BMC Psychiatry | |
Long-acting methylphenidate formulations in the treatment of attention-deficit/hyperactivity disorder: a systematic review of head-to-head studies | |
Manfred Doepfner1  Antonella Gagliano4  Antonio Pelaz5  Alessandro Zuddas3  Tobias Banaschewski2  David Coghill6  | |
[1] Department of Child and Adolescent Psychiatry, University of Cologne, Cologne, Germany;Department of Child and Adolescent Psychiatry, Central Institute of Mental Health, Medical Faculty of Mannheim, University of Heidelberg, Mannheim, Germany;Department of Biomedical Sciences, University of Cagliari, Cagliari, Sardinia, Italy;Department of Pediatric Science, University of Messina, Policlinico Universitario G. Martino, Messina, Italy;Department of Child and Adolescent Psychiatry, Hospital Clinico Universitario San Carlos, Madrid, Spain;Division of Neuroscience, Medical Research Institute, Ninewells Hospital and Medical School, Dundee DD1 9SY, UK | |
关键词: Review; Pharmacokinetics; Long-acting formulation; Comparison; Attention-deficit/hyperactivity disorder; Methylphenidate; | |
Others : 1123956 DOI : 10.1186/1471-244X-13-237 |
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received in 2013-02-24, accepted in 2013-09-11, 发布年份 2013 | |
【 摘 要 】
Background
The stimulant methylphenidate (MPH) has been a mainstay of treatment for attention-deficit/hyperactivity disorder (ADHD) for many years. Owing to the short half-life and the issues associated with multiple daily dosing of immediate-release MPH formulations, a new generation of long-acting MPH formulations has emerged. Direct head-to-head studies of these long-acting MPH formulations are important to facilitate an evaluation of their comparative pharmacokinetics and efficacy; however, to date, relatively few head-to-head studies have been performed.
The objective of this systematic review was to compare the evidence available from head-to-head studies of long-acting MPH formulations and provide information that can guide treatment selection.
Methods
A systematic literature search was conducted in MEDLINE and PsycINFO in March 2012 using the MeSH terms: attention deficit disorder with hyperactivity/drug therapy; methylphenidate/therapeutic use and All Fields: Concerta; Ritalin LA; OROS and ADHD; Medikinet; Equasym XL and ADHD; long-acting methylphenidate; Diffucaps and ADHD; SODAS and methylphenidate. No filters were applied and no language, publication date or publication status limitations were imposed. Articles were selected if the title indicated a comparison of two or more long-acting MPH preparations in human subjects of any age; non-systematic review articles and unpublished data were not included.
Results
Of 15,295 references returned in the literature search and screened by title, 34 articles were identified for inclusion: nine articles from pharmacokinetic studies (nine studies); nine articles from laboratory school studies (six studies); two articles from randomized controlled trials (two studies); three articles from switching studies (two studies) and three articles from one observational study.
Conclusions
Emerging head-to-head studies provide important data on the comparative efficacy of the formulations available. At a group level, efficacy across the day generally follows the pharmacokinetic profile of the MPH formulation. No formulation is clearly superior to another; careful consideration of patient needs and subtle differences between formulations is required to optimize treatment. For patients achieving suboptimal symptom control, switching long-acting MPH formulations may be beneficial. When switching formulations, it is usually appropriate to titrate the immediate-release component of the formulation; a limitation of current studies is a focus on total daily dose rather than equivalent immediate-release components. Further studies are necessary to provide guidance in clinical practice, particularly in the treatment of adults and pre-school children and the impact of comorbidities and symptom severity on treatment response.
【 授权许可】
2013 Coghill et al.; licensee BioMed Central Ltd.
【 预 览 】
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【 参考文献 】
- [1]Polanczyk G, de Lima MS, Horta BL, Biederman J, Rohde LA: The worldwide prevalence of ADHD: a systematic review and metaregression analysis. Am J Psychiatry 2007, 164:942-948.
- [2]Kooij SJ, Bejerot S, Blackwell A, Caci H, Casas-Brugue M, Carpentier PJ, Edvinsson D, Fayyad J, Foeken K, Fitzgerald M, Gaillac V, Ginsberg Y, Henry C, Krause J, Lensing MB, Manor I, Niederhofer H, Nunes-Filipe C, Ohlmeier MD, Oswald P, Pallanti S, Pehlivanidis A, Ramos-Quiroga JA, Rastam M, Ryffel-Rawak D, Stes S, Asherson P: European consensus statement on diagnosis and treatment of adult ADHD: The European Network Adult ADHD. BMC Psychiatry 2010, 10:67. BioMed Central Full Text
- [3]Wolraich M, Brown L, Brown RT, DuPaul G, Earls M, Feldman HM, Ganiats TG, Kaplanek B, Meyer B, Perrin J, Pierce K, Reiff M, Stein MT, Visser S: ADHD: clinical practice guideline for the diagnosis, evaluation, and treatment of attention-deficit/hyperactivity disorder in children and adolescents. Pediatrics 2011, 128:1007-1022.
- [4]Greenhill LL, Pliszka S, Dulcan MK, Bernet W, Arnold V, Beitchman J, Benson RS, Bukstein O, Kinlan J, McClellan J, Rue D, Shaw JA, Stock S: Practice parameter for the use of stimulant medications in the treatment of children, adolescents, and adults. J Am Acad Child Adolesc Psychiatry 2002, 41:26S-49S.
- [5]Ritalin SR® prescribing information. http://www.pharma.us.novartis.com/product/pi/pdf/ritalin_ritalin-sr.pdf webcite. Date accessed 10/1/13
- [6]Ritalin LA® prescribing information. http://www.pharma.us.novartis.com/product/pi/pdf/ritalin_la.pdf webcite. Date accessed 10/1/13
- [7]Focalin XR® prescribing information. http://www.pharma.us.novartis.com/product/pi/pdf/focalinXR.pdf webcite. Date accessed 10/1/13
- [8]Heal DJ, Pierce DM: Methylphenidate and its isomers: their role in the treatment of attention-deficit hyperactivity disorder using a transdermal delivery system. CNS Drugs 2006, 20:713-738.
- [9]Medikinet® XL 5 Mg summary of product characteristics. http://www.medicines.org.uk/emc/medicine/24854/ webcite. Date accessed 10/1/13
- [10]Biphentin® product monograph. http://www.purdue.ca/files/Biphentin%20Capsules%20PM%20EN.pdf webcite. Date accessed 10/1/13
- [11]Equasym XL® summary of product characteristics. http://www.medicines.org.uk/emc/medicine/15804/SPC/Equasym+XL+10+mg,+20+mg+or+30+mg+Capsules webcite. Date accessed 10/1/13
- [12]Concerta® XL summary of product characteristics. http://www.medicines.org.uk/EMC/medicine/8382/SPC/Concerta+XL+18+mg+-+36+mg+prolonged+release+tablets/ webcite. Date accessed 10/1/13
- [13]Daytrana® prescribing information. http://www.daytrana.com/documents/daytrana-prescribing-information.pdf webcite. Date accessed 10/1/13
- [14]Froehlich TE, Epstein JN, Nick TG, Melguizo Castro MS, Stein MA, Brinkman WB, Graham AJ, Langberg JM, Kahn RS: Pharmacogenetic predictors of methylphenidate dose–response in attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry 2011, 50:1129-1139.
- [15]Greenhill LL, Abikoff HB, Arnold LE, Cantwell DP, Conners CK, Elliott G, Hechtman L, Hinshaw SP, Hoza B, Jensen PS, March JS, Newcorn J, Pelham WE, Severe JB, Swanson JM, Vitiello B, Wells K: Medication treatment strategies in the MTA study: relevance to clinicians and researchers. J Am Acad Child Adolesc Psychiatry 1996, 35:1304-1313.
- [16]Vitiello B, Severe JB, Greenhill LL, Arnold LE, Abikoff HB, Bukstein OG, Elliott GR, Hechtman L, Jensen PS, Hinshaw SP, March JS, Newcorn JH, Swanson JM, Cantwell DP: Methylphenidate dosage for children with ADHD over time under controlled conditions: lessons from the MTA. J Am Acad Child Adolesc Psychiatry 2001, 40:188-196.
- [17]Döpfner M, Gerber WD, Banaschewski T, Breuer D, Freisleder FJ, Gerber-von MG, Gunter M, Hassler F, Ose C, Rothenberger A, Schmeck K, Sinzig J, Stadler C, Uebel H, Lehmkuhl G: Comparative efficacy of once-a-day extended-release methylphenidate, two-times-daily immediate-release methylphenidate, and placebo in a laboratory school setting. Eur Child Adolesc Psychiatry 2004, 13(Suppl 1):93-101.
- [18]Silva R, Muniz R, McCague K, Childress A, Brams M, Mao A: Treatment of children with attention-deficit/hyperactivity disorder: results of a randomized, multicenter, double-blind, crossover study of extended-release dexmethylphenidate and D,L-methylphenidate and placebo in a laboratory classroom setting. Psychopharmacol Bull 2008, 41:19-33.
- [19]Brams M, Moon E, Pucci M, Lopez FA: Duration of effect of oral long-acting stimulant medications for ADHD throughout the day. Curr Med Res Opin 2010, 26:1809-1825.
- [20]Gonzalez MA, Pentikis HS, Anderl N, Benedict MF, DeCory HH, Dirksen SJ, Hatch SJ: Methylphenidate bioavailability from two extended-release formulations. Int J Clin Pharmacol Ther 2002, 40:175-184.
- [21]Spencer TJ, Bonab AA, Dougherty DD, Martin J, McDonnell T, Fischman AJ: A PET study examining pharmacokinetics and dopamine transporter occupancy of two long-acting formulations of methylphenidate in adults. Int J Mol Med 2010, 25:261-265.
- [22]Markowitz JS, Straughn AB, Patrick KS, DeVane CL, Pestreich L, Lee J, Wang Y, Muniz R: Pharmacokinetics of methylphenidate after oral administration of two modified-release formulations in healthy adults. Clin Pharmacokinet 2003, 42:393-401.
- [23]Modi NB, Lindemulder B, Gupta SK: Single- and multiple-dose pharmacokinetics of an oral once-a-day osmotic controlled-release OROS (methylphenidate HCl) formulation. J Clin Pharmacol 2000, 40:379-388.
- [24]Pierce D, Katic A, Buckwalter M, Webster K: Single- and multiple-dose pharmacokinetics of methylphenidate administered as methylphenidate transdermal system or osmotic-release oral system methylphenidate to children and adolescents with attention deficit hyperactivity disorder. J Clin Psychopharmacol 2010, 30:554-564.
- [25]Reiz JL, Donnelly GA, Michalko K: Comparative bioavailability of single-dose methylphenidate from a multilayer-release bead formulation and an osmotic system: a two-way crossover study in healthy young adults. Clin Ther 2008, 30:59-69.
- [26]Haessler F, Tracik F, Dietrich H, Stammer H, Klatt J: A pharmacokinetic study of two modified-release methylphenidate formulations under different food conditions in healthy volunteers. Int J Clin Pharmacol Ther 2008, 46:466-476.
- [27]Tuerck D, Wang Y, Maboudian M, Wang Y, Sedek G, Pommier F, Appel-Dingemanse S: Similar bioavailability of dexmethylphenidate extended (bimodal) release, dexmethyl-phenidate immediate release and racemic methylphenidate extended (bimodal) release formulations in man. Int J Clin Pharmacol Ther 2007, 45:662-668.
- [28]Schutz H, Fischer R, Grossmann M, Mazur D, Leis HJ, Ammer R: Lack of bioequivalence between two methylphenidate extended modified release formulations in healthy volunteers. Int J Clin Pharmacol Ther 2009, 47:761-769.
- [29]Graham J, Banaschewski T, Buitelaar J, Coghill D, Danckaerts M, Dittmann RW, Dopfner M, Hamilton R, Hollis C, Holtmann M, Hulpke-Wette M, Lecendreux M, Rosenthal E, Rothenberger A, Santosh P, Sergeant J, Simonoff E, Sonuga-Barke E, Wong IC, Zuddas A, Steinhausen HC, Taylor E: European guidelines on managing adverse effects of medication for ADHD. Eur Child Adolesc Psychiatry 2011, 20:17-37.
- [30]Graham J, Coghill D: Adverse effects of pharmacotherapies for attention-deficit hyperactivity disorder: epidemiology, prevention and management. CNS Drugs 2008, 22:213-237.
- [31]Lopez F, Silva R, Pestreich L, Muniz R: Comparative efficacy of two once daily methylphenidate formulations (Ritalin LA and Concerta) and placebo in children with attention deficit hyperactivity disorder across the school day. Paediatr Drugs 2003, 5:545-555.
- [32]Silva R, Muniz R, Pestreich LK, Brams M, Childress A, Lopez FA: Efficacy of two long-acting methylphenidate formulations in children with attention-deficit/hyperactivity disorder in a laboratory classroom setting. J Child Adolesc Psychopharmacol 2005, 15:637-654.
- [33]Muniz R, Brams M, Mao A, McCague K, Pestreich L, Silva R: Efficacy and safety of extended-release dexmethylphenidate compared with d, l-methylphenidate and placebo in the treatment of children with attention-deficit/hyperactivity disorder: a 12-hour laboratory classroom study. J Child Adolesc Psychopharmacol 2008, 18:248-256.
- [34]Sonuga-Barke EJ, Swanson JM, Coghill D, DeCory HH, Hatch SJ: Efficacy of two once-daily methylphenidate formulations compared across dose levels at different times of the day: preliminary indications from a secondary analysis of the COMACS study data. BMC Psychiatry 2004, 4:28. BioMed Central Full Text
- [35]Sonuga-Barke EJ, Coghill D, Markowitz JS, Swanson JM, Vandenberghe M, Hatch SJ: Sex differences in the response of children with ADHD to once-daily formulations of methylphenidate. J Am Acad Child Adolesc Psychiatry 2007, 46:701-710.
- [36]Sonuga-Barke EJ, Van Lier P, Swanson JM, Coghill D, Wigal S, Vandenberghe M, Hatch S: Heterogeneity in the pharmacodynamics of two long-acting methylphenidate formulations for children with attention deficit/hyperactivity disorder. A growth mixture modelling analysis. Eur Child Adolesc Psychiatry 2008, 17:245-254.
- [37]Swanson JM, Wigal SB, Wigal T, Sonuga-Barke E, Greenhill LL, Biederman J, Kollins S, Nguyen AS, DeCory HH, Hirshe Dirksen SJ, Hatch SJ: A comparison of once-daily extended-release methylphenidate formulations in children with attention-deficit/hyperactivity disorder in the laboratory school (the COMACS Study). Pediatrics 2004, 113:e206-e216.
- [38]Schulz E, Fleischhaker C, Hennighausen K, Heiser P, Oehler KU, Linder M, Haessler F, Huss M, Warnke A, Schmidt M, Schulte-Markworth M, Sieder C, Klatt J, Tracik F: A double-blind, randomized, placebo/active controlled crossover evaluation of the efficacy and safety of Ritalin® LA in children with attention-deficit/hyperactivity disorder in a laboratory classroom setting. J Child Adolesc Psychopharmacol 2010, 20:377-385.
- [39]Wigal SB, Wigal TL: The laboratory school protocol: its origin, use, and new applications. J Atten Disord 2006, 10:92-111.
- [40]Wigal SB, Gupta S, Guinta D, Swanson JM: Reliability and validity of the SKAMP rating scale in a laboratory school setting. Psychopharmacol Bull 1998, 34:47-53.
- [41]Swanson J, Wigal S, Greenhill L, Browne R, Waslick B, Lerner M, Williams L, Flynn D, Agler D, Crowley KL, Fineberg E, Regino R, Baren M, Cantwell D: Objective and subjective measures of the pharmacodynamic effects of Adderall in the treatment of children with ADHD in a controlled laboratory classroom setting. Psychopharmacol Bull 1998, 34:55-60.
- [42]Döpfner M, Ose C, Fischer R, Ammer R, Scherag A: Comparison of the efficacy of two different modified release preparations for children and adolescents with attention-deficit/hyperactivity disorder in a natural setting: comparison of the efficacy of Medikinet Retard and Concerta - a randomised, controlled, double-blind multicentre clinical cross-over trial. J Child Adolesc Psychopharmacol 2011, 21:445-454.
- [43]Findling RL, Bukstein OG, Melmed RD, Lopez FA, Sallee FR, Arnold LE, Pratt RD: A randomized, double-blind, placebo-controlled, parallel-group study of methylphenidate transdermal system in pediatric patients with attention-deficit/hyperactivity disorder. J Clin Psychiatry 2008, 69:149-159.
- [44]Pelham WE, Burrows-Maclean L, Gnagy EM, Fabiano GA, Coles EK, Tresco KE, Chacko A, Wymbs BT, Wienke AL, Walker KS, Hoffman MT: Transdermal methylphenidate, behavioral, and combined treatment for children with ADHD. Exp Clin Psychopharmacol 2005, 13:111-126.
- [45]Pelham WE, Manos MJ, Ezzell CE, Tresco KE, Gnagy EM, Hoffman MT, Onyango AN, Fabiano GA, Lopez-Williams A, Wymbs BT, Caserta D, Chronis AM, Burrows-Maclean L, Morse G: A dose-ranging study of a methylphenidate transdermal system in children with ADHD. J Am Acad Child Adolesc Psychiatry 2005, 44:522-529.
- [46]Arnold LE, Bozzolo DR, Hodgkins P, McKay M, Beckett-Thurman L, Greenbaum M, Bukstein O, Patel A: Switching from oral extended-release methylphenidate to the methylphenidate transdermal system: continued attention-deficit/hyperactivity disorder symptom control and tolerability after abrupt conversion. Curr Med Res Opin 2010, 26:129-137.
- [47]Bukstein OG, Arnold LE, Landgraf JM, Hodgkins P: Does switching from oral extended-release methylphenidate to the methylphenidate transdermal system affect health-related quality-of-life and medication satisfaction for children with attention-deficit/hyperactivity disorder? Child Adolesc Psychiatry Ment Health 2009, 3:39. BioMed Central Full Text
- [48]Dirksen SJ, D’Imperio JM, Birdsall D, Hatch SJ: A postmarketing clinical experience study of Metadate CD. Curr Med Res Opin 2002, 18:371-380.
- [49]Döpfner M, Görtz-Dorten A, Breuer D, Rothenberger A: An observational study of once-daily modified-release methylphenidate in ADHD: effectiveness on symptoms and impairment, and safety. Eur Child Adolesc Psychiatry 2011, 20:S243-S255.
- [50]Döpfner M, Breuer D, Walter D, Rothenberger A: An observational study of once-daily modified-release methylphenidate in ADHD: the effect of previous treatment on ADHD symptoms, other externalising symptoms and quality of life outcomes. Eur Child Adolesc Psych 2011, 20:S277-S288.
- [51]Rothenberger A, Becker A, Breuer D, Döpfner M: An observational study of once-daily modified-release methylphenidate in ADHD: quality of life, satisfaction with treatment and adherence. Eur Child Adolesc Psychiatry 2011, 20:S257-S265.
- [52]Banaschewski T, Coghill D, Santosh P, Zuddas A, Asherson P, Buitelaar J, Danckaerts M, Dopfner M, Faraone SV, Rothenberger A, Sergeant J, Steinhausen HC, Sonuga-Barke EJ, Taylor E: Long-acting medications for the hyperkinetic disorders. A systematic review and European treatment guideline. Eur Child Adolesc Psychiatry 2006, 15:476-495.
- [53]Brams M, Mao AR, Doyle RL: Onset of efficacy of long-acting psychostimulants in pediatric attention-deficit/hyperactivity disorder. Postgrad Med 2008, 120:69-88.
- [54]Swanson JM, Lerner M, Wigal T, Steinhoff K, Greenhill L, Posner K, Freid J, Wigal S: The use of a laboratory school protocol to evaluate concepts about efficacy and side effects of new formulations of stimulant medications. J Atten Disord 2002, 6(Suppl 1):S73-S88.
- [55]Faraone SV, Biederman J, Spencer TJ, Aleardi M: Comparing the efficacy of medications for ADHD using meta-analysis. Med Gen Med 2006, 8:4.
- [56]Faraone SV, Buitelaar J: Comparing the efficacy of stimulants for ADHD in children and adolescents using meta-analysis. Eur Child Adolesc Psychiatry 2010, 19:353-364.
- [57]Faraone SV, Glatt SJ: A comparison of the efficacy of medications for adult attention-deficit/hyperactivity disorder using meta-analysis of effect sizes. J Clin Psychiatry 2010, 71:754-763.
- [58]Peterson K, McDonagh MS, Fu R: Comparative benefits and harms of competing medications for adults with attention-deficit hyperactivity disorder: a systematic review and indirect comparison meta-analysis. Psychopharmacology (Berl) 2008, 197:1-11.
- [59]Swanson J, Arnold LE, Kraemer H, Hechtman L, Molina B, Hinshaw S, Vitiello B, Jensen P, Steinhoff K, Lerner M, Greenhill L, Abikoff H, Wells K, Epstein J, Elliott G, Newcorn J, Hoza B, Wigal T: Evidence, interpretation, and qualification from multiple reports of long-term outcomes in the multimodal treatment study of children with ADHD (MTA): part II: supporting details. J Atten Disord 2008, 12:15-43.
- [60]Swanson J, Volkow N: Pharmacokinetic and pharmacodynamic properties of methylphenidate in humans. In Stimulant drugs and ADHD. Edited by Solanto MV, Arnsten AF, Castellanos FX. New York: Oxford University Press; 2001:259-282.
- [61]Coghill D, Soutullo C, d’Aubuisson C, Preuss U, Lindback T, Silverberg M, Buitelaar J: Impact of attention-deficit/hyperactivity disorder on the patient and family: results from a European survey. Child Adolesc Psychiatry Ment Health 2008, 2:31. BioMed Central Full Text
- [62]Döpfner M, Breuer D, Ose C, Fischer R: Modified-release methylphenidate in routine care. Monatsschr Kinderheilkd 2011, 159:1119-1125.
- [63]Healthcare Improvement Scotland: Difficult times of the Day scale. http://www.healthcareimprovementscotland.org/our_work/mental_health/adhd_services_over_scotland/stage_3_adhd_final_report.aspx webcite. Date accessed 14/1/13