Effects of Sacubitril-Valsartan Versus Valsartan in Women Compared With Men With Heart Failure and Preserved Ejection Fraction Insights From PARAGON-HF

Circulation

Volumn 141, Issue 5, 2020, Pages 338-351

  McMurray, John J V ^a   Jackson, Alice M ^a   Lam, Carolyn S P ^b,c,d   Redfield, Margaret M ^e   Anand, Inder S ^f   Ge, Junbo ^g   Lefkowitz, Marty P ^h   Maggioni, Aldo P ⁱ   Martinez, Felipe ^j   Packer, Milton ^k   Pfeffer, Marc A ^l   Pieske, Burkert ^m   Rizkala, Adel R ^h   Sabarwal, Shalini V ^h   Shah, Amil M ^l   Shah, Sanjiv J ⁿ   Shi, Victor C ^h   van Veldhuisen, Dirk J ^c   Zannad, Faiez ^o   Zile, Michael R ^p   Cikes, Maja ^q   Goncalvesova, Eva ^r   Katova, Tzvetana ^s   Kosztin, Anamaria ^t   Lelonek, Malgorzata ^u   Sweitzer, Nancy ^v   Vardeny, Orly ^f   Claggett, Brian ^l   Jhund, Pardeep S ^a   Solomon, Scott D ^l   more..

^a UNIVERSITY OF GLASGOW   (United Kingdom)

^b NATIONAL UNIVERSITY OF SINGAPORE   (Singapore)

^c UNIVERSITY MEDICAL CENTER GRONINGEN   (Netherlands)

^d GEORGE INSTITUTE FOR GLOBAL HEALTH   (Australia)

^e MAYO CLINIC   (United States)

^f UNIVERSITY OF MINNESOTA   (United States)

^g Shanghai Institute of Cardiovascular Diseases   (China)

^h NOVARTIS PHARMA AG   (Switzerland)

ⁱ ANMCO RESEARCH CENTER   (Italy)

^j UNIVERSIDAD NACIONAL DE CÓRDOBA   (Argentina)

^k BAYLOR UNIVERSITY MEDICAL CENTER   (United States)

^l HARVARD MEDICAL SCHOOL   (United States)

^m DZHK GERMAN CENTRE FOR CARDIOVASCULAR RESEARCH   (Germany)

ⁿ NORTHWESTERN UNIVERSITY   (United States)

^o UNIVERSITÉ DE LORRAINE   (France)

^p MEDICAL UNIVERSITY OF SOUTH CAROLINA   (United States)

^q KBC Zagreb   (Croatia)

^r National Cardiovascular Institute   (Slovakia)

^s National Cardiology Hospital   (Bulgaria)

^t SEMMELWEIS UNIVERSITY   (Hungary)

^u MEDICAL UNIVERSITY OF LODZ   (Poland)

^v UNIVERSITY OF ARIZONA   (United States)

more..

Author keywords

heart failure; hospitalization; neprilysin; women

Indexed keywords

AMINOBUTYRIC ACID DERIVATIVE; ANGIOTENSIN RECEPTOR ANTAGONIST; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; SACUBITRIL-VALSARTAN; TETRAZOLE DERIVATIVE; VALSARTAN;

AGED; DRUG EFFECT; FEMALE; HEART FAILURE; HEART STROKE VOLUME; HUMAN; MALE; MIDDLE AGED; PATHOPHYSIOLOGY; SEX FACTOR; VERY ELDERLY;

AGED; AGED, 80 AND OVER; AMINOBUTYRATES; ANGIOTENSIN RECEPTOR ANTAGONISTS; ANGIOTENSIN-CONVERTING ENZYME INHIBITORS; FEMALE; HEART FAILURE; HUMANS; MALE; MIDDLE AGED; SEX FACTORS; STROKE VOLUME; TETRAZOLES; VALSARTAN;

EID: 85076138791     PISSN: 00097322     EISSN: 15244539     Source Type: Journal    
DOI: 10.1161/CIRCULATIONAHA.119.044491     Document Type: Article

References (44)

1. Dewan P, Rørth R, Jhund PS, Shen L, Raparelli V, Petrie MC, Abraham WT, Desai AS, Dickstein K, Køber L, et al. Differential impact of heart failure with reduced ejection fraction on men and women. J Am Coll Cardiol. 2019;73:29–40. doi: 10.1016/j.jacc.2018.09.081
2. Gori M, Lam CS, Gupta DK, Santos AB, Cheng S, Shah AM, Claggett B, Zile MR, Kraigher-Krainer E, Pieske B, et al; PARAMOUNT Investigators. Sex-specific cardiovascular structure and function in heart failure with preserved ejection fraction. Eur J Heart Fail. 2014;16:535–542. doi: 10.1002/ejhf.67
3. Stolfo D, Uijl A, Vedin O, Strömberg A, Faxén UL, Rosano GMC, Sinagra G, Dahlström U, Savarese G. Sex-based differences in heart failure across the ejection fraction spectrum: phenotyping, and prognostic and therapeutic implications. JACC Heart Fail. 2019;7:505–515. doi: 10.1016/j.jchf.2019.03.011
4. Beale AL, Nanayakkara S, Segan L, Mariani JA, Maeder MT, van Empel V, Vizi D, Evans S, Lam CSP, Kaye DM. Sex differences in heart failure with preserved ejection fraction pathophysiology: a detailed invasive hemodynamic and echocardiographic analysis. JACC Heart Fail. 2019;7:239–249. doi: 10.1016/j.jchf.2019.01.004
5. Beale AL, Meyer P, Marwick TH, Lam CSP, Kaye DM. Sex differences in cardiovascular pathophysiology: why women are overrepresented in heart failure with preserved ejection fraction. Circulation. 2018;138:198–205. doi: 10.1161/CIRCULATIONAHA.118.034271
6. Tibrewala A, Yancy CW. Heart failure with preserved ejection fraction in women. Heart Fail Clin. 2019;15:9–18. doi: 10.1016/j.hfc.2018.08.002
7. Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, González-Juanatey JR, Harjola VP, Jankowska EA, et al; ESC Scientific Document Group. 2016 ESC guidelines for the diagnosis and treatment of acute and chronic heart failure: the task force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC): developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016;37:2129–2200. doi: 10.1093/eurheartj/ehw128
8. Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Colvin MM, Drazner MH, Filippatos GS, Fonarow GC, Givertz MM, et al. 2017 ACC/ AHA/HFSA focused update of the 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology/ American Heart Association task force on clinical practice guidelines and the Heart Failure Society of America. Circulation. 2017;136:e137–e161. doi: 10.1161/CIR.0000000000000509
9. Solomon SD, Rizkala AR, Gong J, Wang W, Anand IS, Ge J, Lam CSP, Maggioni AP, Martinez F, Packer M, et al. Angiotensin receptor neprilysin inhibition in heart failure with preserved ejection fraction: rationale and design of the PARAGON-HF trial. JACC Heart Fail. 2017;5:471–482. doi: 10.1016/j.jchf.2017.04.013
10. Solomon SD, Rizkala AR, Lefkowitz MP, Shi VC, Gong J, Anavekar N, Anker SD, Arango JL, Arenas JL, Atar D, et al. Baseline characteristics of patients with heart failure and preserved ejection fraction in the PARAGON-HF trial. Circ Heart Fail. 2018;11:e004962. doi: 10.1161/CIRCHEARTFAILURE.118.004962
11. Solomon SD, McMurray JJV, Anand IS, Ge J, Lam CSP, Maggioni AP, Martinez F, Packer M, Pfeffer MA, Pieske B, et al; PARAGON-HF Investigators and Committees. Angiotensin-neprilysin inhibition in heart failure with preserved ejection fraction. N Engl J Med. 2019;381:1609–1620. doi: 10.1056/NEJMoa1908655
12. Green CP, Porter CB, Bresnahan DR, Spertus JA. Development and evaluation of the Kansas City Cardiomyopathy Questionnaire: a new health status measure for heart failure. J Am Coll Cardiol. 2000;35:1245–1255. doi: 10.1016/s0735-1097(00)00531-3
13. Claggett B, Pocock S, Wei LJ, Pfeffer MA, McMurray JJV, Solomon SD. Comparison of time-to-first event and recurrent-event methods in randomized clinical trials. Circulation. 2018;138:570–577. doi: 10.1161/CIRCULATIONAHA.117.033065
14. Wittes J. On looking at subgroups. Circulation. 2009;119:912–915. doi: 10.1161/CIRCULATIONAHA.108.836601
15. Yusuf S, Wittes J, Probstfield J, Tyroler HA. Analysis and interpretation of treatment effects in subgroups of patients in randomized clinical trials. JAMA. 1991;266:93–98. doi: 10.1001/jama.1991.03470010097038
16. Wang R, Lagakos SW, Ware JH, Hunter DJ, Drazen JM. Statistics in medicine: reporting of subgroup analyses in clinical trials. N Engl J Med. 2007;357:2189–2194. doi: 10.1056/NEJMsr077003
17. Sun X, Briel M, Busse JW, You JJ, Akl EA, Mejza F, Bala MM, Bassler D, Mertz D, Diaz-Granados N, et al. Credibility of claims of subgroup effects in randomised controlled trials: systematic review. BMJ. 2012;344:e1553. doi: 10.1136/bmj.e1553
18. Echocardiographic Normal Ranges Meta-Analysis of the Left Heart Collaboration. Ethnic-specific normative reference values for echocardiographic LA and LV size, LV mass, and systolic function: the EchoNoRMAL study. JACC Cardiovasc Imaging. 2015;8:656–665. doi: 10.1016/j.jcmg.2015.02.014
19. Kraigher-Krainer E, Shah AM, Gupta DK, Santos A, Claggett B, Pieske B, Zile MR, Voors AA, Lefkowitz MP, Packer M, et al; PARAMOUNT Investigators. Impaired systolic function by strain imaging in heart failure with preserved ejection fraction. J Am Coll Cardiol. 2014;63:447–456. doi: 10.1016/j.jacc.2013.09.052
20. Föll D, Jung B, Schilli E, Staehle F, Geibel A, Hennig J, Bode C, Markl M. Magnetic resonance tissue phase mapping of myocardial motion: new insight in age and gender. Circ Cardiovasc Imaging. 2010;3:54–64. doi: 10.1161/CIRCIMAGING.108.813857
21. Redfield MM, Jacobsen SJ, Borlaug BA, Rodeheffer RJ, Kass DA. Age- and gender-related ventricular-vascular stiffening: a community-based study. Circulation. 2005;112:2254–2262. doi: 10.1161/CIRCULATIONAHA. 105.541078
22. Chirinos JA. Arterial stiffness: basic concepts and measurement techniques. J Cardiovasc Transl Res. 2012;5:243–255. doi: 10.1007/s12265-012-9359-6
23. Lam CS, Cheng S, Choong K, Larson MG, Murabito JM, Newton-Cheh C, Bhasin S, McCabe EL, Miller KK, Redfield MM, et al. Influence of sex and hormone status on circulating natriuretic peptides. J Am Coll Cardiol. 2011;58:618–626. doi: 10.1016/j.jacc.2011.03.042
24. Clerico A, Passino C, Emdin M. When gonads talk to the heart sex hormones and cardiac endocrine function. J Am Coll Cardiol. 2011;58:627–628. doi: 10.1016/j.jacc.2011.03.043
25. Glisic M, Rojas LZ, Asllanaj E, Vargas KG, Kavousi M, Ikram MA, Fauser BCJM, Laven JSE, Muka T, Franco OH. Sex steroids, sex hormone-binding globulin and levels of N-terminal pro-brain natriuretic peptide in postmenopausal women. Int J Cardiol. 2018;261:189–195. doi: 10.1016/j.ijcard.2018.03.008
26. Ying W, Zhao D, Ouyang P, Subramanya V, Vaidya D, Ndumele CE, Sharma K, Shah SJ, Heckbert SR, Lima JA, et al. Sex hormones and change in N-terminal pro-B-type natriuretic peptide levels: the Multi-Ethnic Study of Atherosclerosis. J Clin Endocrinol Metab. 2018;103:4304–4314. doi: 10.1210/jc.2018-01437
27. Moreau KL, Hildreth KL. Vascular aging across the menopause transition in healthy women. Adv Vasc Med. 2014;pii:204390. doi: 10.1155/2014/204390
28. Novella S, Pérez-Cremades D, Mompeón A, Hermenegildo C. Mechanisms underlying the influence of oestrogen on cardiovascular physiology in women. J Physiol. 2019;597:4873–4886. doi: 10.1113/JP278063
29. Mannacio V, Di Tommaso L, Antignano A, De Amicis V, Stassano P, Pinna GB, Vosa C. Endothelial nitric oxide synthase expression in postmenopausal women: a sex-specific risk factor in coronary surgery. Ann Thorac Surg. 2012;94:1934–1939. doi: 10.1016/j.athoracsur.2012.06.040
30. Cui R, Iso H, Pi J, Kumagai Y, Yamagishi K, Tanigawa T, Shimamoto T. Relationship between urinary cGMP excretion and serum total cholesterol levels in a general population. Atherosclerosis. 2005;179:379–386. doi: 10.1016/j.atherosclerosis.2004.10.031
31. Salhotra S, Arora S, Anubhuti, Trivedi SS, Bhattacharjee J. Influence of menopause on biochemical markers of endothelial dysfunction: a case-control pilot study in North Indian population. Maturitas. 2009;62:166–170. doi: 10.1016/j.maturitas.2008.11.024
32. Kostis WJ, Shetty M, Chowdhury YS, Kostis JB. ACE inhibitor-induced angioedema: a review. Curr Hypertens Rep. 2018;20:55. doi: 10.1007/s11906-018-0859-x
33. Reddy YNV, Iyer SR, Scott CG, Rodeheffer RJ, Bailey K, Jenkins G, Batzler A, Redfield MM, Burnett JC Jr, Pereira NL. Soluble neprilysin in the general population: clinical determinants and its relationship to cardiovascular disease. J Am Heart Assoc. 2019;8:e012943. doi: 10.1161/JAHA.119.012943
34. Platz E, Jhund PS, Claggett BL, Pfeffer MA, Swedberg K, Granger CB, Yusuf S, Solomon SD, McMurray JJ. Prevalence and prognostic importance of precipitating factors leading to heart failure hospitalization: recurrent hospitalizations and mortality. Eur J Heart Fail. 2018;20:295–303. doi: 10.1002/ejhf.901
35. Fajardo J, Cummings A, Brown E, Cuomo K, Rhodes P, Woodbury S, Gilotra N, Russell S, Judge D. Clinical pathway to screen for cardiac amyloidosis in heart failure with preserved ejection fraction. Amyloid. 2019;26(suppl 1):166–167. doi: 10.1080/13506129.2019.1583178
36. Linde C, Cleland JGF, Gold MR, Claude Daubert J, Tang ASL, Young JB, Sherfesee L, Abraham WT. The interaction of sex, height, and QRS duration on the effects of cardiac resynchronization therapy on morbidity and mortality: an individual-patient data meta-analysis. Eur J Heart Fail. 2018;20:780–791. doi: 10.1002/ejhf.1133
37. Adams KF Jr, Patterson JH, Gattis WA, O’Connor CM, Lee CR, Schwartz TA, Gheorghiade M. Relationship of serum digoxin concentration to mortality and morbidity in women in the digitalis investigation group trial: a retrospective analysis. J Am Coll Cardiol. 2005;46:497–504. doi: 10.1016/j.jacc.2005.02.091
38. Solomon SD, Claggett B, Lewis EF, Desai A, Anand I, Sweitzer NK, O’Meara E, Shah SJ, McKinlay S, Fleg JL, et al; TOPCAT Investigators. Influence of ejection fraction on outcomes and efficacy of spironolactone in patients with heart failure with preserved ejection fraction. Eur Heart J. 2016;37:455–462. doi: 10.1093/eurheartj/ehv464
39. Young JB, Dunlap ME, Pfeffer MA, Probstfield JL, Cohen-Solal A, Dietz R, Granger CB, Hradec J, Kuch J, McKelvie RS, et al; Candesartan in Heart Failure Assessment of Reduction in Mortality and Morbidity (CHARM) Investigators and Committees. Mortality and morbidity reduction with candesartan in patients with chronic heart failure and left ventricular systolic dysfunction: results of the CHARM low-left ventricular ejection fraction trials. Circulation. 2004;110:2618–2626. doi: 10.1161/01.CIR.0000146819.43235.A9
40. McMurray JJ, Packer M, Desai AS, Gong J, Lefkowitz MP, Rizkala AR, Rouleau JL, Shi VC, Solomon SD, Swedberg K, et al; PARADIGM-HF Investigators and Committees. Angiotensin-neprilysin inhibition versus enalapril in heart failure. N Engl J Med. 2014;371:993–1004. doi: 10.1056/NEJMoa1409077
41. Hsich EM, Piña IL. Heart failure in women: a need for prospective data. J Am Coll Cardiol. 2009;54:491–498. doi: 10.1016/j.jacc. 2009.02.066
42. Rossello X, Ariti C, Pocock SJ, Ferreira JP, Girerd N, McMurray JJV, Van Veldhuisen DJ, Pitt B, Zannad F. Impact of mineralocorticoid receptor antagonists on the risk of sudden cardiac death in patients with heart failure and left-ventricular systolic dysfunction: an individual patient-level meta-analysis of three randomized-controlled trials. Clin Res Cardiol. 2019;108:477–486. doi: 10.1007/s00392-018-1378-0
43. Santema BT, Ouwerkerk W, Tromp J, Sama IE, Ravera A, Regitz-Zagrosek V, Hillege H, Samani NJ, Zannad F, Dickstein K, et al; ASIAN-HF investigators. Identifying optimal doses of heart failure medications in men compared with women: a prospective, observational, cohort study. Lancet. 2019;394:1254–1263. doi: 10.1016/S0140-6736(19)31792-1
44. Gan L, Langenickel T, Petruck J, Kode K, Rajman I, Chandra P, Zhou W, Rebello S, Sunkara G. Effects of age and sex on the pharmacokinetics of LCZ696, an angiotensin receptor neprilysin inhibitor. J Clin Pharmacol. 2016;56:78–86. doi: 10.1002/jcph.571