V. Joint statement of professional societies on pharmacological treatment of obesity Obesity has become a worldwide

Česká verzia

Authors: D. Müllerová ^1,2; M. Haluzík ³ ; P. Sucharda ⁴; J. Boženský ⁵; M. Fried ⁶ ; P. Holéczy ⁷; M. Kunešová ⁸; I. Málková ⁹; Š. Slabá ¹⁰; P. Šrámková ⁶; R. Taxová Braunerová ⁸; V. Hainer ⁸
Authors place of work: Ústav hygieny a preventivní medicíny, Lékařská fakulta v Plzni, Univerzita Karlova, Vedoucí: prof. MUDr. Dana Müllerová, Ph. D. ¹; Obezitologická ambulance I. interní kliniky, FN Plzeň, Přednosta: prof. MUDr. Martin Matějovič, Ph. D. ²; Centrum diabetologie, Institut experimentální a klinické medicíny, Praha, Přednosta: prof. MUDr. František Saudek, DrSc. ³; 3. interní klinika 1. lékařské fakulty Univerzity Karlovy a VFN, Praha, Přednosta: prof. MUDr. Michal Kršek, CSc. ⁴; Dětské oddělení, nemocnice AGEL Ostrava-Vítkovice, a. s., Primář: MUDr. Jan Boženský ⁵; OB KLINIKA, a. s., Praha, Přednosta: prof. MUDr. Martin Fried, CSc. ⁶; Chirurgické oddělení, Nemocnice AGEL Ostrava-Vítkovice, a. s., Primář: MUDr. Miloslav Mazur, Ph. D., MBA ⁷; Endokrinologický ústav, Centrum pro diagnostiku a léčbu obezity, Praha, Ředitelka: doc. RNDr. Běla Bendlová, CSc. ⁸; STOB, Praha ⁹; Gynekologicko-porodnická klinika 1. lékařské fakulty Univerzity Karlovy a VFN, Praha, Přednosta: prof. MUDr. Alois Martan, DrSc. ¹⁰
Published in the journal: Prakt. Lék. 2021; 101(1): 32-47
Category: Of different specialties

Summary

Obesity has become a worldwide pandemic in the last thirty years. Its treatment is primarily based on the life-style changes that, however, often fail in the long-term run. For the next decade, major perspectives in the successful obesity treatment include, in addition to bariatric surgery, a long-term treatment with anti-obesity drugs, in particular the ones that in addition to weight reduction also directly affect obesity-related pathologies. This paper summarizes current possibilities of obesity pharmacotherapy including its indication, proper selection of patients and side effects of anti-obesity drugs. It also reviews the studies describing long-term efficacy and safety of anti-obesity drugs. Despite the availability of efficacious and safe anti-obesity drugs, these therapies are not even partially covered by health insurance. The costs of anti-obesity drugs are for the majority of patients with obesity unacceptably high. The actual unavailability of anti-obesity drugs for patients with obesity has significant health-economic consequences. Limited use of these medications that have evidence-based data supporting their efficacy, contributes to high prevalence of obesity-related pathologies with subsequent low treatment efficacy and high treatment costs. We believe that at least partial reimbursement of anti-obesity drugs from general health insurance, in patients with verified compliance and under clearly defined conditions, is a necessary step to improve this situation which could lead to clearly economically effective results.

Keywords:

obesity – pharmacotherapy – obesity complications – type 2 diabetes – reimbursement of anti-obesity drugs

Zdroje

1. König HH, Lehnert T, Brenner H, et al. Health service use and costs associated with excess weight in older adults in Germany. Age Ageing 2015; 44(4): 616–623. doi:10.1093/ageing/afu120

2. Specchia ML, Veneziano MA, Cadeddu C, et al. Economic impact of adult obesity on health systems: a systematic review. Eur J Public Health 2015; 25(2): 255–262. doi:10.1093/eurpub/cku170

3. Tremmel M, Gerdtham UG, Nilsson PM, et al. Economic burden of obesity: a systematic literature review. Int J Environ Res Public Health 2017; 14(4): 435. doi:10.3390/ijerph14040435

4. Flegal KM, Panagiotou OA, Graubard BI. Estimating population attributable fractions to quantify the health burden of obesity. Ann Epidemiol 2015; 25(3): 201–207. doi:10.1016/j. annepidem.2014.11.010

5. Hebebrand J, Holm JC, Woodward E, et al. A proposal of the European association for the study of obesity to improve the ICD-11 diagnostic criteria for obesity based on the three dimensions etiology, degree of adiposity and health risk. Obes Facts 2017; 10(4): 284–307. doi:10.1159/000479208

6. Yumuk V, Tsigos C, Fried M, et al. European guidelines for obesity management in adults. Obes Facts 2015; 8(6): 402–424. doi:10.1159/000442721

7. Greenway FL. Physiological adaptations to weight loss and factors favouring weight regain. Int J Obes (Lond) 2015; 39(8): 1188–1196. doi:10.1038/ijo.2015.59

8. Sumithran P, Prendergast LA, Delbridge E et al. Long-term persistence of hormonal adaptations to weight loss. N Engl J Med 2011; 365(17): 1597–1604. doi:10.1056/NEJMoa1105816

9. Jensen MD, Ryan DH, Apovian CM, et al. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. J Am Coll Cardiol 2014; 63(25 Pt B): 2985–3023. doi:10.1016/j.jacc.2013.11.004

10. Lean ME, Leslie WS, Barnes AC, et al. Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial. Lancet 2018; 391(10120): 541–551. doi:10.1016/S0140-6736(17)33102-1

11. Schutz DD, Busetto L, Dicker D, et al. European practical and patient-centred guidelines for adult obesity management in primary care. Obes Facts 2019; 12(1): 40–66. doi: 10.1159/000496183.

12. Wadden TA, West DS, Neiberg , et al. One-year weight losses in the Look AHEAD study: factors associated with success. Obesity (Silver Spring) 2009; 17(4): 713–722. doi:10.1038/oby.2008.637

13. Hainer V. Základy klinické obezitologie. Praha: Grada Publidhing 2011.

14. Sjöström L, Rissanen A, Andersen T, et al. Randomised placebo-controlled trial of orlistat for weight loss and prevention of weight regain in obese patients. European Multicentre Orlistat Study Group. Lancet 1998; 352(9123): 167–172. doi:10.1016/s0140-6736(97)11509-4

15. Leblanc ES, O’Connor E, Whitlock EP, et al. Effectiveness of primary care-relevant treatments for obesity in adults: a systematic evidence review for the U.S. Preventive Services Task Force. Ann Intern Med 2011; 155(7): 434–447. doi:10.7326/0003-4819-155-7-201110040-00006

16. Torgerson JS, Hauptman J, Boldrin MN, et al. XENical in the prevention of diabetes in obese subjects (XENDOS) study: a randomized study of orlistat as an adjunct to lifestyle changes for the prevention of type 2 diabetes in obese patients. Diabetes Care 2004; 27(1): 155–161. doi:10.2337/diacare.27.1.155

17. Davidson MH, Hauptman J, DiGirolamo M, et al. Weight control and risk factor reduction in obese subjects treated for 2 years with orlistat: a randomized controlled trial. JAMA 1999; 281(3): 235–242. doi:10.1001/jama.281.3.235

18. Kelley DE, Bray GA, Pi-Sunyer FX, et al. Clinical efficacy of orlistat therapy in overweight and obese patients with insulin-treated type 2 diabetes: A 1-year randomized controlled trial. Diabetes Care 2002; 25(6): 1033–1041. doi:10.2337/diacare.25.6.1033

19. Tonstad S, Pometta D, Erkelens DW, et al. The effect of the gastrointestinal lipase inhibitor, orlistat, on serum lipids and lipoproteins in patients with primary hyperlipidaemia. Eur J Clin Pharmacol 1994; 46(5): 405–410. doi:10.1007/BF00191901

20. Hvizdos KM, Markham A. Orlistat: a review of its use in the management of obesity. Drugs 1999; 58(4): 743–760. doi:10.2165/00003495-19995804 0-00015

21. McNeely W, Benfield P. Orlistat. Drugs 1998; 56(2): 241–250. doi:10.2165/00003495-19985 6020-00007

22. Greig SL, Keating GM. Naltrexone ER/Bupropion ER: a review in obesity management. Drugs 2015; 75(11): 1269–1280. doi:10.1007/ s40265-015-0427-5

23. Caixàs A, Albert L, Capel I, et al. Naltrexone sustained-release/bupropion sustained-release for the management of obesity: review of the data to date. Drug Des Devel Ther 2014; 8: 1419–1427. doi:10.2147/DDDT.S55587

24. Greenway FL, Dunayevich E, Tollefson G, et al. Comparison of combined bupropion and naltrexone therapy for obesity with monotherapy and placebo. J Clin Endocrinol Metab 2009; 94(12): 4898–4906. doi:10.1210/jc.2009-1350

25. Hollander P, Gupta AK, Plodkowski R, et al. 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. doi:10.2337/dc13-0234

26. 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. doi:10.1038/oby.2010.147

27. 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. doi:10.1001/jama.2016.1558

28. Bode B. An overview of the pharmacokinetics, efficacy and safety of liraglutide. Diabetes Res Clin Pract 2012; 97(1): 27–42. doi:10.1016/j. diabres.2011.12.015

29. Jacobsen LV, Flint A, Olsen AK, et al. Liraglutide in type 2 diabetes mellitus: clinical pharmacokinetics and pharmacodynamics. Clin Pharmacokinet 2016; 55(6): 657–672. doi:10.1007/s40262-015-0343-6

30. van Can J, Sloth B, Jensen CB, et al. Effects of the once-daily GLP-1 analog liraglutide on gastric emptying, glycemic parameters, appetite and energy metabolism in obese, non-diabetic adults. Int J Obes (Lond) 2014; 38(6): 784–793. doi:10.1038/ijo.2013.162

31. Flint A, Kapitza C, Hindsberger C, et al. The once-daily human glucagon-like peptide-1 (GLP-1) analog liraglutide improves postprandial glucose levels in type 2 diabetes patients. Adv Ther 2011; 28(3): 213–226. doi:10.1007/s12325-010-0110-x

32. Horowitz M, Flint A, Jones KL, et al. Effect of the once-daily human GLP-1 analogue liraglutide on appetite, energy intake, energy expenditure and gastric emptying in type 2 diabetes. Diabetes Res Clin Pract 2012; 97(2): 258–266. doi:10.1016/j.diabres.2012.02.016

33. Pi-Sunyer X, Astrup A, Fujioka K et al. A randomized, controlled trial of 3.0 mg of liraglutide in weight management. N Engl J Med 2015; 373(1): 11–22. doi:10.1056/NEJMoa1411 892

34. le Roux CW, Astrup A, Fujioka K et al. 3 years of liraglutide versus placebo for type 2 diabetes risk reduction and weight management in individuals with prediabetes: a randomised, double-blind trial. Lancet 2017; 389(10077): 1399–1409. doi:10.1016/S0140-6736(17)30069-7

35. Davies MJ, Bergenstal R, Bode B et al. Efficacy of liraglutide for weight loss among patients with type 2 diabetes: The SCALE Diabetes Randomized Clinical Trial. JAMA 2015; 314(7): 687–699. doi:10.1001/JAMA.2015.9676

36. Wadden TA, Hollander P, Klein S, et al. Weight maintenance and additional weight loss with liraglutide after low-calorie-diet-induced weight loss: The SCALE Maintenance randomized study. Int J Obes (Lond) 2013; 37: 1443–1451. doi:10.1038/ijo.2013.120

37. Blackman A, Foster GD, Zammit G, et al. Effect of liraglutide 3.0 mg in individuals with obesity and moderate or severe obstructive sleep apnea: the SCALE sleep apnea randomized clinical trial. Int J Obes (Lond) 2016; 40(8): 1310–1319. doi:10.1038/ijo.2016.52

38. Sleep-related breathing disorders in adults: recommendations for syndrome definition and measurement techniques in clinical research. The Report of an American Academy of Sleep Medicine Task Force. Sleep 1999; 22(5): 667–689.

39. Marso SP, Daniels GH, Brown-Frandsen K, et al. Liraglutide and cardiovascular outcomes in type 2 diabetes. N Engl J Med 2016; 375(4): 311–322. doi:10.1056/NEJMoa1603827

40. Bays H, Pi-Sunyer X, Hemmingsson JU, et al. Liraglutide 3.0 mg for weight management: weight-loss dependent and independent effects. Curr Med Res Opin 2017; 33(2): 225–229. doi:10.1080/03007995.2016.1251892

41. Kolotkin RL, Fujioka K, Wolden ML, et al. Improvements in health-related quality of life with liraglutide 3.0 mg compared with placebo in weight management. Clin Obes 2016; 6(4): 233–242. doi:10.1111/cob.12146

42. Fujioka K, O‘Neil PM, Davies M, et al. Early weight loss with liraglutide 3.0mg predicts 1-year weight loss and is associated with improvements in clinical markers. Obesity (Silver Spring) 2016; 24(11): 2278–2288. doi:10.1002/oby.21629

43. Wadden TA, Walsh OA, Berkowitz RI, et al. Intensive behavioral therapy for obesity combined with liraglutide 3.0mg: a randomized controlled trial. Obesity (Silver Spring) 2019; 27(1): 75–86. doi:10.1002/oby.22359

44. Modi R, Rye P, Cawsey, et al. Liraglutide effects on upper gastrointestinal investigations: implications prior to bariatric surgery. Obes Surg 2018; 28(7): 2113–2116. doi:10.1007/s11695-018-3249-1

45. Suliman M, Buckley A, Tikriti AA, et al. Routine clinical use of liraglutide 3mg for the treatment of obesity: outcomes in non‐surgical and bariatric surgery patients. Diabetes Obes Metab 2019; 21(6): 1498–1501. doi:10.1111/dom.13672

46. Garvey WT, Mechanick, JI, Brett EM, et al. American Association of Clinical Endocrinologists and American College of Endocrinology comprehensive clinical practice guidelines for mediccal care of patients with obesity. Endocr Pract 2016; 22(Suppl 3): 1–203. doi:10.4158/EP161365.GL

47. Aronne LJ, Waden T, Peterson C, et al. Evaluation of phentermine and topiramate versus phentermine/topiramate extended-release in obese adults. Obesity 2013; 21: 2163–2171. doi.10.1002/oby.20584