ADHD Treatment With Once-Daily OROS Methylphenidate: Final Results From a Long-Term Open-Label Study

Massachusetts General Hospital, Pediatric Psychopharmacology, Boston, MA 02114, USA.
Journal of the American Academy of Child & Adolescent Psychiatry (Impact Factor: 7.26). 11/2005; 44(10):1015-23. DOI: 10.1097/01.chi.0000173291.28688.e7
Source: PubMed


Few studies have assessed effectiveness and tolerability of stimulants when used for prolonged periods in children with attention-deficit/hyperactivity disorder (ADHD). This article presents final results from an open-label, multisite study of a once-daily formulation of methylphenidate (MPH), OROS MPH.
Subjects received OROS MPH (18-54 mg initially, with adjustments based on clinical condition) for up to 24 months. Multiple measures of ADHD symptoms, vital signs, weight, height, and laboratory results were assessed throughout the study period.
A total of 407 children enrolled in the open-label study and 229 completed the trial. Effectiveness of OROS MPH therapy was maintained throughout the study as indicated by parent and investigator assessments. There was a 26% increase in mean daily dose over the study period, with the majority of the increase occurring during year 1. In general, treatment was well tolerated, with 31 (7.6%) of subjects discontinuing because of adverse events. Minimal effects on growth in height and weight were observed during the study. No clinically significant effects on vital signs or laboratory test parameters were observed.
: Sustained effectiveness of OROS MPH was maintained for up to 24 months with minimal effects on growth, tics, vital signs, or laboratory test values.

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    • "= drug holidays.A drug holiday means having no or less medication at weekends or school holidays 53% at weekend, 59% at school holiday, and 24% sometimes at weekends and school holidaysHugtenburg et al. (2005)A drug holiday means having no medication at weekends and school holidays (such as holidays less than 2 weeks or summer holidays) 30% at weekends, 30% at summer holidays, 25% at school holidays less than 2 weeks, and 25% to 30% use less medication at weekends and school holidays Faraone, Biederman, andZimmerman (2007)A drug holiday means missing the medication on ≥7 consecutive days 32% stopped the medication for more than 7 consecutive daysWilens et al. (2005)A drug holiday means missing the medication on ≥7 consecutive days 40% stopped the medication for more than 7 consecutive days Barnard-Brak, Schmidt, andSulak (2013)A drug holiday is defined as any period of 24 hr or more without the administration of medication 58.6% took drug holidaysDosreis et al. (2003)A drug holiday means having no medication at weekends and school holidays 42% of parents reported undertaking drug holidays over school holidays Hazell, McDowell, andWalton (1996)A drug holiday refers to missing the medication any time 70% of parents report missing the medication at some point during the treatment courseMoreover, adolescents assume increased responsibility for managing their health and especially medication taking as they grow up and mature. Adolescents with ADHD, driven by their curiosity or rebellious nature, seem to interrupt the medication themselves (Brinkman et al., 2012). "
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    ABSTRACT: Objective: ADHD is managed by stimulants that are effective but can cause growth retardation. Prescribers should ideally monitor children and trial a "drug holiday" to enable catch-up growth. Our aim was to map the experience of drug holidays from ADHD medication in children and adolescents. Method: A comprehensive search of the literature identified 22 studies published during the period 1972 to 2013. Results: Drug holidays are prevalent in 25% to 70% of families and are more likely to be exercised during school holidays. They test whether medication is still needed and are also considered for managing medication side effects and drug tolerance. The impact of drug holidays was reported in terms of side effects and ADHD symptoms. There was evidence of a positive impact on child growth with longer breaks from medication, and shorter breaks could reduce insomnia and improve appetite. Conclusion: Drug holidays from ADHD medication could be a useful tool with multiple purposes: assessment, management, prevention, and negotiation.
    Full-text · Article · Sep 2014 · Journal of Attention Disorders
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    • "Randomized, controlled clinical trials in subjects with ADHD have been conducted in children and have been short-term. Most long-term ADHD treatment trials have been observational and open-label in nature (Table 1).50–64 Open-label trials are valuable because they often approximate real-world clinical practice, marked by flexible dosing, to address changes in efficacy or treatment tolerability. "
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    ABSTRACT: Attention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental disorder that often persists throughout life. Approximately two-thirds of patients with a childhood diagnosis of ADHD continue to experience clinically significant symptoms into adulthood. Nevertheless, most of these individuals consider themselves "well," and a vast majority discontinue medication treatment during adolescence. As evidence concerning the adult presentation of ADHD becomes more widely accepted, increasing numbers of physicians and patients will face decisions about the benefits and risks of continuing ADHD treatment. The risks associated with psychostimulant pharmacotherapy, including abuse, dependence, and cardiovascular events, are well understood. Multiple clinical trials demonstrate the efficacy of psychostimulants in controlling ADHD symptoms in the short term. Recent investigations using randomized withdrawal designs now provide evidence of a clinically significant benefit with continued long-term ADHD pharmacotherapy and provide insight into the negative consequences associated with discontinuation. Because many patients lack insight regarding their ADHD symptoms and impairments, they may place a low value on maintaining treatment. Nevertheless, for patients who choose to discontinue treatment, physicians can remain a source of support and schedule follow-up appointments to reassess patient status. Medication discontinuation can be used as an opportunity to help patients recognize their most impairing symptoms, learn and implement behavioral strategies to cope with ADHD symptoms, and understand when additional supportive resources and the resumption of medication management may be necessary.
    Preview · Article · Mar 2013 · Therapeutics and Clinical Risk Management
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    • "Of note, an open-label study that evaluated the tolerability and effectiveness of once-daily OROS MPH in children with ADHD reported that effectiveness was maintained throughout 12 months, as demonstrated by stable inattention and overactivity with aggression scale (IOWA), Conners ratings and sustained improvements in peer interaction and global assessment scale scores [115]; analysis at 24 months also demonstrated effective symptom control [114]. A large, double-blind, placebo-controlled, multicentre trial also confirmed the efficacy and safety of OROS MPH in the treatment of adolescents with ADHD [118]. "
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    ABSTRACT: Attention-deficit/hyperactivity disorder (ADHD), one of the most common neuropsychiatric conditions of childhood, often has a chronic course and persists into adulthood in many individuals. ADHD may have a clinically important impact on health-related quality of life in children, a significant impact on parents' emotional health and interfere with family activities/cohesion. To date, the main targets of ADHD treatment have focused on reducing the severity of symptoms during the school day and improving academic performance. However, the treatment of ADHD should reach beyond symptom control to address the issues of social competencies and improvement of health-related quality of life from the perspectives of individuals with ADHD and their families, to support them in reaching their full developmental potential. Methylphenidate (MPH) is recognised as the first-line choice of pharmacotherapy for ADHD in children and adolescents. This paper focuses on the importance and benefits to child development of ADHD symptom control beyond the school day only, i.e. extending into late afternoon and evening and uses the example of an extended-release MPH formulation (OROS((R)) MPH) to demonstrate the potential benefits of active full day coverage (12 h) with a single daily dose. Concerns of long-term stimulant treatment are also discussed.
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