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Start Over Author "Rouleau, J.L." Topic heart failure
2 results on '"Rouleau, J.L."'

1. Effect of Nesiritide in Patients with Acute Decompensated Heart Failure.

Author

O'Connor, C.M., Starling, R.C., Hernandez, A.F., Armstrong, P.W., Dickstein, K., Hasselblad, V., Heizer, G.M., Komajda, M., Massie, B.M., McMurray, J.J.V., Nieminen, M.S., Reist, C.J., Rouleau, J.L., Swedberg, K., Adams, K.F., Anker, S.D., Atar, D., Battler, A., Botero, R., and Bohidar, N.R.

Subjects
*HEART failure, *TREATMENT of dyspnea, *META-analysis, *NEPHROTOXICOLOGY, *MORTALITY
Abstract

Background: Nesiritide is approved in the United States for early relief of dyspnea in patients with acute heart failure. Previous meta-analyses have raised questions regarding renal toxicity and the mortality associated with this agent. Methods: We randomly assigned 7141 patients who were hospitalized with acute heart failure to receive either nesiritide or placebo for 24 to 168 hours in addition to standard care. Coprimary end points were the change in dyspnea at 6 and 24 hours, as measured on a 7-point Likert scale, and the composite end point of rehospitalization for heart failure or death within 30 days. Results: Patients randomly assigned to nesiritide, as compared with those assigned to placebo, more frequently reported markedly or moderately improved dyspnea at 6 hours (44.5% vs. 42.1%, P=0.03) and 24 hours (68.2% vs. 66.1%, P=0.007), but the prespecified level for significance (P≤0.005 for both assessments or P≤0.0025 for either) was not met. The rate of rehospitalization for heart failure or death from any cause within 30 days was 9.4% in the nesiritide group versus 10.1% in the placebo group (absolute difference, −0.7 percentage points; 95% confidence interval [CI], −2.1 to 0.7; P=0.31). There were no significant differences in rates of death from any cause at 30 days (3.6% with nesiritide vs. 4.0% with placebo; absolute difference, −0.4 percentage points; 95% CI, −1.3 to 0.5) or rates of worsening renal function, defined by more than a 25% decrease in the estimated glomerular filtration rate (31.4% vs. 29.5%; odds ratio, 1.09; 95% CI, 0.98 to 1.21; P=0.11). Conclusions: Nesiritide was not associated with an increase or a decrease in the rate of death and rehospitalization and had a small, nonsignificant effect on dyspnea when used in combination with other therapies. It was not associated with a worsening of renal function, but it was associated with an increase in rates of hypotension. On the basis of these results, nesiritide cannot be recommended for routine use in the broad population of patients with acute heart failure. (Funded by Scios; ClinicalTrials.gov number, NCT00475852.) [ABSTRACT FROM PUBLISHER]

Published
2011
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2. Angiotensin–Neprilysin Inhibition in Heart Failure with Preserved Ejection Fraction

Author

Hans-Dirk Düngen, Margaret M. Redfield, Jean L. Rouleau, Brian Claggett, Faiez Zannad, Aldo P. Maggioni, Junbo Ge, Eva Goncalvesova, Marc A. Pfeffer, Béla Merkely, Inder S. Anand, Jianjian Gong, Sergey Boytsov, Felipe Martinez, José Francisco Kerr Saraiva, Victor Shi, Małgorzata Lelonek, Milton Packer, Martin Lefkowitz, Dirk J. van Veldhuisen, Adel R. Rizkala, Scott D. Solomon, Burkert Pieske, John G.F. Cleland, Akshay S. Desai, Michael R. Zile, Michele Senni, Jingmin Zhou, Sanjiv J. Shah, Tzvetana Katova, Pardeep S. Jhund, Carolyn S.P. Lam, Josep Comín-Colet, John J.V. McMurray, Solomon, S, Mcmurray, J, Anand, I, Ge, J, Lam, C, Maggioni, A, Martinez, F, Packer, M, Pfeffer, M, Pieske, B, Redfield, M, Rouleau, J, van Veldhuisen, D, Zannad, F, Zile, M, Desai, A, Claggett, B, Jhund, P, Boytsov, S, Comin-Colet, J, Cleland, J, Düngen, H, Goncalvesova, E, Katova, T, Kerr Saraiva, J, Lelonek, M, Merkely, B, Senni, M, Shah, S, Zhou, J, Rizkala, A, Gong, J, Shi, V, Lefkowitz, M, PARAGON-HF Investigators and, C, Cardiovascular Centre (CVC), Solomon S.D., McMurray J.J.V., Anand I.S., Ge J., Lam C.S.P., Maggioni A.P., Martinez F., Packer M., Pfeffer M.A., Pieske B., Redfield M.M., Rouleau J.L., Van Veldhuisen D.J., Zannad F., Zile M.R., Desai A.S., Claggett B., Jhund P.S., Boytsov S.A., Comin-Colet J., Cleland J., Dungen H.-D., Goncalvesova E., Katova T., Kerr Saraiva J.F., Lelonek M., Merkely B., Senni M., Shah S.J., Zhou J., Rizkala A.R., Gong J., Shi V.C., Lefkowitz M.P., and Borghi C

Subjects
Male, MIDRANGE, MIDDLE CHILD, Tetrazoles, Insuficiència cardíaca, Sex Factor, 030204 cardiovascular system & hematology, Hospital patients, 0302 clinical medicine, Cardiovascular Disease, Single-Blind Method, 030212 general & internal medicine, Neprilysin, Tetrazole, Angiotensin Receptor Antagonists, Aminobutyrates, Angiotensin Receptor Antagonist, IMPAIRED SYSTOLIC FUNCTION, General Medicine, Stroke volume, Middle Aged, SPIRONOLACTONE, Hospitalization, Drug Combinations, HIPOTENSÃO, Valsartan, Cardiovascular Diseases, Cardiology, Female, Hypotension, medicine.drug, Human, Angiotensines, medicine.medical_specialty, Angiotensins, Aminobutyrate, Aged, Angioedema, Double-Blind Method, Follow-Up Studies, Heart Failure, Humans, Quality of Life, Sex Factors, Stroke Volume, Heart failure, Follow-Up Studie, 03 medical and health sciences, Internal medicine, Renin–angiotensin system, medicine, Mortalitat, Mortality, Malalts hospitalitzats, business.industry, fungi, medicine.disease, business, Heart failure with preserved ejection fraction, Sacubitril, Valsartan
Abstract

Background: \ud The angiotensin receptor–neprilysin inhibitor sacubitril–valsartan led to a reduced risk of hospitalization for heart failure or death from cardiovascular causes among patients with heart failure and reduced ejection fraction. The effect of angiotensin receptor–neprilysin inhibition in patients with heart failure with preserved ejection fraction is unclear.\ud \ud Methods: \ud We randomly assigned 4822 patients with New York Heart Association (NYHA) class II to IV heart failure, ejection fraction of 45% or higher, elevated level of natriuretic peptides, and structural heart disease to receive sacubitril–valsartan (target dose, 97 mg of sacubitril with 103 mg of valsartan twice daily) or valsartan (target dose, 160 mg twice daily). The primary outcome was a composite of total hospitalizations for heart failure and death from cardiovascular causes. Primary outcome components, secondary outcomes (including NYHA class change, worsening renal function, and change in Kansas City Cardiomyopathy Questionnaire [KCCQ] clinical summary score [scale, 0 to 100, with higher scores indicating fewer symptoms and physical limitations]), and safety were also assessed.\ud \ud Results: \ud There were 894 primary events in 526 patients in the sacubitril–valsartan group and 1009 primary events in 557 patients in the valsartan group (rate ratio, 0.87; 95% confidence interval [CI], 0.75 to 1.01; P=0.06). The incidence of death from cardiovascular causes was 8.5% in the sacubitril–valsartan group and 8.9% in the valsartan group (hazard ratio, 0.95; 95% CI, 0.79 to 1.16); there were 690 and 797 total hospitalizations for heart failure, respectively (rate ratio, 0.85; 95% CI, 0.72 to 1.00). NYHA class improved in 15.0% of the patients in the sacubitril–valsartan group and in 12.6% of those in the valsartan group (odds ratio, 1.45; 95% CI, 1.13 to 1.86); renal function worsened in 1.4% and 2.7%, respectively (hazard ratio, 0.50; 95% CI, 0.33 to 0.77). The mean change in the KCCQ clinical summary score at 8 months was 1.0 point (95% CI, 0.0 to 2.1) higher in the sacubitril–valsartan group. Patients in the sacubitril–valsartan group had a higher incidence of hypotension and angioedema and a lower incidence of hyperkalemia. Among 12 prespecified subgroups, there was suggestion of heterogeneity with possible benefit with sacubitril–valsartan in patients with lower ejection fraction and in women.\ud \ud Conclusions: \ud Sacubitril–valsartan did not result in a significantly lower rate of total hospitalizations for heart failure and death from cardiovascular causes among patients with heart failure and an ejection fraction of 45% or higher. (Funded by Novartis; PARAGON-HF ClinicalTrials.gov number, NCT01920711.)

Published
2019
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