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N Engl J Med. 2015 Nov 26;373(22):2117-28. doi: 10.1056/NEJMoa1504720. Epub 2015 Sep 17.

Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes.

Collaborators (705)

Aizenberg D, Ulla M, Waitman J, De Loredo L, Farías J, Fideleff H, Lagrutta M, Maldonado N, Colombo H, Ferre Pacora F, Wasserman A, Maffei L, Lehman R, Selvanayagam J, d’Emden M, Fasching P, Paulweber B, Toplak H, Luger A, Drexel H, Prager R, Schnack C, Schernthaner G, Fliesser-Görzer E, Kaser S, Scheen A, Van Gaal L, Hollanders G, Kockaerts Y, Capiau L, Chachati A, Persu A, Hermans M, Vantroyen D, Vercammen C, Van de Borne P, Benhalima K, Mathieu C, Lienart F, Mortelmans J, Strivay M, Vereecken G, Keymeulen B, Lamkanfi F, Chacra A, Eliaschewitz F, Zanella M, Faludi A, Bertolami M, Hayashida C, Nunes Salles J, Monte O, Dinato M, Manenti E, Rassi N, Halpern A, Lima Filho M, Ayoub J, Felicio J, Borges J, Gross J, Sgarbi J, Betti R, Tiburcio A, Purisch S, Schmid H, Takahashi M, Castro M, Rea R, Hissa M, Geloneze Neto B, Saraiva J, Henein S, Lochnan H, Imran SA, Clayton D, Bayly K, Berlingieri J, Boucher P, Chan Y, Gupta M, Chehayeb R, Ouellett A, Ur E, Woo V, St Amour E, Terront Lozano M, Yupanqui Lozno H, Urina M, Lopez Jaramillo P, Jaramillo N, Sanchez G, Pérez G, Tusek S, Mirosevic G, Goldoni V, Jurisic-Erzen D, Balasko A, Balic S, Drvodelic-Sunic E, Canecki Varzic S, Machkova M, Weiner P, Lastuvka J, Olsovsky J, Krarup T, Ridderstråle M, Tarnow L, Sætre Lihn A, Christensen P, Juhl H, Urhammer S, Lund P, Adojaan B, Jakovlev Ü, Lanno R, Lubi M, Marandi T, Gouet D, Courrèges J, Zaoui P, Choukroun G, Petit C, Formagne L, Estour B, Mabire P, Daugenet C, Lemarie B, Clavel S, Aure P, Remaud P, Halimi J, Hadjadj S, Couffinhal T, Glonti S, Metreveli D, Lominadze Z, Giorgadze E, Burtchuladze T, Javashvili L, Kurashvili G, Kurashvili R, Virsaladze D, Nadareishvili L, Khomasuridze A, Cahill T, Green F, MacRury S, Waldron M, Middleton A, McKnight J, Pearson E, Butler M, Choksi M, Caldwell I, Farmer I, Wyatt N, Patrick J, O'Brien I, Devers M, Bousboulas S, Pappas S, Piaditis G, Vryonidou A, Tentolouris N, Karamitsos K, Manes C, Benroubi M, Avramidis I, Ozaki R, Tan K, Siu S, Ip T, Tsang C, Dudas M, Nagy K, Salamon C, Gerö L, Patkay J, Tabak A, Tamas G, Juhasz F, Szentpeteri I, Ghaisas N, Bantwal G, Mohan V, Gupta J, Sadhu N, Kulkarni A, Garg N, Reddy S, Deshpande N, Gutlapalli K, Pillai M, Premchand R, Badgandi M, Jain S, Aravind S, Shamanna P, Pandey A, Gupta S, Pramono B, Dante Saksono H, Agung P, Djoko Wahono S, Suastika K, Tanggo Y, Juwana Y, Siswanto B, Adawi F, Efrati S, Mazen E, Bashkin A, Herskovits T, Jaffe A, Schiff E, Wainstein J, Taddei S, Aiello A, Arca M, Calabro P, Cignarelli M, Fioretto P, Marchesini Reggiani G, Gnasso A, Marchionni N, Marsilii A, Bucci M, Mezzetti A, Pozzilli P, Colivicchi F, Santini M, Moro E, Semplicini A, Toscano V, Fucili A, Monno S, Furui K, Higashiue S, Hiramatsu N, Kawamitsu K, Takenaka T, Takahashi H, Hojo F, Onishi Y, Izumino K, Okubo M, Wakida Y, Kondo Y, Hieshima K, Jinnouchi H, Suzuki A, Ito M, Park S, Kim Y, Hong T, Park H, Gwon H, Kim H, Kang K, Lee S, Jeong M, Seung K, Lim D, Rha S, Tahk S, Yang J, Yoon J, Shin M, Kim D, Jeong J, Nik Ahmad N, Mustafa N, Wan Mohamed W, Fung Y, Abdul Ghani R, Chandramouli A, Chee K, Abdul Kadir K, Ling K, Abu Hassan M, Foo S, Garcia Hernandez P, Aguilar-Salinas C, Vidrio Velazquez M, Flores F, Alpizar Salazar M, Micher Escalante D, Garcia Soria M, Cardona Muñoz E, Storms G, Schaper N, Kooy A, Krekels M, vab Bemmel T, Verhoeven R, Mulder H, Oldenburg-Ligtenberg P, Gonkel F, de Jong A, van Soest J, Viergever P, Mevissen H, Lochorn G, Zwiers G, Hoogslag P, Ronner E, Nierop P, Al-Windy N, Kragten J, Dekelver P, Benatar J, Krebs J, Scott R, Heggen E, Berz A, Fossum C, Hurtig U, Langslet G, Baranowski M, Sparby J, Karlsson T, Delgado Torres C, Rodriguez Escudero A, Lisson R, Allemant Maldonado A, Gallardo Rojas W, Gonzales Bravo L, Lema Osores J, Farfan J, Zapata L, Godoy Junchaya J, Roldan Concha Y, Urquiaga Calderon J, Sy R, Tan G, Aquitania G, De Los Santos G, Panelo A, Roderos O, Rosales R, Toledo R, Liwag A, Ramoncito H, Skokowska E, Krzyzagorska E, Ogorek M, Wojnowski L, Spyra J, Konieczny M, Piesiewicz W, Kus W, Ocicka-Kozakiewicz A, Orlowska-Kunikowska E, Zmuda W, Duarte S, Leitão A, Monteiro P, Rita H, Salgado V, Pinto L, Queirós J, Teixeira J, Rogado C, Duarte R, Sobral do Rosário F, Silva A, Andrade L, Velez M, Brazão M, Istratoaie O, Lichiardopol R, Catrinoiu D, Militaru C, Zetu C, Barbonta D, Cosma D, Crisan C, Pop L, Esip V, Arutyunov G, Boyarkin M, Agafyina A, Vorokhobina N, Petunina N, Libov I, Zalevskaya A, Nikolaev K, Barbarash O, Potemkin V, Bystrova A, Krasilnikova E, Barbarich V, Chumakova G, Tarasov N, Meleshkevich T, Zateyshchikov D, Lantseva O, Belenkiy D, Obrezan A, Rossolko L, Fillipova E, Yakhontova P, Khokhlov A, Tan R, Sum C, Chang H, Distiller L, Pretorius M, Nortje H, Mitha E, Burgess L, Blignaut S, Venter T, Moodley R, Lombaard J, Govind U, Naidoo V, Mookadam M, Engelbrecht J, Omar M, Jurgens J, Podgorski G, Vawda H, Naidoo D, Emanuel S, Roodt A, Amod A, Van Zyl L, Segura J, Brito M, Fernandez-Cruz A, Artola S, Iglesias R, Toural E, Garcia-Ortiz L, Saban J, Mesa J, Vidal J, Linares J, del Cañizo F, Rigla M, Suarez C, Llorente I, Moreno B, Antoli A, Gomez Peralta F, Iglesias M, Pereg V, de Teresa L, Camafort M, Trescoli C, Satarasinghe R, Somasundaram N, Siyambalapitiya S, Antonypillai C, Bulugahapitiya D, Medagama U, Huang C, Lu Y, Hwang J, Chiang C, Wen M, Chen J, Lai W, Chang K, Wang J, Yeh H, Kriangsak P, Deerochanawong C, Suwanwalaikorn S, Mangklabruks A, Kaewsuwanna P, Piyayotai D, Iabluchanskyi M, Samoylov O, Godlevska O, Kovalyova O, Voloshyna O, Tseluyko V, Zotov S, Vykhovanyuk I, Dulgeroff A, Mayfield R, Zaniewski-Singh M, Ullal J, Aloi J, De La Rosa R, Mosely J, Wittmer B, Aronoff S, Rosenfeld J, Seidner M, Warren M, Fishman N, Weiss R, Arif A, Sandberg M, Lewis D, Ball E, Graf R, Breton C, Tamayo R, Richards R, Cefalu W, Uwaifo G, Zayour D, Hoffman J, Fitz-Patrick D, Khan B, Blaze K, Bressler P, Halpern S, Chappell D, Bergenstal R, Cuddihy R, Matfin G, Freedman Z, Gonzalez-Campoy J, Lerman S, Rendell M, Sitar S, Reeves M, Howard T, Soufer J, Miranda-Palma B, Laliotis A, Shomali M, Teltser M, Hurley D, Morawski E, Cherlin R, Houchin V, Welch M, Goytia-Leos D, Syed M, Kowaloff E, Weinrauch L, Peniston J, Brockmyre A, First B, Feld L, Huffman D, Nassim O, Gottschlich G, Patel A, Knopke C, Hernandez M, Diaz J, Giugliano G, Nicasio J, Eagerton D, Huntley R, Reed J III, Magee M, Hippert R, Sofley C Jr, Alzohaili O, Levins P, Anspach R, Shah S, Brusco O, Naidu J, Lindenbaum J, Jacks R, Hammond G, Arena C, Saxman K, Mach M, Kerstein H, Kereiakes D, Wahlen J, Wehmeier K, Chaykin L, Rothman J, Fogelfeld L, Stroger J Jr, Bittar N, Rosenstock J, Kayne D, Navarro J, Colfer H, Mokshagundam S, Shandilya L, Connery L, Wysham C, Dela Llana A, Jardula M, MacAdams M, Flippo G, Heurich E, Curtis C, Sanders D, Rawls R, Velazquez F, Osea E, Mahood K, Feldman G, Eder F, Riley E, Jain M, IVFowler W, Shepard M, Schear M, Barker B, Strout C, Obiekwe O, Shanik M, Green C, Blakney E, Roberson K, Bretton E, Pish R, Kaveh K, Maynard B, Barager W, Soldyshev R, Austin B, Parmar P, Simpson R, Chauhan A, Kasper J, Burr R, Patel N, Mariano H, Pluto T, Bratcher C, Juarez M, Levinson L, Awad A, Longshaw K, Hoffman K, Richwine R, Molter D, Boscia J III, Kowalyk S, Lemis P, Liss J, Orr R, Riser J, Wood J, Ubani A, Paine W, Hassani F, Miranda F, Hansen V, Farris N, Bowden R, Ajani D, Maw K, Andersen J, Bergman B, Dunmyer S, Brandon D, Anderson M, Bononi P, Prawer J, Seidman B, Cruz H, Wilks K, DiSanto L, Buynak R, Christensen T, Denker P, Koppel W, Stedman M, Lewy-Alterbaum L, Karim S, Shapiro J, Gardner T, Oskin T, Gabra N, Malano J, Welty FK, Parhofer KG, Pedersen TR, Lees KR, Clayton T, Pocock S, Palmer M, Clemmensen P, Grande P, Pehrson S, Januzzi J Jr, Wood MJ, Petrie M, Sairanen T, Tatlisumak T, Soinne L, Kase C, Turan T, Watkins P, Lewis J, Freston J, Schenker S, Heist R, Lee RJ, Natale RB, Sullivan RJ, Buchbinder EI, Chodak G, Schumacher M, Schmoor C, Hieke S, Ohneberg K.

Abstract

BACKGROUND:

The effects of empagliflozin, an inhibitor of sodium-glucose cotransporter 2, in addition to standard care, on cardiovascular morbidity and mortality in patients with type 2 diabetes at high cardiovascular risk are not known.

METHODS:

We randomly assigned patients to receive 10 mg or 25 mg of empagliflozin or placebo once daily. The primary composite outcome was death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke, as analyzed in the pooled empagliflozin group versus the placebo group. The key secondary composite outcome was the primary outcome plus hospitalization for unstable angina.

RESULTS:

A total of 7020 patients were treated (median observation time, 3.1 years). The primary outcome occurred in 490 of 4687 patients (10.5%) in the pooled empagliflozin group and in 282 of 2333 patients (12.1%) in the placebo group (hazard ratio in the empagliflozin group, 0.86; 95.02% confidence interval, 0.74 to 0.99; P=0.04 for superiority). There were no significant between-group differences in the rates of myocardial infarction or stroke, but in the empagliflozin group there were significantly lower rates of death from cardiovascular causes (3.7%, vs. 5.9% in the placebo group; 38% relative risk reduction), hospitalization for heart failure (2.7% and 4.1%, respectively; 35% relative risk reduction), and death from any cause (5.7% and 8.3%, respectively; 32% relative risk reduction). There was no significant between-group difference in the key secondary outcome (P=0.08 for superiority). Among patients receiving empagliflozin, there was an increased rate of genital infection but no increase in other adverse events.

CONCLUSIONS:

Patients with type 2 diabetes at high risk for cardiovascular events who received empagliflozin, as compared with placebo, had a lower rate of the primary composite cardiovascular outcome and of death from any cause when the study drug was added to standard care. (Funded by Boehringer Ingelheim and Eli Lilly; EMPA-REG OUTCOME ClinicalTrials.gov number, NCT01131676.).

PMID:
26378978
DOI:
10.1056/NEJMoa1504720
[Indexed for MEDLINE]
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