Cognitive performance of patients with chronic heart failure on sacubitril/valsartan

Vecchis, Renato De; Ariano, Carmelina; Biase, Giuseppina Di; Noutsias, Michel

doi:10.1007/s00059-018-4683-5

Cited by 17 publications

(13 citation statements)

References 18 publications

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“…2B. A study by De Vecchis et al [36] reported a significantly higher reduction in NT-proBNP levels compared with that seen with conventional therapy over a period of 3 months (65.6% vs 24.8%; p < 0.0001). The rest of the studies comparing the before and after NYHA class or NT-proBNP levels did not report the level of statistical significance (NYHA, n = 10; NT-proBNP, n = 8), were non-significant (NYHA, n = 2; NT-proBNP, n = 3) or did not provide data for the overall population (NYHA, n = 1; NT-proBNP, n = 1) (Supplementary Table 2 and Table 3).…”

Section: Clinical Effectiveness Outcomesmentioning

confidence: 90%

Real-world effectiveness and safety of sacubitril/valsartan in heart failure: A systematic review

Proudfoot

Studer

Rajput

et al. 2021

International Journal of Cardiology

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Background: PARADIGM-HF demonstrated superiority of sacubitril/valsartan (sac/val) over enalapril in patients with heart failure with reduced ejection fraction (HFrEF). However, patients in clinical practice may differ in their characteristics and overall risk compared with patients in clinical trials, and additional outcomes can be observed in real world (RW). Hence, a systematic review was conducted to identify and describe RW data on sac/val. Methods: RW studies evaluating the effects of sac/val in adult patients with HFrEF with a sample size ≥100 were identified via MEDLINE® and Embase® from 2015 to January 2020. Citations were screened, critically appraised and relevant data were extracted. Results: A total of 68 unique studies were identified. Nearly half of the studies were conducted in Europe (n = 34), followed by the US (n = 15) and Asia (n = 11). Median follow-up period varied from 1 to 19 months. Mean age ranged between 48.7 and 79.0 years; patients were mostly male and in New York Heart Association (NYHA) functional class II/III, and mean left ventricular ejection fraction varied between 23%and 38%. Of studies performing comparisons, most reported superior efficacy of sac/val in reducing the risk of HF hospitalisations, allcause hospitalisations, and all-cause mortality as compared to standard-of-care. Many studies reported significant improvements in NYHA functional class and reduction in biomarker levels post sac/val. Hypotension and hyperkalaemia were the most frequently reported adverse events. Conclusions: This comprehensive overview of currently available RW evidence on sac/val complements the evidence from randomised controlled trials, substantiating its effectiveness in heterogeneous real-world HF populations.

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Section: Clinical Effectiveness Outcomesmentioning

confidence: 90%

Real-world effectiveness and safety of sacubitril/valsartan in heart failure: A systematic review

Proudfoot

Studer

Rajput

et al. 2021

International Journal of Cardiology

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“…10 Çalışmamızda 6 aylık süre boyunca %2,6 hasta kaybedilmiş olup yeni yayımlanan retrospektif bir çalışmada, 6 aylık mortalite %6,8 olarak bizden daha sık izlenmiştir. 11 Yakın zamanda özeti yayımlanan başka bir prospektif çalışmada ise 7,0±0,1 aylık takip sonucunda mortalite oranı %2,8 olarak çalışmamıza benzer sıklıkta gözlenmiştir. 12 Bilindiği gibi iskemik ve non-iskemik KY'nin patogenezi, prognozu ve tedavi stratejileri birbirinden tamamen farklıdır.…”

Section: Discussionunclassified

The Effect of Sacubitril/Valsartan on Clinical and Laboratory Findings Comparatively in Ischemic and Non-Ischemic Heart Failure Patients

Öz¹,

Kıvrak²,

Gürol³

et al. 2019

Turkiye Klinikleri J Cardiovasc Sci

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Am ma aç ç: : Sakubitril/valsartan tedavisinin, enalaprile kıyasla düşük ejeksiyon fraksiyonlu kalp yetersizliği (DEF-KY) hastalarında hastaneye yatış ve mortalite riskini azalttığı ve yaşam kalitesini artırdığı gösterilmiştir, ancak bugüne kadar ülkemizde yapılmış, sakubitril/valsartanın klinik bulgulara ve laboratuvar sonuçlarına olan etkilerini gösteren çalışma bulunmamaktadır. Biz çalışmamızda, sakubitril/valsartan tedavisinin kliniğe ve laboratuvar bulgularına olan etkilerini hem iskemik hem de non-iskemik DEF-KY hastalarında karşılaştırmalı olarak araştırmayı hedefledik. G Ge er re eç ç v ve e Y Yö ön nt te em ml le er r: : Çalışmamıza, 18 yaşından büyük, KY kılavuzlarına göre sakubitril/valsartan tedavisi başlama endikasyonu olan hastalar dâhil edildi. Tüm hastalardan tedavi başlamadan önce ve tolere edilebilen maksimal doz sakubitril/valsartan tedavisinin 6. ayında olmak üzere iki kez ayrıntılı öykü alındı, tüm sistem fizik muayene yapıldı ve elektrokardiyogram çekildi. Venöz kanda sodyum (Na), potasyum (K), kreatinin ve NT-ProBNP düzeylerine bakıldı. Tedavi öncesi ve sonrası bulgular karşılaştırıldı. B Bu ul lg gu u-l la ar r: : Çalışmaya başlangıçta 150 hasta katıldı. Bu hastalardan 19'u takip süresini tamamlayamadığı için çalışma dışı bırakıldı ve toplamda 71'i iskemik, 56'sı ise non-iskemik KY hastası olmak üzere 127 hasta (%27,6'sı kadın) çalışmaya dâhil edildi. Her iki grupta da sistolik ve diyastolik kan basıncı, dakikadaki kalp hızı, NT-proBNP ve Na düzeyi ve haftalık furosemid ihtiyacında istatistiksel olarak anlamlı azalma gözlendi. Glomerüler filtrasyon hızı (GFH)'nda anlamlı değişiklik olmazken, kreatinin ve potasyum (K) düzeylerinde istatistiksel olarak anlamlı artış tespit edildi. S So on nu uç ç: : Bu çalışmanın sonuçları göstermiştir ki sakubitril/valsartan, hem iskemik hem de non-iskemik DEF-KY'de benzer etkiler yaratmakta, her iki grupta da hastaların laboratuvar ve klinik bulgularında belirgin düzelme, semptomlarında rahatlama, haftalık furosemid ihtiyacında azalma ve kalp hızında düşüş sağlamaktadır. Bununla birlikte, yan etkiler olarak semptomatik hipotansiyon, hiperpotasemi ve GFH düşüşü açısından dikkatli olunmalıdır.

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“…There are limited case reports documenting the development of psychiatric symptoms and neurocognitive deficits, including one with otherwise unexplainable intracranial volume loss in the setting of recent initiation of sacubitril/ valsartan [5]. A small retrospective cohort study comprising 102 patients followed up for 3 months found no differences in cognitive performance using a Mini-Mental State Examination between heart failure patients receiving Entresto and previous conventional therapy [6].…”

Section: Further Studiesmentioning

confidence: 99%

Effect of Sacubitril/Valsartan on Neurocognitive Function: Current Status and Future Directions

Galo

Celli

Colombo

2020

Am J Cardiovasc Drugs

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Sacubitril/valsartan is a new medication approved for the treatment of heart failure with reduced ejection fraction. While the drug failed to meet the primary endpoint in patients with heart failure with preserved ejection fraction in the PARAGON-HF trial, improvements were noted in several secondary endpoints. Valsartan is an angiotensin receptor blocker and sacubitril is a neprilysin inhibitor. Neprilysin is postulated to have a role in the degradation of beta-amyloid in the brain; therefore, sacubitril could theoretically increase beta-amyloid plaque deposition in the brain and potentially increase the risk of Alzheimer's disease. Although pre-clinical and clinical studies have shown promising safety results, those studies have been heavily criticized for short monitoring time and targeted populations. In accordance with the requirements of the US Food and drug Administration (FDA), the ongoing Prospective Evaluation of Cognitive Function in Heart Failure: Efficacy and Safety of Entresto compared to Valsartan on Cognitive Function in Patients with Chronic Heart Failure and Preserved Ejection Fraction (PERSPECTIVE; NCT02884206) multicenter, randomized, double-blinded trial is assessing the long-term neurocognitive effects and safety of sacubitril/valsartan, and results are expected in early 2022.

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Cognitive performance of patients with chronic heart failure on sacubitril/valsartan

Abstract: In our study, we did not find any evidence of the alleged harmful influence of sacubitril/valsartan on cognitive function. Patients taking sacubitril/valsartan for at least 3 months had similar mean MMSE scores to control subjects.

Cited by 17 publications

References 18 publications

Real-world effectiveness and safety of sacubitril/valsartan in heart failure: A systematic review

Real-world effectiveness and safety of sacubitril/valsartan in heart failure: A systematic review

The Effect of Sacubitril/Valsartan on Clinical and Laboratory Findings Comparatively in Ischemic and Non-Ischemic Heart Failure Patients

Effect of Sacubitril/Valsartan on Neurocognitive Function: Current Status and Future Directions

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