PMID- 33309581 OWN - NLM STAT- MEDLINE DCOM- 20210917 LR - 20210917 IS - 2213-1787 (Electronic) IS - 2213-1779 (Linking) VI - 9 IP - 2 DP - 2021 Feb TI - Reverse Cardiac Remodeling Following Initiation of Sacubitril/Valsartan in Patients With Heart Failure With and Without Diabetes. PG - 137-145 LID - S2213-1779(20)30578-3 [pii] LID - 10.1016/j.jchf.2020.09.014 [doi] AB - OBJECTIVE: This study sought to determine whether patients with heart failure and reduced ejection fraction (HFrEF) with type 2 diabetes mellitus (T2DM) have similar reverse cardiac remodeling with sacubitril/valsartan as patients without T2DM. BACKGROUND: Sacubitril/valsartan promotes reverse cardiac remodeling and improves outcomes in patients with HFrEF. Patients with HFrEF with T2DM have worse prognosis than those without T2DM. METHODS: In this post hoc analysis of PROVE-HF (Prospective Study of Biomarkers, Symptom Improvement, and Ventricular Remodeling During Sacubitril/Valsartan Therapy for Heart Failure), we examined changes in N-terminal pro-b-type natriuretic peptide (NT-proBNP), measures of cardiac remodeling, and Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) scores from baseline to 12 months following initiation of sacubitril/valsartan between patients with HFrEF with and without T2DM. Using latent growth curve modeling, we evaluated the longitudinal association between changes in NT-proBNP, left ventricular ejection fraction, and KCCQ-OS. RESULTS: Among 794 patients enrolled, 361 (45.5%) had T2DM. NT-proBNP concentrations were modestly higher at baseline among patients with T2DM but were reduced after initiation of sacubitril/valsartan. Cross-sectional improvement was observed in left ventricular ejection fraction (T2DM: 28.3% at baseline and 37% at 12 months vs. non-T2DM: 28.1% at baseline and 38.3% at 12 months) and KCCQ-OS (T2DM: 71 at baseline and 83 at 12 months vs. non-T2DM: 76 at baseline and 88 at 12 months). Similar changes were also observed for other echocardiographic measures. In longitudinal analyses, the average NT-proBNP change was similar in patients with T2DM (-5.6% vs. -7.1% per 90-day interval; p = 0.64), whereas improvements in KCCQ-OS scores were slightly smaller (2.1 vs. 3.46 per 90-day interval; p = 0.07). CONCLUSIONS: Sacubitril/valsartan favorably affects natriuretic peptide levels, reverse cardiac remodeling, and health status in patients with HFrEF with and without T2DM. (Effects of Sacubitril/Valsartan Therapy on Biomarkers, Myocardial Remodeling and Outcomes [PROVE-HF]; NCT02887183). CI - Copyright (c) 2021 The Authors. Published by Elsevier Inc. All rights reserved. FAU - Khan, Muhammad Shahzeb AU - Khan MS AD - University of Mississippi, Jackson, Mississippi, USA. FAU - Felker, G Michael AU - Felker GM AD - Duke University Medical Center and Duke Clinical Research Institute, Durham, North Carolina, USA. FAU - Pina, Ileana L AU - Pina IL AD - Detroit Medical Center, Detroit, Michigan, USA. FAU - Camacho, Alexander AU - Camacho A AD - Massachusetts General Hospital, Boston, Massachusetts, USA. FAU - Bapat, Devavrat AU - Bapat D AD - Massachusetts General Hospital, Boston, Massachusetts, USA. FAU - Ibrahim, Nasrien E AU - Ibrahim NE AD - Massachusetts General Hospital, Boston, Massachusetts, USA. FAU - Maisel, Alan S AU - Maisel AS AD - University of California-San Diego School of Medicine, San Diego, California, USA. FAU - Prescott, Margaret F AU - Prescott MF AD - Novartis Pharmaceuticals, East Hanover, New Jersey, USA. FAU - Ward, Jonathan H AU - Ward JH AD - Novartis Pharmaceuticals, East Hanover, New Jersey, USA. FAU - Solomon, Scott D AU - Solomon SD AD - Brigham and Women's Hospital, Boston, Massachusetts, USA. FAU - Januzzi, James L AU - Januzzi JL AD - Massachusetts General Hospital, Boston, Massachusetts, USA. FAU - Butler, Javed AU - Butler J AD - University of Mississippi, Jackson, Mississippi, USA. Electronic address: jbutler4@umc.edu. LA - eng SI - ClinicalTrials.gov/NCT02887183 PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20201209 PL - United States TA - JACC Heart Fail JT - JACC. Heart failure JID - 101598241 RN - 0 (Aminobutyrates) RN - 0 (Angiotensin Receptor Antagonists) RN - 0 (Biphenyl Compounds) RN - 0 (Drug Combinations) RN - 80M03YXJ7I (Valsartan) RN - WB8FT61183 (sacubitril and valsartan sodium hydrate drug combination) SB - IM MH - Aminobutyrates MH - Angiotensin Receptor Antagonists/therapeutic use MH - Biphenyl Compounds MH - Cross-Sectional Studies MH - *Diabetes Mellitus, Type 2/complications/drug therapy MH - Drug Combinations MH - *Heart Failure/complications/drug therapy MH - Humans MH - Prospective Studies MH - Stroke Volume MH - Valsartan/therapeutic use MH - Ventricular Function, Left MH - Ventricular Remodeling OTO - NOTNLM OT - NT-proBNP OT - cardiac remodeling OT - diabetes OT - heart failure OT - sacubitril/valsartan COIS- Funding Support and Author Disclosures Dr. Felker has received personal fees from Novartis, Bristol Myers Squibb, Medtronic, Innolife, EBR Systems, Arena, Abbott, Alnylam, SC Pharma, Rocket, Sphingotec, LivaNova, Cardionomic, Relypsa, V-Wave, and MyoKardia; grants from the National Heart, Lung, and Blood Institute, American Heart Association, and Merck; and grants and personal fees from Amgen, Cytokinetics, and Roche Diagnostics. Dr. Pina has received consulting income from Relypsa and Novartis. Dr. Ibrahim is funded in part by the Dennis and Marilyn Barry Fund in Cardiovascular Research and has received honoraria from Novartis and Roche Diagnostics. Dr. Maisel has received consulting income from Abbott Vascular, Ortho Clinical Diagnostics, and Novartis. Drs. Prescott and Ward are employees of Novartis Pharmaceuticals Inc. Dr. Solomon has received research grants from Alnylam, Amgen, AstraZeneca, Bellerophon, Bayer, Bristol Myers Squibb, Celladon, Cytokinetics, Eidos, Gilead, GlaxoSmithKline, Ionis, Lilly, Lone Star Heart, Mesoblast, MyoKardia, NIH/NHLBI, Neurotronik, Novartis, Respicardia, Sanofi Pasteur, and Theracos; and has consulted for Abbott, Akros, Alnylam, Amgen, Arena, AstraZeneca, Bayer, Bristol Myers Squibb, Cardior, Cardurion, Corvia, Cytokinetics, Daiichi-Sankyo, Gilead, GlaxoSmithKline, Ironwood, Lilly, Merck, Myokardia, Novartis, Roche, Takeda, Theracos, Quantum Genetics, Cardurion, AoBiome, Janssen, Cardiac Dimensions, Tenaya, Sanofi-Pasteur, Dinaqor, Tremeau, CellProThera, and Moderna. Dr. Januzzi reported receiving personal fees from the American College of Cardiology, Pfizer, Merck, AbbVie, Amgen, Boehringer Ingelheim, and Takeda; grants and personal fees from Novartis, Roche, Abbott, and Janssen; and grants from Singulex and Prevencio. Dr. Butler serves as a consultant for Abbott, Adrenomed, Amgen, Array, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, CVRx, G3 Pharmaceutical, Impulse Dynamics, Innolife, Janssen, LivaNova, Luitpold, Medtronic, Merck, Novartis, Novo Nordisk, Relypsa, Roche, V-Wave Limited, and Vifor. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. EDAT- 2020/12/15 06:00 MHDA- 2021/09/18 06:00 CRDT- 2020/12/14 10:15 PHST- 2020/07/15 00:00 [received] PHST- 2020/09/23 00:00 [revised] PHST- 2020/09/29 00:00 [accepted] PHST- 2020/12/15 06:00 [pubmed] PHST- 2021/09/18 06:00 [medline] PHST- 2020/12/14 10:15 [entrez] AID - S2213-1779(20)30578-3 [pii] AID - 10.1016/j.jchf.2020.09.014 [doi] PST - ppublish SO - JACC Heart Fail. 2021 Feb;9(2):137-145. doi: 10.1016/j.jchf.2020.09.014. Epub 2020 Dec 9.