Empagliflozin after Acute Myocardial Infarction
Por:
Butler, J, Jones, WS, Udell, JA, Anker, SD, Petrie, MC, Harrington, J, Mattheus, M, Zwiener, I, Amir, O, Bahit, MC, Bauersachs, J, Bayes-Genis, A, Chen, YD, Chopra, VK, Figtree, G, Ge, JB, Goodman, SG, Gotcheva, N, Goto, S, Gasior, T, Jamal, W, Januzzi, JL, Jeong, MH, Lopatin, Y, Lopes, RD, Merkely, B, Parikh, PB, Parkhomenko, A, Ponikowski, P, Rossello, X, Schou, M, Simic, D, Steg, PG, Szachniewicz, J, van der Meer, P, Vinereanu, D, Zieroth, S, Brueckmann, M, Sumin, M, Bhatt, DL and Hernandez, AF
Publicada:
25 abr 2024
Ahead of Print:
1 abr 2024
Resumen:
Background Empagliflozin improves cardiovascular outcomes in patients with heart failure, patients with type 2 diabetes who are at high cardiovascular risk, and patients with chronic kidney disease. The safety and efficacy of empagliflozin in patients who have had acute myocardial infarction are unknown.Methods In this event-driven, double-blind, randomized, placebo-controlled trial, we assigned, in a 1:1 ratio, patients who had been hospitalized for acute myocardial infarction and were at risk for heart failure to receive empagliflozin at a dose of 10 mg daily or placebo in addition to standard care within 14 days after admission. The primary end point was a composite of hospitalization for heart failure or death from any cause as assessed in a time-to-first-event analysis.Results A total of 3260 patients were assigned to receive empagliflozin and 3262 to receive placebo. During a median follow-up of 17.9 months, a first hospitalization for heart failure or death from any cause occurred in 267 patients (8.2%) in the empagliflozin group and in 298 patients (9.1%) in the placebo group, with incidence rates of 5.9 and 6.6 events, respectively, per 100 patient-years (hazard ratio, 0.90; 95% confidence interval [CI], 0.76 to 1.06; P=0.21). With respect to the individual components of the primary end point, a first hospitalization for heart failure occurred in 118 patients (3.6%) in the empagliflozin group and in 153 patients (4.7%) in the placebo group (hazard ratio, 0.77; 95% CI, 0.60 to 0.98), and death from any cause occurred in 169 (5.2%) and 178 (5.5%), respectively (hazard ratio, 0.96; 95% CI, 0.78 to 1.19). Adverse events were consistent with the known safety profile of empagliflozin and were similar in the two trial groups.Conclusions Among patients at increased risk for heart failure after acute myocardial infarction, treatment with empagliflozin did not lead to a significantly lower risk of a first hospitalization for heart failure or death from any cause than placebo. (Funded by Boehringer Ingelheim and Eli Lilly; EMPACT-MI ClinicalTrials.gov number, NCT04509674.)
Among patients hospitalized for acute myocardial infarction and at risk for heart failure, empagliflozin did not lead to a significantly lower risk of a first heart-failure hospitalization or death from any cause than placebo.
Filiaciones:
Butler, J:
Baylor Scott & White Res Inst, 3434 Live Oak St, Dallas, TX 75204 USA
Univ Mississippi, Dept Med, Jackson, MS USA
Jones, WS:
Duke Univ, Dept Med, Div Cardiol, Med Ctr, Durham, NC USA
Udell, JA:
Womens Coll Hosp, Toronto, ON, Canada
Univ Toronto, Univ Hlth Network, Peter Munk Cardiac Ctr, Toronto, ON, Canada
Anker, SD:
Charite, Berlin Inst Hlth, German Ctr Cardiovasc Res Partner Site Berlin, Dept Cardiol,German Heart Ctr Charite,Ctr Regener, Berlin, Germany
Petrie, MC:
Univ Glasgow, British Heart Fdn Glasgow Cardiovasc Res Ctr, Sch Cardiovasc & Med Sci, Glasgow, Lanark, Scotland
Harrington, J:
Duke Univ, Dept Med, Div Cardiol, Med Ctr, Durham, NC USA
Mattheus, M:
Boehringer Ingelheim Pharm, Ingelheim, Germany
Zwiener, I:
Boehringer Ingelheim Pharm, Ingelheim, Germany
Amir, O:
Hebrew Univ Jerusalem, Heart Inst, Hadassah Med Ctr, Jerusalem, Israel
Bahit, MC:
Fdn INECO, Inst Neurol INECO Neurociencias Orono, Rosario, Argentina
Bauersachs, J:
Hannover Med Sch, Dept Cardiol & Angiol, Hannover, Germany
:
Hosp Badalona Germans Trias & Pujol, Heart Inst, Barcelona, Spain
Univ Autonomoa Barcelona, Dept Med, Barcelona, Spain
Chen, YD:
Chinese Peoples Liberat Army Gen Hosp, Dept Cardiol, Med Ctr 1, Beijing, Peoples R China
Chopra, VK:
Medanta, Dept Cardiol, Gurgaon, India
Figtree, G:
Univ Sydney, Fac Med & Hlth, Sydney, NSW, Australia
Ge, JB:
Fudan Univ, Zhongshan Hosp, Dept Cardiol, Shanghai, Peoples R China
Natl Clin Res Ctr Intervent Med, Shanghai Inst Cardiovasc Dis, Shanghai, Peoples R China
Goodman, SG:
Univ Toronto, Univ Hlth Network, Peter Munk Cardiac Ctr, Toronto, ON, Canada
St Michaels Hosp, Unity Hlth Toronto, Dept Med, Div Cardiol, Toronto, ON, Canada
Univ Alberta, Canadian VIGOUR Ctr, Edmonton, AB, Canada
Gotcheva, N:
Natl Cardiol Hosp, Dept Cardiol, Sofia, Bulgaria
Goto, S:
Tokai Univ, Sch Med, Isehara, Kanagawa, Japan
Gasior, T:
Boehringer Ingelheim Int, Ingelheim, Germany
WSB Univ, Fac Med, Coll Med, Dabrowa Gornicz, Poland
Jamal, W:
Boehringer Ingelheim Int, Ingelheim, Germany
Januzzi, JL:
Harvard Med Sch, Div Cardiol, Boston, MA USA
Massachusetts Gen Hosp, Boston, MA USA
Jeong, MH:
Chonnam Natl Univ Hosp & Med Sch, Gwangju, South Korea
Lopatin, Y:
Volgograd State Med Univ, Volgograd, Russia
Lopes, RD:
Duke Clin Res Inst, Durham, NC USA
Merkely, B:
Semmelweis Univ, Heart & Vasc Ctr, Budapest, Hungary
Parikh, PB:
SUNY Stony Brook, Dept Med, Div Cardiovasc Med, Stony Brook, NY USA
Parkhomenko, A:
Natl Acad Med Sci, Ukrainian Inst Cardiol MD Strazhesko, Kiev, Ukraine
Ponikowski, P:
Inst Heart Dis Med Univ, Wroclaw, Poland
Rossello, X:
Univ Balearic Isl, Son Espases Univ Hosp, Hlth Res Inst Balearic Isl, Palma De Mallorca, Spain
Schou, M:
Herlev & Gentofte Univ Hosp, Dept Cardiol, Copenhagen, Denmark
Simic, D:
Univ Clin Ctr Belgrade, Dept Cardiovasc Dis, Belgrade, Serbia
Steg, PG:
Univ Paris Cite, Hop Bichat, AP HP, French Alliance Cardiovasc Trials,INSERM,U1148, Paris, France
Szachniewicz, J:
Jan Mikulicz Radecki Univ Clin Hosp, Wroclaw, Poland
van der Meer, P:
Univ Groningen, Univ Med Ctr Groningen, Dept Cardiol, Groningen, Netherlands
Vinereanu, D:
Univ Bucharest, Bucharest, Romania
Emergency Hosp Bucharest, Bucharest, Romania
Zieroth, S:
Univ Manitoba, Max Rady Coll Med, Sect Cardiol, Winnipeg, MB, Canada
Brueckmann, M:
Boehringer Ingelheim Int, Ingelheim, Germany
Heidelberg Univ, Fac Med Mannheim, Dept Med 1, Mannheim, Germany
Sumin, M:
Boehringer Ingelheim Int, Ingelheim, Germany
Bhatt, DL:
Icahn Sch Med Mt Sinai, Mt Sinai Fuster Heart Hosp, New York, NY USA
Hernandez, AF:
Duke Univ, Dept Med, Div Cardiol, Med Ctr, Durham, NC USA
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