Cargando…

Safety and tolerability of flexible dosages of prolonged-release OROS methylphenidate in adults with attention-deficit/hyperactivity disorder

The osmotic release oral system (OROS) methylphenidate formulation is a prolonged-release medication for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children, adolescents, and adults. We conducted a seven-week open-label extension of a double-blind study to assess the safety...

Descripción completa

Detalles Bibliográficos
Autores principales: Buitelaar, Jan K, Ramos-Quiroga, J Antoni, Casas, Miguel, Kooij, J J Sandra, Niemelä, Asko, Konofal, Eric, Dejonckheere, Joachim, Challis, Bradford H, Medori, Rossella
Formato: Texto
Lenguaje:English
Publicado: Dove Medical Press 2009
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2747385/
https://www.ncbi.nlm.nih.gov/pubmed/19777067
_version_ 1782172082037063680
author Buitelaar, Jan K
Ramos-Quiroga, J Antoni
Casas, Miguel
Kooij, J J Sandra
Niemelä, Asko
Konofal, Eric
Dejonckheere, Joachim
Challis, Bradford H
Medori, Rossella
author_facet Buitelaar, Jan K
Ramos-Quiroga, J Antoni
Casas, Miguel
Kooij, J J Sandra
Niemelä, Asko
Konofal, Eric
Dejonckheere, Joachim
Challis, Bradford H
Medori, Rossella
author_sort Buitelaar, Jan K
collection PubMed
description The osmotic release oral system (OROS) methylphenidate formulation is a prolonged-release medication for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children, adolescents, and adults. We conducted a seven-week open-label extension of a double-blind study to assess the safety and tolerability of OROS methylphenidate in a flexible dose regimen (18–90 mg daily) for the treatment of adults diagnosed with ADHD (N =370). Medication was adjusted to optimize efficacy and tolerability for each patient. Adverse events, vital signs, and laboratory parameters were assessed. Most patients (337; 91%) completed the seven-week treatment and the final dispensed dose was 18 mg (8%), 36 mg (29%), 54 mg (34%), 72 mg (20%), or 90 mg (9%). Adverse events were reported in 253 (68%) patients and most were mild or moderate in severity; most frequently reported included headache (17%), decreased appetite (13%), and insomnia (11%). Adverse events were rarely serious (<1%; 2/370). Small mean increases in systolic and diastolic blood pressure (both 2.4 mmHg) and pulse (3.2 bpm) were observed. Body weight decreased slightly (−1.5 kg). The results provide additional support for the safety and tolerability of prolonged-release OROS methylphenidate in a flexible dose regimen (18–90 mg/day) for the treatment of adults with ADHD.
format Text
id pubmed-2747385
institution National Center for Biotechnology Information
language English
publishDate 2009
publisher Dove Medical Press
record_format MEDLINE/PubMed
spelling pubmed-27473852009-09-23 Safety and tolerability of flexible dosages of prolonged-release OROS methylphenidate in adults with attention-deficit/hyperactivity disorder Buitelaar, Jan K Ramos-Quiroga, J Antoni Casas, Miguel Kooij, J J Sandra Niemelä, Asko Konofal, Eric Dejonckheere, Joachim Challis, Bradford H Medori, Rossella Neuropsychiatr Dis Treat Original Research The osmotic release oral system (OROS) methylphenidate formulation is a prolonged-release medication for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children, adolescents, and adults. We conducted a seven-week open-label extension of a double-blind study to assess the safety and tolerability of OROS methylphenidate in a flexible dose regimen (18–90 mg daily) for the treatment of adults diagnosed with ADHD (N =370). Medication was adjusted to optimize efficacy and tolerability for each patient. Adverse events, vital signs, and laboratory parameters were assessed. Most patients (337; 91%) completed the seven-week treatment and the final dispensed dose was 18 mg (8%), 36 mg (29%), 54 mg (34%), 72 mg (20%), or 90 mg (9%). Adverse events were reported in 253 (68%) patients and most were mild or moderate in severity; most frequently reported included headache (17%), decreased appetite (13%), and insomnia (11%). Adverse events were rarely serious (<1%; 2/370). Small mean increases in systolic and diastolic blood pressure (both 2.4 mmHg) and pulse (3.2 bpm) were observed. Body weight decreased slightly (−1.5 kg). The results provide additional support for the safety and tolerability of prolonged-release OROS methylphenidate in a flexible dose regimen (18–90 mg/day) for the treatment of adults with ADHD. Dove Medical Press 2009 2009-09-15 /pmc/articles/PMC2747385/ /pubmed/19777067 Text en © 2009 Buitelaar et al, publisher and licensee Dove Medical Press Ltd. This is an Open Access article which permits unrestricted noncommercial use, provided the original work is properly cited.
spellingShingle Original Research
Buitelaar, Jan K
Ramos-Quiroga, J Antoni
Casas, Miguel
Kooij, J J Sandra
Niemelä, Asko
Konofal, Eric
Dejonckheere, Joachim
Challis, Bradford H
Medori, Rossella
Safety and tolerability of flexible dosages of prolonged-release OROS methylphenidate in adults with attention-deficit/hyperactivity disorder
title Safety and tolerability of flexible dosages of prolonged-release OROS methylphenidate in adults with attention-deficit/hyperactivity disorder
title_full Safety and tolerability of flexible dosages of prolonged-release OROS methylphenidate in adults with attention-deficit/hyperactivity disorder
title_fullStr Safety and tolerability of flexible dosages of prolonged-release OROS methylphenidate in adults with attention-deficit/hyperactivity disorder
title_full_unstemmed Safety and tolerability of flexible dosages of prolonged-release OROS methylphenidate in adults with attention-deficit/hyperactivity disorder
title_short Safety and tolerability of flexible dosages of prolonged-release OROS methylphenidate in adults with attention-deficit/hyperactivity disorder
title_sort safety and tolerability of flexible dosages of prolonged-release oros methylphenidate in adults with attention-deficit/hyperactivity disorder
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2747385/
https://www.ncbi.nlm.nih.gov/pubmed/19777067
work_keys_str_mv AT buitelaarjank safetyandtolerabilityofflexibledosagesofprolongedreleaseorosmethylphenidateinadultswithattentiondeficithyperactivitydisorder
AT ramosquirogajantoni safetyandtolerabilityofflexibledosagesofprolongedreleaseorosmethylphenidateinadultswithattentiondeficithyperactivitydisorder
AT casasmiguel safetyandtolerabilityofflexibledosagesofprolongedreleaseorosmethylphenidateinadultswithattentiondeficithyperactivitydisorder
AT kooijjjsandra safetyandtolerabilityofflexibledosagesofprolongedreleaseorosmethylphenidateinadultswithattentiondeficithyperactivitydisorder
AT niemelaasko safetyandtolerabilityofflexibledosagesofprolongedreleaseorosmethylphenidateinadultswithattentiondeficithyperactivitydisorder
AT konofaleric safetyandtolerabilityofflexibledosagesofprolongedreleaseorosmethylphenidateinadultswithattentiondeficithyperactivitydisorder
AT dejonckheerejoachim safetyandtolerabilityofflexibledosagesofprolongedreleaseorosmethylphenidateinadultswithattentiondeficithyperactivitydisorder
AT challisbradfordh safetyandtolerabilityofflexibledosagesofprolongedreleaseorosmethylphenidateinadultswithattentiondeficithyperactivitydisorder
AT medorirossella safetyandtolerabilityofflexibledosagesofprolongedreleaseorosmethylphenidateinadultswithattentiondeficithyperactivitydisorder