Tom 13, Nr 5 (2016)
Wytyczne / stanowisko ekspertów
Opublikowany online: 2017-01-03

dostęp otwarty

Wyświetlenia strony 7697
Wyświetlenia/pobrania artykułu 32780
Pobierz cytowanie

Eksport do Mediów Społecznościowych

Eksport do Mediów Społecznościowych

Stanowisko Zespołu Ekspertów dotyczące zastosowania produktu leczniczego Mysimba® (chlorowodorek bupropionu i chlorowodorek naltreksonu) we wspomaganiu leczenia otyłości i nadwagi (BMI ≥ 27 kg/m2) z chorobami towarzyszącymi

Magdalena Olszanecka-Glinianowicz, Krzysztof J. Filipiak, Krzysztof Narkiewicz, Małgorzata Szelachowska, Adam Windak, Leszek Czupryniak, Tomasz Pawłowski
Choroby Serca i Naczyń 2016;13(5):333-346.

Streszczenie

Leczenie nadwagi i otyłości jest trudnym i długotrwałym procesem, wymagającym zarówno prawidłowego rozpoznania przyczyn rozwoju tych chorób, jak i wdrażania metod adekwatnych do stanu zdrowia pacjenta. Podstawą leczenia jest zmiana stylu życia prowadząca do uzyskania ujemnego bilansu energetycznego (zmiana nawyków żywieniowych i zwiększenie aktywności fizycznej). Niemniej duża grupa pacjentów w celu ułatwienia realizacji zaleceń dotyczących zmian stylu życia wymaga wsparcia farmakologicznego i/lub sychoterapeutycznego. Ostatni szczebel leczenia otyłości II stopnia z powikłaniami i otyłości III stopnia stanowi leczenie operacyjne.

Możliwości stosowania farmakoterapii wspomagającej leczenie otyłości są bardzo ograniczone, przez ostatnie 6 lat na polskim rynku dostępny był wyłącznie orlistat. Obecnie po zarejestrowaniu przez EMA w marcu 2015 roku, od listopada 2016 roku, dostępny jest złożony produkt leczniczy Mysimba® zawierający dwie substancje czynne — chlorowodorek bupropionu i chlorowodorek naltreksonu. Ze względu na addytywne działanie tych substancji czynnych w ośrodkowym układzie nerwowym zarówno na poziomie jądra łukowatego podwzgórza (stymulacja odczucia sytości), jak i zlokalizowanego w obszarze limbicznym układu nagrody (hamowanie apetytu) lek ten budzi nadzieję na zwiększenie skuteczności w leczeniu otyłości. Celem niniejszego stanowiska jest pomoc lekarzom praktykom w podejmowaniu decyzji o zastosowaniu produktu leczniczego Mysimba® tak, aby uzyskać jak najwięcej korzyści z leczenia dla pacjenta przy jak najniższym ryzyku.

Artykuł dostępny w formacie PDF

Pokaż PDF Pobierz plik PDF

Referencje

  1. Zhang M, Hu T, Zhang S, et al. Associations of Different Adipose Tissue Depots with Insulin Resistance: A Systematic Review and Meta-analysis of Observational Studies. Sci Rep. 2015; 5: 18495.
  2. Herpertz S. [Obesity is more than an eating disorder--the multidimensional perspective of a pandemia]. Z Psychosom Med Psychother. 2008; 54(1): 4–31.
  3. Hauner H. [Obesity--a somatic or psychological condition or both?]. Herz. 2006; 31(3): 207–212.
  4. Di Francesco M, Motterlini M, Colombo M. In search of the neurobiological basis of decision making: explanation, reduction and emergence. Funct Neurol. 2007; 22(4): 197–204.
  5. Porges SW. The Polyvagal Theory: phylogenetic contributions to social behavior. Physiol Behav. 2003; 79(3): 503–513.
  6. Nicholls W, Devonport TJ, Blake M. The association between emotions and eating behaviour in an obese population with binge eating disorder. Obes Rev. 2016; 17(1): 30–42.
  7. Frey L, Riva M, Grosshans M, et al. ["Food addiction" as a possible risk factor for obesity]. Praxis (Bern 1994). 2016; 105(7): 397–404.
  8. Obesity. Preventing and managing the global epidemic. Report of a WHO Geneva, 1998.
  9. Feinle-Bisset C. Upper gastrointestinal sensitivity to meal-related signals in adult humans - relevance to appetite regulation and gut symptoms in health, obesity and functional dyspepsia. Physiol Behav. 2016; 162: 69–82.
  10. Alberti KG, Zimmet P, Shaw J. Metabolic syndrome--a new world-wide definition. A Consensus Statement from the International Diabetes Federation. Diabet Med. 2006; 23(5): 469–480.
  11. Kushner RF. Barriers to providing nutrition counseling by physicians: a survey of primary care practitioners. Prev Med. 1995; 24(6): 546–552.
  12. Vetter ML, Herring SJ, Sood M, et al. What do resident physicians know about nutrition? An evaluation of attitudes, self-perceived proficiency and knowledge. J Am Coll Nutr. 2008; 27(2): 287–298.
  13. Huizinga MM, Cooper LA, Bleich SN, et al. Physician respect for patients with obesity. J Gen Intern Med. 2009; 24(11): 1236–1239.
  14. Ruelaz AR, Diefenbach P, Simon B, et al. Perceived barriers to weight management in primary care--perspectives of patients and providers. J Gen Intern Med. 2007; 22(4): 518–522.
  15. European Association for the Study of Obesity (EASO). Obesity: an underestimated threat: public perceptions of obesity in Europe. 03.2015.
  16. Yumuk V, Tsigos C, Fried M, et al. Obesity Management Task Force of the European Association for the Study of Obesity. European Guidelines for Obesity Management in Adults. Obes Facts. 2015; 8(6): 402–424.
  17. Olszanecka-Glinianowicz M. Otyłość jako narastający problem medyczny i społeczny — co może zrobić lekarz rodzinny? Terapia. 2014; 22: 11–14.
  18. Plewa M, Markiewicz A. Aktywność fizyczna w profilaktyce i leczeniu otyłości. Endokryn Otył Zab Przem Mat. 2006; 2: 30–37.
  19. Welbourn R, Dixon J, Barth JH, et al. Guidance Development Group. NICE-Accredited Commissioning Guidance for Weight Assessment and Management Clinics: a Model for a Specialist Multidisciplinary Team Approach for People with Severe Obesity. Obes Surg. 2016; 26(3): 649–659.
  20. McNeely W, Benfield P. Orlistat. Drugs. 1998; 56(2): 241–9; discussion 250.
  21. Jones BJ, Bloom SR. The New Era of Drug Therapy for Obesity: The Evidence and the Expectations. Drugs. 2015; 75(9): 935–945.
  22. Dhillon S, Yang LPH, Curran MP. Bupropion: a review of its use in the management of major depressive disorder. Drugs. 2008; 68(5): 653–689.
  23. Dwoskin LP, Rauhut AS, King-Pospisil KA, et al. Review of the pharmacology and clinical profile of bupropion, an antidepressant and tobacco use cessation agent. CNS Drug Rev. 2006; 12(3-4): 178–207.
  24. Foley KF, DeSanty KP, Kast RE. Bupropion: pharmacology and therapeutic applications. Expert Rev Neurother. 2006; 6(9): 1249–1265.
  25. Settle EC. Bupropion sustained release: side effect profile. J Clin Psychiatry. 1998; 59 Suppl 4: 32–36.
  26. Ruffmann C, Bogliun G, Beghi E. Epileptogenic drugs: a systematic review. Expert Rev Neurother. 2006; 6(4): 575–589.
  27. Montgomery SA. Antidepressants and seizures: emphasis on newer agents and clinical implications. Int J Clin Pract. 2005; 59(12): 1435–1440.
  28. Johnston JA, Lineberry CG, Ascher JA, et al. A 102-center prospective study of seizure in association with bupropion. J Clin Psychiatry. 1991; 52(11): 450–456.
  29. Tripp AC. Bupropion, a brief history of seizure risk. Gen Hosp Psychiatry. 2010; 32(2): 216–217.
  30. Wenger TL, Stern WC. The cardiovascular profile of bupropion. J Clin Psychiatry. 1983; 44(5 Pt 2): 176–182.
  31. Thase ME, Haight BR, Johnson MC, et al. A randomized, double-blind, placebo-controlled study of the effect of sustained-release bupropion on blood pressure in individuals with mild untreated hypertension. J Clin Psychopharmacol. 2008; 28(3): 302–307.
  32. https://bazalekow.mp.pl/leki/doctor_subst.html?id=2655 (12.12.2016).
  33. Froehlich J, O'Malley S, Hyytiä P, et al. Preclinical and clinical studies on naltrexone: what have they taught each other? Alcohol Clin Exp Res. 2003; 27(3): 533–539.
  34. Bodnar RJ. Endogenous opioids and feeding behavior: a 30-year historical perspective. Peptides. 2004; 25(4): 697–725.
  35. Levine AS, Billington CJ. Opioids as agents of reward-related feeding: a consideration of the evidence. Physiol Behav. 2004; 82(1): 57–61.
  36. McLaughlin PJ, Zagon IS. Duration of opioid receptor blockade determines biotherapeutic response. Biochem Pharmacol. 2015; 97(3): 236–246.
  37. http://www.baza-lekow.com.pl/naltex/ (12.12.2016).
  38. Hassanian-Moghaddam H, Afzali S, Pooya A. Withdrawal syndrome caused by naltrexone in opioid abusers. Hum Exp Toxicol. 2014; 33(6): 561–567.
  39. Greenway FL, Whitehouse MJ, Guttadauria M, et al. Rational design of a combination medication for the treatment of obesity. Obesity (Silver Spring). 2009; 17(1): 30–39.
  40. Atkinson RL, Berke LK, Drake CR, et al. Effects of long-term therapy with naltrexone on body weight in obesity. Clin Pharmacol Ther. 1985; 38(4): 419–422.
  41. Anderson JW, Greenway FL, Fujioka K, et al. Bupropion SR enhances weight loss: a 48-week double-blind, placebo- controlled trial. Obes Res. 2002; 10(7): 633–641.
  42. Greenway FL, Dunayevich E, Tollefson G, et al. NB-201 Study Group. Comparison of combined bupropion and naltrexone therapy for obesity with monotherapy and placebo. J Clin Endocrinol Metab. 2009; 94(12): 4898–4906.
  43. Billes SK, Sinnayah P, Cowley MA. Naltrexone/bupropion for obesity: an investigational combination pharmacotherapy for weight loss. Pharmacol Res. 2014; 84: 1–11.
  44. Picciotto M, Mineur Y. Nicotine, Food Intake, and Activation of POMC Neurons. Neuropsychopharmacology. 2013; 38(1): 245–245.
  45. Greenway FL, Fujioka K, Plodkowski RA, et al. COR-I Study Group. Effect of naltrexone plus bupropion on weight loss in overweight and obese adults (COR-I): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2010; 376(9741): 595–605.
  46. Apovian CM, Aronne L, Rubino D, et al. COR-II Study Group. A randomized, phase 3 trial of naltrexone SR/bupropion SR on weight and obesity-related risk factors (COR-II). Obesity (Silver Spring). 2013; 21(5): 935–943.
  47. Wadden TA, Foreyt JP, Foster GD, et al. Weight loss with naltrexone SR/bupropion SR combination therapy as an adjunct to behavior modification: the COR-BMOD trial. Obesity (Silver Spring). 2011; 19(1): 110–120.
  48. Hollander P, Gupta AK, Plodkowski R, et al. COR-Diabetes Study Group. Effects of naltrexone sustained-release/bupropion sustained-release combination therapy on body weight and glycemic parameters in overweight and obese patients with type 2 diabetes. Diabetes Care. 2013; 36(12): 4022–4029.
  49. Khera R, Murad MH, Chandar AK, et al. Association of Pharmacological Treatments for Obesity With Weight Loss and Adverse Events: A Systematic Review and Meta-analysis. JAMA. 2016; 315(22): 2424–2434.
  50. MacDaniels JS, Schwartz TL. Effectiveness, tolerability and practical application of the newer generation anti-obesity medications. Drugs Context. 2016; 5: 212–291.
  51. Patel R, Reiss P, Shetty H, et al. Do antidepressants increase the risk of mania and bipolar disorder in people with depression? A retrospective electronic case register cohort study. BMJ Open. 2015; 5(12): e008341.
  52. Leverich G, Altshuler L, Frye M, et al. Risk of Switch in Mood Polarity to Hypomania or Mania in Patients With Bipolar Depression During Acute and Continuation Trials of Venlafaxine, Sertraline, and Bupropion as Adjuncts to Mood Stabilizers. American Journal of Psychiatry. 2006; 163(2): 232–239.
  53. Tek C, Kucukgoncu S, Guloksuz S, et al. Antipsychotic-induced weight gain in first-episode psychosis patients: a meta-analysis of differential effects of antipsychotic medications. Early Interv Psychiatry. 2016; 10(3): 193–202.
  54. Kumar S, Kodela S, Detweiler JG, et al. Bupropion-induced psychosis: folklore or a fact? A systematic review of the literature. Gen Hosp Psychiatry. 2011; 33(6): 612–617.
  55. Nissen SE, Wolski KE, Prcela L, et al. Effect of Naltrexone-Bupropion on Major Adverse Cardiovascular Events in Overweight and Obese Patients With Cardiovascular Risk Factors: A Randomized Clinical Trial. JAMA. 2016; 315(10): 990–1004.
  56. Jain AK, Kaplan RA, Gadde KM, et al. Bupropion SR vs. placebo for weight loss in obese patients with depressive symptoms. Obes Res. 2002; 10(10): 1049–1056.
  57. Croft H, Houser TL, Jamerson BD, et al. Effect on body weight of bupropion sustained-release in patients with major depression treated for 52 weeks. Clin Ther. 2002; 24(4): 662–672.
  58. Zundel N, Ikramuddin S, Rosenthal R. Optimizing outcomes in bariatric surgery: a primer in patient selection. J Obes. 2012; 2012: 837216.
  59. Wilcox CS, Oskooilar N, Erickson JS, et al. An open-label study of naltrexone and bupropion combination therapy for smoking cessation in overweight and obese subjects. Addict Behav. 2010; 35(3): 229–234.
  60. Zwaan Mde. Binge eating disorder and obesity. International Journal of Obesity. 2001; 25: S51–S55.
  61. Palavras MA, Hay P, Touyz S, et al. Comparing cognitive behavioural therapy for eating disorders integrated with behavioural weight loss therapy to cognitive behavioural therapy-enhanced alone in overweight or obese people with bulimia nervosa or binge eating disorder: study protocol for a randomised controlled trial. Trials. 2015; 16: 578.
  62. Auger RR. Sleep-related eating disorders. Psychiatry (Edgmont). 2006; 3(11): 64–70.
  63. White MA, Grilo CM. Bupropion for overweight women with binge-eating disorder: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2013; 74(4): 400–406.
  64. http://www.valeantinfo.pl/pl/a/Mysimba (12.12.2016).