Efetividade a longo prazo da lisdexanfetamina para o tratamento de transtorno do déficit de atenção e hiperatividade e transtorno de compulsão alimentar

Vigil Sanit Debate, Rio de Janeiro, 2026, v.14: e02484| Publicado em: 05/05/2026

Autores

  • Maíra Catharina Ramos Programa de Evidências para Políticas e Tecnologias de Saúde, Fundação Oswaldo Cruz (Fiocruz), Brasília, DF, Brasil | Programa de Pós-graduação em Saúde Coletiva, Faculdade de Ciências da Saúde, Universidade de Brasília, Brasília, DF, Brasil Autor https://orcid.org/0000-0003-3829-975X
  • Viviane Cássia Pereira Programa de Evidências para Políticas e Tecnologias de Saúde, Fundação Oswaldo Cruz (Fiocruz), Brasília, DF, Brasil Autor https://orcid.org/0000-0002-9628-9974
  • Flávia Tavares Silva Elias Programa de Evidências para Políticas e Tecnologias de Saúde, Fundação Oswaldo Cruz (Fiocruz), Brasília, DF, Brasil Autor https://orcid.org/0000-0002-7142-6266

DOI:

https://doi.org/10.22239/2317-269X.02484

Palavras-chave:

Dimesilato de Lisdexanfetamina, Transtorno do Déficit de Atenção com Hiperatividade, Transtorno da Compulsão Alimentar, Revisão

Resumo

Introdução: A lisdexanfetamina (LDX) é um medicamento indicado para o tratamento de transtorno do déficit de atenção/hiperatividade (TDAH) e transtorno de compulsão alimentar (TCA). Após sua administração oral, o medicamento é rapidamente absorvido pelo trato gastrointestinal e convertido em D-anfetamina ligada covalentemente ao aminoácido natural L-lisina, responsável pela atividade do medicamento. Objetivo: Avaliar a efetividade a longo prazo da LDX para o tratamento de TDAH e de TCA. Método: Foi realizada busca na PubMed, Embase, Web of Science e Cochrane utilizando descritores e seus respectivos sinônimos para identificar a eficácia e a segurança a longo prazo da LDX em pessoas com TDAH e TCA. Foram incluídos estudos intervencionais e com grupo controle cujo seguimento foi superior a cinco semanas. Resultados: Foram incluídos 30 estudos. Em relação à população, foram investigados os efeitos da LDX desde cinco a 55 anos; e o maior seguimento foi de 108 semanas. De forma geral, a literatura aponta para uma grande redução dos sintomas nas primeiras cinco a seis semanas de tratamento, se estabilizando nas semanas seguintes. Em TDAH, estudos de até 108 semanas relataram reduções médias de -25,8 pontos no ADHD-RS-IV (IC95% -27,0 a -24,5), melhora em CGI-I de 42,3% para 89,1% e taxas de manutenção de resposta superiores a 75% em adultos após 12 meses. Em TCA, estudos de até 52 semanas mostraram que 89,8% dos participantes apresentaram melhora clínica no CGI-I, com reduções significativas no número de dias de compulsão alimentar por semana (diferenças médias de até -1,66; p < 0,001) e melhora de -1,95 pontos no EDE-Q. Conclusões: Os achados indicam que a LDX apresenta resultados promissores em longo prazo para ambas as condições de saúde. Entretanto, é preciso acompanhamento com profissional de saúde devido aos eventos adversos do medicamento.

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Biografia do Autor

  • Maíra Catharina Ramos, Programa de Evidências para Políticas e Tecnologias de Saúde, Fundação Oswaldo Cruz (Fiocruz), Brasília, DF, Brasil | Programa de Pós-graduação em Saúde Coletiva, Faculdade de Ciências da Saúde, Universidade de Brasília, Brasília, DF, Brasil
  • Viviane Cássia Pereira, Programa de Evidências para Políticas e Tecnologias de Saúde, Fundação Oswaldo Cruz (Fiocruz), Brasília, DF, Brasil
  • Flávia Tavares Silva Elias, Programa de Evidências para Políticas e Tecnologias de Saúde, Fundação Oswaldo Cruz (Fiocruz), Brasília, DF, Brasil

Referências

1. Elia J, Easley C, Kirkpatrick P. Lisdexamfetamine dimesylate. Nat Rev Drug Discov. 2007;6(5):343-4.https://doi.org/10.1038/nrd2315

2. Ministério da Saúde (BR). Portaria conjunta Nº 14, de 29 de julho de 2022. Aprova o protocolo clínico e diretrizes terapêuticas do transtorno do déficit de atenção com hiperatividade.Diário Oficial União. 30 jul 2022.

3. Adler LA, Alperin S, Leon T, Faraone S. Clinical effects of lisdexamfetamine and mixed amphetamine salts immediate release in adult ADHD: results of a crossover design clinical trial. Postgrad Med.2014;126(5):17-24.

4. Fava DC, Barbosa ACC, Portes JRM, Ornelas O. Transtorno de déficit de atenção/hiperatividade. In: Moreno AL, Melo W, editor. Casos clínicos em saúde mental: diagnóstico e indicação de tratamentos baseados em evidências. Porto Alegre: Artmed; 2022. p. 232.

5. Davis HA, Graham AK, Wildes JE. Overview of binge eating disorder. Curr Cardiovasc Risk Rep. 2020;14(12).https://doi.org/10.1007/s12170-020-00664-2

6. Kjeldbjerg ML, Clausen L. Prevalence of binge-eating disorder among children and adolescents: a systematic review and meta-analysis. Eur Child Adolesc Psych. 2023;32(4):549-74.https://doi.org/10.1007/s00787-021-01850-2

7. McElroy SL, Hudson J, Ferreira-Cornwell MC, Radewonuk J, Whitaker T, Gasior M. Lisdexamfetamine dimesylate for adults with moderate to severe binge eating disorder: results of two pivotal phase 3 randomized controlled trials. Neuropsychopharmacology. 2016;41(5):1251-60.https://doi.org/10.1038/npp.2015.275

8. Yee KS, Pokrzywinski R, Hareendran A, Shaffer S, Sheehan D V. Evaluating functional disability in clinical trials of lisdexamfetamine dimesylate in binge eating disorder using the Sheehan Disability Scale. Int J Methods Psychiatr Res. 2021;30(1):1-13.https://doi.org/10.1002/mpr.1849

9. Banaschewski T, Johnson M, Nagy P, Otero IH, Soutullo CA, Yan B et al. Growth and puberty in a 2-year open-label study of lisdexamfetamine dimesylate in children and adolescents with attention-deficit/hyperactivity disorder. CNS Drugs. 2018;32(5):455-67.https://doi.org/10.1007/s40263-018-0514-8

10. Childress AC, Lloyd E, Johnson SAJ, Gunawardhana L, Arnold V. A long-term, open-label safety and tolerability study of lisdexamfetamine dimesylate in children aged 4-5 years with attention-deficit/hyperactivity disorder.J Child Adolesc Psychoph. 2022;32(2):98-106.https://doi.org/10.1089/cap.2021.0138

11. Sheehan DV, Gasior M, McElroy SL, Radewonuk J, Herman BK, Hudson J. Effects of lisdexamfetamine dimesylate on functional impairment measured on the sheehan disability scale in adults with moderate-to-severe binge eating disorder: results from two randomized, placebo-controlled trials.Innov Clin Neurosci. 2018;15(5-6):22-9.

12. Dittmann RW, Cardo E, Nagy P, Anderson CS, Adeyi B, Caballero B et al. Treatment response and remission in a double-blind, randomized, head-to-head study of lisdexamfetamine dimesylate and atomoxetine in children and adolescents with attention-deficit hyperactivity disorder. CNS Drugs. 2014;28(11):1059-69.https://doi.org/10.1007/s40263-014-0188-9

13. McElroy SL, Mitchell JE, Wilfley D, Gasior M, Ferreira-Cornwell MC, McKay M et al. Lisdexamfetamine dimesylate effects on binge eating behaviour and obsessive-compulsive and impulsive features in adults with binge eating disorder. Eur Eat Disord Rev. 2016;24(3):223-31.https://doi.org/10.1002/erv.2418

14. 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(7):614-20.https://doi.org/10.1017/s1092852900016898

15. Coghill DR, Banaschewski T, Nagy P, Otero IH, Soutullo C, Yan B et al. Long-term safety and efficacy of lisdexamfetamine dimesylate in children and adolescents with ADHD: a phase IV, 2-year, openlabel study in Europe. CNS Drugs. 2017;31(7):625-38.https://doi.org/10.1007/s40263-017-0443-y

16. Banaschewski T, Johnson M, Lecendreux M, Zuddas A, Adeyi B, Hodgkins P et al. Health-related quality of life and functional outcomes from a randomized-withdrawal study of long-term lisdexamfetamine dimesylate treatment in children and adolescents with attention-deficit/hyperactivity disorder. CNS Drugs. 2014;28(12):1191-203.https://doi.org/10.1007/s40263-014-0193-z

17. Adler LA, Lynch LR, Shaw DM, Wallace SP, O’Donnell KE, Ciranni MA et al. Effectiveness and duration of effect of open-label lisdexamfetamine dimesylate in adults with ADHD. J Atten Disord. 2017;21(2):149-57.https://doi.org/10.1177/1087054713485421

18. Guerdjikova AI, Mori N, Blom TJ, Keck PE Jr, Williams SL, Welge JA et al. Lisdexamfetamine dimesylate in binge eating disorder: a placebo controlled trial. Hum Psychopharmacol. 2016;31(5):382-91.https://doi.org/10.1002/hup.2547

19. Findling RL, Cutler AJ, Saylor K, Gasior M, Hamdani M, Ferreira-Cornwell MC et al. 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(1):11-21.https://doi.org/10.1089/cap.2011.0088

20. Findling RL, Ginsberg LD, Jain R, Gao J. Effectiveness, safety, and tolerability of lisdexamfetamine dimesylate in children with attention-deficit/hyperactivity disorder: an open-label, dose-optimization study.J Child Adolesc Psychopharmacol. 2009;19(6):649-62.https://doi.org/10.1089/cap.2008.0165

21. Coghill DR, Banaschewski T, Bliss C, Robertson B, Zuddas A. Cognitive function of children and adolescents with attention-deficit/hyperactivity disorder in a 2-year open-label study of lisdexamfetamine dimesylate. CNS Drugs. 2018;32(1):85-95.https://doi.org/10.1007/s40263-017-0487-z

22. Hudson JI, McElroy SL, Ferreira-Cornwell MC, Radewonuk J, Gasior M. Efficacy of lisdexamfetamine in adults with moderate to severe binge-eating disorder: a randomized clinical trial. JAMA psychiatry.2017;74(9):903-10. https://doi.org/10.1001/jamapsychiatry.2017.1889

23. Kornstein SG, Bliss C, Kando J, Madhoo M. Clinical characteristics and treatment response to lisdexamfetamine dimesylate versus placebo in adults with binge eating disorder: analysis by gender and age. J Clin Psychiatry. 2019;80(2).

24. 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(10):1208-18.https://doi.org/10.1016/j.euroneuro.2012.11.012

25. Citrome L, Kando JC, Bliss C. Relationships between clinical scales and binge eating days in adults with moderate to severe binge eating disorder in two Phase III studies. Neuropsychiatr Dis Treat. 2018;14:537-46.https://doi.org/10.2147/NDT.S158395

26. Childress AC, Lloyd E, Jacobsen L, Gunawardhana L, Johnson SA Jr, Findling RL. Efficacy and safety of lisdexamfetamine in preschool children with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2022;61(12):1423-34.https://doi.org/10.1016/j.jaac.2022.03.034

27. 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 attention-deficit/hyperactivity disorder: results from a randomized, controlled trial. Eur Child Adolesc Psychiatry.2014;23(2):61-8.https://doi.org/10.1007/s00787-013-0421-y

28. 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 Psychiatry.2014;53(6):647-57.https://doi.org/10.1016/j.jaac.2014.01.017

29. Mattingly GW, Weisler RH, Young J, Adeyi B, Dirks B, Babcock T et al. Clinical response and symptomatic remission in short- and long-term trials of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder. BMC Psychiatry. 2013;13:1-12. https://doi.org/10.1186/1471-244X-13-39

30. Setyawan J, Yang HB, Cheng D, Cai XP, Signorovitch J, Xie JP et al. Developing a risk score to guide individualized treatment selection in attention deficit/hyperactivity disorder. Value Health.2015;18(6):824-31. https://doi.org/10.1016/j.jval.2015.06.005

31. McElroy SL, Hudson JI, Gasior M, Herman BK, Radewonuk J, Wilfley D et al. Time course of the effects of lisdexamfetamine dimesylate in two phase 3, randomized, double-blind, placebo-controlled trials in adults with binge-eating disorder. Int J Eat Disord.2017;50(8):884-92. https://doi.org/10.1002/eat.22722

32. 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 attentiondeficit/hyperactivity disorder: a head-to-head, randomized, double-blind, phase IIIb study.CNS Drugs.2013;27(12):1081-92. https://doi.org/10.1007/s40263-013-0104-8

33. Ichikawa H, Miyajima T, Yamashita Y, Fujiwara M, Fukushi A, Saito K. Long-term study of lisdexamfetamine dimesylate in Japanese children and adolescents with attention-deficit/hyperactivity disorder. Neuropsychopharmacol Rep. 2020;40(1):52-62.https://doi.org/10.1002/npr2.12091

34. Hansen MV, Darling L, Holst H. Safety and tolerability of lisdexamfetamine: a retrospective cohort study.CNS Drugs. 2015;29(5):415-23.https://doi.org/10.1007/s40263-015-0246-y

35. Adler LA, Alperin S, Leon T, Faraone S. Clinical effects of lisdexamfetamine and mixed amphetamine salts immediate release in adult ADHD: results of a crossover design clinical trial. Postgrad Med. 2014;126(5):17-24.https://doi.org/10.3810/pgm.2014.09.2796

36. Gasior M, Hudson J, Quintero J, Ferreira-Cornwell MC, Radewonuk J, McElroy SL. A phase 3, multicenter, open-label, 12-month extension safety and tolerability trial of lisdexamfetamine dimesylate in adults with binge eating disorder. J Clin Psychopharmacol. 2017;37(3):315-22.https://doi.org/10.1097/JCP.0000000000000702

37. Guerdjikova AI, Mori N, Blom TJ, Keck PE, Williams SL, Welge JA et al. Lisdexamfetamine dimesylate in binge eating disorder: a placebo controlled trial.Hum Psychopharmacol Exp.2016;31(5):382–91.https://doi.org/10.1002/hup.2547

38. Stuhec M, Lukic P, Locatelli I, Lukić P, Locatelli I, Lukic P et al. Efficacy, acceptability, and tolerability of lisdexamfetamine, mixed amphetamine salts, methylphenidate, and modafinil in the treatment of attention-deficit hyperactivity disorder in adults: a systematic review and metaanalysis.Ann Pharmacother.2019;53(2):121-33.https://doi.org/10.1177/ 1060028018795703

39. Maneeton N, Maneeton B, Suttajit S, Reungyos J, Srisurapanont M, Martin SD. Exploratory meta-analysis on lisdexamfetamine versus placebo in adult ADHD. Drug Des Dev Ther. 2014;8:1385-93.https://doi.org/10.2147/DDDT.S68393

40. Schneider E, Higgs S, Dourish CT. Lisdexamfetamine and binge-eating disorder: A systematic review and meta-analysis of the preclinical and clinical data with a focus on mechanism of drug action in treating the disorder.Eur Neuropsychopharmacol. 2021;53:49-78.https://doi.org/10.1016/j.euroneuro.2021.08.001

41. Fornaro M, Solmi M, Perna G, De Berardis D, Veronese N, Orsolini L et al. Lisdexamfetamine in the treatment of moderate-to-severe binge eating disorder in adults: systematic review and exploratory meta-analysis of publicly available placebo-controlled, randomized clinical trials. Neuropsychiatr Dis Treat. 2016;12:1827-36.https://doi.org/10.2147/NDT.S109637

42. Mathews M. Clinical Review - s-NDA 21977. Washington DC: FDA; 2011[acesso 22 out 2023].Disponível em:https://www.fda.gov/files/drugs/published/21977S-Lisdexamfetamine-Clinical-PREA.pdf

43. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use – ICH. Guia introdutório do MedDRA versão 23.1. Geneva: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; 2020.

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05-05-2026

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Revisão | VIGILÂNCIA PÓS-COMERCIALIZAÇÃO

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Efetividade a longo prazo da lisdexanfetamina para o tratamento de transtorno do déficit de atenção e hiperatividade e transtorno de compulsão alimentar: Vigil Sanit Debate, Rio de Janeiro, 2026, v.14: e02484| Publicado em: 05/05/2026. (2026). Vigilância Sanitária Em Debate , 14, 1-10. https://doi.org/10.22239/2317-269X.02484

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