>1527-5418</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kE9rGzEQR0Vpady0X6CHomMvu52RrF0t5BJM2gYcCsUh9CS00mwss39cSQ7Jt-8ap6WnnObyfg_mMfYRoUTA6suu3FnrSgECS5AlYPOKLVCJulBL1K_ZAnQDhVZVfcbepbQDAKy1fsvOpNSNQMQFa9fTeF9sKA58E8nmgcbM70Le8qvHTKMnX_yknmwifkN5-9TvtzQGbzP9x4eRr7ah95FGfnlPni95nvhFxX-Rjek9e9PZPtGH53vObr9ebVbfi_WPb9ery3XhlgC5qJX3HitXu1q6pvOyUqqFpvVAVnrfSd9iI6DDJZBSCrWUVlOnrYauqlQtz9nnk3cfp98HStkMITnqezvSdEhGzBshBMpqRsUJdXFKKVJn9jEMNj4ZBHNsa3bm2NYc2xqQZm47jz49-w_tQP7f5G_MGbg4ATR_-RAomuQCjY58iOSy8VN4yf8H11KJtw</recordid><startdate>202201</startdate><enddate>202201</enddate><creator>Childress, Ann C.</creator><creator>Foehl, Henry C.</creator><creator>Newcorn, Jeffrey H.</creator><creator>Faraone, Stephen V.</creator><creator>Levinson, Benjamin</creator><creator>Adjei, Akwete L.</creator><general>Elsevier Inc</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>7X8</scope><orcidid>https://orcid.org/0000-0001-5772-7866</orcidid><orcidid>https://orcid.org/0000-0001-5782-7891</orcidid><orcidid>https://orcid.org/0000-0001-5154-4612</orcidid><orcidid>https://orcid.org/0000-0001-8993-9337</orcidid><orcidid>https://orcid.org/0000-0002-9217-3982</orcidid><orcidid>https://orcid.org/0000-0003-0933-2717</orcidid></search><sort><creationdate>202201</creationdate><title>Long-Term Treatment With Extended-Release Methylphenidate Treatment in Children Aged 4 to <6 Years</title><author>Childress, Ann C. ; Foehl, Henry C. ; Newcorn, Jeffrey H. ; Faraone, Stephen V. ; Levinson, Benjamin ; Adjei, Akwete L.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c400t-75ddd16c7c73c9fd3655b09bd0ea3ddf3db1920f140e5551833a8ef8a80f66573</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>ADHD</topic><topic>Attention Deficit Disorder with Hyperactivity - drug therapy</topic><topic>Central Nervous System Stimulants - adverse effects</topic><topic>Child</topic><topic>Child, Preschool</topic><topic>Delayed-Action Preparations</topic><topic>Dose-Response Relationship, Drug</topic><topic>Double-Blind Method</topic><topic>Humans</topic><topic>methylphenidate</topic><topic>Methylphenidate - adverse effects</topic><topic>preschool children</topic><topic>safety</topic><topic>Sleep Quality</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Childress, Ann C.</creatorcontrib><creatorcontrib>Foehl, Henry C.</creatorcontrib><creatorcontrib>Newcorn, Jeffrey H.</creatorcontrib><creatorcontrib>Faraone, Stephen V.</creatorcontrib><creatorcontrib>Levinson, Benjamin</creatorcontrib><creatorcontrib>Adjei, Akwete L.</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>MEDLINE - Academic</collection><jtitle>Journal of the American Academy of Child and Adolescent Psychiatry</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Childress, Ann C.</au><au>Foehl, Henry C.</au><au>Newcorn, Jeffrey H.</au><au>Faraone, Stephen V.</au><au>Levinson, Benjamin</au><au>Adjei, Akwete L.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Long-Term Treatment With Extended-Release Methylphenidate Treatment in Children Aged 4 to <6 Years</atitle><jtitle>Journal of the American Academy of Child and Adolescent Psychiatry</jtitle><addtitle>J Am Acad Child Adolesc Psychiatry</addtitle><date>2022-01</date><risdate>2022</risdate><volume>61</volume><issue>1</issue><spage>80</spage><epage>92</epage><pages>80-92</pages><issn>0890-8567</issn><eissn>1527-5418</eissn><abstract>To investigate long-term (12-month) safety and symptom control of extended-release methylphenidate (MPH-MLR) in children aged 4 to <6 years after treatment optimization.
A total of 90 children aged 4 to <6 years with attention-deficit/hyperactivity disorder (ADHD) were enrolled from 2 MPH-MLR studies. Treatment-emergent adverse events (TEAEs) and ADHD symptom control were assessed in the safety population (n = 89) and modeled with mixed model analyses.
Most TEAEs (89.9%) were rated by investigators as of mild or moderate severity. One serious AE was reported (unrelated to study drug). Ten children discontinued because of TEAEs. Two discontinued because of weight loss; no significant increase in the rate of underweight children from baseline to endpoint was observed. Overall, 18% lost weight and 18% reported decreased appetite. Weight and height z scores and obesity rates decreased significantly from baseline to endpoint. Insomnia was reported (9%); none of these children discontinued. Sleep quality did not change significantly. Hypertension was reported (6.7%); none of these children dropped out. Diastolic, but not systolic, blood pressure increased significantly during the follow-up. Control of ADHD symptoms was maintained throughout follow-up.
These data contribute to the understanding of the long-term safety of an extended-release stimulant in children 4 to <6 years of age. The observed risk of a TEAE-related discontinuation was ∼11%. TEAEs were not dose related, and most were of mild to moderate severity. Symptom control was maintained through the year-long study.
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| ispartof | Journal of the American Academy of Child and Adolescent Psychiatry, 2022-01, Vol.61 (1), p.80-92 |
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| source | MEDLINE; ScienceDirect Journals (5 years ago - present) |
| subjects | ADHD Attention Deficit Disorder with Hyperactivity - drug therapy Central Nervous System Stimulants - adverse effects Child Child, Preschool Delayed-Action Preparations Dose-Response Relationship, Drug Double-Blind Method Humans methylphenidate Methylphenidate - adverse effects preschool children safety Sleep Quality Treatment Outcome |
| title | Long-Term Treatment With Extended-Release Methylphenidate Treatment in Children Aged 4 to <6 Years |
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