201
Views
3
CrossRef citations to date
0
Altmetric
Review

Cardiovascular Safety and Superiority of Anti-Obesity Medications

ORCID Icon, , , &
Pages 3199-3208 | Published online: 13 Jul 2021

References

  • World Health Organization. Cardiovascular Diseases (CVDs) Fact Sheets . World Health Organization; 2016.
  • World Health Organization. Fact Sheet: Obesity and Overweight . World Health Organization; 2020.
  • Jensen MD , Ryan DH , Apovian CM , et al. 2013 AHA/ACC/TOS guideline for obesity in adults: a report of the American College of Cardiology/American Heart Association task force on society. J Am Coll Cardiol . 2014;63(25 Pt B):2985–3023. doi:10.1016/j.jacc.2013.11.004 24239920
  • Sharma AM , Kushner RF . A proposed clinical staging system for obesity. Int J Obes . 2009;33(3):289–295. doi:10.1038/ijo.2009.2
  • Benotti PN , Wood GC , Carey DJ , et al. Gastric bypass surgery produces a durable reduction in cardiovascular disease risk factors and reduces the long-term risks of congestive heart failure. J Am Heart Assoc . 2017;6(5). doi:10.1161/JAHA.116.005126
  • Garvey W , Garber A , Mechanick J , et al. American association of clinical endocrinologists and American College of Endocrinology position statement on the 2014 advanced framework for a new diagnosis of obesity as a chronic disease. Endocr Pract . 2014;20(9):977–989. doi:10.4158/EP14280.PS 25253227
  • Kim GW , Lin JE , Blomain ES , Waldman SA . New advances in models and strategies for developing anti-obesity drugs. Expert Opin Drug Discov . 2013;8(6):655–671. doi:10.1517/17460441.2013.792804 23621300
  • FDA. FDA approves new drug treatment for chronic weight management, first since 2014 [Internet]. FDA Drug Safety Communication; 2021. Available from: https://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-treatment-chronic-weight-management-first-2014. Accessed 6 29, 2021.
  • Connolly HM , Crary JL , McGoon MD , et al. Valvular heart disease associated with fenfluramine–phentermine. N Engl J Med . 1997;337(24):1772–1776. Available from: http://www.nejm.org/doi/abs/10.1056/NEJM199712113372414.
  • James WPT , Caterson ID , Coutinho W , et al. Effect of sibutramine on cardiovascular outcomes in overweight and obese subjects. N Engl J Med . 2010;363(10):905–917. doi:10.1056/NEJMoa1003114 20818901
  • FDA. Belviq, Belviq XR (lorcaserin) by Eisai: drug safety communication - FDA requests withdrawal of weight-loss drug. U.S. Food and Drug Administration; 2020.
  • U.S. Food and Drug Administration. FDA Requires Removal of Some Prescribing and Dispensing Restrictions for Rosiglitazone-Containing Diabetes Medicines . FDA Drug Safety Communication; 2013.
  • Nissen SE , Wolski K , Topol EJ . Effect of muraglitazar on death and major adverse cardiovascular events in patients with type 2 diabetes mellitus. J Am Med Assoc . 2005;294(20):2581. doi:10.1001/jama.294.20.joc50147
  • Lopaschuk G , Kuzo RS , Gerber TC . Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes: commentary. Heart Metab . 2007;34:5–9.20011235
  • Patel DK , Stanford FC . Safety and tolerability of new-generation anti-obesity medications: a narrative review. Postgrad Med . 2018;130(2):173–182. doi:10.1080/00325481.2018.1435129 29388462
  • Franklin JM , Schneeweiss S . When and how can real world data analyses substitute for randomized controlled trials? Clin Pharmacol Ther . 2017;102(6):924–933.:.28836267
  • Framework for FDA’s real-world evidence program [Internet]; 2018 [cited 2021 6 8 ]. Available from: www.fda.gov.
  • Bryan J . Characterizing RWD Quality and Relevancy for Regulatory Purposes . 2018.
  • Anglemyer A , Horvath HT , Bero L . Healthcare outcomes assessed with observational study designs compared with those assessed in randomized trials. Cochrane Database Syst Rev . 2014;2014(4). doi: 10.1002/14651858.MR000034.pub2
  • Concato J , Shah N , Horwitz RI . Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med . 2000;342(25):1887–1892. doi:10.1056/NEJM200006223422507 10861325
  • Lonjon G , Boutron I , Trinquart L , et al. Comparison of treatment effect estimates from prospective nonrandomized studies with propensity score analysis and randomized controlled trials of surgical procedures. Ann Surg . 2014;259(1):18–25. doi:10.1097/SLA.0000000000000256 24096758
  • Schneeweiss S , Seeger JD , Landon J , Walker AM , Aprotinin during coronary-artery bypass grafting and risk of death. N Engl J Med . 2008;358(8):771–783. doi:10.1056/NEJMoa0707571 18287600
  • Fergusson DA , Hébert PC , Mazer CD , et al. A comparison of aprotinin and lysine analogues in high-risk cardiac surgery. N Engl J Med . 2008;358(22):2319–2331. doi:10.1056/NEJMoa0802395 18480196
  • Patorno E , Goldfine AB , Schneeweiss S , et al. Cardiovascular outcomes associated with canagliflozin versus other non-gliflozin antidiabetic drugs: Population Based Cohort Study. BMJ . 2018:360. Available from: https://pubmed.ncbi.nlm.nih.gov/29437648/.
  • Neal B , Perkovic V , Mahaffey KW , et al. Canagliflozin and cardiovascular and renal events in type 2 diabetes. N Engl J Med . 2017;377(7):644–657. doi:10.1056/NEJMoa1611925 28605608
  • Cohen AT , Goto S , Schreiber K , Torp-Pedersen C . Why do we need observational studies of everyday patients in the real-life setting? Eur Hear J . 2015;17(suppl D):D2–D8. doi:10.1093/eurheartj/suv035
  • Fong LCW , Ford TJ , da Costa BR , Jüni P , Berry C . Bias and loss to follow-up in cardiovascular randomized trials: a systematic review. J Am Heart Assoc . 2020;9(14). doi: 10.1161/JAHA.119.015361
  • Balk EM , Bonis PAL , Moskowitz H , et al. Correlation of quality measures with estimates of treatment effect in meta-analyses of randomized controlled trials. J Am Med Assoc . 2002;287(22):2973–2982. doi:10.1001/jama.287.22.2973
  • Gadde KM , Allison DB , Ryan DH , 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(9774):1341–1352. doi:10.1016/S0140-6736(11)60205-5 21481449
  • Cunningham JW , Wiviott SD . Modern obesity pharmacotherapy: weighing cardiovascular risk and benefit. Clin Cardiol . 2014;37(11):693–699. doi:10.1002/clc.22304 25223901
  • Garvey WT , Ryan DH , Look M , 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(2):297–308. doi:10.3945/ajcn.111.024927 22158731
  • European Medicines Agency. Refusal of the Marketing Authorisation for Qsiva (Phentermine/Topiramate) . EMA; 2013.
  • Halpern B , Mancini MC . Safety assessment of combination therapies in the treatment of obesity: focus on naltrexone/bupropion extended release and phentermine-topiramate extended release. Expert Opin Drug Saf . 2017;16(1):27–39. doi:10.1080/14740338.2017.1247807 27732121
  • 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 J Am Med Assoc . 2016;315(10):990. doi:10.1001/jama.2016.1558
  • ClinicalTrials.gov. Naltrexone/bupropion cardiovascular outcomes study [Internet]; 2017. Available from: https://clinicaltrials.gov/ct2/show/NCT02638129?term=contrave+cardiovascular&rank=1. Accessed 6 29, 2021.
  • Krentz AJ , Hompesch M . Targeting hyperglycaemia with anti-obesity drugs: time for a paradigm shift? Drugs . 2013;73(15):1649–1651. doi:10.1007/s40265-013-0123-2 24092613
  • Røder ME . Major adverse cardiovascular event reduction with GLP-1 and SGLT2 agents: evidence and clinical potential. Ther Adv Chronic Dis . 2018;9(1):33–50. doi:10.1177/2040622317735283 29344329
  • Sandoval DA , D’Alessio DA . Physiology of proglucagon peptides: role of glucagon and GLP-1 in health and disease. Physiol Rev . 2015;95(2):513–548. doi:10.1152/physrev.00013.2014 25834231
  • Van Can J , Sloth B , Jensen CB , Flint A , Blaak EE , Saris WHM . 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 . 2014;38(6):784–793. doi:10.1038/ijo.2013.162
  • Scott LJ . Liraglutide: a review of its use in the management of obesity. Drugs . 2015;75(8):899–910. doi:10.1007/s40265-015-0408-8 25985864
  • 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/NEJMoa1411892 26132939
  • Kelly AS , Auerbach P , Barrientos-Perez M , Gies I , Hale PM , Marcus C . A randomized, controlled trial of liraglutide for adolescents with obesity. N Engl J Med . 2020;382(22):2117–2128. doi:10.1056/NEJMoa1916038 32233338
  • Novo Nordisk A/S. Novo Nordisk A/S: CHMP endorses EU label update of Saxenda® based on the LEADER trial 2017. 2017.
  • Davies MJ , Aronne LJ , Caterson ID , Thomsen AB , Jacobsen PB , Marso SP . Liraglutide and cardiovascular outcomes in adults with overweight or obesity: a post hoc analysis from SCALE randomized controlled trials. Diabetes Obes Metab . 2018;20(3):734–739. doi:10.1111/dom.13125 28950422
  • O’Neil PM , Birkenfeld AL , McGowan B , et al. Efficacy and safety of semaglutide compared with liraglutide and placebo for weight loss in patients with obesity: a randomised, double-blind, placebo and active controlled, dose-ranging, Phase 2 trial. Lancet . 2018;392(10148):637–649. doi:10.1016/S0140-6736(18)31773-2 30122305
  • Marso SP , Bain SC , Consoli A , et al. Semaglutide and cardiovascular outcomes in patients with type 2 diabetes. N Engl J Med . 2016.
  • 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.:.27295427
  • Bain SC , Mosenzon O , Arechavaleta R , et al. Cardiovascular safety of oral semaglutide in patients with type 2 diabetes: rationale, design and patient baseline characteristics for the PIONEER 6 trial. Diabetes Obes Metab . 2019;21(3):499–508. doi:10.1111/dom.13553 30284349
  • Wilding JPH , Batterham RL , Calanna S , Davies M , Van Gaal LF , Lingvay I . Once-weekly semaglutide in adults with overweight or obesity. N Engl J Med . 2021;384(11):989–1002.33567185
  • Davies M , Færch L , Jeppesen OK , et al. Semaglutide 2·4 mg once a week in adults with overweight or obesity, and type 2 diabetes (STEP 2): a randomised, double-blind, double-dummy, placebo-controlled, phase 3 trial. Lancet . 2021;397(10278):971–984. doi:10.1016/S0140-6736(21)00213-0 33667417
  • Wadden TA , Bailey TS , Billings LK , et al. 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 J Am Med Assoc . 2021;325(14):1403–1413. doi:10.1001/jama.2021.1831
  • Rubino D , Abrahamsson N , Davies M , et al. 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 J Am Med Assoc . 2021;325(14):1414–1425. doi:10.1001/jama.2021.3224
  • Ingelfinger JR , Rosen CJ . STEP 1 for effective weight control — another first step? N Engl J Med . 2021;384(11):1066–1067. doi:10.1056/NEJMe2101705 33567184
  • Ferrannini E , Solini A . SGLT2 inhibition in diabetes mellitus: rationale and clinical prospects. Nat Rev Endocrinol . 2012;8(8):495–502. doi:10.1038/nrendo.2011.243 22310849
  • Zinman B , Wanner C , Lachin JM , et al. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med . 2015;373(22):2117–2128. doi:10.1056/NEJMoa1504720 26378978
  • Rådholm K , Figtree G , Perkovic V , et al. Canagliflozin and heart failure in type 2 diabetes mellitus. Circulation . 2018;138(5):458–468. doi:10.1161/CIRCULATIONAHA.118.034222 29526832
  • McMurray JJV , Solomon SD , Inzucchi SE , et al. Dapagliflozin in patients with heart failure and reduced ejection fraction. N Engl J Med . 2019;381(21):1995–2008. doi:10.1056/NEJMoa1911303 31535829
  • Wang B , Zhong J , Lin H , et al. Blood pressure-lowering effects of GLP-1 receptor agonists exenatide and liraglutide: a meta-analysis of clinical trials. Diabetes Obes Metab . 2013;15(8):737–749. doi:10.1111/dom.12085 23433305
  • Cannon CP , Pratley R , Dagogo-Jack S , et al. Cardiovascular outcomes with ertugliflozin in type 2 diabetes. N Engl J Med . 2020;383(15):1425–1435. doi:10.1056/NEJMoa2004967 32966714