본문 바로가기
KERD
논문KCI 등재

비만 치료에서 semaglutide의 효능 및 안전성에 대한 고찰

Review of Efficacy and Safety of Semaglutide in the Management of Obesity

2

조회

0

다운로드

0

인용

0

참고문헌

키워드

주제분류약학

초록

This review examines the pivotal clinical trials that evaluated the efficacy and safety of semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, in the management of obesity. The reported findings underscore significant and sustained weight loss achieved with semaglutide in diverse patient groups, although gastrointestinal disorders occurred frequently, leading to therapy discontinuation. Overall, the studies demonstrated the potential of semaglutide as a therapeutic option not only for type 2 diabetes but also for obesity. The treatment landscape in obesity is evolving, as reflected in changing regulatory approvals and clinical guidelines, suggesting a paradigm shift toward personalized approaches in this chronic disease states to achieve optimal treatment outcomes for patients

Abstract

This review examines the pivotal clinical trials that evaluated the efficacy and safety of semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, in the management of obesity. The reported findings underscore significant and sustained weight loss achieved with semaglutide in diverse patient groups, although gastrointestinal disorders occurred frequently, leading to therapy discontinuation. Overall, the studies demonstrated the potential of semaglutide as a therapeutic option not only for type 2 diabetes but also for obesity. The treatment landscape in obesity is evolving, as reflected in changing regulatory approvals and clinical guidelines, suggesting a paradigm shift toward personalized approaches in this chronic disease states to achieve optimal treatment outcomes for patients

참고문헌 (49)

  1. Korean Society for the Study of Obesity, "Clinical practice guidelines for obesity", pp.1~17 (2022)
  2. "2021 obesity fact sheet"[URL]
  3. Clinical practice guidelines for diabetes, "Korean Diabetes Association", 21~183 (2023)
  4. Drucker DJ, "The incretin system : glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors in type 2 diabetes", Lancet, 368(9548), pp.1696~1705 (2006)
  5. Holst JJ, "Glucagonlike peptide 1 : a newly discovered gastrointestinal hormone", Gastroenterology, 107(6), pp.1848~1855 (1994)
  6. Vilsbøll T, "Reduced postprandial concentrations of intact biologically active glucagon-like peptide 1 in type 2 diabetic patients", Diabetes, 50(3), pp.609~613 (2001)
  7. "FDA approves Novo Nordisk diabetes drug Ozempic" (2017)[URL]
  8. "FDA approves new drug treatment for chronic weight management, first since 2014" (2021)[URL]
  9. "Ozempic prefilled pen (semaglutide)"[URL]
  10. "Wegovy prefilled pen (semaglutide)"[URL]
  11. "FDA approves first oral GLP-1 treatment for type 2 diabetes" (2019)[URL]
  12. "Rybelsus (semaglutide)"[URL]
  13. Sorli C, "Efficacy and safety of once-weekly semaglutide monotherapy versus placebo in patients with type 2 diabetes(SUSTAIN 1) : a double-blind, randomised, placebo-controlled, parallel-group, multinational, multicentre phase 3a trial", Lancet Diabetes Endocrinol, 5(4), pp.251~260 (2017)
  14. Rodbard HW, "Semaglutide Added to Basal Insulin in Type 2 Diabetes(SUSTAIN 5) : A Randomized, Controlled Trial", J Clin Endocrinol Metab, 103(6), pp.2291~2301 (2018)
  15. Zinman B, "Semaglutide once weekly as add-on to SGLT-2 inhibitor therapy in type 2 diabetes(SUSTAIN 9) : a randomised, placebo-controlled trial", Lancet Diabetes Endocrinol, 7(5), pp.356~367 (2019)
  16. Ahmann AJ, "Efficacy and safety of once-weekly semaglutide versus exenatide ER in subjects with type 2 diabetes(SUSTAIN 3) : A 56-week, open-label, randomized clinical trial", Diabetes Care, 41(2), pp.258~266 (2018)
  17. Pratley RE, "Semaglutide versus dulaglutide once weekly in patients with type 2 diabetes(SUSTAIN 7) : a randomised, open-label, phase 3b trial", Lancet Diabetes Endocrinol, 6(4), pp.275~286 (2018)
  18. Capehorn MS, "Efficacy and safety of once-weekly semaglutide 1. 0mg vs once-daily liraglutide 1. 2mg as add-on to 1-3 oral antidiabetic drugs in subjects with type 2 diabetes(SUSTAIN 10)", Diabetes Metab, 46(2), pp.100~109 (2020)
  19. Lingvay I, "Efficacy and safety of once-weekly semaglutide versus daily canagliflozin as add-on to metformin in patients with type 2 diabetes(SUSTAIN 8) : a double-blind, phase 3b, randomised controlled trial", Lancet Diabetes Endocrinol, 7(11), pp.834~844 (2019)
  20. Wilding JPH, "Once-weekly semaglutide in adults with overweight or obesity", N Engl J Med, 384(11), pp.989~1002 (2021)
  21. Rubino D, "Effect of continued weekly subcutaneous semaglutide vs placebo on weight loss maintenance in adults with overweight or obesity : The STEP 4 randomized clinical trial", JAMA, 325(14), pp.1414~1425 (2021)
  22. Wadden TA, "Effect of subcutaneous semaglutide vs placebo as an adjunct to intensive behavioral therapy on body weight in adults with overweight or obesity : The STEP 3 randomized clinical trial", JAMA, 325(14), pp.1403~1413 (2021)
  23. Garvey WT, "Two-year effects of semaglutide in adults with overweight or obesity : the STEP 5 trial", Nat Med, 28(10), pp.2083~2091 (2022)
  24. Weghuber D, "Once-weekly semaglutide in adolescents with obesity", N Engl J Med, 387(24), pp.2245~2257 (2022)
  25. Rubino DM, "Effect of weekly subcutaneous semaglutide vs daily liraglutide on body weight in adults with overweight or obesity without diabetes : The STEP 8 randomized clinical trial", JAMA, 327(2), pp.138~150 (2022)
  26. Frías JP, "Tirzepatide versus semaglutide once weekly in patients with type 2 diabetes", N Engl J Med, 385(6), pp.503~515 (2021)
  27. McGowan BM, "Impact of BMI and comorbidities on efficacy of once-weekly semaglutide : Post hoc analyses of the STEP 1 randomized trial", Obesity(Silver Spring), 31(4), pp.990~928 (2023)
  28. Wilding JPH, "Weight regain and cardiometabolic effects after withdrawal of semaglutide : The STEP 1 trial extension", Diabetes Obes Metab, 24(8), pp.1553~1564 (2022)
  29. Aroda VR, "PIONEER 1 : Randomized clinical trial of the efficacy and safety of oral semaglutide monotherapy in comparison with placebo in patients with type 2 diabetes", Diabetes Care, 42(9), pp.1724~1732 (2019)
  30. Mosenzon O, "Efficacy and safety of oral semaglutide in patients with type 2 diabetes and moderate renal impairment(PIONEER 5) : a placebo-controlled, randomised, phase 3a trial", Lancet Diabetes Endocrinol, 7(7), pp.515~527 (2019)
  31. Pratley R, "Oral semaglutide versus subcutaneous liraglutide and placebo in type 2 diabetes(PIONEER 4) : a randomised, double-blind, phase 3a trial", Lancet, 394(10192), pp.39~50 (2019)
  32. Rodbard HW, "Oral semaglutide versus empagliflozin in patients with type 2 diabetes uncontrolled on metformin : The PIONEER 2 trial", Diabetes Care, 42(12), pp.2272~2281 (2019)
  33. Yabe D, "Safety and efficacy of oral semaglutide versus dulaglutide in Japanese patients with type 2 diabetes(PIONEER 10) : an open-label, randomised, active-controlled, phase 3a trial", Lancet Diabetes Endocrinol, 8(5), pp.392~406 (2020)
  34. Yamada Y, "Dose-response, efficacy, and safety of oral semaglutide monotherapy in Japanese patients with type 2 diabetes(PIONEER 9) : a 52-week, phase 2", 3a, randomised, controlled trial, 2020, pp.8(5), 377~391
  35. Zinman B, "Efficacy, safety, and tolerability of oral semaglutide versus placebo added to insulin with or without metformin in patients with type 2 diabetes : The PIONEER 8 trial", Diabetes Care, 42(12), pp.2262~2271 (2019)
  36. Knop FK, "Oral semaglutide 50 mg taken once per day in adults with overweight or obesity(OASIS 1) : a randomised, double-blind, placebo-controlled, phase 3 trial", Lancet, 402(10403), pp.705~719 (2023)
  37. American Diabetes Association, "Standards of care in diabetes – 2023", Diabetes Care, 46(Suppl. 1) (2023)
  38. Blonde L, "American Association of Clinical Endocrinology clinical practice guideline : developing a diabetes mellitus comprehensive care plan – 2022 update", Endocr Pract, 28(10), pp.923~1049 (2022)
  39. Korean Diabetes Association, "Clinical practice guidelines for diabetes", pp.89~ (2021)
  40. Korean Diabetes Association, "Clinical practice guidelines for diabetes", pp.125~ (2023)
  41. Grunvald E, "AGA clinical practice guideline on pharmacological interventions for adults with obesity", Gastroenterology, 163(5), pp.1198~1225 (2022)
  42. "Ozempic this, Wegovy that: no matter what you call it, semaglutide is having a moment" (2023)[URL]
  43. "CNN exclusive: prescriptions for popular diabetes and weight-loss drugs soared, but access is limited for some patients" (2023)[URL]
  44. "Semaglutide injection" (2024)[URL]
  45. Klein HE, "An ongoing crisis : semaglutide shortage raises dual concerns for obesity and diabetes treatment", American Journal of Managed Care (2023)
  46. Leitner DR, "Obesity and type 2 diabetes : two diseases with a need for combined treatment strategies – EASO can lead the way", Obes Facts, 10(5), pp.483~492 (2017)
  47. Lincoff AM, "Semaglutide and cardiovascular outcomes in obesity without diabetes", N Engl J Med, 389(24), pp.2221~2232 (2023)
  48. "Novo Nordis", 2022
  49. "Finally, a survey?...Is misuse of ‘obesity treatment’ okay?" (2023)[URL]

관련 논문AI추천

이 간행물의 다른 논문 (5건)