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Irbesartan in Patients with Heart Failure and Preserved Ejection Fraction
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BACKGROUND: Approximately 50% of patients with heart failure have a left ventricular ejection fraction of at least 45%, but no therapies have been shown to improve the outcome of these patients. Therefore, we studied the effects of irbesartan in patients with this syndrome. METHODS: We enrolled 4128 patients who were at least 60 years of age and had New York Heart Association class II, III, or IV heart failure and an ejection fraction of at least 45% and randomly assigned them to receive 300 mg of irbesartan or placebo per day. The primary composite outcome was death from any cause or hospitalization for a cardiovascular cause (heart failure, myocardial infarction, unstable angina, arrhythmia, or stroke). Secondary outcomes included death from heart failure or hospitalization for heart failure, death from any cause and from cardiovascular causes, and quality of life. RESULTS: During a mean follow-up of 49.5 months, the primary outcome occurred in 742 patients in the irbesartan group and 763 in the placebo group. Primary event rates in the irbesartan and placebo groups were 100.4 and 105.4 per 1000 patient-years, respectively (hazard ratio, 0.95; 95% confidence interval [CI], 0.86 to 1.05; P=0.35). Overall rates of death were 52.6 and 52.3 per 1000 patient-years, respectively (hazard ratio, 1.00; 95% CI, 0.88 to 1.14; P=0.98). Rates of hospitalization for cardiovascular causes that contributed to the primary outcome were 70.6 and 74.3 per 1000 patient-years, respectively (hazard ratio, 0.95; 95% CI, 0.85 to 1.08; P=0.44). There were no significant differences in the other prespecified outcomes. CONCLUSIONS: Irbesartan did not improve the outcomes of patients with heart failure and a preserved left ventricular ejection fraction. (ClinicalTrials.gov number, NCT00095238.)
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Metadata
- Authors
- Massie, B. M., Carson, P. E., McMurray, J. J., Komajda, M., McKelvie, R., Zile, M. R., Anderson, S., Donovan, M., Iverson, E., Staiger, C., & Ptaszynska, A.
- Affiliations
- San Francisco VA Medical Center (US)
- Georgetown University (US)
- University of Glasgow (GB)
- Hamilton Health Sciences (CA)
- Medical University of South Carolina (US)
- University of Wisconsin–Madison (US)
- Bristol-Myers Squibb (United States) (US)
- Sanofi (United States) (US)
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2008-12-04
- Volume
- 359
- Issue
- 23
- Pages
- 2456-2467
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2068519950
- Cited by
- 1,960
- References
- 37
- Citations by year
- 2026: 61 · 2025: 72 · 2024: 92 · 2023: 94 · 2022: 128 · 2021: 120 · 2020: 123 · 2019: 118 · 2018: 117 · 2017: 138 · 2016: 105 · 2015: 127 · 2014: 119 · 2013: 122 · 2012: 109
- FWCI
- 75.20
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Ghent University Academic Bibliography (Ghent University) (submittedVersion)
- University of Debrecen Electronic Archive (University of Debrecen) (submittedVersion, other-oa)
- IRIS Research product catalog (Sapienza University of Rome) (submittedVersion)
- Use Siena air (University of Siena) (submittedVersion)
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Heart Failure Treatment and Management
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiovascular Function and Risk Factors
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Blood Pressure and Hypertension Studies
- Keywords
- irbesartan, heart failure with preserved ejection fraction, angiotensin receptor blockers, cardiovascular mortality, cardiovascular hospitalization, heart failure hospitalization, quality of life, elderly patients
- MeSH terms
- Irbesartan, Adrenergic beta-Antagonists, Aged, Angiotensin-Converting Enzyme Inhibitors, Biphenyl Compounds, Cardiovascular Diseases, Drug Therapy, Combination, Female, Follow-Up Studies, Heart Failure, Hospitalization, Humans, Male, Middle Aged, Quality of Life, Stroke Volume, Tetrazoles, Proportional Hazards Models, Treatment Failure, Angiotensin II Type 1 Receptor Blockers, Kaplan-Meier Estimate
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