Real-World Safety of Sacubitril/Valsartan in Women and Men With Heart Failure and Reduced Ejection Fraction: A Meta-analysis

Nuechterlein, Kaitlin; AlTurki, Ahmed; Ni, Jiayi; Martínez‐Sellés, Manuel; Martens, Pieter; Russo, Vincenzo; Backelin, Charlotte Nordberg; Huynh, Thao

doi:10.1016/j.cjco.2021.09.009

Cited by 11 publications

(9 citation statements)

References 20 publications

(116 reference statements)

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“…This high reduction in real-world setting (by comparison with ~ 21% vs . enalapril in the pivotal trial) 1 , is in line with previous reports 5 , 13 , 14 . In addition, real-world patients exhibited an improvement in NYHA class and a decreased use of most medications for HF and other relevant concomitant pharmaceutical therapies following treatment initiation.…”

Section: Discussionsupporting

confidence: 91%

Real-life effectiveness of sacubitril/valsartan in older Belgians with heart failure, reduced ejection fraction and most severe symptoms

Maury,

Belmans,

Bogaerts

et al. 2024

Sci Rep

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We assessed the real-world effectiveness of sacubitril/valsartan in patients with chronic heart failure (HF) and reduced ejection fraction (HFrEF) with an emphasis on those with older age (≥ 75 years) or with New York Heart Association (NYHA) class IV, for whom greater uncertainty existed regarding clinical outcomes. We conducted a retrospective cohort study based on patient-level linkage of electronic healthcare datasets. Data from all adults with HFrEF in Belgium receiving a prescription for sacubitril/valsartan between 01-November-2016 and 31-December-2018 were collected, with a follow-up of > 6 years. The total study population comprised 5446 patients, older than the PARADIGM-HF trial participants, and with higher NYHA class (all P < 0.0001). NYHA class improved following sacubitril/valsartan initiation (P < 0.0001 baseline vs. reassessment). Most concomitant medications were reduced. Remarkably, the risk of hospitalization for a cardiovascular reason and for HF was reduced by > 26% in the overall cohort, and in subgroups of patients ≥ 75 years, with NYHA class III/IV (all P < 0.0001) or with NYHA class IV (P < 0.05), vs. baseline. All-cause mortality did not increase in real-world patients with NYHA class III/IV. The results support the long-term beneficial effects of sacubitril/valsartan in older patients and in those experiencing the most severe symptoms.

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Section: Discussionsupporting

confidence: 91%

Real-life effectiveness of sacubitril/valsartan in older Belgians with heart failure, reduced ejection fraction and most severe symptoms

Maury,

Belmans,

Bogaerts

et al. 2024

Sci Rep

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“…Moreover, a recent meta‐analysis of cohort studies assessed sex‐specific data on major adverse outcomes and long‐term safety in 8981 patients treated with S/V. AEs were infrequent in both men and women and comparable with the findings of the pivotal trials, indicating that the safety of S/V can be replicated outside the clinical trial context 56 …”

Section: Safety and Tolerability In And Outside Clinical Trialsmentioning

confidence: 86%

“…AEs were infrequent in both men and women and comparable with the findings of the pivotal trials, indicating that the safety of S/V can be replicated outside the clinical trial context. 56…”

Section: Safety and Tolerability In And Outside Clinical Trialsmentioning

confidence: 99%

Sacubitril/valsartan in heart failure: efficacy and safety in and outside clinical trials

Abdin

Schulz²,

Riemer

et al. 2022

ESC Heart Failure

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Heart failure (HF) treatment has changed substantially over the last 30 years, leading to significant reductions in mortality and hospital admissions in patients with HF with reduced ejection fraction (HFrEF). Currently, the optimization of guideline‐directed chronic HF therapy remains the mainstay to further improve quality of life, mortality, and HF hospitalizations for patients with HFrEF. The angiotensin receptor‐neprilysin inhibitor sacubitril/valsartan (S/V) has an important role in the treatment of patients with HFrEF. The PARADIGM‐HF (Prospective Comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure) randomized controlled trial has established solid evidence for the treatment of HFrEF in various subgroups. Apart from HFrEF, several studies have been conducted using S/V in various indications: patients hospitalized with acute decompensated HF, HF with preserved ejection fraction, acute myocardial infarction with reduced ejection fraction, uncontrolled and resistant hypertension, and chronic kidney disease. Data from the German Institute for Drug Use Evaluation reveal that implementation of S/V has increased steadily over time and, by the end of 2021, an estimated 266 000 patients were treated with S/V in Germany. The estimated cumulative real‐world patient exposure is >5.5 million patient‐treatment years worldwide. The number of patients treated with S/V largely exceeds the number of patients treated in clinical trials, and the current indication for S/V is larger than the strict inclusion/exclusion criteria of the randomized trials. Especially elderly patients, women, and patients with more and more severe comorbidities are underrepresented in the clinical trials. We therefore aimed to summarize the importance of S/V in HF in terms of efficacy and safety in clinical trials and daily clinical practice.

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“…Furthermore, in HFpEF patients, women responded to treatment with ARNI at higher LVEF ranges than men [107]. The different efficacy in women and men was justified because postmenopausal women had greater visceral adipose tissue with increased neprilysin activity and lower NO synthases, microvascular inflammation, and bradykinin production [108]. However, a meta-analysis found that the safety profile was similar in both sexes in patients treated with ACEIs [109].…”

Section: Sandgds and Pharmacologic Therapy In Hfmentioning

confidence: 99%

Impact of Sex and Gender Differences on Heart Failure, Especially in Elderly Patients

Cocco,

Hofmann,

Pandolfi

2024

OBM Geriatr

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Heart failure is one of the major health threats in Western societies, and its prevalence is steadily increasing. Many data show the important impact of sex (biological) and gender (sociocultural) differences on most aspects (diagnosis, etiology, treatments, and outcomes) of heart failure. For example, compared to men, women with heart failure are older, have more co-morbidities, and develop different phenotypes of heart failure. Postpartum cardiopathy is unique in women. The iatrogenic effects of cancer therapies are more frequent among women compared to men. Currently, the integration of sex and gender differences into the therapy of heart failure is rare. Consequently, women derive disadvantages from a nonspecifically adapted therapy for heart failure, get worse outcomes, and have more iatrogenic adverse effects than men. This situation is medically unfortunate and increases medical expenditures. A sex-guided approach to the correct evaluation of patients with heart failure should become the cornerstone for the correct management of these patients.

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Real-World Safety of Sacubitril/Valsartan in Women and Men With Heart Failure and Reduced Ejection Fraction: A Meta-analysis

Cited by 11 publications

References 20 publications

Real-life effectiveness of sacubitril/valsartan in older Belgians with heart failure, reduced ejection fraction and most severe symptoms

Real-life effectiveness of sacubitril/valsartan in older Belgians with heart failure, reduced ejection fraction and most severe symptoms

Sacubitril/valsartan in heart failure: efficacy and safety in and outside clinical trials

Impact of Sex and Gender Differences on Heart Failure, Especially in Elderly Patients

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