Τίτλος:
Effect of empagliflozin on exercise ability and symptoms in heart failure patients with reduced and preserved ejection fraction, with and without type 2 diabetes
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
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.
Συγγραφείς:
Abraham, W.T.
Lindenfeld, J.
Ponikowski, P.
Agostoni, P.
Butler, J.
Desai, A.S.
Filippatos, G.
Gniot, J.
Fu, M.
Gullestad, L.
Howlett, J.G.
Nicholls, S.J.
Redon, J.
Schenkenberger, I.
Silva-Cardoso, J.
Störk, S.
Krzysztof Wranicz, J.
Savarese, G.
Brueckmann, M.
Jamal, W.
Nordaby, M.
Peil, B.
Ritter, I.
Ustyugova, A.
Zeller, C.
Salsali, A.
Anker, S.D.
Περιοδικό:
EUROPEAN HEART JOURNAL-CARDIOVASCULAR PHARMACOTHERAPY
Εκδότης:
Oxford University Press
Λέξεις-κλειδιά:
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
DOI:
10.1093/eurheartj/ehaa943
