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Int J Obes (Lond). 2021 Nov 22; doi: 10.1038/s41366-021-01019-6. Epub 2021 Nov 22.

Effectiveness of anti-obesity medications approved for long-term use in a multidisciplinary weight management program: a multi-center clinical experience.

International journal of obesity (2005)

Gerardo Calderon, Daniel Gonzalez-Izundegui, Kuangda L Shan, Oscar A Garcia-Valencia, Lizeth Cifuentes, Alejandro Campos, Maria L Collazo-Clavell, Meera Shah, Daniel L Hurley, Haitham S Abu Lebdeh, Mayank Sharma, Kristine Schmitz, Matthew M Clark, Karen Grothe, Manpreet S Mundi, Michael Camilleri, Barham K Abu Dayyeh, Maria D Hurtado Andrade, Mohamad A Mokadem, Andres Acosta

Affiliations

  1. Precision Medicine for Obesity Program, Division of Gastroenterology and Hepatology, Department of Medicine, Mayo Clinic, Rochester, MN, USA.
  2. Division of Gastroenterology and Hepatology, Department of Internal Medicine, and Fraternal Order of Eagles Diabetes Research Center, University of Iowa Carver College of Medicine, Iowa City, IA, USA.
  3. Division of Endocrinology, Diabetes, Metabolism & Nutrition, Mayo Clinic, Rochester, MN, USA.
  4. Department of Psychiatry and Psychology, Mayo Clinic, Rochester, MN, USA.
  5. Precision Medicine for Obesity Program, Division of Gastroenterology and Hepatology, Department of Medicine, Mayo Clinic, Rochester, MN, USA. [email protected].
  6. Division of Endocrinology, Diabetes, Metabolism & Nutrition, Mayo Clinic Health System, La Crosse, WI, USA. [email protected].
  7. Division of Gastroenterology and Hepatology, Department of Internal Medicine, and Fraternal Order of Eagles Diabetes Research Center, University of Iowa Carver College of Medicine, Iowa City, IA, USA. [email protected].
  8. Precision Medicine for Obesity Program, Division of Gastroenterology and Hepatology, Department of Medicine, Mayo Clinic, Rochester, MN, USA. [email protected].

PMID: 34811486 DOI: 10.1038/s41366-021-01019-6

Abstract

BACKGROUND AND AIMS: Randomized clinical trials have proven the efficacy and safety of Food and Drug Administration (FDA) approved anti-obesity medications (AOMs) for long-term use. It is unclear whether these outcomes can be replicated in real-world clinical practice where clinical complexities arise. The aim of this study was to evaluate the effectiveness and side effects of these medications in real-world multidisciplinary clinical practice settings.

METHODS: We reviewed the electronic medical records (EMR) of patients with obesity who were prescribed an FDA-approved AOM for long-term use in academic and community multidisciplinary weight loss programs between January 2016 and January 2020.

INTERVENTION: We assessed percentage total body weight loss (%TBWL), metabolic outcomes, and side effect profile up to 24 months after AOM initiation.

RESULTS: The full cohort consisted of 304 patients (76% women, 95.2% White, median age of 50 years old [IQR, 39-58]). The median follow-up time was 9.1 months [IQR, 4.2-14.1] with a median number of 3 visits [IQR, 2-4]. The most prescribed medication was phentermine/topiramate extended-release (ER) (51%), followed by liraglutide (26.3%), bupropion/naltrexone sustained-release (SR) (16.5%), and lorcaserin (6.2%). %TBWL was 5.0%, 6.8%, 9.3%, 10.3%, and 10.5% at 3, 6, 12, 18, and 24 months. 60.2% of the entire cohort achieved at least 5% TBWL. Overall, phentermine/topiramate-ER had the most robust weight loss response during follow-up, with the highest %TBWL at 12 months of 12.0%. Adverse events were reported in 22.4% of patients. Only 9% of patients discontinued the medication due to side effects.

CONCLUSIONS: AOMs resulted in significant long-term weight loss, that was comparable to outcomes previously reported in clinical trials.

© 2021. The Author(s), under exclusive licence to Springer Nature Limited.

References

  1. Ogden CL, Carroll MD, Fryar CD, Flegal KM. Prevalence of obesity among adults and youth: United States, 2011–2014. NCHS Data Brief. 2015;219:1–8. - PubMed
  2. Waters H, Graf M. America’s obesity crisis. The Health and Economic Costs of Excess Weight. Santa Monica, California: Milken Institute; 2018. - PubMed
  3. Su W, Huang J, Chen F, Iacobucci W, Mocarski M, Dall TM, et al. Modeling the clinical and economic implications of obesity using microsimulation. J Med Econ. 2015;18:886–97. - PubMed
  4. Kim DD, Basu A. Estimating the medical care costs of obesity in the United States: systematic review, meta-analysis, and empirical analysis. Value Health. 2016;19:602–13. - PubMed
  5. Heymsfield SB, Wadden TA. Mechanisms, pathophysiology, and management of obesity. N Engl J Med. 2017;376:1492. - PubMed
  6. Acosta A, Streett S, Kroh MD, Cheskin LJ, Saunders KH, Kurian M, et al. White paper AGA: POWER - practice guide on obesity and weight management, education, and resources. Clin Gastroenterol Hepatol. 2017;15:631–49. e10. - PubMed
  7. Jensen MD, Ryan DH, Apovian CM, Ard JD, Comuzzie AG, Donato KA, 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;63:2985–3023. - PubMed
  8. Apovian CM, Aronne LJ, Bessesen DH, McDonnell ME, Murad MH, Pagotto U, et al. Pharmacological management of obesity: an endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2015;100:342–62. - PubMed
  9. Sharretts J, Galescu O, Gomatam S, Andraca-Carrera E, Hampp C, Yanoff L. Cancer risk associated with lorcaserin - the FDA’s review of the CAMELLIA-TIMI 61 trial. N Engl J Med. 2020;383:1000–2. - PubMed
  10. CllinicalTrials.gov. A research study of NNC0165-1562 and semaglutide in people who are overweight or obese. 2020. https://clinicaltrials.gov/ct2/show/NCT03574584 . - PubMed
  11. Lewis KH, Fischer H, Ard J, Barton L, Bessesen DH, Daley MF, et al. Safety and effectiveness of longer-term phentermine use: clinical outcomes from an electronic health record cohort. Obesity. 2019;27:591–602. - PubMed
  12. Gadde KM, Allison DB, Ryan DH, Peterson CA, Troupin B, Schwiers ML, et al. Effects of low-dose, controlled-release, phentermine plus topiramate combination on weight and associated comorbidities in overweight and obese adults (CONQUER): a randomised, placebo-controlled, phase 3 trial. Lancet. 2011;377:1341–52. - PubMed
  13. Smith SR, Weissman NJ, Anderson CM, Sanchez M, Chuang E, Stubbe S, et al. Multicenter, placebo-controlled trial of lorcaserin for weight management. N Engl J Med. 2010;363:245–56. - PubMed
  14. Greenway FL, Fujioka K, Plodkowski RA, Mudaliar S, Guttadauria M, Erickson J, et al. 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;376:595–605. - PubMed
  15. Pi-Sunyer X, Astrup A, Fujioka K, Greenway F, Halpern A, Krempf M, et al. A randomized, controlled trial of 3.0 mg oF Liraglutide in Weight Management. N Engl J Med. 2015;373:11–22. - PubMed
  16. Wadden TA, Hollander P, Klein S, Niswender K, Woo V, Hale PM, 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. 2013;37:1443–51. - PubMed
  17. Astrup A, Carraro R, Finer N, Harper A, Kunesova M, Lean ME, et al. Safety, tolerability and sustained weight loss over 2 years with the once-daily human GLP-1 analog, liraglutide. Int J Obes. 2012;36:843–54. - PubMed
  18. Garvey WT, Ryan DH, Look M, Gadde KM, Allison DB, Peterson CA, et al. Two-year sustained weight loss and metabolic benefits with controlled-release phentermine/topiramate in obese and overweight adults (SEQUEL): a randomized, placebo-controlled, phase 3 extension study. Am J Clin Nutr. 2012;95:297–308. - PubMed
  19. Allison DB, Gadde KM, Garvey WT, Peterson CA, Schwiers ML, Najarian T. et al. Controlled-release phentermine/topiramate in severely obese adults: a randomized controlled trial (EQUIP). Obesity. 2012;20:330–42. - PubMed
  20. Khera R, Murad MH, Chandar AK, Dulai PS, Wang Z, Prokop LJ, et al. Association of pharmacological treatments for obesity with weight loss and adverse events: a systematic review and meta-analysis. JAMA. 2016;315:2424–34. - PubMed
  21. Carey TA, Stiles WB. Some problems with randomized controlled trials and some viable alternatives. Clin Psychol Psychother. 2016;23:87–95. - PubMed
  22. Grudell AB, Sweetser S, Camilleri M, Eckert DJ, Vazquez-Roque MI, Carlson PJ, et al. A controlled pharmacogenetic trial of sibutramine on weight loss and body composition in obese or overweight adults. Gastroenterology. 2008;135:1142–54. - PubMed
  23. Holgerson AA, Clark MM, Ames GE, Collazo-Clavell ML, Kellogg TA, Graszer KM, et al. Association of adverse childhood experiences and food addiction to bariatric surgery completion and weight loss outcome. Obes Surg. 2018;28:3386–92. - PubMed
  24. Gorgojo-Martínez JJ, Basagoiti-Carreño B, Sanz-Velasco A, Serrano-Moreno C, Almodóvar-Ruiz F. Effectiveness and tolerability of orlistat and liraglutide in patients with obesity in a real-world setting: The XENSOR Study. Int J Clin Pract. 2019;73:e13399. - PubMed
  25. Park JH, Kim JY, Choi JH, Park HS, Shin H-Y, Lee JM, et al. Effectiveness of liraglutide 3 mg for the treatment of obesity in a real-world setting without intensive lifestyle intervention. Int J Obes. 2021;45:776–86. - PubMed
  26. Piantanida E, Gallo D, Tanda ML. Liraglutide is an effective drug for the treatment of obesity also in real life. J Endocrinol Investig. 2020;43:1827–8. - PubMed
  27. Wharton S, Liu A, Pakseresht A, Nørtoft E, Haase CL, Mancini J, et al. Real-world clinical effectiveness of liraglutide 3.0 mg for weight management in Canada. Obesity. 2019;27:917–24. - PubMed
  28. Ferrari F, Fierabracci P, Salvetti G, Jaccheri R, Vitti J, Scartabelli G, et al. Weight loss effect of liraglutide in real-life: the experience of a single Italian obesity center. J Endocrinol Investig. 2020;43:1779–85. - PubMed
  29. Fakhreddine AY, Bagsic S, Fujioka K, Frenette CT. Safety and efficacy of pharmacologic weight loss in patients with cirrhosis. Obes Sci Pract. 2021;7:159–67. - PubMed
  30. Ganguly R, Tian Y, Kong SX, Hersloev M, Hobbs T, Smolarz BG, et al. Persistence of newer anti-obesity medications in a real-world setting. Diabetes Res Clin Pract. 2018;143:348–56. - PubMed
  31. Shibuya K, Ali KF, Ji X, Milinoivh A, Bauman J, Kattan MW, et al. The benefit of short-term weight loss with anti-obesity medications in real-world clinical practice. Endocr Pract. 2019;25:1022–8. - PubMed
  32. Elangovan A, Shah R, Smith ZL. Pharmacotherapy for obesity—trends using a population level national database. Obes Surg. 2021;31:1105–12. - PubMed
  33. Wilding JPH, Batterham RL, Calanna S, Davies M, Van Gaal LF, Lingvay I, et al. Once-weekly semaglutide in adults with overweight or obesity. N Engl J Med. 2021;384:989–1002. - PubMed
  34. Fidler MC, Sanchez M, Raether B, Weissman NJ, Smith SR, Shanahan WR, et al. A one-year randomized trial of lorcaserin for weight loss in obese and overweight adults: the BLOSSOM trial. J Clin Endocrinol Metab. 2011;96:3067–77. - PubMed
  35. Wadden TA, Foreyt JP, Foster GD, Hill JO, Klein S, O’Neil PM, et al. Weight loss with naltrexone SR/bupropion SR combination therapy as an adjunct to behavior modification: the COR-BMOD trial. Obesity. 2011;19:110–20. - PubMed
  36. Apovian CM, Aronne L, Rubino D, Still C, Wyatt H, Burns C, et al. A randomized, phase 3 trial of naltrexone SR/bupropion SR on weight and obesity-related risk factors (COR-II). Obesity. 2013;21:935–43. - PubMed
  37. Lei XG, Ruan JQ, Lai C, Sun Z, Yang X. Efficacy and safety of phentermine/topiramate in adults with overweight or obesity: a systematic review and meta-analysis. Obesity 2021;29:985–94. - PubMed
  38. Lewis KH, Fischer H, Ard J, Barton L, Bessesen DH, Daley MF, et al. Safety and effectiveness of longer-term phentermine use: clinical outcomes from an electronic health record cohort. Obesity. 2019;27:591–602. - PubMed

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