Li Shen1, Pardeep S Jhund2, Inder S Anand3, Ankeet S Bhatt4, Akshay S Desai4, Aldo P Maggioni5, Felipe A Martinez6, Marc A Pfeffer4, Adel R Rizkala7, Jean L Rouleau8, Karl Swedberg9, Muthiah Vaduganathan4, Orly Vardeny10, Dirk J van Veldhuisen11, Faiez Zannad12, Michael R Zile13, Milton Packer14, Scott D Solomon4, John J V McMurray15. 1. School of Medicine, Hangzhou Normal University, Hangzhou, China; British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom. 2. British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom. 3. Department of Medicine, University of Minnesota Medical School and VA Medical Center, Minneapolis, Minnesota, USA. 4. Department of Medicine, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA. 5. Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy. 6. National University of Cordoba, Cordoba, Argentina. 7. Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA. 8. Montreal Heart Institute, Université de Montréal, Montreal, Quebec, Canada. 9. Department of Molecular and Clinical Medicine, University of Gothenburg, Gothenburg, Sweden. 10. Center for Care Delivery and Outcomes Research, Minneapolis Veterans Administration Health Care System and University of Minnesota, Minneapolis, Minnesota, USA. 11. Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands. 12. Centre d'Investigations Cliniques-Plurithématique 1433 and Institut National de la Santé et de la Recherche Médicale U1116, Centre Hospitalier Regional Universitaire, French Clinical Research Infrastructure Network, Investigation Network Initiative Cardiovascular and Renal Clinical Trialists, Nancy, France. 13. Ralph H. Johnson Department of Veterans Affairs Medical Center, Division of Cardiology, Medical University of South Carolina, Charleston, South Carolina, USA. 14. Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, Texas, USA. 15. British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom. Electronic address: john.mcmurray@glasgow.ac.uk.
Abstract
BACKGROUND: The incidence of pneumonia and subsequent outcomes has not been compared in patients with heart failure and reduced ejection fraction (HFrEF) and preserved ejection fraction (HFpEF). OBJECTIVES: This study aimed to examine the rate and impact of pneumonia in the PARADIGM-HF (Prospective Comparison of Angiotensin Receptor-Neprilysin Inhibitor With Angiotensin Converting Enzyme Inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure) and PARAGON-HF (Prospective Comparison of ARNI with ARB Global Outcomes in Heart Failure with Preserved Ejection Fraction) trials. METHODS: The authors analyzed the incidence of investigator-reported pneumonia and the rates of HF hospitalization, cardiovascular death, and all-cause death before and after the occurrence of pneumonia, and estimated risk after the first occurrence of pneumonia in unadjusted and adjusted analyses (the latter including N-terminal pro-B-type natriuretic peptide). RESULTS: In PARADIGM-HF, 528 patients (6.3%) developed pneumonia after randomization, giving an incidence rate of 29 (95% CI: 27 to 32) per 1,000 patient-years. In PARAGON-HF, 510 patients (10.6%) developed pneumonia, giving an incidence rate of 39 (95% CI: 36 to 42) per 1,000 patient-years. The subsequent risk of all trial outcomes was elevated after the occurrence of pneumonia. In PARADIGM-HF, the adjusted hazard ratio (HR) for the risk of death from any cause was 4.34 (95% CI: 3.73 to 5.05). The corresponding adjusted HR in PARAGON-HF was 3.76 (95% CI: 3.09 to 4.58). CONCLUSIONS: The incidence of pneumonia was high in patients with HF, especially HFpEF, at around 3 times the expected rate. A first episode of pneumonia was associated with 4-fold higher mortality. (Prospective Comparison of Angiotensin Receptor-Neprilysin Inhibitor With Angiotensin-Converting Enzyme Inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure [PARADIGM-HF], NCT01035255; Prospective Comparison of ARNI [Angiotensin Receptor-Neprilysin Inhibitor] With ARB [Angiotensin Receptor Blocker] Global Outcomes in Heart Failure With Preserved Ejection Fraction [PARAGON-HF], NCT01920711).
BACKGROUND: The incidence of pneumonia and subsequent outcomes has not been compared in patients with heart failure and reduced ejection fraction (HFrEF) and preserved ejection fraction (HFpEF). OBJECTIVES: This study aimed to examine the rate and impact of pneumonia in the PARADIGM-HF (Prospective Comparison of Angiotensin Receptor-Neprilysin Inhibitor With Angiotensin Converting Enzyme Inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure) and PARAGON-HF (Prospective Comparison of ARNI with ARB Global Outcomes in Heart Failure with Preserved Ejection Fraction) trials. METHODS: The authors analyzed the incidence of investigator-reported pneumonia and the rates of HF hospitalization, cardiovascular death, and all-cause death before and after the occurrence of pneumonia, and estimated risk after the first occurrence of pneumonia in unadjusted and adjusted analyses (the latter including N-terminal pro-B-type natriuretic peptide). RESULTS: In PARADIGM-HF, 528 patients (6.3%) developed pneumonia after randomization, giving an incidence rate of 29 (95% CI: 27 to 32) per 1,000 patient-years. In PARAGON-HF, 510 patients (10.6%) developed pneumonia, giving an incidence rate of 39 (95% CI: 36 to 42) per 1,000 patient-years. The subsequent risk of all trial outcomes was elevated after the occurrence of pneumonia. In PARADIGM-HF, the adjusted hazard ratio (HR) for the risk of death from any cause was 4.34 (95% CI: 3.73 to 5.05). The corresponding adjusted HR in PARAGON-HF was 3.76 (95% CI: 3.09 to 4.58). CONCLUSIONS: The incidence of pneumonia was high in patients with HF, especially HFpEF, at around 3 times the expected rate. A first episode of pneumonia was associated with 4-fold higher mortality. (Prospective Comparison of Angiotensin Receptor-Neprilysin Inhibitor With Angiotensin-Converting Enzyme Inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure [PARADIGM-HF], NCT01035255; Prospective Comparison of ARNI [Angiotensin Receptor-Neprilysin Inhibitor] With ARB [Angiotensin Receptor Blocker] Global Outcomes in Heart Failure With Preserved Ejection Fraction [PARAGON-HF], NCT01920711).
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