Switching From Ramipril to Sacubitril/Valsartan Favorably Alters Electrocardiographic Indices of Ventricular Repolarization in Heart Failure With Reduced Ejection Fraction

Okutucu, Sercan; Şabanoğlu, Cengiz; Yetis, Begum; Aksoy, Hakan; Bursa, Nurbanu; Oto, Ali̇

doi:10.1016/s0735-1097(19)31314-2

Cited by 4 publications

(6 citation statements)

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“…These findings have been reinforced by the results of a single centre study on implantable cardioverter defibrillator (ICD) carriers showing a reduction on anti-tachycardia interventions after 9 months of therapy with sacubitril/valsartan [23]. Furthermore, a positive electrical remodelling after switching from ACE-inhibitors to ARNI were reported, as documented by a reduction in QTc, T peak-T end interval and other measures of dispersion of ventricular repolarization [24].…”

Section: Discussionmentioning

confidence: 96%

Adverse events with sacubitril/valsartan in the real world: emerging signals to target preventive strategies from the FDA adverse event reporting system

Gatti

Antonazzo

Diemberger

et al. 2020

European Journal of Preventive Cardiology

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Aims The aim of this study was to characterise clinical priority of adverse events with sacubitril/valsartan for targeting preventive measures. Methods We used the US Food and Drug Administration adverse event reporting system (worldwide pharmacovigilance database) to compare adverse events recording sacubitril/valsartan as suspect with other cardiovascular drugs. Disproportionality analyses were performed by calculating the reporting odds ratios, deemed significant when the lower limit of the 95% confidence interval was greater than 1. Clinical priority was assigned to adverse events with significant disproportionality by scoring (range 0–10 points) five features (number of events, magnitude of the lower limit of the 95% confidence interval, mortality frequency, important/designated medical event, biological plausibility). Results Sacubitril/valsartan was recorded in 20,021 reports, with 178 adverse events associated with significant disproportionality: 71.9%, 25.9% and 2.2% were classified as weak, moderate and strong clinical priorities, respectively. Increased reporting emerged for several cardiovascular adverse events, including ‘renal failure’ ( N = 388; lower limit of the 95% confidence interval 2.26), ‘hyperkalaemia’ (314; 2.42) and ‘angioedema’ (309; 1.56). Sudden cardiac death (priority score 9 points) was the only designated medical event with strong clinical priority. Notably, sudden cardiac death occurred early after sacubitril/valsartan administration (average onset 124 days), with concomitant drugs known for pro-arrhythmic potential (e.g. amiodarone, escitalopram, mirtazapine, loop diuretics) in 26.2% of records. Conclusion The increased cardiovascular reporting of sacubitril/valsartan in the real world was largely predictable from pre-approval evidence, underlying disease and likely patients’ comorbidities. The unexpected reporting of sudden cardiac death occurred well before the complete development of positive electrical remodelling induced by sacubitril/valsartan, and calls for stringent clinical monitoring (to reduce the pro-arrhythmic burden related to co-medications), and further investigation on appropriate combination with other preventive measures.

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Section: Discussionmentioning

confidence: 96%

Adverse events with sacubitril/valsartan in the real world: emerging signals to target preventive strategies from the FDA adverse event reporting system

Gatti

Antonazzo

Diemberger

et al. 2020

European Journal of Preventive Cardiology

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“…16,17 The effect of sacubitril/valsartan on ECG QRS durations and on QTc intervals was uncertain, 7 and little research has focused on the association between cardiac electrocardiographic changes and clinical outcomes during sacubitril/valsartan treatment. Okutucu et al 1 demonstrated that switching from ramipril to sacubitril/valsartan could alter the myocardial electrophysiological properties in HFrEF. In another prospective study, anti-arrhythmia effects seen as shortened QRS complexes and QTc intervals were notable after sacubitril/valsartan therapy.…”

Section: Discussionmentioning

confidence: 99%

“…Guideline-directed medical therapy (GDMT) for heart failure with reduced ejection fraction (HFrEF) is recommended to reduce morbidity and mortality, regardless of the patient’s background, etiology, and pathogenesis. 1,2 A prolonged QRS duration appears common in patients with HFrEF and is an independent predictor of high mortality. 3 Reverse remodeling of left ventricular ejection fraction (LVEF) could be deteriorating if the QRS duration progresses.…”

Section: Introductionmentioning

confidence: 99%

Duration of Heart Failure With Reduced Ejection Fraction Associated With Electrocardiographic Outcomes Before and After Sacubitril/Valsartan

Lin

Lee

Liu

et al. 2022

J Cardiovasc Pharmacol Ther

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Aim: Changes in QRS duration in patients with heart failure with reduced ejection fraction (HFrEF) after sacubitril/valsartan therapy is not fully understood. This study aimed to assess the association of duration of HFrEF diagnosis with electrocardiographic and echocardiographic outcomes between before and after sacubitril/valsartan. Methods: We included HFrEF patients who received naïve sacubitril/valsartan therapy for ≥3 months, between January 2016 and March 2018. All patients were divided into 2 groups based on their duration of HFrEF. Generalized linear models were analyzed the cardiac outcomes after sacubitril/valsartan therapy by HFrEF duration. Results: Among these, 42 patients were HFrEF duration of <1 year and 47 patients were ≥1 year. The mean difference of QRS duration was lesser in the <1-year group than in the ≥1-year group (−2.3 msec vs 6.3 msec; P = .029). However, the mean difference of left ventricular ejection fraction (LVEF) was higher in the ≥1-year group (13.8% vs 5.8%; P = .008). After adjusting for patient demographics and clinical characteristics, the ≥1-year group had a significantly prolonged QRS duration (coefficient = 11; 95% confidence interval [CI], 0.3-21.7) and an unfavorable LVEF recovery (coefficient = −10.3; 95% CI −14.5 to −6.1) compared with the <1-year group. Conclusion: Prolonged QRS durations and unfavorable LVEF recoveries after sacubitril/valsartan therapy were observed in patients with HFrEF duration of ≥1 year. Earlier diagnosis of HFrEF and appropriate medication treatment may be beneficial in the improvement of QRS duration and LVEF recovery.

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“…[9,16,17] Ayrıca S/V'ın olumlu anti-aritmik etkilerinin olduğu ve ventriküler aritmilerde ve AKÖ'de azalma sağladığı bildirilmiştir. [9,10,[18][19][20][21][22] Tüm bu veriler dikkate alındığında mortalite ve morbiditede sağladığı belirgin üstünlük nedeniyle DEF-KY hastalarında OMT'nin gerçekten "optimal" olabilmesi için ACEI/ARB yerine S/V kullanılması gerektiğini düşündürmektedir. Sakubitril/valsartan'ın semptom, mortalite, EF, ventriküler aritmi ve AKÖ üzerine olumlu etkileri düşünüldüğünde ICD/CRT implantasyonu ile sağlanacak ilave sürvi avantajı belirgin olmayabilir.…”

unclassified

ICD/CRT kararındaki optimal medikal tedavi koşulu içinde sakubitril/valsartan yer almalı mı?

Kılıçaslan¹

2020

updates cardiol

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Switching From Ramipril to Sacubitril/Valsartan Favorably Alters Electrocardiographic Indices of Ventricular Repolarization in Heart Failure With Reduced Ejection Fraction

Cited by 4 publications

References 0 publications

Adverse events with sacubitril/valsartan in the real world: emerging signals to target preventive strategies from the FDA adverse event reporting system

Adverse events with sacubitril/valsartan in the real world: emerging signals to target preventive strategies from the FDA adverse event reporting system

Duration of Heart Failure With Reduced Ejection Fraction Associated With Electrocardiographic Outcomes Before and After Sacubitril/Valsartan

ICD/CRT kararındaki optimal medikal tedavi koşulu içinde sakubitril/valsartan yer almalı mı?

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