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1. Angiotensin Receptor Neprilysin Inhibition Compared With Enalapril on the Risk of Clinical Progression in Surviving Patients With Heart Failure

Author

Packer, M, Mcmurray, J, Desai, A, Gong, J, Lefkowitz, M, Rizkala, A, Rouleau, J, Shi, V, Solomon, S, Swedberg, K, Zile, M, Andersen, K, Arango, J, Arnold, J, Belohlavek, J, Bohm, M, Boytsov, S, Burgess, L, Cabrera, W, Calvo, C, Chen, C, Dukat, A, Duarte, Y, Erglis, A, Fu, M, Gomez, E, Gonzalez-Medina, A, Hagege, A, Huang, J, Katova, T, Kiatchoosakun, S, Kim, K, Kozan, O, Llamas, E, Martinez, F, Merkely, B, Mendoza, I, Mosterd, A, Negrusz-Kawecka, M, Peuhkurinen, K, Ramires, F, Refsgaard, J, Rosenthal, A, Senni, M, Jr, A, Silva-Cardoso, J, Squire, I, Starling, R, Teerlink, J, Vanhaecke, J, Vinereanu, D, Wong, R, Packer M, McMurray JJV, Desai AS, Gong J, Lefkowitz MP, Rizkala AR, Rouleau JL, Shi VC, Solomon SD, Swedberg K, Zile M, Andersen K, Arango JL, Arnold JM, Belohlavek J, Bohm M, Boytsov S, Burgess LJ, Cabrera W, Calvo C, Chen CH, Dukat A, Duarte YC, Erglis A, Fu M, Gomez E, Gonzalez-Medina A, Hagege AA, Huang J, Katova T, Kiatchoosakun S, Kim KS, Kozan O, Llamas EB, Martinez F, Merkely B, Mendoza I, Mosterd A, Negrusz-Kawecka M, Peuhkurinen K, Ramires FJA, Refsgaard J, Rosenthal A, Senni M, Jr ASS, Silva-Cardoso J, Squire IB, Starling RC, Teerlink JR, Vanhaecke J, Vinereanu D, Wong RCC, Packer, M, Mcmurray, J, Desai, A, Gong, J, Lefkowitz, M, Rizkala, A, Rouleau, J, Shi, V, Solomon, S, Swedberg, K, Zile, M, Andersen, K, Arango, J, Arnold, J, Belohlavek, J, Bohm, M, Boytsov, S, Burgess, L, Cabrera, W, Calvo, C, Chen, C, Dukat, A, Duarte, Y, Erglis, A, Fu, M, Gomez, E, Gonzalez-Medina, A, Hagege, A, Huang, J, Katova, T, Kiatchoosakun, S, Kim, K, Kozan, O, Llamas, E, Martinez, F, Merkely, B, Mendoza, I, Mosterd, A, Negrusz-Kawecka, M, Peuhkurinen, K, Ramires, F, Refsgaard, J, Rosenthal, A, Senni, M, Jr, A, Silva-Cardoso, J, Squire, I, Starling, R, Teerlink, J, Vanhaecke, J, Vinereanu, D, Wong, R, Packer M, McMurray JJV, Desai AS, Gong J, Lefkowitz MP, Rizkala AR, Rouleau JL, Shi VC, Solomon SD, Swedberg K, Zile M, Andersen K, Arango JL, Arnold JM, Belohlavek J, Bohm M, Boytsov S, Burgess LJ, Cabrera W, Calvo C, Chen CH, Dukat A, Duarte YC, Erglis A, Fu M, Gomez E, Gonzalez-Medina A, Hagege AA, Huang J, Katova T, Kiatchoosakun S, Kim KS, Kozan O, Llamas EB, Martinez F, Merkely B, Mendoza I, Mosterd A, Negrusz-Kawecka M, Peuhkurinen K, Ramires FJA, Refsgaard J, Rosenthal A, Senni M, Jr ASS, Silva-Cardoso J, Squire IB, Starling RC, Teerlink JR, Vanhaecke J, Vinereanu D, and Wong RCC

Abstract

Background-Clinical trials in heart failure have focused on the improvement in symptoms or decreases in the risk of death and other cardiovascular events. Little is known about the effect of drugs on the risk of clinical deterioration in surviving patients. Methods and Results-We compared the angiotensin-neprilysin inhibitor LCZ696 (400 mg daily) with the angiotensinconverting enzyme inhibitor enalapril (20 mg daily) in 8399 patients with heart failure and reduced ejection fraction in a double-blind trial. The analyses focused on prespecified measures of nonfatal clinical deterioration. In comparison with the enalapril group, fewer LCZ696-treated patients required intensification of medical treatment for heart failure (520 versus 604; hazard ratio, 0.84; 95% confidence interval, 0.74-0.94; P=0.003) or an emergency department visit for worsening heart failure (hazard ratio, 0.66; 95% confidence interval, 0.52-0.85; P=0.001). The patients in the LCZ696 group had 23% fewer hospitalizations for worsening heart failure (851 versus 1079; P<0.001) and were less likely to require intensive care (768 versus 879; 18% rate reduction, P=0.005), to receive intravenous positive inotropic agents (31% risk reduction, P<0.001), and to have implantation of a heart failure device or cardiac transplantation (22% risk reduction, P=0.07). The reduction in heart failure hospitalization with LCZ696 was evident within the first 30 days after randomization. Worsening of symptom scores in surviving patients was consistently more common in the enalapril group. LCZ696 led to an early and sustained reduction in biomarkers of myocardial wall stress and injury (N-terminal pro-Btype natriuretic peptide and troponin) versus enalapril. Conclusions-Angiotensin-neprilysin inhibition prevents the clinical progression of surviving patients with heart failure more effectively than angiotensin-converting enzyme inhibition.

Published
2015

2. A putative placebo analysis of the effects of LCZ696 on clinical outcomes in heart failure

Author

Mcmurray, J, Packer, M, Desai, A, Gong, J, Greenlaw, N, Lefkowitz, M, Rizkala, A, Shi, V, Rouleau, J, Solomon, S, Swedberg, K, Zile, M, Andersen, K, Arango, J, Arnold, M, Belohlavek, J, Bohm, M, Boytsov, S, Burgess, L, Cabrera, W, Chen, C, Erglis, A, Fu, M, Gomez, E, Gonzalez, A, Hagege, A, Katova, T, Kiatchoosakun, S, Kim, K, Bayram, E, Martinez, F, Merkely, B, Mendoza, I, Mosterd, A, Negrusz-Kawecka, M, Peuhkurinen, K, Ramires, F, Refsgaard, J, Senni, M, Sibulo, A, Silva-Cardoso, J, Squire, I, Starling, R, Vinereanu, D, Teerlink, J, Wong, R, McMurray J, Packer M, Desai A, Gong JJ, Greenlaw N, Lefkowitz M, Rizkala A, Shi V, Rouleau J, Solomon S, Swedberg K, Zile MR, Andersen K, Arango JL, Arnold M, Belohlavek J, Bohm M, Boytsov S, Burgess L, Cabrera W, Chen CH, Erglis A, Fu M, Gomez E, Gonzalez A, Hagege AA, Katova T, Kiatchoosakun S, Kim KS, Bayram E, Martinez F, Merkely B, Mendoza I, Mosterd A, Negrusz-Kawecka M, Peuhkurinen K, Ramires F, Refsgaard J, Senni M, Sibulo AS, Silva-Cardoso J, Squire I, Starling RC, Vinereanu D, Teerlink JR, Wong R, Mcmurray, J, Packer, M, Desai, A, Gong, J, Greenlaw, N, Lefkowitz, M, Rizkala, A, Shi, V, Rouleau, J, Solomon, S, Swedberg, K, Zile, M, Andersen, K, Arango, J, Arnold, M, Belohlavek, J, Bohm, M, Boytsov, S, Burgess, L, Cabrera, W, Chen, C, Erglis, A, Fu, M, Gomez, E, Gonzalez, A, Hagege, A, Katova, T, Kiatchoosakun, S, Kim, K, Bayram, E, Martinez, F, Merkely, B, Mendoza, I, Mosterd, A, Negrusz-Kawecka, M, Peuhkurinen, K, Ramires, F, Refsgaard, J, Senni, M, Sibulo, A, Silva-Cardoso, J, Squire, I, Starling, R, Vinereanu, D, Teerlink, J, Wong, R, McMurray J, Packer M, Desai A, Gong JJ, Greenlaw N, Lefkowitz M, Rizkala A, Shi V, Rouleau J, Solomon S, Swedberg K, Zile MR, Andersen K, Arango JL, Arnold M, Belohlavek J, Bohm M, Boytsov S, Burgess L, Cabrera W, Chen CH, Erglis A, Fu M, Gomez E, Gonzalez A, Hagege AA, Katova T, Kiatchoosakun S, Kim KS, Bayram E, Martinez F, Merkely B, Mendoza I, Mosterd A, Negrusz-Kawecka M, Peuhkurinen K, Ramires F, Refsgaard J, Senni M, Sibulo AS, Silva-Cardoso J, Squire I, Starling RC, Vinereanu D, Teerlink JR, and Wong R

Abstract

Aims Although active-controlled trials with renin-angiotensin inhibitors are ethically mandated in heart failure with reduced ejection fraction, clinicians and regulators often want to know how the experimental therapy would perform compared with placebo. The angiotensin receptor-neprilysin inhibitor LCZ696 was compared with enalapril in PARADIGM-HF. We made indirect comparisons of the effects of LCZ696 with putative placebos. Methods and results We used the treatment-armof the Studies OfLeftVentricularDysfunction(SOLVD-T) as the reference trial for comparison of an ACE inhibitor to placebo and the Candesartan in Heart failure: Assessment of Reduction in Mortality and morbidity-Alternative trial (CHARM-Alternative) as the reference trial for comparison of an ARB to placebo. The hazard ratio of LCZ696vs. aputativeplacebowasestimatedthroughtheproductof the hazardratioofLCZ696vs. enalapril (active-control) and that of the historical active-control (enalapril or candesartan) vs. placebo. For the primary composite outcome of cardiovascular death or heart failure hospitalization in PARADIGM-HF, the relative risk reduction with LCZ696 vs. a putative placebo from SOLVD-T was 43% (95%CI 34-50%; P< 0.0001) with similarly large effects on cardiovascular death (34%, 21-44%; P< 0.0001) and heart failure hospitalization (49%, 39-58%; P< 0.0001). For all-cause mortality, the reduction comparedwith a putative placebowas 28% (95%CI 15-39%; P< 0.0001). Putative placebo analyses based onCHARM-Alternative gave relative risk reductions of 39% (95%CI 27-48%; P< 0.0001) for the composite outcome of cardiovascular death or heart failure hospitalization, 32% (95%CI 16-45%; P< 0.0001) for cardiovascular death, 46% (33-56%; P< 0.0001) for heart failure hospitalization, and 26% (95%CI 11-39%; P< 0.0001) for all-cause mortality. Conclusion These indirect comparisons of LCZ696 with a putative placebo show that the strategy of combined angiotensin receptor blockade and nep

Published
2015

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