Valsartan, captopril, or both in myocardial infarction complicated by heart failure, left ventricular dysfunction, or both

Marc A Pfeffer; John J V McMurray; Eric J Velazquez; Jean-Lucien Rouleau; Lars Køber; Aldo P Maggioni; Scott D Solomon; Karl Swedberg; Frans Van de Werf; Harvey White; Jeffrey D Leimberger; Marc Henis; Susan Edwards; Steven Zelenkofske; Mary Ann Sellers; Robert M Califf; Valsartan in Acute Myocardial Infarction Trial Investigators

doi:10.1056/NEJMoa032292

Valsartan, captopril, or both in myocardial infarction complicated by heart failure, left ventricular dysfunction, or both

Marc A Pfeffer, John J V McMurray, Eric J Velazquez, Jean-Lucien Rouleau, Lars Køber, Aldo P Maggioni, Scott D Solomon, Karl Swedberg, Frans Van de Werf, Harvey White, Jeffrey D Leimberger, Marc Henis, Susan Edwards, Steven Zelenkofske, Mary Ann Sellers, Robert M Califf, Valsartan in Acute Myocardial Infarction Trial Investigators

2000 Citations (Scopus)

Abstract

BACKGROUND: Angiotensin-converting-enzyme (ACE) inhibitors such as captopril reduce mortality and cardiovascular morbidity among patients with myocardial infarction complicated by left ventricular systolic dysfunction, heart failure, or both. In a double-blind trial, we compared the effect of the angiotensin-receptor blocker valsartan, the ACE inhibitor captopril, and the combination of the two on mortality in this population of patients. METHODS: Patients receiving conventional therapy were randomly assigned, 0.5 to 10 days after acute myocardial infarction, to additional therapy with valsartan (4909 patients), valsartan plus captopril (4885 patients), or captopril (4909 patients). The primary end point was death from any cause. RESULTS: During a median follow-up of 24.7 months, 979 patients in the valsartan group died, as did 941 patients in the valsartan-and-captopril group and 958 patients in the captopril group (hazard ratio in the valsartan group as compared with the captopril group, 1.00; 97.5 percent confidence interval, 0.90 to 1.11; P=0.98; hazard ratio in the valsartan-and-captopril group as compared with the captopril group, 0.98; 97.5 percent confidence interval, 0.89 to 1.09; P=0.73). The upper limit of the one-sided 97.5 percent confidence interval for the comparison of the valsartan group with the captopril group was within the prespecified margin for noninferiority with regard to mortality (P=0.004) and with regard to the composite end point of fatal and nonfatal cardiovascular events (P<0.001). The valsartan-and-captopril group had the most drug-related adverse events. With monotherapy, hypotension and renal dysfunction were more common in the valsartan group, and cough, rash, and taste disturbance were more common in the captopril group. CONCLUSIONS: Valsartan is as effective as captopril in patients who are at high risk for cardiovascular events after myocardial infarction. Combining valsartan with captopril increased the rate of adverse events without improving survival.

Original language	English
Journal	New England Journal of Medicine
Volume	349
Issue number	20
Pages (from-to)	1893-906
Number of pages	13
ISSN	0028-4793
DOIs	https://doi.org/10.1056/NEJMoa032292
Publication status	Published - 2003

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10.1056/NEJMoa032292

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Pfeffer, M. A., McMurray, J. J. V., Velazquez, E. J., Rouleau, J-L., Køber, L., Maggioni, A. P., Solomon, S. D., Swedberg, K., Van de Werf, F., White, H., Leimberger, J. D., Henis, M., Edwards, S., Zelenkofske, S., Sellers, M. A., Califf, R. M., & Valsartan in Acute Myocardial Infarction Trial Investigators (2003). Valsartan, captopril, or both in myocardial infarction complicated by heart failure, left ventricular dysfunction, or both. New England Journal of Medicine, 349(20), 1893-906. https://doi.org/10.1056/NEJMoa032292

Pfeffer, MA, McMurray, JJV, Velazquez, EJ, Rouleau, J-L, Køber, L, Maggioni, AP, Solomon, SD, Swedberg, K, Van de Werf, F, White, H, Leimberger, JD, Henis, M, Edwards, S, Zelenkofske, S, Sellers, MA, Califf, RM & Valsartan in Acute Myocardial Infarction Trial Investigators 2003, 'Valsartan, captopril, or both in myocardial infarction complicated by heart failure, left ventricular dysfunction, or both', New England Journal of Medicine, vol. 349, no. 20, pp. 1893-906. https://doi.org/10.1056/NEJMoa032292

@article{b3cad680118d11df803f000ea68e967b,

title = "Valsartan, captopril, or both in myocardial infarction complicated by heart failure, left ventricular dysfunction, or both",

abstract = "BACKGROUND: Angiotensin-converting-enzyme (ACE) inhibitors such as captopril reduce mortality and cardiovascular morbidity among patients with myocardial infarction complicated by left ventricular systolic dysfunction, heart failure, or both. In a double-blind trial, we compared the effect of the angiotensin-receptor blocker valsartan, the ACE inhibitor captopril, and the combination of the two on mortality in this population of patients. METHODS: Patients receiving conventional therapy were randomly assigned, 0.5 to 10 days after acute myocardial infarction, to additional therapy with valsartan (4909 patients), valsartan plus captopril (4885 patients), or captopril (4909 patients). The primary end point was death from any cause. RESULTS: During a median follow-up of 24.7 months, 979 patients in the valsartan group died, as did 941 patients in the valsartan-and-captopril group and 958 patients in the captopril group (hazard ratio in the valsartan group as compared with the captopril group, 1.00; 97.5 percent confidence interval, 0.90 to 1.11; P=0.98; hazard ratio in the valsartan-and-captopril group as compared with the captopril group, 0.98; 97.5 percent confidence interval, 0.89 to 1.09; P=0.73). The upper limit of the one-sided 97.5 percent confidence interval for the comparison of the valsartan group with the captopril group was within the prespecified margin for noninferiority with regard to mortality (P=0.004) and with regard to the composite end point of fatal and nonfatal cardiovascular events (P<0.001). The valsartan-and-captopril group had the most drug-related adverse events. With monotherapy, hypotension and renal dysfunction were more common in the valsartan group, and cough, rash, and taste disturbance were more common in the captopril group. CONCLUSIONS: Valsartan is as effective as captopril in patients who are at high risk for cardiovascular events after myocardial infarction. Combining valsartan with captopril increased the rate of adverse events without improving survival.",

author = "Pfeffer, {Marc A} and McMurray, {John J V} and Velazquez, {Eric J} and Jean-Lucien Rouleau and Lars K{\o}ber and Maggioni, {Aldo P} and Solomon, {Scott D} and Karl Swedberg and {Van de Werf}, Frans and Harvey White and Leimberger, {Jeffrey D} and Marc Henis and Susan Edwards and Steven Zelenkofske and Sellers, {Mary Ann} and Califf, {Robert M} and {Valsartan in Acute Myocardial Infarction Trial Investigators}",

note = "Keywords: Aged; Angiotensin-Converting Enzyme Inhibitors; Captopril; Cardiovascular Diseases; Double-Blind Method; Drug Therapy, Combination; Female; Heart Failure; Humans; Male; Middle Aged; Myocardial Infarction; Receptors, Angiotensin; Tetrazoles; Valine; Ventricular Dysfunction, Left",

year = "2003",

doi = "10.1056/NEJMoa032292",

language = "English",

volume = "349",

pages = "1893--906",

journal = "New England Journal of Medicine",

issn = "0028-4793",

publisher = "Massachusetts Medical Society",

number = "20",

}

TY - JOUR

T1 - Valsartan, captopril, or both in myocardial infarction complicated by heart failure, left ventricular dysfunction, or both

AU - Pfeffer, Marc A

AU - McMurray, John J V

AU - Velazquez, Eric J

AU - Rouleau, Jean-Lucien

AU - Køber, Lars

AU - Maggioni, Aldo P

AU - Solomon, Scott D

AU - Swedberg, Karl

AU - Van de Werf, Frans

AU - White, Harvey

AU - Leimberger, Jeffrey D

AU - Henis, Marc

AU - Edwards, Susan

AU - Zelenkofske, Steven

AU - Sellers, Mary Ann

AU - Califf, Robert M

AU - Valsartan in Acute Myocardial Infarction Trial Investigators

N1 - Keywords: Aged; Angiotensin-Converting Enzyme Inhibitors; Captopril; Cardiovascular Diseases; Double-Blind Method; Drug Therapy, Combination; Female; Heart Failure; Humans; Male; Middle Aged; Myocardial Infarction; Receptors, Angiotensin; Tetrazoles; Valine; Ventricular Dysfunction, Left

PY - 2003

Y1 - 2003

N2 - BACKGROUND: Angiotensin-converting-enzyme (ACE) inhibitors such as captopril reduce mortality and cardiovascular morbidity among patients with myocardial infarction complicated by left ventricular systolic dysfunction, heart failure, or both. In a double-blind trial, we compared the effect of the angiotensin-receptor blocker valsartan, the ACE inhibitor captopril, and the combination of the two on mortality in this population of patients. METHODS: Patients receiving conventional therapy were randomly assigned, 0.5 to 10 days after acute myocardial infarction, to additional therapy with valsartan (4909 patients), valsartan plus captopril (4885 patients), or captopril (4909 patients). The primary end point was death from any cause. RESULTS: During a median follow-up of 24.7 months, 979 patients in the valsartan group died, as did 941 patients in the valsartan-and-captopril group and 958 patients in the captopril group (hazard ratio in the valsartan group as compared with the captopril group, 1.00; 97.5 percent confidence interval, 0.90 to 1.11; P=0.98; hazard ratio in the valsartan-and-captopril group as compared with the captopril group, 0.98; 97.5 percent confidence interval, 0.89 to 1.09; P=0.73). The upper limit of the one-sided 97.5 percent confidence interval for the comparison of the valsartan group with the captopril group was within the prespecified margin for noninferiority with regard to mortality (P=0.004) and with regard to the composite end point of fatal and nonfatal cardiovascular events (P<0.001). The valsartan-and-captopril group had the most drug-related adverse events. With monotherapy, hypotension and renal dysfunction were more common in the valsartan group, and cough, rash, and taste disturbance were more common in the captopril group. CONCLUSIONS: Valsartan is as effective as captopril in patients who are at high risk for cardiovascular events after myocardial infarction. Combining valsartan with captopril increased the rate of adverse events without improving survival.

AB - BACKGROUND: Angiotensin-converting-enzyme (ACE) inhibitors such as captopril reduce mortality and cardiovascular morbidity among patients with myocardial infarction complicated by left ventricular systolic dysfunction, heart failure, or both. In a double-blind trial, we compared the effect of the angiotensin-receptor blocker valsartan, the ACE inhibitor captopril, and the combination of the two on mortality in this population of patients. METHODS: Patients receiving conventional therapy were randomly assigned, 0.5 to 10 days after acute myocardial infarction, to additional therapy with valsartan (4909 patients), valsartan plus captopril (4885 patients), or captopril (4909 patients). The primary end point was death from any cause. RESULTS: During a median follow-up of 24.7 months, 979 patients in the valsartan group died, as did 941 patients in the valsartan-and-captopril group and 958 patients in the captopril group (hazard ratio in the valsartan group as compared with the captopril group, 1.00; 97.5 percent confidence interval, 0.90 to 1.11; P=0.98; hazard ratio in the valsartan-and-captopril group as compared with the captopril group, 0.98; 97.5 percent confidence interval, 0.89 to 1.09; P=0.73). The upper limit of the one-sided 97.5 percent confidence interval for the comparison of the valsartan group with the captopril group was within the prespecified margin for noninferiority with regard to mortality (P=0.004) and with regard to the composite end point of fatal and nonfatal cardiovascular events (P<0.001). The valsartan-and-captopril group had the most drug-related adverse events. With monotherapy, hypotension and renal dysfunction were more common in the valsartan group, and cough, rash, and taste disturbance were more common in the captopril group. CONCLUSIONS: Valsartan is as effective as captopril in patients who are at high risk for cardiovascular events after myocardial infarction. Combining valsartan with captopril increased the rate of adverse events without improving survival.

U2 - 10.1056/NEJMoa032292

DO - 10.1056/NEJMoa032292

M3 - Journal article

C2 - 14610160

SN - 0028-4793

VL - 349

SP - 1893

EP - 1906

JO - New England Journal of Medicine

JF - New England Journal of Medicine

IS - 20

ER -

Valsartan, captopril, or both in myocardial infarction complicated by heart failure, left ventricular dysfunction, or both

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