Angiotensin receptor neprilysin inhibition compared with enalapril on the risk of clinical progression in surviving patients with heart failure

Circulation

Volumn 131, Issue 1, 2015, Pages 54-61

  Packer, Milton ^a   McMurray, John J V ^b   Desai, Akshay S ^c   Gong, Jianjian ^d   Lefkowitz, Martin P ^d   Rizkala, Adel R ^d   Rouleau, Jean L ^e   Shi, Victor C ^d   Solomon, Scott D ^c   Swedberg, Karl ^f   Zile, Michael ^g   Andersen, Karl ^h   Arango, Juan Luis ⁱ   Arnold, J Malcolm ^j   Belohlávek, Jan ^k   Böhm, Michael ^l   Boytsov, Sergey ^m   Burgess, Lesley J ⁿ   Cabrera, Walter ^o   Calvo, Carlos ^p   Chen, Chen Huan ^q   Dukat, Andrej ^r   Duarte, Yan Carlos ^s   Erglis, Andrejs ^t   Fu, Michael ^u   Gomez, Efrain ^v   Gonzàlez Medina, Angel ^w   Hagège, Albert A ^x,y,z   Huang, Jun ^aa   Katova, Tzvetana ^ab   Kiatchoosakun, Songsak ^ac   Kim, Kee Sik ^ad   Kozan, Ömer ^ae   Llamas, Edmundo Bayram ^af   Martinez, Felipe ^ag   Merkely, Bela ^ah   Mendoza, Iván ^ai   Mosterd, Arend ^aj   Negrusz Kawecka, Marta ^ak   Peuhkurinen, Keijo ^al   Ramires, Felix J A ^am   Refsgaard, Jens ^an   Rosenthal, Arvo ^ao   Senni, Michele ^ap   Sibulo, Antonio S ^aq   Silva Cardoso, José ^ar   Squire, Iain B ^as   Starling, Randall C ^at   Teerlink, John R ^au   Vanhaecke, Johan ^av   Vinereanu, Dragos ^aw   Wong, Raymond Ching Chiew ^ax   more..

^a UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER   (United States)

^b UNIVERSITY OF GLASGOW   (United Kingdom)

^c BRIGHAM AND WOMEN S HOSPITAL   (United States)

^d NOVARTIS PHARMA AG   (Switzerland)

^e MONTREAL HEART INSTITUTE   (Canada)

^f Clinical Medicine   (Sweden)

^g MEDICAL UNIVERSITY OF SOUTH CAROLINA   (United States)

^h UNIVERSITY OF ICELAND   (Iceland)

ⁱ Unidad de Cirugia Cardiovascular de Guatemala   (Guatemala)

^j UNIVERSITY OF WESTERN ONTARIO   (Canada)

^k CHARLES UNIVERSITY   (Czech Republic)

^l SAARLAND UNIVERSITY   (Germany)

^m NATIONAL MEDICAL RESEARCH CENTER FOR THERAPY AND PREVENTIVE MEDICINE   (Russian Federation)

ⁿ STELLENBOSCH UNIVERSITY   (South Africa)

^o Clinica Vesalio   (Peru)

^p Instituto de Salud Carlos III   (Spain)

^q NATIONAL YANG MING UNIVERSITY   (Taiwan)

^r Physics and Informatics   (Slovakia)

^s HOSPITAL LUIS VERNAZA   (Ecuador)

^t UNIVERSITY OF LATVIA   (Latvia)

^u SAHLGRENSKA UNIVERSITY HOSPITAL   (Sweden)

^v Division of Cardiovascular Surgery   (Colombia)

^w Universidad Autónoma de Santo Domingo   (Dominican Republic)

^x HÔPITAL EUROPÉEN GEORGES POMPIDOU   (France)

^y UNIVERSITÉ PARIS DESCARTES   (France)

^z PARIS CARDIOVASCULAR RESEARCH CENTER   (France)

^aa NANJING MEDICAL UNIVERSITY   (China)

^ab National Cardiology Hospital   (Bulgaria)

^ac KHON KAEN UNIVERSITY   (Thailand)

^ad Catholic University of Daegu   (South Korea)

^ae DOKUZ EYLUL UNIVERSITY   (Turkey)

^af Fundación Cardiovascular de Aguascalientes A C   (Mexico)

^ag UNIVERSIDAD NACIONAL DE CÓRDOBA   (Argentina)

^ah SEMMELWEIS UNIVERSITY   (Hungary)

^ai UNIVERSIDAD CENTRAL DE VENEZUELA   (Venezuela)

^aj MEANDER MEDICAL CENTER   (Netherlands)

^ak WROCLAW MEDICAL UNIVERSITY   (Poland)

^al KUOPIO UNIVERSITY HOSPITAL   (Finland)

^am UNIVERSITY OF SÃO PAULO   (Brazil)

^an VIBORG HOSPITAL   (Denmark)

^ao Dr Arvo Rosenthal LLC   (Estonia)

^ap Azienda Ospedaliera Papa Giovanni XXIII   (Italy)

^aq St LukesHeart Institute   (Philippines)

^ar UNIVERSITY OF PORTO   (Portugal)

^as UNIVERSITY OF LEICESTER   (United Kingdom)

^at LERNER RESEARCH INSTITUTE   (United States)

^au UNIVERSITY OF CALIFORNIA   (United States)

^av UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^aw CAROL DAVILA UNIVERSITY OF MEDICINE AND PHARMACY   (Romania)

^ax NATIONAL UNIVERSITY HEALTH SYSTEM   (Singapore)

more..

Author keywords

Angiotensin; Heart failure; Neprilysin; Receptors

Indexed keywords

3 (1 BIPHENYL 4 YLMETHYL 3 ETHOXYCARBONYL 1 BUTYLCARBAMOYL)PROPIONIC ACID PLUS VALSARTAN; BRAIN NATRIURETIC PEPTIDE; CYCLIC GMP; ENALAPRIL; INOTROPIC AGENT; MEMBRANE METALLOENDOPEPTIDASE; 3-(1-BIPHENYL-4-YLMETHYL-3-ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONATE-3'-METHYL-2'-(PENTANOYL(2'-(TETRAZOL-5-YLATE)BIPHENYL-4'-YLMETHYL)AMINO)BUTYRATE; AMINOBUTYRIC ACID DERIVATIVE; ANGIOTENSIN RECEPTOR ANTAGONIST; BIOLOGICAL MARKER; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; PEPTIDE FRAGMENT; PRO-BRAIN NATRIURETIC PEPTIDE (1-76); TETRAZOLE DERIVATIVE; TROPONIN;

ARTICLE; CARDIOVASCULAR THERAPEUTIC DEVICE; DISEASE COURSE; DOUBLE BLIND PROCEDURE; ENZYME INHIBITION; HEART EJECTION FRACTION; HEART FAILURE; HEART TRANSPLANTATION; HOSPITALIZATION; HUMAN; INTENSIVE CARE; MAJOR CLINICAL STUDY; PRIORITY JOURNAL; RISK REDUCTION; SINGLE BLIND PROCEDURE; ANTAGONISTS AND INHIBITORS; BLOOD; CONTROLLED STUDY; HEART STROKE VOLUME; KAPLAN MEIER METHOD; PATHOPHYSIOLOGY; PHYSIOLOGY; RANDOMIZED CONTROLLED TRIAL; RISK FACTOR; SURVIVOR; TREATMENT OUTCOME;

AMINOBUTYRATES; ANGIOTENSIN RECEPTOR ANTAGONISTS; ANGIOTENSIN-CONVERTING ENZYME INHIBITORS; BIOLOGICAL MARKERS; DISEASE PROGRESSION; DOUBLE-BLIND METHOD; ENALAPRIL; HEART FAILURE; HUMANS; KAPLAN-MEIER ESTIMATE; NATRIURETIC PEPTIDE, BRAIN; NEPRILYSIN; PEPTIDE FRAGMENTS; RISK FACTORS; STROKE VOLUME; SURVIVORS; TETRAZOLES; TREATMENT OUTCOME; TROPONIN;

EID: 84924243546     PISSN: 00097322     EISSN: 15244539     Source Type: Journal    
DOI: 10.1161/CIRCULATIONAHA.114.013748     Document Type: Article

References (42)

1. Butler J, Braunwald E, Gheorghiade M. Recognizing worsening chronic heart failure as an entity and an end point in clinical trials. JAMA. 2014;312:789-790.
2. Cleland JG. How to assess new treatments for the management of heart failure: composite scoring systems to assess the patients' clinical journey. Eur J Heart Fail. 2002;4:243-247.
3. Packer M. Evolution of the neurohormonal hypothesis to explain the progression of chronic heart failure. Eur Heart J. 1995;16(suppl F):4-6.
4. Krum H, Shi H, Pitt B, McMurray J, Swedberg K, van Veldhuisen DJ, Vincent J, Pocock S, Zannad F; EMPHASIS-HF Study Group. Clinical benefit of eplerenone in patients with mild symptoms of systolic heart failure already receiving optimal best practice background drug therapy: Analysis of the EMPHASIS-HF study. Circ Heart Fail. 2013;6:711-718.
5. Tsutamoto T, Kanamori T, Morigami N, Sugimoto Y, Yamaoka O, Kinoshita M. Possibility of downregulation of atrial natriuretic peptide receptor coupled to guanylate cyclase in peripheral vascular beds of patients with chronic severe heart failure. Circulation. 1993;87:70-75.
6. Cugno M, Agostoni P, Mari D, Meroni PL, Gregorini L, Bussotti M, Anguissola GB, Donatelli F, Nussberger J. Impaired bradykinin response to ischaemia and exercise in patients with mild congestive heart failure during angiotensin-converting enzyme treatment. Relationships with endothelial function, coagulation and inflammation. Br J Haematol. 2005;130:113-120.
7. Jougasaki M, Heublein DM, Sandberg SM, Burnett JC Jr. Attenuated natriuretic response to adrenomedullin in experimental heart failure. J Card Fail. 2001;7:75-83.
8. Cataliotti A, Tonne JM, Bellavia D, Martin FL, Oehler EA, Harders GE, Campbell JM, Peng KW, Russell SJ, Malatino LS, Burnett JC Jr, Ikeda Y. Long-term cardiac pro-B-type natriuretic peptide gene delivery prevents the development of hypertensive heart disease in spontaneously hypertensive rats. Circulation. 2011;123:1297-1305.
9. Tonduangu D, Hittinger L, Ghaleh B, Le Corvoisier P, Sambin L, Champagne S, Badoual T, Vincent F, Berdeaux A, Crozatier B, Su JB. Chronic infusion of bradykinin delays the progression of heart failure and preserves vascular endothelium-mediated vasodilation in conscious dogs. Circulation. 2004;109:114-119.
10. Nakamura R, Kato J, Kitamura K, Onitsuka H, Imamura T, Cao Y, Marutsuka K, Asada Y, Kangawa K, Eto T. Adrenomedullin administration immediately after myocardial infarction ameliorates progression of heart failure in rats. Circulation. 2004;110:426-431.
11. Knecht M, Pagel I, Langenickel T, Philipp S, Scheuermann-Freestone M, Willnow T, Bruemmer D, Graf K, Dietz R, Willenbrock R. Increased expression of renal neutral endopeptidase in severe heart failure. Life Sci. 2002;71:2701-2712.
12. McMurray JJ, Packer M, Desai AS, Gong J, Lefkowitz MP, Rizkala AR, Rouleau JL, Shi VC, Solomon SD, Swedberg K, Zile MR; PARADIGM-HF Investigators and Committees. Angiotensin-neprilysin inhibition versus enalapril in heart failure. N Engl J Med. 2014;371:993-1004.
13. Margulies KB, Perrella MA, McKinley LJ, Burnett JC Jr. Angiotensin inhibition potentiates the renal responses to neutral endopeptidase inhibition in dogs with congestive heart failure. J Clin Invest. 1991;88:1636-1642.
14. Shaltout HA, Westwood BM, Averill DB, Ferrario CM, Figueroa JP, Diz DI, Rose JC, Chappell MC. Angiotensin metabolism in renal proximal tubules, urine, and serum of sheep: evidence for ACE2-dependent processing of angiotensin II. Am J Physiol Renal Physiol. 2007;292:F82-F91.
15. Kostis JB, Packer M, Black HR, Schmieder R, Henry D, Levy E. Omapatrilat and enalapril in patients with hypertension: The Omapatrilat Cardiovascular Treatment vs. Enalapril (OCTAVE) trial. Am J Hypertens. 2004;17:103-111.
16. Packer M, Califf RM, Konstam MA, Krum H, McMurray JJ, Rouleau JL, Swedberg K. Comparison of omapatrilat and enalapril in patients with chronic heart failure: The Omapatrilat Versus Enalapril Randomized Trial of Utility in Reducing Events (OVERTURE). Circulation. 2002;106:920-926.
17. Hegde LG, Yu C, Renner T, Thibodeaux H, Armstrong SR, Park T, Cheruvu M, Olsufka R, Sandvik ER, Lane CE, Budman J, Hill CM, Klein U, Hegde SS. Concomitant angiotensin AT1 receptor antagonism and neprilysin inhibition produces omapatrilat-like antihypertensive effects without promoting tracheal plasma extravasation in the rat. J Cardiovasc Pharmacol. 2011;57:495-504.
18. McMurray JJ, Packer M, Desai AS, Gong J, Lefkowitz MP, Rizkala AR, Rouleau J, Shi VC, Solomon SD, Swedberg K, Zile MR; PARADIGM-HF Committees and Investigators. Dual angiotensin receptor and neprilysin inhibition as an alternative to angiotensin-converting enzyme inhibition in patients with chronic systolic heart failure: rationale for and design of the Prospective comparison of ARNI with ACEI to Determine Impact on Global Mortality and morbidity in Heart Failure trial (PARADIGM-HF). Eur J Heart Fail. 2013;15:1062-1073.
19. The SOLVD Investigators. Effect of Enal April on survival in patients with reduced left ventricular ejection fractions and congestive heart failure. N Engl J Med. 1991;325:293-302.
20. CONSENSUS Trial Study Group. Effects of enalapril on mortality in severe congestive heart failure. Results of the Cooperative North Scandinavian Enalapril Survival Study (CONSENSUS). N Engl J Med. 1987;316:1429-1435.
21. Nanas JN, Alexopoulos G, Anastasiou-Nana MI, Karidis K, Tirologos A, Zobolos S, Pirgakis V, Anthopoulos L, Sideris D, Stamatelopoulos SF, Moulopoulos SD. Outcome of patients with congestive heart failure treated with standard versus high doses of enalapril: A multicenter study. High Enalapril Dose Study Group. J Am Coll Cardiol. 2000;36:2090-2095.
22. The NETWORK Investigators. Clinical outcome with enalapril in symptomatic chronic heart failure; a dose comparison. Eur Heart J. 1998;19:481-489.
23. Spertus J, Peterson E, Conard MW, Heidenreich PA, Krumholz HM, Jones P, McCullough PA, Pina I, Tooley J, Weintraub WS, Rumsfeld JS; Cardiovascular Outcomes Research Consortium. Monitoring clinical changes in patients with heart failure: A comparison of methods. Am Heart J. 2005;150:707-715.
24. Hilbe JM. Negative Binomial Regression. Cambridge, UK: Cambridge University Press; 2007.
25. Lawless JF, Nadeau JC. Nonparametric estimation of cumulative mean functions for recurrent events. Technometrics. 1995;37:158-168.
26. Wei LJ, Glidden DV. An overview of statistical methods for multiple failure time data in clinical trials. Stat Med. 1997;16:833-839.
27. Kleber FX, Niemöller L, Doering W. Impact of converting enzyme inhibition on progression of chronic heart failure: results of the Munich Mild Heart Failure Trial. Br Heart J. 1992;67:289-296.
28. Brown EJ Jr, Chew PH, MacLean A, Gelperin K, Ilgenfritz JP, Blumenthal M. Effects of fosinopril on exercise tolerance and clinical deterioration in patients with chronic congestive heart failure not taking digitalis. Fosinopril Heart Failure Study Group. Am J Cardiol. 1995;75:596-600.
29. Hjalmarson A, Goldstein S, Fagerberg B, Wedel H, Waagstein F, Kjekshus J, Wikstrand J, El Allaf D, Vítovec J, Aldershvile J, Halinen M, Dietz R, Neuhaus KL, Jánosi A, Thorgeirsson G, Dunselman PH, Gullestad L, Kuch J, Herlitz J, Rickenbacher P, Ball S, Gottlieb S, Deedwania P. Effects of controlled-release metoprolol on total mortality, hospitalizations, and well-being in patients with heart failure: The Metoprolol CR/XL Randomized Intervention Trial in congestive heart failure (MERIT-HF). MERIT-HF Study Group. JAMA. 2000;283:1295-1302.
30. Rogers JK, McMurray JJ, Pocock SJ, Zannad F, Krum H, van Veldhuisen DJ, Swedberg K, Shi H, Vincent J, Pitt B. Eplerenone in patients with systolic heart failure and mild symptoms: Analysis of repeat hospitalizations. Circulation. 2012;126:2317-2323.
31. Rogers WJ, Johnstone DE, Yusuf S, Weiner DH, Gallagher P, Bittner VA, Ahn S, Schron E, Shumaker SA, Sheffield LT. Quality of life among 5, 025 patients with left ventricular dysfunction randomized between placebo and enal April: The studies of left ventricular dysfunction. J Am Coll Cardiol. 1994;23:393-400.
32. O'Meara E, Solomon S, McMurray J, Pfeffer M, Yusuf S, Michelson E, Granger C, Olofsson B, Young JB, Swedberg K. Effect of candesartan on New York Heart Association functional class. Results of the Candesartan in Heart failure: Assessment of Reduction in Mortality and morbidity (CHARM) programme. Eur Heart J. 2004;25:1920-1926.
33. Pitt B, Zannad F, Remme WJ, Cody R, Castaigne A, Perez A, Palensky J, Wittes J. The effect of spironolactone on morbidity and mortality in patients with severe heart failure. Randomized Aldactone Evaluation Study Investigators. N Engl J Med. 1999;341:709-717.
34. Charles CJ, Espiner EA, Nicholls MG, Richards AM, Yandle TG, Protter A, Kosoglou T. Clearance receptors and endopeptidase 24.11: equal role in natriuretic peptide metabolism in conscious sheep. Am J Physiol. 1996;271:R373-R380.
35. Rosenkranz AC, Hood SG, Woods RL, Dusting GJ, Ritchie RH. B-type natriuretic peptide prevents acute hypertrophic responses in the diabetic rat heart: Importance of cyclic GMP. Diabetes. 2003;52:2389-2395.
36. Hamid SA, Totzeck M, Drexhage C, Thompson I, Fowkes RC, Rassaf T, Baxter GF. Nitric oxide/cGMP signalling mediates the cardioprotective action of adrenomedullin in reperfused myocardium. Basic Res Cardiol. 2010;105:257-266.
37. Pham I, Gonzalez W, Doucet J, Fournie-Zaluski MC, Roques BP, Michel JB. Effects of angiotensin-converting enzyme and neutral endopeptidase inhibitors: Influence of bradykinin. Eur J Pharmacol. 1996;296:267-276.
38. Alehagen U, Svensson E, Dahlström U. Natriuretic peptide biomarkers as information indicators in elderly patients with possible heart failure followed over six years: A head-to-head comparison of four cardiac natriuretic peptides. J Card Fail. 2007;13:452-461.
39. Solomon SD, Zile M, Pieske B, Voors A, Shah A, Kraigher-Krainer E, Shi V, Bransford T, Takeuchi M, Gong J, Lefkowitz M, Packer M, McMurray JJ; Prospective comparison of ARNI with ARB on Management Of heart failUre with preserved ejectioN fracTion (PARAMOUNT) Investigators. The angiotensin receptor neprilysin inhibitor LCZ696 in heart failure with preserved ejection fraction: A phase 2 double-blind randomised controlled trial. Lancet. 2012;380:1387-1395.
40. Fertin M, Hennache B, Hamon M, Ennezat PV, Biausque F, Elkohen M, Nugue O, Tricot O, Lamblin N, Pinet F, Bauters C. Usefulness of serial assessment of B-type natriuretic peptide, troponin I, and C-reactive protein to predict left ventricular remodeling after acute myocardial infarction (from the REVE-2 study). Am J Cardiol. 2010;106:1410-1416.
41. Jungbauer CG, Riedlinger J, Buchner S, Birner C, Resch M, Lubnow M, Debl K, Buesing M, Huedig H, Riegger G, Luchner A. Highsensitive troponin T in chronic heart failure correlates with severity of symptoms, left ventricular dysfunction and prognosis independently from N-terminal pro-B-type natriuretic peptide. Clin Chem Lab Med. 2011;49:1899-1906.
42. Masson S, Anand I, Favero C, Barlera S, Vago T, Bertocchi F, Maggioni AP, Tavazzi L, Tognoni G, Cohn JN, Latini R; Valsartan Heart Failure Trial (Val-HeFT) and Gruppo Italiano per lo Studio della Sopravvivenza nell'Insufficienza Cardiaca-Heart Failure (GISSI-HF) Investigators. Serial measurement of cardiac troponin T using a highly sensitive assay in patients with chronic heart failure: Data from 2 large randomized clinical trials. Circulation. 2012;125:280-288.