Yıl: 2023 Cilt: 30 Sayı: 1 Sayfa Aralığı: 20 - 27 Metin Dili: Türkçe DOI: 10.4274/tjcamh.galenos.2023.87587 İndeks Tarihi: 31-05-2023

Dikkat Eksikliği Hiperaktivite Bozukluğu Tedavisinde Uzun Etkili Guanfasinin Yeri

Öz:
Dikkat eksikliği hiperaktivite bozukluğu (DEHB) çocukluk çağının en sık görülen psikiyatrik bozukluğu olmasının yanı sıra tedavi edilmediğinde son derece ciddi psikiyatrik, akademik ve sosyal sorunlara yol açabilen ciddi bir psikiyatrik bozukluktur. Yarım asırı aşkın bir süredir DEHB, metilfenidat ve amfetamin gibi stimülan ilaçlarla başarılı bir şekilde tedavi edilmektedir. Klinik araştırmalardaki katılımcıların %20-35’i başlangıçtaki stimülan tedavisine yetersiz yanıt verdiği bildirilmektedir. Bu nedenle DEHB tedavisinde stimülan dışı alternatifler araştırılmış ve stimülan olmayan atomoksetin, klonidin ve guanfasin geliştirilmiştir. Çocuklarda DEHB tedavisi için uzun etkili guanfasinin kullanımı incelenmiş ve hiperaktivite ve dikkat eksikliğinde anlamlı iyileşme saptanmıştır. Bu erken çalışmalar, uzun etkili guanfasinin geliştirilmesini ve 2009 yılında DEHB tedavisinde formülasyonun Amerika Birleşik Devletleri Gıda ve İlaç Dairesi onayı almasını sağlamıştır. Amfetamin veya metilfenidatı tolere etmeyen hastalar, özellikle iştah azalması, uykusuzluk veya taşikardisi olan hastalar için guanfasin uygun bir seçenektir. Bu makale, DEHB için uzun salımlı guanfasin ile ilgili mevcut literatürü gözden geçirmekte ve bu ilacın kimyasal yapısını, dozaj ve uygulamasını, etki mekanizmasını, farmakokinetiğini ve farmakodinamiğini, klinik deneylerdeki etkinliğini, güvenliğini ve tolere edilebilirliğini ve DEHB tedavisindeki rolünü tartışmaktadır.
Anahtar Kelime:

The Role of Long-acting Guanfasine in the Treatment of Attention Deficit Hyperactivity Disorder

Öz:
Attention deficit hyperactivity disorder ADHD is a serious psychiatric disorder that can lead to extremely serious psychiatric, academic and social problems if not treated, as well as being the most common psychiatric disorder of childhood. ADHD has been successfully treated with stimulant drugs such as methylphenidate and amphetamines for over half a century. It is reported that 20-35% of participants in clinical trials have an inadequate response to initial stimulant treatment. Therefore, non-stimulant alternatives have been investigated in the treatment of ADHD and non-stimulant atomoxetine, clonidine and guanfacine have been developed. The use of long-acting guanfacine for the treatment of ADHD in children was examined and significant improvement was found in hyperactivity and attention deficit. These early studies led to the development of long-acting guanfacine and, in 2009, the formulation received United States Food and Drug Administration approval for the treatment of ADHD. For patients who do not tolerate amphetamine or methylphenidate, especially those with decreased appetite, insomnia or tachycardia, guanfacine is a suitable option. This article reviews the available literature on extended-release guanfacine for ADHD and discusses its chemical structure, dosage and administration, mechanism of action, pharmacokinetics and pharmacodynamics, efficacy, safety and tolerability in clinical trials, and its role in the treatment of ADHD.
Anahtar Kelime:

Belge Türü: Makale Makale Türü: Derleme Erişim Türü: Erişime Açık
  • 1. Pelham WE, Aronoff HR, Midlam JK, Shapiro CJ, Gnagy EM, Chronis AM, Onyango AN, Forehand G, Nguyen A, Waxmonsky J. A comparison of ritalin and adderall: efficacy and time-course in children with attention-deficit/hyperactivity disorder. Pediatrics. 1999;103:e43.
  • 2. Pliszka S; AACAP Work Group on Quality Issues. Practice parameter for the assessment and treatment of children and adolescents with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2007;46:894-921.
  • 3. Sallee FR, McGough J, Wigal T, Donahue J, Lyne A, Biederman J; SPD503 STUDY GROUP. Guanfacine extended release in children and adolescents with attention-deficit/hyperactivity disorder: a placebo- controlled trial. J Am Acad Child Adolesc Psychiatry. 2009;48:155- 165.
  • 4. Biederman J, Melmed RD, Patel A, McBurnett K, Konow J, Lyne A, Scherer N; SPD503 Study Group. A randomized, double-blind, placebo-controlled study of guanfacine extended release in children and adolescents with attention-deficit/hyperactivity disorder. Pediatrics. 2008;121:e73-84.
  • 5. Jain R, Segal S, Kollins SH, Khayrallah M. Clonidine extended-release tablets for pediatric patients with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2011;50:171-179.
  • 6. Faraone SV, Biederman J, Spencer TJ, Aleardi M. Comparing the efficacy of medications for ADHD using meta-analysis. MedGenMed. 2006;8:4.
  • 7. FDA. Intuniv Guanfacine extended-release tablets [Internet]. 2010 [cited 2023 Jan 15]. Available from: www.fda.gov/medwatch.
  • 8. Arnsten AF, Steere JC, Hunt RD. The contribution of alpha 2-noradrenergic mechanisms of prefrontal cortical cognitive function. Potential significance for attention-deficit hyperactivity disorder. Arch Gen Psychiatry. 1996;53:448-455.
  • 9. Arnsten AF, Cai JX, Goldman-Rakic PS. The alpha-2 adrenergic agonist guanfacine improves memory in aged monkeys without sedative or hypotensive side effects: evidence for alpha-2 receptor subtypes. J Neurosci. 1988;8:4287-4298.
  • 10. Hunt RD, Arnsten AF, Asbell MD. An open trial of guanfacine in the treatment of attention-deficit hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 1995;34:50-54.
  • 11. FDA, Cder. Intuniv (guanfacine) extended-release tablets. [cited 2023 Jan 15]; Available from: http://www.fda.gov/ForIndustry/ DataStandards/StructuredProductLabeling/default.htm.
  • 12. Boellner SW, Pennick M, Fiske K, Lyne A, Shojaei A. Pharmacokinetics of a guanfacine extended-release formulation in children and adolescents with attention-deficit-hyperactivity disorder. Pharmacotherapy. 2007;27:1253-1262.
  • 13. Li A, Yeo K, Welty D, Rong H. Development of Guanfacine Extended- Release Dosing Strategies in Children and Adolescents with ADHD Using a Physiologically Based Pharmacokinetic Model to Predict Drug-Drug Interactions with Moderate CYP3A4 Inhibitors or Inducers. Paediatr Drugs. 2018;20:181-194.
  • 14. Wilens TE, Robertson B, Sikirica V, Harper L, Young JL, Bloomfield R, Lyne A, Rynkowski G, Cutler AJ. A Randomized, Placebo-Controlled Trial of Guanfacine Extended Release in Adolescents With Attention- Deficit/Hyperactivity Disorder. J Am Acad Child Adolesc Psychiatry. 2015;54:916-925.
  • 15. Hervas A, Huss M, Johnson M, McNicholas F, van Stralen J, Sreckovic S, Lyne A, Bloomfield R, Sikirica V, Robertson B. Efficacy and safety of extended-release guanfacine hydrochloride in children and adolescents with attention-deficit/hyperactivity disorder: a randomized, controlled, phase III trial. Eur Neuropsychopharmacol. 2014;24:1861-1872.
  • 16. Gajria K, Kosinski M, Sikirica V, Huss M, Livote E, Reilly K, Dittmann RW, Erder MH. Psychometric validation of the Weiss Functional Impairment Rating Scale-Parent Report Form in children and adolescents with attention-deficit/hyperactivity disorder. Health Qual Life Outcomes. 2015;13:184.
  • 17. Sallee FR, Kollins SH, Wigal TL. Efficacy of guanfacine extended release in the treatment of combined and inattentive only subtypes of attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2012;22:206-214.
  • 18. Newcorn JH, Stein MA, Childress AC, Youcha S, White C, Enright G, Rubin J. Randomized, double-blind trial of guanfacine extended release in children with attention-deficit/hyperactivity disorder: morning or evening administration. J Am Acad Child Adolesc Psychiatry. 2013;52:921-930.
  • 19. Spencer TJ, Greenbaum M, Ginsberg LD, Murphy WR. Safety and effectiveness of coadministration of guanfacine extended release and psychostimulants in children and adolescents with attention- deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2009;19:501-510.
  • 20. Wilens TE, Bukstein O, Brams M, Cutler AJ, Childress A, Rugino T, Lyne A, Grannis K, Youcha S. A controlled trial of extended-release guanfacine and psychostimulants for attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2012;51:74-85.
  • 21. Cutler AJ, Brams M, Bukstein O, Mattingly G, McBurnett K, White C, Rubin J. Response/remission with guanfacine extended-release and psychostimulants in children and adolescents with attention- deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2014;53:1092-1101.
  • 22. Wilens TE, McBurnett K, Turnbow J, Rugino T, White C, Youcha S. Morning and Evening Effects of Guanfacine Extended Release Adjunctive to Psychostimulants in Pediatric ADHD. J Atten Disord. 2017;21:110-119.
  • 23. van Stralen JPM. A Controlled Trial of Extended-Release Guanfacine and Psychostimulants on Executive Function and ADHD. J Atten Disord. 2020;24:318-325.
  • 24. Ruggiero S, Clavenna A, Reale L, Capuano A, Rossi F, Bonati M. Guanfacine for attention deficit and hyperactivity disorder in pediatrics: a systematic review and meta-analysis. Eur Neuropsychopharmacol. 2014;24:1578-1590.
  • 25. Hirota T, Schwartz S, Correll CU. Alpha-2 agonists for attention- deficit/hyperactivity disorder in youth: a systematic review and meta-analysis of monotherapy and add-on trials to stimulant therapy. J Am Acad Child Adolesc Psychiatry. 2014;53:153-173.
  • 26. Sallee FR, Lyne A, Wigal T, McGough JJ. Long-term safety and efficacy of guanfacine extended release in children and adolescents with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2009;19:215-226.
  • 27. Biederman J, Melmed RD, Patel A, McBurnett K, Donahue J, Lyne A. Long-term, open-label extension study of guanfacine extended release in children and adolescents with ADHD. CNS Spectr. 2008;13:1047-1055.
  • 28. Huss M, Dirks B, Gu J, Robertson B, Newcorn JH, Ramos-Quiroga JA. Long-term safety and efficacy of guanfacine extended release in children and adolescents with ADHD. Eur Child Adolesc Psychiatry. 2018;27:1283-1294.
  • 29. Wilens TE, Robertson B, Sikirica V, Harper L, Young JL, Bloomfield R, Lyne A, Rynkowski G, Cutler AJ. A Randomized, Placebo-Controlled Trial of Guanfacine Extended Release in Adolescents With Attention- Deficit/Hyperactivity Disorder. J Am Acad Child Adolesc Psychiatry. 2015;54:916-925.
  • 30. Huss M, McBurnett K, Cutler AJ, Hervás A, Bliss C, Gao J, Dirks B, Newcorn JH. Distinguishing the efficacy and sedative effects of guanfacine extended release in children and adolescents with attention-deficit/hyperactivitydisorder.EurNeuropsychopharmacol. 2019;29:432-443.
  • 31. Faraone SV, McBurnett K, Sallee FR, Steeber J, López FA. Guanfacine extended release: a novel treatment for attention- deficit/hyperactivity disorder in children and adolescents. Clin Ther. 2013;35:1778-1793.
  • 32. Martin P, Satin L, Kahn RS, Robinson A, Corcoran M, Purkayastha J, Youcha S, Ermer JC. A thorough QT study of guanfacine. Int J Clin Pharmacol Ther. 2015;53:301-316.
  • 33. Connor DF, Findling RL, Kollins SH, Sallee F, López FA, Lyne A, Tremblay G. Effects of guanfacine extended release on oppositional symptoms in children aged 6-12 years with attention-deficit hyperactivity disorder and oppositional symptoms: a randomized, double-blind, placebo-controlled trial. CNS Drugs. 2010;24:755-768.
  • 34. 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.
  • 35. Cortese S, Adamo N, Del Giovane C, Mohr-Jensen C, Hayes AJ, Carucci S, Atkinson LZ, Tessari L, Banaschewski T, Coghill D, Hollis C, Simonoff E, Zuddas A, Barbui C, Purgato M, Steinhausen HC, Shokraneh F, Xia J, Cipriani A. Comparative efficacy and tolerability of medications for attention-deficit hyperactivity disorder in children, adolescents, and adults: a systematic review and network meta-analysis. Lancet Psychiatry. 2018;5:727-738.
  • 36. Wolraich ML, Hagan JF Jr, Allan C, Chan E, Davison D, Earls M, Evans SW, Flinn SK, Froehlich T, Frost J, Holbrook JR, Lehmann CU, Lessin HR, Okechukwu K, Pierce KL, Winner JD, Zurhellen W; subcommıttee on chıldren and adolescents wıth attentıon- defıcıt/hyperactıve dısorder. Clinical Practice Guideline for the Diagnosis, Evaluation, and Treatment of Attention-Deficit/ Hyperactivity Disorder in Children and Adolescents. Pediatrics. 2019;144:e20192528. Erratum in: Pediatrics. 2020;145.
  • 37. Attention Deficit Hyperactivity Disorder: Diagnosis and Management [Internet]. [cited 2023 Jan 21]. Available from: https:// www.medscape.co.uk/viewarticle/attention-deficit-hyperactivity- disorder-diagnosis-and-2022a1001a97
  • 38. Coghill DR, Banaschewski T, Nagy P, Otero IH, Soutullo C, Yan B, Caballero B, Zuddas A. Long-Term Safety and Efficacy of Lisdexamfetamine Dimesylate in Children and Adolescents with ADHD: A Phase IV, 2-Year, Open-Label Study in Europe. CNS Drugs. 2017;31:625-638.
  • 39. Spencer TJ, Faraone SV, Biederman J, Lerner M, Cooper KM, Zimmerman B; concerta study group. Does prolonged therapy with a long-acting stimulant suppress growth in children with ADHD? J Am Acad Child Adolesc Psychiatry. 2006;45:527-537.
  • 40. Sikirica V, Findling RL, Signorovitch J, Erder MH, Dammerman R, Hodgkins P, Lu M, Xie J, Wu EQ. Comparative efficacy of guanfacine extended release versus atomoxetine for the treatment of attention- deficit/hyperactivity disorder in children and adolescents: applying matching-adjusted indirect comparison methodology. CNS Drugs. 2013;27:943-953.
  • 41. Li Y, Gao J, He S, Zhang Y, Wang Q. An Evaluation on the Efficacy and Safety of Treatments for Attention Deficit Hyperactivity Disorder in Children and Adolescents: a Comparison of Multiple Treatments. Mol Neurobiol. 2017;54:6655-6669.
  • 42. Childress AC, Sallee FR. Attention-deficit/hyperactivity disorder with inadequate response to stimulants: approaches to management. CNS Drugs. 2014;28:121-129.
  • 43. Fiks AG, Mayne SL, Song L, Steffes J, Liu W, McCarn B, Margolis B, Grimes A, Gotlieb E, Localio R, Ross ME, Grundmeier RW, Wasserman R, Leslie LK. Changing patterns of alpha agonist medication use in children and adolescents 2009-2011. J Child Adolesc Psychopharmacol. 2015;25:362-367.
  • 44. Pringsheim T, Stewart DG, Chan P, Tehrani A, Patten SB. The Pharmacoepidemiology of Psychotropic Medication Use in Canadian Children from 2012 to 2016. J Child Adolesc Psychopharmacol. 2019;29:740-745.
  • 45. Goel R, Hong JS, Findling RL, Ji NY. An update on pharmacotherapy of autism spectrum disorder in children and adolescents. Int Rev Psychiatry. 2018;30:78-95.
  • 46. Scahill L, McCracken JT, King BH, Rockhill C, Shah B, Politte L, Sanders R, Minjarez M, Cowen J, Mullett J, Page C, Ward D, Deng Y, Loo S, Dziura J, McDougle CJ; Research Units on Pediatric Psychopharmacology Autism Network. Extended-Release Guanfacine for Hyperactivity in Children With Autism Spectrum Disorder. Am J Psychiatry. 2015;172:1197-1206.
  • 47. Pringsheim T, Hirsch L, Gardner D, Gorman DA. The pharmacological management of oppositional behaviour, conduct problems, and aggression in children and adolescents with attention- deficit hyperactivity disorder, oppositional defiant disorder, and conduct disorder: a systematic review and meta-analysis. Part 1: psychostimulants, alpha-2 agonists, and atomoxetine. Can J Psychiatry. 2015;60:42-51.
  • 48. Strawn JR, Compton SN, Robertson B, Albano AM, Hamdani M, Rynn MA. Extended Release Guanfacine in Pediatric Anxiety Disorders: A Pilot, Randomized, Placebo-Controlled Trial. J Child Adolesc Psychopharmacol. 2017;27:29-37.
  • 49. Mineur YS, Bentham MP, Zhou WL, Plantenga ME, McKee SA, Picciotto MR. Antidepressant-like effects of guanfacine and sex- specific differences in effects on c-fos immunoreactivity and paired- pulse ratio in male and female mice. Psychopharmacology (Berl). 2015;232:3539-3549.
APA Işık Ü, Ogutlu H, Kutuk M, Ercan E (2023). Dikkat Eksikliği Hiperaktivite Bozukluğu Tedavisinde Uzun Etkili Guanfasinin Yeri. , 20 - 27. 10.4274/tjcamh.galenos.2023.87587
Chicago Işık Ümit,Ogutlu Hakan,Kutuk Meryem Ozlem,Ercan Eyüp Sabri Dikkat Eksikliği Hiperaktivite Bozukluğu Tedavisinde Uzun Etkili Guanfasinin Yeri. (2023): 20 - 27. 10.4274/tjcamh.galenos.2023.87587
MLA Işık Ümit,Ogutlu Hakan,Kutuk Meryem Ozlem,Ercan Eyüp Sabri Dikkat Eksikliği Hiperaktivite Bozukluğu Tedavisinde Uzun Etkili Guanfasinin Yeri. , 2023, ss.20 - 27. 10.4274/tjcamh.galenos.2023.87587
AMA Işık Ü,Ogutlu H,Kutuk M,Ercan E Dikkat Eksikliği Hiperaktivite Bozukluğu Tedavisinde Uzun Etkili Guanfasinin Yeri. . 2023; 20 - 27. 10.4274/tjcamh.galenos.2023.87587
Vancouver Işık Ü,Ogutlu H,Kutuk M,Ercan E Dikkat Eksikliği Hiperaktivite Bozukluğu Tedavisinde Uzun Etkili Guanfasinin Yeri. . 2023; 20 - 27. 10.4274/tjcamh.galenos.2023.87587
IEEE Işık Ü,Ogutlu H,Kutuk M,Ercan E "Dikkat Eksikliği Hiperaktivite Bozukluğu Tedavisinde Uzun Etkili Guanfasinin Yeri." , ss.20 - 27, 2023. 10.4274/tjcamh.galenos.2023.87587
ISNAD Işık, Ümit vd. "Dikkat Eksikliği Hiperaktivite Bozukluğu Tedavisinde Uzun Etkili Guanfasinin Yeri". (2023), 20-27. https://doi.org/10.4274/tjcamh.galenos.2023.87587
APA Işık Ü, Ogutlu H, Kutuk M, Ercan E (2023). Dikkat Eksikliği Hiperaktivite Bozukluğu Tedavisinde Uzun Etkili Guanfasinin Yeri. Çocuk ve Gençlik Ruh Sağlığı Dergisi, 30(1), 20 - 27. 10.4274/tjcamh.galenos.2023.87587
Chicago Işık Ümit,Ogutlu Hakan,Kutuk Meryem Ozlem,Ercan Eyüp Sabri Dikkat Eksikliği Hiperaktivite Bozukluğu Tedavisinde Uzun Etkili Guanfasinin Yeri. Çocuk ve Gençlik Ruh Sağlığı Dergisi 30, no.1 (2023): 20 - 27. 10.4274/tjcamh.galenos.2023.87587
MLA Işık Ümit,Ogutlu Hakan,Kutuk Meryem Ozlem,Ercan Eyüp Sabri Dikkat Eksikliği Hiperaktivite Bozukluğu Tedavisinde Uzun Etkili Guanfasinin Yeri. Çocuk ve Gençlik Ruh Sağlığı Dergisi, vol.30, no.1, 2023, ss.20 - 27. 10.4274/tjcamh.galenos.2023.87587
AMA Işık Ü,Ogutlu H,Kutuk M,Ercan E Dikkat Eksikliği Hiperaktivite Bozukluğu Tedavisinde Uzun Etkili Guanfasinin Yeri. Çocuk ve Gençlik Ruh Sağlığı Dergisi. 2023; 30(1): 20 - 27. 10.4274/tjcamh.galenos.2023.87587
Vancouver Işık Ü,Ogutlu H,Kutuk M,Ercan E Dikkat Eksikliği Hiperaktivite Bozukluğu Tedavisinde Uzun Etkili Guanfasinin Yeri. Çocuk ve Gençlik Ruh Sağlığı Dergisi. 2023; 30(1): 20 - 27. 10.4274/tjcamh.galenos.2023.87587
IEEE Işık Ü,Ogutlu H,Kutuk M,Ercan E "Dikkat Eksikliği Hiperaktivite Bozukluğu Tedavisinde Uzun Etkili Guanfasinin Yeri." Çocuk ve Gençlik Ruh Sağlığı Dergisi, 30, ss.20 - 27, 2023. 10.4274/tjcamh.galenos.2023.87587
ISNAD Işık, Ümit vd. "Dikkat Eksikliği Hiperaktivite Bozukluğu Tedavisinde Uzun Etkili Guanfasinin Yeri". Çocuk ve Gençlik Ruh Sağlığı Dergisi 30/1 (2023), 20-27. https://doi.org/10.4274/tjcamh.galenos.2023.87587