Sacubitril/Valsartan in Real-Life Practice: Experience in Patients with Advanced Heart Failure and Systematic Review

Moliner-Abós, Carles; Rivas‐Lasarte, Mercedes; Besora, Julia Pamies; Fluvia, P.; Solé‐González, Eduard; Mirabet, Sònia; López, Laura; Brossa, Vicens; Pirla, Maria José; Mesado, Nuria; Álvarez‐García, Jesús; Roig, Eulàlia

doi:10.1007/s10557-019-06858-0

Cited by 29 publications

(27 citation statements)

References 23 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…For instance, Joly et al [6] have reviewed sac/val clinical trials that led to the key updates to guidelines and also reviewed utilisation in clinical practice but did not report on effectiveness in a real-world setting. Moliner-Abos et al [7] conducted a retrospective study to analyse the efficacy and safety of sac/val in an advanced heart failure (HF) cohort and have also reviewed systematically previous real-world studies. However, only an overview of the studies and patient characteristics were reported.…”

Section: Introductionmentioning

confidence: 99%

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

Proudfoot

Studer

Rajput

et al. 2021

International Journal of Cardiology

View full text Add to dashboard Cite

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.

show abstract

Section: Introductionmentioning

confidence: 99%

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

Proudfoot

Studer

Rajput

et al. 2021

International Journal of Cardiology

View full text Add to dashboard Cite

show abstract

“…In the past few years, two landmark randomized controlled trials 4,5 and several real‐world studies had demonstrated the beneficial effects of ivabradine and Sac/Val over standard HF treatment 15–18 . These two medications have different action mechanisms, and it is reasonable to apply both drugs in the same patients with HF if clinically indicated.…”

Section: Discussionmentioning

confidence: 99%

Combination of ivabradine and sacubitril/valsartan in patients with heart failure and reduced ejection fraction

et al. 2021

View full text Add to dashboard Cite

Aims Ivabradine and sacubitril/valsartan are second-line therapies for patients with heart failure and reduced ejection fraction (HFrEF) based on guideline recommendations. We aimed to evaluate the synergistic effects of these two medications. Methods and results Patients' data were extracted from a multicentre database between 2016 and 2018. Patients were classified into (1) Simultaneous group: simultaneous prescription of ivabradine and sacubitril/valsartan within 6 weeks; (2A) Sequential group, ivabradine-first: ivabradine was prescribed first, followed by sacubitril/valsartan; and (2B) Sequential group, sacubitril/valsartan-first: sacubitril/valsartan was prescribed first, followed by ivabradine. A total of 464 patients with HFrEF were enrolled. Cardiovascular death and/or unplanned re-hospitalizations for HF were less frequent (28.6% vs. 44.8%, P = 0.01), and the improvement of left ventricular ejection fraction (LVEF) was significantly greater in patients from the Simultaneous group than those from the Sequential group (ΔLVEF 12.8 ± 12.9% vs. 9.3 ± 12.6%, P = 0.007). Among Sequential subgroups, the ivabradine-first treatment decreased heart rate and increased systolic blood pressure (SBP) compared with sacubitril/valsartan-first treatment (Δheart rate À9.1 ± 12.9 b.p.m. vs. 2.6 ± 16.0 b.p.m., P < 0.001; ΔSBP 4.6 ± 16.5 mmHg vs. À4.8 ± 17.2 mmHg, P < 0.001), whereas sacubitril/valsartan-first treatment showed a higher degree of LVEF improvement (ΔLVEF 3.6 ± 7.8% vs. 0.7 ± 7.7%, P = 0.002) than ivabradine-first treatment. At the end of follow-up, SBP, LVEF, and left ventricular volume were comparable between two Sequential subgroups. Conclusions Among patients with HFrEF, simultaneous rather than sequential treatment with sacubitril/valsartan and ivabradine was a better strategy to reduce adverse events and achieve left ventricular reverse remodelling. Ivabradine treatment had a more significant benefit on improving haemodynamic stability, whereas sacubitril/valsartan treatment showed a more significant effect on improving LVEF.

show abstract

“…26 Yeni yayımlanan çalışmaların sonuçlarına göre sakubitril/valsartan tedavisi atriyal natriüretik seviyesini artırırken, NT-pro BNP seviyesini çalışmamızda olduğu gibi azaltmıştır. 27,28 Ayrıca PARADIGM-HF çalışmasının sonuçlarında da kandaki BNP seviyesi bazal değerlere ve enalapril grubuna göre artarken, NT-proBNP seviyesinde düşme tespit edilmiştir. BNP ve NT-proBNP arasındaki ters ilişki, BNP'nin neprilisinin substratı olmasına, buna karşın NT-proBNP'nin neprilisinin substratı olmamasına ve kompanzasyona sekonder NT-proBNP seviyelerinin düşme eğilimi göstermesine bağlanmıştır.…”

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

View full text Add to dashboard Cite

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.

show abstract

Sacubitril/Valsartan in Real-Life Practice: Experience in Patients with Advanced Heart Failure and Systematic Review

Cited by 29 publications

References 23 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

Combination of ivabradine and sacubitril/valsartan in patients with heart failure and reduced ejection fraction

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

Contact Info

Product

Resources

About