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

Jan K. Buitelaar, J. Antoni Ramos-Quiroga, Miguel Casas, J. J. Sandra Kooij, Asko Niemelä, Eric Konofal, Joachim Dejonckheere, Bradford H. Challis, Rossella Medori

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

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. © 2009 Buitelaar et al, publisher and licensee Dove Medical Press Ltd.
Original languageEnglish
Pages (from-to)457-466
JournalNeuropsychiatric Disease and Treatment
Volume5
Issue number1
Publication statusPublished - 2009
Externally publishedYes

Cite this

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. In: Neuropsychiatric Disease and Treatment. 2009 ; Vol. 5, No. 1. pp. 457-466.
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abstract = "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. {\circledC} 2009 Buitelaar et al, publisher and licensee Dove Medical Press Ltd.",
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Buitelaar, JK, Ramos-Quiroga, JA, Casas, M, Kooij, JJS, Niemelä, A, Konofal, E, Dejonckheere, J, Challis, BH & Medori, R 2009, 'Safety and tolerability of flexible dosages of prolonged-release OROS methylphenidate in adults with attention-deficit/hyperactivity disorder' Neuropsychiatric Disease and Treatment, vol. 5, no. 1, pp. 457-466.

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.

In: Neuropsychiatric Disease and Treatment, Vol. 5, No. 1, 2009, p. 457-466.

Research output: Contribution to journalArticleAcademicpeer-review

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