TY - JOUR
TI - Effect of empagliflozin on exercise ability and symptoms in heart failure patients with reduced and preserved ejection fraction, with and without type 2 diabetes
AU - Abraham, W.T.
AU - Lindenfeld, J.
AU - Ponikowski, P.
AU - Agostoni, P.
AU - Butler, J.
AU - Desai, A.S.
AU - Filippatos, G.
AU - Gniot, J.
AU - Fu, M.
AU - Gullestad, L.
AU - Howlett, J.G.
AU - Nicholls, S.J.
AU - Redon, J.
AU - Schenkenberger, I.
AU - Silva-Cardoso, J.
AU - Störk, S.
AU - Krzysztof Wranicz, J.
AU - Savarese, G.
AU - Brueckmann, M.
AU - Jamal, W.
AU - Nordaby, M.
AU - Peil, B.
AU - Ritter, I.
AU - Ustyugova, A.
AU - Zeller, C.
AU - Salsali, A.
AU - Anker, S.D.
JO - EUROPEAN HEART JOURNAL-CARDIOVASCULAR PHARMACOTHERAPY
PY - 2021
VL - 42
TODO - 6
SP - 700-710
PB - Oxford University Press
SN - null
TODO - 10.1093/eurheartj/ehaa943
TODO - 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
TODO - 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.
ER -