The EMPRISE study (Real World Evidence): empagliflozin is reducing number of hospitalizations for heart failure, even in patients without cardiovascular disease


Authors: Emil Martinka
Authors‘ workplace: Národný endokrinologický a diabetologický ústav, n. o., Ľubochňa
Published in: Forum Diab 2019; 8(3): 193-199
Category:

EMPRISE (Empagliflozin Comparative Effectiveness and Safety) je prebiehajúca rozsiahla RWE (Real World Evidence) štúdia, ktorá začala v roku 2016 a ktorej hlavným cieľom je zistiť, či kardiovaskulárny benefit empagliflozínu, ktorý bol pozorovaný v štúdii EMPA-REG OUTCOME, sa potvrdí aj v podmienkach bežnej klinickej praxe.

Overview

EMPRISE (Empagliflozin Comparative Effectiveness and Safety) is an ongoing, extensive RWE (“real world evidence”) study launched in 2016, whose main goal is to establish whether the CV benefit of empagliflozin as observed in the study EMPA-REG OUTCOME will also be confirmed under the conditions of normal clinical practice. The study is based on patient data collected from US medical databases and compares the results relating to patients who started treatment with empagliflozin versus a DPP-4 inhibitor, sitagliptin. The first results of the planned interim analysis of the EMPRISE study not only confirmed the findings of the RCT CVOT of the study EMPA-REG OUTCOME on the reduction of hospitalizations for heart failure (HHF), but also showed that HHF-related benefit is also present in patients without previous cardiovascular disease (CVD) or without previous heart failure (HF), and thus treatment could also be beneficial in primary prevention of HF and should be preferred over DPP4i, especially in patients where the goal is to reduce the development of HF and its consequences. Although the results of RWE studies may be limited by possible residual variables, the consistent study design and extensive “propensity score matching” of EMPRISE minimized possible sources of “bias”, which supports credibility and reliability of the results of this study.

Keywords:

diabetes – empagliflozin – EMPRISE – heart failure – real world evidence


Sources
  1. Arnett DK, Blumenthal RS, Albert MA et al. 2019 ACC/AHA guideline on the primary prevention of cardiovascular disease. J Am Coll Cardiol 2019; 74(10): e177-e232. Dostupné z DOI: <http://dx.doi.org/https://doi.org/10.1016/j.jacc.2019.03.010>. Erratum in Correction. [J Am Coll Cardiol 2019].
  2. Cosentino F, Grant PJ, Aboyans V et al. 2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD. Eur Heart J 2019; pii: ehz486. Dostupné z DOI: <https://doi.org/10.1093/eurheartj/ehz486>.
  3. Davies MJ, D‘Alessio DA, Fradkin J et al. Management of hyperglycaemia in type 2 diabetes, 2018. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetologia. 2018; 61(12): 2461–2498. Dostupné z DOI: <http://dx.doi.org/10.1007/s00125–018–4729–5> .Erratum in Correction to: Management of hyperglycaemia in type 2 diabetes, 2018. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). [Diabetologia. 2019].
  4. Einarson TR, Acs A, Ludwig Ca et al. Prevalence of cardiovascular disease in type 2 diabetes: a systematic literature review of scientific evidence from across the world in 2007–2017. Cardiovasc Diabetol 2018; 17(1): 83. Dostupné z DOI: <http://dx.doi.org/10.1186/s12933–018–0728–6>.
  5. Sarwar, N; Gao, P; Seshasai, SR; et al. [Emerging Risk Factors Collaboration]. Diabetes mellitus, fasting blood glucose concentration, and risk of vascular disease: a collaborative meta-analysis of 102 prospective studies. Lancet 375(9733): 2215–2222. Dostupné z DOI: <https://doi.org/10.1016/S0140–6736(10)60484–9>. Erratum in Lancet 2010; 376(9745): 958. Hillage HL [corrected to Hillege HL].
  6. Fitchett D, Butler J, van de Borne P et al. Effects of empagliflozin on risk for cardiovascular death and heart failure hospitalization across the spectrum of heart failure risk in the EMPA-REG OUTCOME ® trial. Eur Heart J 2018; 39(5): 363–370. Dostupné z DOI: <http://dx.doi.org/10.1093/eurheartj/ehx511>.
  7. Gaede P, Lund-Andersen H, Parving HH et al. Effect of a Multifactorial Intervention on Mortality in Type 2 Diabetes. N Engl J Med 2008; 358(6): 580–591. Dostupné z DOI: <http://dx.doi.org/10.1056/NEJMoa0706245>.
  8. Gallwitz B. The cardiovascular benefits associated with the use of sodiumglucose cotransporter 2 inhibitors – real-world data. Eur Endocrinol 2018; 14(1): 17–23. Dostupné z DOI: <http://dx.doi.org/10.17925/EE.2018.14.1.17>.
  9. Gerstein HC, Miller ME, Byington RP et al. [Action to Control Cardiovascular Risk in Diabetes Study Group]. Effects of Intensive Glucose Lowering in Type 2 Diabetes. N Engl J Med 2008; 358(24): 2545–2559. Dostupné z DOI: <http://dx.doi.org/10.1056/NEJMoa0802743>.
  10. Gregg EW, Li Y, Wang J et al. Changes in diabetes-related complications in the United States, 1990–2010. N Engl J Med 2014; 370(16): 1514–1523. Dostupné z DOI: <http://dx.doi.org/10.1056/NEJMoa1310799>.
  11. Home P. Cardiovascular outcome trials of glucose-lowering medications: an update. Diabetologia 2019; 62(3): 357–369. Dostupné z DOI: <http://dx.doi.org/10.1007/s00125–018–4801–1>.
  12. Johansson I, Edner M, Dahlström U et al. Is the prognosis in patients with diabetes and heart failure a matter of unsatisfactory management? An observational study from the Swedish Heart Failure Registry. Eur J Heart Fail 2014; 16(4): 409–418. Dostupné z DOI: <http://dx.doi.org/10.1002/ejhf.44>.
  13. Kosiborod M, Cavender MA, Fu AZ et al. Lower risk of heart failure and death in patients initiated on sodium–glucose cotransporter-2 inhibitors versus other glucose-lowering drugs: the CVD-REAL study (comparative effectiveness of cardiovascular outcomes in new users of sodium-glucose cotransporter-2 inhibitors). Circulation 2017; 136(3): 249–259. Dostupné z DOI: <http://dx.doi.org/10.1161/CIRCULATIONAHA.117.029190>.
  14. Kosiborod M, Lam CSP, Kohsaka S et al. Cardiovascular events associated with SGLT-2 inhibitors versus other glucose-lowering drugs: the CVD-REAL 2 study. J Am Coll Cardiol 2018; 71(23): 2628–2639. Dostupné z DOI: <http://dx.doi.org/10.1016/j.jacc.2018.03.009>.
  15. Martinka E, Tkáč I, Mokáň M (eds). Interdisciplinárne štandardy diagnostiky a liečby diabetes mellitus, jeho komplikácií a najvýznamnejších sprievodných ochorení. Forum Diab 2018; 7(2 Suppl 1): 5–153.
  16. Martinka E. Implementujeme aktuálne odporúčania ADA/EASD do liečby pacientov s diabetes mellitus 2. typu dostatočne? Forum Diab 2019; 8(2): 63–70.
  17. McEwen LN, Karter AJ, Waitzfelder BE et al. Predictors of Mortality over 8 Years in Type 2 Diabetic Patients. Translating Research Into Action for Diabetes (TRIAD). Diabetes Care 2012; 35(6): 1301–1309. Dostupné z DOI: <http://dx.doi.org/10.2337/dc11–2281>.
  18. Neal B, Perkovic V, Matthews DR. Canagliflozin and cardiovascular and renal events in type 2 diabetes. N Engl J Med 2017; 377(21): 644–657. Dostupné z DOI: <http://dx.doi.org/10.1056/NEJMc1712572>.
  19. Patorno E, Pawar A, Franklin JM et al. Empagliflozin and the risk of heart failure hospitalization in routine clinical care: a first analysis from the empagliflozin comparative effectiveness and safety (EMPRISE) Study. Circulation. 2019; 139(25): 2822–2830. Dostupné z DOI: <https://doi.org/10.1161/CIRCULATIONAHA.118.039177>.
  20. Pawar A, Patorno E, Deruaz-Luyet A et al. Reduced healthcare utilization in routine care initiators of empagliflozin with and without heart failure: interim analysis from the EMPagliflozin compaRative effectIveness and SafEty (EMPRISE) study. Eur Heart J 2019; 40(Suppl 1): ehz746.0181. <https://doi.org/10.1093/eurheartj/ehz746.0181>.
  21. Perkovic V, Jardine MJ, Neal B, et al. Canagliflozin and renal outcomes in type 2 diabetes and nephropathy. N Engl J Med 2019; 380(24): 2295–2306. Dostupné z DOI: <http://dx.doi.org/10.1056/NEJMoa1811744.
  22. Shah AD, Langenberg C, Rapsomaniki E et al. Type 2 diabetes and incidence of cardiovascular diseases: a cohort study in 1·9 million people. Lancet Diabetes Endocrinol 2015; 3(2): 105–113. Dostupné z DOI: <http://dx.doi.org/10.1016/S2213–8587(14)70219–0>.
  23. Schernthaner G, Lehmann R, Prázný M et al. Translating recent results from the Cardiovascular Outcomes Trials into clinical practice: recommendations from the Central and Eastern European Diabetes Expert Group (CEEDEG).Cardiovasc Diabetol 2017; 16(1): 137.Dostupné z DOI: <http://dx.doi.org/10.1186/s12933–017–0622–7>.
  24. Schernthaner G, Karasik A, Abraitienė A et al. Evidence from routine clinical practice: EMPRISE provides a new perspective on CVOTs Cardiovasc Diabetol 2019; 18(1): 115. Dostupné z DOI: <http://dx.doi.org/10.1186/s12933–019–0920–3>
  25. Schernthaner G, Drexel H, Moshkovich E et al. SGLT2 inhibitors in T2D and associated comorbidities — differentiating within the class. BMC Endocr Disord 2019; 19(1): 64. Dostupné z DOI: <http://dx.doi.org/10.1186/s12902–019–0387-y>.
  26. Schramm TK, Gislason GH, Vaag A et al. Mortality and cardiovascular risk associated with different insulin secretagogues compared with metformin in type 2 diabetes, with or without a previous myocardial infarction: a nationwide study. Eur Heart J 2011; 32(15): 1900–1908. Dostupné z DOI: <http://dx.doi.org/10.1093/eurheartj/ehr077>.
  27. Wiviott SD, Raz I, Bonaca MP et al. Dapagliflozin and cardiovascular outcomes in type 2 diabetes. New Engl J Med 2019; 380(4): 347–357. Dostupné z DOI: <http://dx.doi.org/10.1056/NEJMoa1812389>.
  28. Zelniker TA, Wiviott SD, Raz I et al. SGLT2 inhibitors for primary and secondary prevention of cardiovascular and renal outcomes in type 2 diabetes: a systematic review and meta-analysis of cardiovascular outcome trials. Lancet 2019; 393(10166): 31–39. Dostupné z DOI: <http://dx.doi.org/10.1016/S0140–6736(18)32590-X>.
  29. 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. Dostupné z DOI: <http://dx.doi.org/10.1056/NEJMoa1504720>.
Labels
Diabetology Endocrinology Internal medicine Cardiology
Login
Forgotten password

Don‘t have an account?  Create new account

Forgotten password

Enter the email address that you registered with. We will send you instructions on how to set a new password.

Login

Don‘t have an account?  Create new account