Dataset Information

Effectiveness and Safety of Sacubitril/Valsartan in Patients with Chronic Kidney Disease-A Real-World Experience.

ABSTRACT:

Background

data regarding the effectiveness and safety of sacubitril/valsartan in heart failure and reduced ejection fraction (HFrEF) patients with chronic kidney disease (CKD) are scarse.

Objective

to evaluate the effectiveness and safety of sacubitril/valsartan in HFrEF and CKD in a real-world population.

Methods

we included consecutive ambulatory HFrEF patients that initiated sacubitril/valsartan between February 2017 and October 2020, stratified by CKD (KDIGO stage 5 excluded).

Primary outcomes

the incidence rate per 100 patient-years and the annualized length of stay (LOS) of acute decompensated HF hospitalizations (HFH).

Secondary outcomes

all-cause mortality, NYHA improvement, and titration of sacubitril/valsartan.

Results

We included 179 patients, 77 with CKD, those being older (72 ± 10 vs. 65 ± 12 years, p < 0.001), had higher NT-proBNP (4623 ± 5266 vs. 1901 ± 1835 pg/mL, p < 0.001), and high anaemia incidence (p < 0.001). After 19 ± 11 months, a significant reduction in HFH adjusted incidence rate (57.5% decrease in CKD vs. 74.6%, p = 0.261) was observed, with 5 days there was a reduction in annualized LOS in both groups (p = 0.319). NYHA improved similarly in both groups (p = 0.670). CKD patients presented non-significant higher all-cause mortality (HR = 2.405, 95%CI: [0.841; 6.879], p = 0.102). Both groups had similar sacubitril/valsartan maximum dose achievement and drug withdrawal.

Conclusion

sacubitril/valsartan was effective on reducing HFH and LOS without affecting all-cause mortality in a CKD real-world population.

SUBMITTER: Pereira SC

PROVIDER: S-EPMC9967392 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effectiveness and Safety of Sacubitril/Valsartan in Patients with Chronic Kidney Disease-A Real-World Experience.

Pereira Sara C SC Rodrigues Tiago T Nunes-Ferreira Afonso A Agostinho João R JR Pinto Fausto J FJ Brito Dulce D

Journal of clinical medicine 20230207 4

<h4>Background</h4>data regarding the effectiveness and safety of sacubitril/valsartan in heart failure and reduced ejection fraction (HFrEF) patients with chronic kidney disease (CKD) are scarse.<h4>Objective</h4>to evaluate the effectiveness and safety of sacubitril/valsartan in HFrEF and CKD in a real-world population.<h4>Methods</h4>we included consecutive ambulatory HFrEF patients that initiated sacubitril/valsartan between February 2017 and October 2020, stratified by CKD (KDIGO stage 5 ex ...[more]

PMID: 36835870

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Project description:IntroductionPatients with end-stage kidney disease (ESKD) frequently develop heart failure, contributing to high mortality. Limited data exist on cardiovascular benefits and safety of sacubitril-valsartan in this population. Our systematic review aims to evaluate the efficacy and safety of sacubitril-valsartan versus standard care in patients with ESKD who are on dialysis.MethodsWe conducted a search in Embase, MEDLINE, and Cochrane databases to identify relevant studies and assessed outcomes using random-effect model and generic inverse variance approach.ResultsAnalysis of 12 studies involving 799 eligible patients with ESKD revealed improvement in left ventricular ejection fraction (LVEF) with sacubitril-valsartan compared to a control group with pooled mean difference (MD) 6.58% (95% confidence interval [CI]: 1.86, 11.29). LVEF significantly improved in patients with LVEF <50% (heart failure with reduced ejection fraction [HFrEF] and heart failure with moderately reduced ejection fraction [HFmrEF]) with MD 12.42% (95% CI: 9.39, 15.45). However, patients with LVEF >50% (heart failure with preserved ejection fraction [HFpEF]) did not exhibit statistically significant effect, MD 2.6% (95% CI: 1.15, 6.35). Sacubitril-valsartan significantly enhanced LVEF in patients with HFrEF, with MD 13.8% (95% CI: 12.04, 15.82). Safety analysis indicated no differences in incidence of hyperkalemia (pooled odds ratio [OR] 0.72; 95% CI: 0.38, 1.36) or hypotension (pooled risk ratio [RR] 1.03; 95% CI: 0.36, 2.98). No cases of angioedema were reported. However, safety analysis relies on evidence of limited robustness due to the observational nature of the studies.ConclusionOur systematic review suggests that sacubitril-valsartan benefits patients with ESKD with HFrEF and HFmrEF by improving LVEF without increasing the risk of hyperkalemia, hypotension, or angioedema compared to standard care. However, safety analysis based on observational studies inherently has limitations for establishing causal relationships.

Project description:AimsThe angiotensin receptor-neprilysin inhibitor (ARNI) sacubitril/valsartan (Sac/Val) demonstrated to be superior to enalapril in reducing hospitalizations, cardiovascular and all-cause mortality in patients with ambulatory heart failure and reduced ejection fraction (HFrEF), in particular when it is maximally up-titrated. Unfortunately, the target dose is achieved in less than 50% of HFrEF patients, thus undermining the beneficial effects on the outcomes. In this study, we aimed to evaluate the role of Sac/Val and its titration dose on reverse cardiac remodelling and determine which echocardiographic index best predicts the up-titration success.Methods and resultsFrom January 2020 to June 2021, we retrospectively identified 95 patients (65.6 [59.1-72.8] years; 15.8% females) with chronic HFrEF who were prescribed Sac/Val from the HF Clinics of 5 Italian University Hospitals and evaluated the tolerability of Sac/Val high dose (the ability of the patient to achieve and stably tolerate the maximum dose) as the primary endpoint in the cohort. We used a multivariable logistic regression analysis, with a stepwise backward selection method, to determine the independent predictors of Sac/Val maximum dose tolerability, using, as candidate predictors, only variables with a P-value < 0.1 in the univariate analyses. Candidate predictors identified for the multivariable backward logistic regression analysis were age, sex, body mass index (BMI), chronic kidney disease (CKD), chronic obstructive pulmonary disease (COPD), dyslipidaemia, atrial fibrillation, systolic blood pressure (SBP), baseline tolerability of ACEi/ARBs maximum dose, left ventricle global longitudinal strain (LVgLS), LV ejection fraction (EF), tricuspid annulus plane systolic excursion (TAPSE), right ventricle (RV) fractional area change (FAC), RV global and free wall longitudinal strain (RVgLS and RV-FW-LS). After the multivariable analysis, only one categorical (ACEi/ARBs maximum dose at baseline) and three continuous (younger age, higher SBP, and higher TAPSE), resulted significantly associated with the study outcome variable with a strong discriminatory capacity (area under the curve 0.874, 95% confidence interval (CI) (0.794-0.954) to predict maximum Sac/Val dose tolerability.ConclusionsOur study is the first to analyse the potential role of echocardiography and, in particular, of RV dysfunction, measured by TAPSE, in predicting Sac/Val maximum dose tolerability. Therefore, patients with RV dysfunction (baseline TAPSE <16 mm, in our cohort) might benefit from a different strategy to titrate Sac/Val, such as starting from the lowest dose and/or waiting for a more extended period of observation before attempting with the higher doses.

Project description:BackgroundTo determine the effectiveness of sacubitril/valsartan 97/103 mg twice daily (b.i.d.) on tolerability, safety, and quality of life (QoL) in Canadian patients with heart failure with reduced ejection fraction in a real-life setting.MethodsIn Prospective, Multicenter, Open Label, Post-Approval Study Aimed at Characterizing the Use of LCZ696 at 97 mg Sacubitril/103 mg Valsartan bid in Patients With HFrEF (PARASAIL), an open-label, prospective, phase IV, multicentre study, outpatients with heart failure with reduced ejection fraction and New York Heart Association functional class II-III were followed up for 12 months. The suggested starting dose of sacubitril/valsartan was 24/26 mg b.i.d. replacing angiotensin-converting enzyme inhibitor or angiotensin receptor blocker, with an uptitration to 97/103 mg b.i.d. or as per clinical judgement. The primary endpoint was the proportion of patients achieving the target dose of sacubitril/valsartan 97/103 mg b.i.d. after 6 months of treatment.ResultsFor the 302 patients included, the mean age was 64.47 years, and a majority of patients (82.8%) belonged to New York Heart Association class II. Overall, 195 (64.6%) patients were on maximum dose of sacubitril/valsartan 97/103 mg b.i.d. after 6 months and 62.3% remained on this dose at month 12. Using patient global assessment, patients experienced an improvement in QoL. For Minnesota Living with Heart Failure Questionnaire scores, a significant decrease from the baseline was observed at weeks 4, 12, and 24 (P < 0.0001 for all), which indicated an improvement in QoL. The patient global assessment and Minnesota Living with Heart Failure Questionnaire results correlate with moderate but significant changes in Euro quality of life-5D visual analogue scale scores.ConclusionsResults of the PARASAIL study in a real-life setting have shown that most patients were on sacubitril/valsartan 97/103 mg b.i.d. and the treatment was well tolerated. The patient-reported outcomes showed an overall improvement in patients' QoL.

Project description:AimsThe study aims to explore the real-world titration patterns of sacubitril/valsartan in a chronic heart failure (HF) follow-up management system and the effect on the recovery of ventricular remodelling and cardiac function in China.Methods and resultsThis is a single-centre, observational study of 153 adult outpatients with HF and reduced ejection fraction who were managed in the chronic HF follow-up management system and prescribed with sacubitril/valsartan from August 2017 to August 2021 in China. All patients tried to titrated sacubitril/valsartan to the tolerant dose during follow-up. The primary outcome was the proportion of patients who reached and maintained the target dose of sacubitril/valsartan. The main secondary outcomes were the changes in left atrium diameter, left ventricular end-diastolic diameter (LVEDD), and left ventricular ejection fraction (LVEF) from baseline to 12 months. Among the patients, 69.3% were male, with a median age of 49 years. The baseline systolic blood pressure (SBP) was 117.6 ± 18.3 mmHg before starting the treatment of sacubitril/valsartan. Benefiting from the management system, 117 (76.5%) patients achieved the target dose of sacubitril/valsartan, and the median time to reach the target dose was 3 (IQR 1-5) months. Advanced age and lower SBP may be predictors of failure to reach the target dose. Compared with baseline, standard treatment resulted in a pronounced improvement in left ventricular geometry and cardiac function. The patients showed a significant increase in LVEF [28 (IQR 21-34) % vs. 42 (IQR 37.0-54.3) %, P < 0.001], with a great reduction in left atrium diameter [45 (IQR 40.3-51.0) mm vs. 41 (IQR 37.0-45.3) mm, P < 0.001] and LVEDD [65 (IQR 60.0-70.3) mm vs. 55 (IQR 52-62) mm, P < 0.001] during 12 month follow-up. Of patients, 36.5% had a LVEF ≥50%, 54.1% had LVEF >40%, and 81.1% experienced an increase in LVEF of ≥10%. After 12 month follow-up, the proportion of patients with New York Heart Association classification I or II increased from 41.8% to 96.4%. Additionally, there was a significant improvement in N-terminal pro-B-type natriuretic peptide (P < 0.001). At Month 12, 50% of patients achieved the target dose of beta-blockers. No serious adverse events caused by sacubitril/valsartan were observed during the follow-up.ConclusionsOptimising HF follow-up management was essential and effective in a real-world clinical setting; the majority could reach the target dose of sacubitril/valsartan within the management system and achieve a remarkable improvement in cardiac function and ventricular remodelling.

Dataset Information

Effectiveness and Safety of Sacubitril/Valsartan in Patients with Chronic Kidney Disease-A Real-World Experience.

Background

Objective

Methods

Primary outcomes

Secondary outcomes

Results

Conclusion

Publications

Effectiveness and Safety of Sacubitril/Valsartan in Patients with Chronic Kidney Disease-A Real-World Experience.

Similar Datasets

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