PMID- 32915523
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20221110
IS  - 2055-5822 (Electronic)
IS  - 2055-5822 (Linking)
VI  - 7
IP  - 6
DP  - 2020 Dec
TI  - Early benefits of empagliflozin in patients with or without heart failure: 
      findings from EMPA-REG OUTCOME.
PG  - 3401-3407
LID - 10.1002/ehf2.12891 [doi]
AB  - AIMS: The EMPA-REG OUTCOME trial demonstrated reductions in cardiovascular (CV) 
      death and heart failure (HF) outcomes with empagliflozin, a sodium-glucose 
      co-transporter 2 inhibitor, in patients with type 2 diabetes and established CV 
      disease over a study period of 3 years. We aimed to investigate the early 
      benefit-risk profile of empagliflozin in patients enrolled in the EMPA-REG 
      OUTCOME trial according to HF status at baseline. METHODS AND RESULTS: The 
      effects of treatments on glycated haemoglobin, systolic blood pressure and body 
      weight, and on the HF endpoints of hospitalization for HF (HHF), HHF or CV death, 
      and HHF or all-cause mortality were evaluated at 12 weeks, 6 months, and 1 year 
      after randomization. Occurrence of adverse events (AEs) during these time points 
      was also evaluated. Compared with placebo, empagliflozin lowered glycated 
      haemoglobin, systolic blood pressure, and body weight and rates of all the HF 
      endpoints, as early as at 12 weeks, regardless of HF status at baseline. 
      Favourable clinical and metabolic effects were maintained over time. AEs were 
      generally higher in those with HF than without HF; however, compared with 
      placebo, empagliflozin did not increase risk of developing AEs over the first 
      year of treatment. CONCLUSIONS: In the EMPA-REG OUTCOME trial, the use of 
      empagliflozin led to early and beneficial effects on clinical, metabolic, and HF 
      outcomes in patients with type 2 diabetes with or without HF at baseline, which 
      were already apparent within 12 weeks from initiation of treatment. Over the 
      first year of treatment, no safety concern was detected with the use of 
      empagliflozin.
CI  - (c) 2020 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on 
      behalf of the European Society of Cardiology.
FAU - Pellicori, Pierpaolo
AU  - Pellicori P
AD  - Robertson Centre for Biostatistics, Glasgow Clinical Trials Unit, University of 
      Glasgow, Glasgow, UK.
FAU - Ofstad, Anne Pernille
AU  - Ofstad AP
AD  - Boehringer Ingelheim Norway KS, Asker, Norway.
FAU - Fitchett, David
AU  - Fitchett D
AD  - St. Michael's Hospital, University of Toronto, Toronto, Canada.
FAU - Zeller, Cordula
AU  - Zeller C
AD  - Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.
FAU - Wanner, Christoph
AU  - Wanner C
AD  - Department of Medicine, Wurzburg University Clinic, Wurzburg, Germany.
FAU - George, Jyothis
AU  - George J
AD  - Boehringer Ingelheim International GmbH, Ingelheim, Germany.
FAU - Zinman, Bernard
AU  - Zinman B
AD  - Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of 
      Toronto, Toronto, Canada.
FAU - Brueckmann, Martina
AU  - Brueckmann M
AD  - Boehringer Ingelheim International GmbH, Ingelheim, Germany.
AD  - Faculty of Medicine Mannheim, University of Heidelberg, Mannheim, Germany.
FAU - Lindenfeld, JoAnn
AU  - Lindenfeld J
AD  - Vanderbilt University Medical Center, Nashville, TN, USA.
LA  - eng
PT  - Journal Article
DEP - 20200911
PL  - England
TA  - ESC Heart Fail
JT  - ESC heart failure
JID - 101669191
SB  - IM
PMC - PMC7754994
OTO - NOTNLM
OT  - Diabetes
OT  - EMPA-REG OUTCOME
OT  - Empagliflozin
OT  - Heart failure
OT  - Trial
COIS- P.P. has received travel support from Boehringer Ingelheim. D.F. has received 
      honoraria from Sanofi, Merck & Co., Amgen, AstraZeneca, Eli Lilly and Company, 
      and Boehringer Ingelheim. C.W. has received honoraria for consultancy and 
      lecturing from Abbvie, Actelion, Amgen, Bayer, Boehringer Ingelheim, 
      GlaxoSmithKline, Janssen, Eli Lilly and Company, Protalix, Sanofi Genzyme, and 
      Shire. B.Z. has received research grants awarded to his institution from 
      Boehringer Ingelheim and Novo Nordisk and honoraria from Janssen, Sanofi, Eli 
      Lilly and Company, Boehringer Ingelheim, Novo Nordisk, and Merck Sharp & Dohme. 
      J.L. has received consultancy fees from Abbott, AstraZeneca, Boehringer 
      Ingelheim, CVRx, Novartis, Relypsa, Impulse Dynamics, V-Wave Medical, and Edwards 
      Lifesciences and grants from AstraZeneca, Sensible Medical, Volumetrix, and the 
      National Institutes of Health. A.P.O., C.Z., J.G., and M.B. are employees of 
      Boehringer Ingelheim.
EDAT- 2020/09/12 06:00
MHDA- 2020/09/12 06:01
PMCR- 2020/09/11
CRDT- 2020/09/11 12:15
PHST- 2020/06/19 00:00 [revised]
PHST- 2019/12/18 00:00 [received]
PHST- 2020/06/23 00:00 [accepted]
PHST- 2020/09/12 06:00 [pubmed]
PHST- 2020/09/12 06:01 [medline]
PHST- 2020/09/11 12:15 [entrez]
PHST- 2020/09/11 00:00 [pmc-release]
AID - EHF212891 [pii]
AID - 10.1002/ehf2.12891 [doi]
PST - ppublish
SO  - ESC Heart Fail. 2020 Dec;7(6):3401-3407. doi: 10.1002/ehf2.12891. Epub 2020 Sep 
      11.