@article{3120023,
    title = "Effect of empagliflozin on exercise ability and symptoms in heart failure patients with reduced and preserved ejection fraction, with and without type 2 diabetes",
    author = "Abraham, W.T. and Lindenfeld, J. and Ponikowski, P. and Agostoni, P. and Butler, J. and Desai, A.S. and Filippatos, G. and Gniot, J. and Fu, M. and Gullestad, L. and Howlett, J.G. and Nicholls, S.J. and Redon, J. and Schenkenberger, I. and Silva-Cardoso, J. and Störk, S. and Krzysztof Wranicz, J. and Savarese, G. and Brueckmann, M. and Jamal, W. and Nordaby, M. and Peil, B. and Ritter, I. and Ustyugova, A. and Zeller, C. and Salsali, A. and Anker, S.D.",
    journal = "EUROPEAN HEART JOURNAL-CARDIOVASCULAR PHARMACOTHERAPY",
    year = "2021",
    volume = "42",
    number = "6",
    pages = "700-710",
    publisher = "Oxford University Press",
    doi = "10.1093/eurheartj/ehaa943",
    keywords = "empagliflozin;  placebo;  benzhydryl derivative;  empagliflozin;  glucoside, acute kidney failure;  adult;  aged;  anuria;  arm fracture;  Article;  asymptomatic bacteriuria;  Chronic Heart Failure Questionnaire Self Administered Standardized;  controlled study;  disease burden;  double blind procedure;  drug fatality;  drug safety;  drug withdrawal;  exercise;  faintness;  female;  femur fracture;  foot fracture;  genital candidiasis;  heart failure with preserved ejection fraction;  heart failure with reduced ejection fraction;  heart protection;  human;  hypoglycemia;  hypotension;  Kansas City Cardiomyopathy Questionnaire Total Symptom Score;  kidney failure;  major clinical study;  male;  non insulin dependent diabetes mellitus;  orthostatic hypotension;  patient-reported outcome;  prospective study;  radius fracture;  randomized controlled trial;  scoring system;  side effect;  six minute walk test;  spine fracture;  treatment duration;  urinary tract infection;  urosepsis;  vagina candidiasis;  vagina disease;  vulval abscess;  complication;  heart failure;  heart stroke volume, Benzhydryl Compounds;  Diabetes Mellitus, Type 2;  Glucosides;  Heart Failure;  Humans;  Stroke Volume",
    abstract = "Aims: The EMPERIAL (Effect of EMPagliflozin on ExeRcise ability and HF symptoms In patients with chronic heArt faiLure) trials evaluated the effects of empagliflozin on exercise ability and patient-reported outcomes in heart failure (HF) with reduced and preserved ejection fraction (EF), with and without type 2 diabetes (T2D), reporting, for the first time, the effects of sodium-glucose co-transporter-2 inhibition in HF with preserved EF (HFpEF). Methods and results: HF patients with reduced EF (HFrEF) (≤40%, N = 312, EMPERIAL-Reduced) or preserved EF (>40%, N = 315, EMPERIAL-Preserved), with and without T2D, were randomized to empagliflozin 10 mg or placebo for 12 weeks. The primary endpoint was 6-minute walk test distance (6MWTD) change to Week 12. Key secondary endpoints included Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) and Chronic Heart Failure Questionnaire Self-Administered Standardized format (CHQ-SAS) dyspnoea score. 6MWTD median (95% confidence interval) differences, empagliflozin vs. placebo, at Week 12 were-4.0 m (-16.0, 6.0; P = 0.42) and 4.0 m (-5.0, 13.0; P = 0.37) in EMPERIAL-Reduced and EMPERIAL-Preserved, respectively. As the primary endpoint was non-significant, all secondary endpoints were considered exploratory. Changes in KCCQ-TSS and CHQ-SAS dyspnoea score were non-significant. Improvements with empagliflozin in exploratory pre-specified analyses of KCCQ-TSS responder rates, congestion score, and diuretic use in EMPERIAL-Reduced are hypothesis generating. Empagliflozin adverse events were consistent with those previously reported. Conclusion: The primary outcome for both trials was neutral. Empagliflozin was well tolerated in HF patients, with and without T2D, with a safety profile consistent with that previously reported in T2D. Hypothesis-generating improvements in exploratory analyses of secondary endpoints with empagliflozin in HFrEF were observed. © 2020 Published on behalf of the European Society of Cardiology. All rights reserved."
}