Lisdexanfetamina en niños y adolescentes con trastorno por déficit de atención e hiperactividad (TDAH):una revisión sistemática global
- Óscar Herreros
- Francisco Díaz Atienza
- Xavier Gastaminza
- Josué Monzón
- Belén Rubio
- A. Muñoz
ISSN: 2660-7271, 1130-9512
Datum der Publikation: 2015
Ausgabe: 32
Nummer: 1
Seiten: 7-30
Art: Artikel
Andere Publikationen in: Revista de Psiquiatría Infanto-Juvenil
Zusammenfassung
Attention Deficit Disorder Hyperactivity Disorder (ADHD) is one of the most common disorders in Child and Adolescent Psychiatry, and very often requires pharmacological intervention in its treatment plan. Among these, lisdexamfetamine is available in Spain since about one year ago, new both as being an amphetamine and as a prodrug. Objective: To review and summarize the evidence on lisdexamfetamine and its use in ADHD children and adolescents. Method: A comprehensive literature search in PubMed was done with the following terms: lisdexamfetamine, OR lisdexamphetamine, OR lisdexanfetamina. Results: Lisdexamfetamine is a prodrug with a safety profile similar to other known ADHD pharmacological treatments, and very effective for ADHD treatment in children and adolescents, with a low potential for abuse or misuse, and a stable clinical response extended along the day. Limitations: Although it is a drug with a known profile of efficacy and security along its nearly 9 years of marketing in the US, it should be necessary to conduct longer-term prospective studies to show more data about its safety and efficacy, efficacy related to other ADHD treatments, and its use in the real patient.
Bibliographische Referenzen
- APA (American Psychiatric Association). Diagnostic and statistical manual of mental disorders, fifth edition (DSM-5). American Psychiatric Publishing: Washington DC; 2013.
- Mardomingo MJ. Trastorno de déficit de atención e hiperactividad (TDAH). En: Mardomingo MJ. Tratado de Psiquiatría del niño y del adolescente. Madrid: Ediciones Díaz de Santos; 2015. Pp. 579-630.
- Catalá-López F, Peiró S, Ridao M, Sanfélix-Gimeno G, Génova-Maleras R, Catalá MA. Prevalence of attention deficit hyperactivity disorder among children and adolescents in Spain: a systematic review and meta-analysis of epidemiological studies. BMC Psychiatry 2012, 12:168-180.
- Jensen PS, Martin D, Cantwell DP. Comorbidity in ADHD: Implications for Research, Practice, and DSM-V. J Am Acad Child Adolesc Psychiatry 1997; 36: 1065-1079.
- Anderson JC, Williams S, McGee R, Silva PA. DSM-III disorders in preadolescent children. Arch Gen Psychiatry 1987; 44: 69-76.
- Offord DR. Boyle MH, Szatmari P et al. Ontario Child Health Study, II: six-month prevalence of disorder and rates of service utilization. Arch Gen Psychiatry 1987; 44: 832-836.
- Offord DR, Boyle MH, Racine Y. Ontario Child Health Study: correlates of disorder. J Am Acad Child Adolesc Psychiatry 1989; 28: 856-860.
- Guía de Práctica Clínica sobre el Trastorno por Déficit de Atención con Hiperactividad (TDAH) en Niños y Adolescentes. Plan de Calidad para el Sistema Nacional de Salud del Ministerio de Sanidad y Política Social. Agència d´Avaluació de Tecnologia i Recerca Mèdiques; 2010. Guías de Práctica Clínica en el SNS: AATRM Nº 2007/18.
- CADDRA (Canadian Attention Deficit hyperactivity Disorder Resource Alliance). Canadian ADHD Practice Guidelines, third edition, Toronto ON; CADDRA, 2011. Disponible en: http://www.caddra.ca/practice-guidelines/download
- Swanson J. Compliance with stimulants for attention deficit/hyperactivity disorder: issues and approaches for improvement. CNS Drugs 2003; 17: 117-131.
- Ramos-Quiroga JA, Bosch R, Castells X, Valero S, Nogueira M, Gomez N et al. Effect of switching drug formulations from immediate-release to extended-release OROS methylphenidate: a chart review of Spanish adults with attention deficithyperactivity disorder. CNS Drugs 2008; 7: 603-611.
- Robledo P. Las anfetaminas. Trastornos Adictivos 2008; 10: 166-174.
- Bradley Ch. The behaviour of children receiving Benzedrine. Am J Psychiatry 1937; 94: 577-585.
- Gross MD. A comparison of d-amphetamine and racemic-amphetamine in the treatment of the hyperkinetic syndrome or minimal brain dysfunction. Dis Nerv Sys 1976; 37: 14-16.
- Heal DJ, Smith ShL, Gosden J, Nutt DJ. Amphetamine, past and present – a pharmacological and clinical perspective. J Psychopharm 2013; 27: 479-496.
- Scorza MC, Carrau C, Silveira R, Zapata-Torres G, Cassels BK, Reyes-Parada M. Monoamine oxidase properties of some methoxilated and alkylthio amphetamine derivatives. Biochem Pharmacol 1997; 54: 1361-1369.
- Barkley RA. Etiologies of ADHD. En: Barkley RA. (ed.). Attention-Deficit Hyperactivity Disorder. A Handbook for diagnosis & treatment. New York: The Guilford Press; 2015. Pp. 356-390.
- Daughton J, Kratochvil Ch. Stimulants. En: Martin A, Scahill L, Kratochvill ChJ (eds.). Pediatric psychopharmacology. Principles and practice. New York: Oxford University Press; 2011. Pp. 251-262.
- Boellner SW, Stark JG, Krishnan S, Zhang Y. Pharmacokinetics of lisdexamfetamine dimesylate and its active metabolite, d-amphetamine, with increasing oral doses of lisdexamfetamine dimesylate in children with Attention-Deficit/ Hyperactivity Disorder: a single-dose, randomized, open-label, crossover study. Clin Ther 2010; 32: 252-264.
- Cabrera S, Diez-Torrubia A. Profármacos: pasado, presente y future. An Quim 2010; 106: 207-214.
- Pennick M. Absorption of lisdexamfetamine dimesylate and its enzymatic conversion to d-amphetamine. Neuropsychiatr Dis Treat 2010; 6: 317-327.
- Krishnan S, Zhang Y. Relative bioavailability of lisdexamfetamine 70 mg capsules in fasted and fed healthy adult volunteers and in solution: a single-dose, crossover pharmacokinetic study. J Clin Pharmacol 2008; 48: 293-302.
- Najib J. The efficacy and safety profile of lisdexamfetamine dimesylate, a progrug of d-amphetamine for the treatment of Attention-Deficit/Hyperactivity Disorder in children and adults. Clin Ther 2009; 31: 142-176.
- Rowley HL, Kulkarni R, Gosden J, Brammer R, Hackett D, Heal DJ. Lisdexamfetamine and immediate release d-amfetamine - differences in pharmacokinetic/pharmacodynamic relationships revealed by striatal microdialysis in freely-moving rats with simultaneous determination of plasma drug concentrations and locomotor activity. Neuropharmacology 2012; 63: 1064-1074.
- Madaan V, Kolli V, Bestha DP, Shah MJ. Update on optimal use of lisdexamfetamine in the treatment of ADHD. Neuropsychiatr Dis Treat 2013; 9: 977-983.
- Krishnan S, Moncrief S. An evaluation of the cytochrome p450 inhibition potential of lisdexamfetamine in human liver microsomes. Drug Metab Dispos 2007a; 35: 180-184.
- Jasinski DR, Krishnan S. Abuse liability and safety of oral lisdexamfetamine dimesylate in individuals with a history of stimulant abuse. J Psychopharmacol 2009; 23: 419-427.
- Popovic B, Bhattacharya P, Sivaswamy L. Lisdexamfetamine: a prodrug for the treatment of attention-deficit/hyperactivity disorder. Am J Health-Syst Pharm 2009; 66: 2005-2012.
- Krishnan S, Montcrief S. Toxicity profile of lisdexamfetamine dimesylate in three independent rat toxicology studies. Basic Clin Pharmacol Toxicol 2007b; 101: 231-240.
- Ramos-Quiroga JA, Casas M. Achieving remission as a routine goal of pharmacotherapy in attentiondeficit hyperactivity disorder. CNS Drugs 2011; 25: 17-36.
- Gandía-Benetó R, Mulas F, Roca P, Ortiz-Sánchez P, Abad-Mas L. Cambio en la estrategia terapéutica ante una respuesta inadecuada al tratamiento farmacológico para el trastorno por déficit de atención/hiperactividad. Rev Neurol 2015; 60 (supl 1): S13-S18.
- Biederman J, Boellner SW, Childress A, Lopez FA, Krishnan S, Zhang Y. Lisdexamfetamine dimesylate and mixed amphetamine salts extendedrelease in children with ADHD: a double-blind, placebo-controlled, cross-over analog classroom study. Biol Psychiatry 2007a; 62: 970-976.
- Biederman J, Krishnan S, Zhang Y, McGough JJ, Findling RL. Efficacy and tolerability of lisdexamfetamine dimesylate (NRP-104) in children with attention-deficit/hyperactivity disorder: a phase III, multicenter, randomized, double-blind, forced-dose, parallel-group study. Clin Ther 2007b; 29: 450-463.
- Findling RL, Ginsberg LD, Jain R, Gao J. Effectiveness, safety, and tolerability of lisdexamfetamine dimesylate in children with attention-deficit/hyperactivity disorder: an openlabel, dose-optimization study. J Child Adolesc Psychopharmacol 2009; 19: 649-662.
- Wigal SB, Kollins SH, Childress AC, Adeyi B. Efficacy and tolerability of lisdexamfetamine dimesylate in children with attention-deficit/ hyperactivity disorder: sex and age effects and effect size across the day. Child Adolesc Psychiatry Ment Health 2010; 4: 32.
- Wigal SB, Wong AA, Jun A, Stehli A, Steinberg-Epstein R, Lerner MA. Adverse events in medication treatment-naïve children with attention-deficit/hyperactivity disorder: results of a small, controlled trial of lisdexamfetamine dimesylate. J Child Adolesc Psychopharmacol 2012a; 22: 149-156.
- Coghill D, Banaschewski T, Lecendreux M, Soutullo C, Johnson M, Zuddas A et al. European, randomized, phase 3 study of lisdexamfetamine dimesylate in children and adolescents with attention-deficit/hyperactivity disorder. Eur Neuropsychopharmacol 2013; 23: 1208-1218.
- Dittmann RW, Cardo E, Nagy P, Anderson CS, Bloomfield R, Caballero B et al. Efficacy and safety of lisdexamfetamine dimesylate and atomoxetine in the treatment of attention-deficit/hyperactivity disorder: a head-to-head, randomized, doubleblind, phase IIIb study. CNS Drugs 2013; 27: 1081-1092.
- Giblin JM, Strobel AL. Effect of lisdexamfetamine dimesylate on sleep in children with ADHD. J Atten Disord 2011; 15: 491-498.
- Findling RL, Childress AC, Krishnan S, McGough JJ. Long-term effectiveness and safety of lisdexamfetamine dimesylate in school-aged children with attention-deficit/hyperactivity disorder. CNS Spectr 2008; 13: 614-620.
- Findling RL, Cutler AJ, Saylor K, Gasior M, Hamdani M, Ferreira-Cornwell MC, Childress AC. A long-term open-label safety and effectiveness trial of lisdexamfetamine dimesylate in adolescents with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol 2013; 23: 11-21.
- Coghill DR, Banaschewski T, Lecendreux M, Johnson M, Zuddas A, Anderson CS et al. Maintenance of efficacy of lisdexamfetamine dimesylate in children and adolescents with attention-deficit/hyperactivity disorder: randomized-withdrawal study design. J Am Acad Child Adolesc Acad 2014a; 53: 647-657.
- Hammerness P, Zusman R, Systrom D, Surman C, Baggish A, Schillinger M et al. A cardiopulmonary study of lisdexamfetamine in adults with attentiondeficit/hyperactivity disorder. World J Biol Psychiatry 2013; 14: 299-306.
- Faraone SV, Spencer TJ, Kollins SH, Glatt SJ. Effects of lisdexamfetamine dimesylate treatment for ADHD on growth. J Am Acad Child Adolesc Psychiatry 2010; 49: 24-32.
- Spiller HA, Griffith JR, Anderson DL, Weber JA, Aleguas A. Poison centers detect an unexpectedly frequent number of adverse drug reactions to lisdexamfetamine. Ann Pharmacother 2008; 42: 1142-1143.
- Brahm NC, Hamilton DR. Alopecia following initiation of lisdexamfetamine in a pediatric patient. Prim Care Companion J Clin Psychiatry 2009; 11: 365.
- Hood B, Nowicki MJ. Eosinophilic hepatitis in an adolescent during lisdexamfetamine dimesylate treatment for ADHD. Pediatrics 2010; 125: e1510-1513.
- Ford JB, Albertson TE, Owen KP, Sutter ME, McKinney WB. Acute, sustained chorea in children after supratherapeutic dosing of amphetaminederived medications. Pediatr Neurol 2012; 47: 216-218.
- Akingbola OA, Singh D. Dexmedetomidine to treat lisdexamfetamine overdose and serotonin toxidrome in a 6-year-old girl. Am J Crit Care 2012; 21: 456-459.
- Jasinski DR, Krishnan S. Human pharmacology of intravenous lisdexamfetamine dimesylate: abuse liability in adult stimulant abusers. J Psychopharmacol 2009a; 23: 410-418.
- Ermer J, Dennis K, Haffey M, Doll WJ, Sandefer EP, Buckwalter M et al. Intranasal versus oral administration of lisdexamfetamine dimesylate: a randomized, open-label, two-period, crossover, single-dose, single-centre pharmacokinetic study in healthy adult men. Clin Drug Investig 2011; 31: 357-370.
- Jasinski DR, Krishnan S. Abuse liability and safety of oral lisdexamfetamine dimesylate: abuse liability in adult stimulant abusers. J Psychopharmacol 2009b; 23: 419-427.
- Sembower MA, Ertischek MD, Buchholtz C, Dasgupta N, Schnoll SH. Surveillance of diversion and nonmedical use of extendedrelease prescription amphetamine and oral methylphenidate in the United States. J Addict Dis 2013; 32: 26-38.
- Wigal SB, Kollins SH, Childress AC, Squires L, for the 311 Study Group. A 13-hour laboratory school study of lisdexamfetamine dimesylate in school-aged children with attention-deficit/hyperactivity disorder. Child Adolesc Psychiatry Ment Health 2009; 3: 17.
- Coghill DR, Banaschewski T, Lecendreux M, Zuddas A, Dittmann RW, Otero IH, et al. Efficacy of lisdexamfetamine dimesylate throughout the day in children and adolescents with attentiondeficit/ hyperactivity disorder: results from a randomized, controlled trial. Eur Child Adolesc Psychiatry 2014b; 23: 61-8.
- Findling RL, Childress AC, Cutler AJ, Gasior M, Hamdani M, Ferreira-Cornwell MC, Squires L. Efficacy and safety of lisdexamfetamine dimesylate in adolescents with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry 2011; 50: 395-405.
- DuPaul GJ, Weyandt LL, Rossi JS, Vilardo BA, O’Dell SM, Carson KM, et al. Double-blind, placebo-controlled, crossover study of the efficacy and safety of lisdexamfetamine dimesylate in college students with ADHD. J Atten Disord 2012; 16: 202-20.
- Findling RL, Adeyi B, Chen G, Dirks B, Babcock T, Scheckner B et al. Clinical response and symptomatic remission in children treated with lisdexamfetamine dimesylate for attention-deficit/hyperactivity disorder. CNS Spectr 2010; 15: 559-568.
- Jain R, Babcock T, Burtea T, Dirks B, Adeyi B, Scheckner B, Lasser R. Efficacy of lisdexamfetamine dimesylate in children with attention-deficit/hyperactivity disorder previously treated with methylphenidate: a post hoc analysis. Child Adolesc Psychiatry Ment Health 2011; 5: 35.
- Jain R, Babcock T, Burtea T, Dirks B, Adeyi B, Scheckner B et al. Efficacy and safety of lisdexamfetamine dimesylate in children with attention-deficit/hyperactivity disorder and recent methylphenidate use. Adv Ther 2013; 30: 472-486.
- Coghill DR, Banaschewski T, Lecendreux M, Soutullo C, Zuddas A, Adeyi B, Sorooshian S. Post hoc analyses of the impact of previous medication on the efficacy of lisdexamfetamine dimesylate in the treatment of attention-deficit/hyperactivity disorder in a randomized, controlled trial. Neuropsychiatr Dis Treat 2014c; 10: 2039-2047.
- Wigal SB, Maltas S, Crinella F, Stehli A, Steinhoff K, Lakes K, Schuck S. Reading performance as a function of treatment with lisdexamfetamine dimesylate in elementary school children diagnosed with ADHD. J Atten Disord 2012b; 16: 23-33.
- Turgay A, Ginsberg L, Sarkis E, Jain R, Adeyi B, Gao J, et al. Executive function deficits in children with attention-deficit / hyperactivity disorder and improvement with lisdexamfetamine dimesylate in an open-label study. J Child Adolesc Psychopharmacol 2010; 20: 503-511.
- Katic A, Ginsberg L, Jain R, Adeyi B, Dirks B, Babcock T, et al. Clinically relevant changes in emotional expression in children with ADHD treated with lisdexamfetamine dimesylate. J Atten Disord 2012; 16: 384-397.
- Banaschewski T, Soutullo C, Lecendreux M, Johnson M, Zuddas A, Hodgkins P, et al. Health-related Quality of Life and functional outcomes from a randomized, controlled study of lisdexamfetamine dimesylate in children and adolescents with attention deficit hyperactivity disorder. CNS Drugs 2013; 27: 829-840.
- Banaschewski T, Johnson M, Lecendreux M, Zuddas A, Adeyi B, Hodgkins P, et al. Healthrelated Quality of Life and functional outcomes from a randomized-withdrawal study of longterm lisdexamfetamine dimesylate treatment in children and adolescents with attention-deficit / hyperactivity disorder. CNS Drugs 2014; 28: 1191-1203.
- Childress AC, Cutler AJ, Saylor K, Gasior M, Hamdani M, Ferreira-Cornwell MC, Findling RL. Participant-perceived Quality of Life in a long-term, open-label trial of lisdexamfetamine dimesylate in adolescents with attentiondeficit/hyperactivity disorder. J Child Adolesc Psychopharmacol 2014; 24: 210-217.
- Dittmann RW, Cardo E, Nagy P, Anderson CS, Adeyi B, Caballero B, et al. Treatment response and remission in a double-blind, randomized, headto-head study of lisdexamfetamine dimesylate and atomoxetine in children and adolescents with attention-deficit/hyperactivity disorder. CNS Drugs 2014; 28: 1059-1069.
- Nagy P, Häge A, Coghill DR, Caballero B, Adeyi B, Anderson CS, et al. Functional outcomes from a head-to-head, randomized, double-blind trial of lisdexamfetamine dimesylate and atomoxetine in children and adolescents with attention-deficit/hyperactivity disorder and an inadequate response to methylphenidate. Eur Child Adolesc Psychiatry 2015; epub ahead of print.
- Hanwella R, Senanayake M, de Silva V. Comparative efficacy and acceptability of methylphenidate and atomoxetine in treatment of attention deficit hyperactivity disorder in children and adolescents: a meta-analysis. BMC Psychiatry 2011; 11: 176.
- Soutullo C, Banaschewski T, Lecendreux M, Johnson M, Zuddas A, Anderson C, et al. A post hoc comparison of the effects of lisdexamfetamine dimesylate and osmotic-release oral system methylphenidate on symptoms of attention-deficit hyperactivity disorder in children and adolescents. CNS Drugs 2013; 27: 743-751.
- Setyawan J, Hodgkins P, Guérin A, Gauthier G, Cloutier M, Wu EQ, Erder MH. Comparing treatment adherence of lisdexamfetamine and other medications for the treatment of attention deficit/hyperactivity disorder: a retrospective analysis. J Med Econ 2013a; 16: 962-75.
- Setyawan J, Guérin A, Hodgkins P, Gauthier G, Cloutier M, Wu E, Erder MH. Treatment persistence in attention deficit/hyperactivity disorder: a retrospective analysis of patients initiated on lisdexamfetamine vs other medications. J Med Econ 2013b; 16: 1275-89.
- Alda JA, Soutullo C, Ramos-Quiroga JA, Quintero J, Hervás A, Hernández-Otero I, et al. Recomendación de expertos: aportaciones a la práctica clínica del nuevo profármaco lisdexanfetamina dimesilato (LDX) en el tratamiento del trastorno por déficit de atención con hiperactividad (TDAH). Actas Esp Psiquiatr 2014; 42 (supl 1): 1-16.