Dataset Information

Real-World Eligibility for Sacubitril/Valsartan in Heart Failure with Reduced Ejection Fraction Patients in Korea: Data from the Korean Acute Heart Failure (KorAHF) Registry.

ABSTRACT:

Background and objectives

Sacubitril/valsartan (SV, LCZ696), the first in class drug, called as angiotensin receptor-neprilysin inhibitor (ARNI) can reduce heart failure (HF) hospitalization and cardiovascular mortality. However, SV prescription rate remains still low despite current HF guideline recommendations. Considering the complex inclusion criteria of Prospective Comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure (PARADIGM-HF) trial, the real-world eligibility for SV remains uncertain in Asian heart failure with reduced ejection fraction (HFrEF) patients. Therefore, we aimed to assess real-world HF population eligibility for SV in a large Korean acute HF registry.

Methods

From March 2011 to February 2014, a total of 5,625 patients who were admitted for HF were enrolled in Korea. After excluding HF patients with left ventricular ejection fraction > 40% and in-hospital death, 2,941 patients were analyzed. Criteria for SV based on Korean Food and Drug Administration (KFDA) label and PARADIGM-HF were applied.

Results

Of 2,941 patients, KFDA label criteria excludes the absence of symptoms (New York Heart Association class I, 20%); PARADIGM-HF criteria excludes chronic kidney disease stage IV (9%), hyperkalemia (1%), hypotension (6%), and sub-optimal pharmacotherapy (52%, e.g. lower dose use of angiotensin converting enzyme inhibitor/angiotensin receptor blocker [ACEI/ARB], beta blocker use). When a daily requirement of ACEI/ARB ≥5 mg enalapril (instead of ≥10 mg) was used, the percent of eligibility for SV rose from 12% to 30% based on the PARADIGM-HF criteria.

Conclusions

Among the Korean hospitalized HFrEF patients, 80% met KFDA label criteria, while only 12% met the inclusion criteria of PARADIGM-HF trial for SV if requiring ≥10 mg enalapril. Sub-optimal pharmacotherapy could be the main reason for ineligible SV use based on the PARADIGM-HF criteria.

SUBMITTER: Oh J

PROVIDER: S-EPMC9536672 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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Publications

Real-World Eligibility for Sacubitril/Valsartan in Heart Failure with Reduced Ejection Fraction Patients in Korea: Data from the Korean Acute Heart Failure (KorAHF) Registry.

Oh Jaewon J Lee Chan Joo CJ Park Jin Joo JJ Lee Sang Eun SE Kim Min-Seok MS Cho Hyun-Jai HJ Choi Jin-Oh JO Lee Hae-Young HY Hwang Kyung-Kuk KK Kim Kye Hun KH Yoo Byung-Su BS Choi Dong-Ju DJ Baek Sang Hong SH Jeon Eun-Seok ES Kim Jae-Joong JJ Cho Myeong-Chan MC Chae Shung Chull SC Oh Byung-Hee BH Kang Seok-Min SM

International journal of heart failure 20191024 1

<h4>Background and objectives</h4>Sacubitril/valsartan (SV, LCZ696), the first in class drug, called as angiotensin receptor-neprilysin inhibitor (ARNI) can reduce heart failure (HF) hospitalization and cardiovascular mortality. However, SV prescription rate remains still low despite current HF guideline recommendations. Considering the complex inclusion criteria of Prospective Comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure (PARADIGM-HF) trial ...[more]

PMID: 36262737

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Project description:AimsARIADNE aimed to assess the association between effects of sacubitril/valsartan and no sacubitril/valsartan treatment and clinical characteristics, functional capacity, and clinical outcomes (cause-specific mortality and hospitalizations) in outpatients with heart failure (HF) with reduced ejection fraction (HFrEF).MethodsARIADNE was a prospective European registry of 9069 patients with HFrEF treated by office-based cardiologists or selected primary care physicians. Of the 8787 eligible for analysis, 4173 patients were on conventional HF treatment (non-S/V group), whereas 4614 patients were either on sacubitril/valsartan treatment at enrolment or started sacubitril/valsartan within 1 month of enrolment (S/V group). We also generated a restricted analysis set (rS/V) including only those 2108 patients who started sacubitril/valsartan treatment within the month prior to or after enrolment.ResultsAt the baseline, average age of patients enrolled in the study was 68 years, and 23.9% (2099/8787) were female. At the baseline, the proportions of patients with New York Heart Association (NYHA) Class III symptoms were 30.9 (1288/4173), 42.8 (1974/4614), and 48.2% (1015/2108), in non-S/V, S/V, and rS/V groups, respectively. After 12 months of treatment, the proportion of patients with NYHA Class III at baseline who improved to Class II was 32.0% (290/907) in the non-S/V group vs. 46.3% (648/1399) in S/V group and 48.7% (349/717) in rS/V group. The overall mortality rate was 5.0 per 100 patient-years. Rates of HF hospitalizations were high (20.9, 20.3, and 21.2 per 100 patient-years in the non-S/V, S/V, and rS/V groups, respectively). Emergency room visits without hospitalization occurred in 3.9, 3.2, and 3.9% of patients in the non-S/V, S/V, and rS/V groups, respectively.ConclusionsThis large HFrEF European registry provides a contemporary outcome profile of outpatients with HFrEF treated with or without sacubitril/valsartan. In a real-world setting, sacubitril/valsartan was associated with an improvement of symptoms in patients with HFrEF compared with the conventional HFrEF treatment.

Project description:AimsIn the heart failure (HF) with preserved ejection fraction (HFpEF) PARAGON-HF trial, sacubitril/valsartan vs. valsartan improved mortality/morbidity in patients with left ventricular ejection fraction (LVEF) below median (57%). We assessed eligibility for sacubitril/valsartan based on four scenarios.Methods and resultsEligibility was assessed in the Karolinska-Rennes study (acute HFpEF, LVEF ≥ 45%, and N-terminal pro-B-type natriuretic peptide ≥300 pg/mL subsequently assessed as outpatients including echocardiography) in (i) a trial scenario (all trial criteria); (ii) a pragmatic scenario (selected trial criteria); (iii) LVEF below lower limit of normal range (<54% in women and <52% in men); and (iv) LVEF below mean of normal range (<64% in women and <62% in men). Among 425 patients [age 78 (72-83) years, 57% women, 28% LVEF ≤ 57% (median in PARAGON-HF), the trial scenario, identified 34% as eligible. Left atrial enlargement and/or left ventricular hypertrophy were present in 99%. Inclusion criteria not met were diuretic treatment and New York Heart Association class. Important exclusion criteria were estimated glomerular filtration rate <30 mL/min/1.73 m2 , haemoglobin <10 g/day, and cancer. In the pragmatic scenario, 63% were eligible. In LVEF below lower limit of normal range, 5.4% were eligible, and in LVEF below mean of normal range, 41% were eligible. In patients with LVEF ≤ 57%, eligibility was 42%, 69%, 21%, and 91% according to the trial scenario, pragmatic scenario, LVEF below lower limit of normal range, and LVEF below mean of normal range, respectively.ConclusionsIn real-world HFpEF (LVEF ≥ 45%) with N-terminal pro-B-type natriuretic peptide and cardiac structure/function assessed, eligibility for sacubitril/valsartan was according to PARAGON-HF complete criteria 34%, pragmatic criteria 63%, LVEF below lower limit of normal range 5.4%, and LVEF below mean of normal range 41%. Cardiac structural impairment was almost ubiquitous. Ineligibility was more due to exclusion criteria than failing to meet inclusion criteria.

Project description:Background Dyslipidemia is common in heart failure with preserved ejection fraction. Sacubitril/valsartan improves glycemic control and augments natriuretic peptide signaling, providing mechanisms by which sacubitril/valsartan may affect serum lipids. However, empiric data on these effects are lacking. Methods and Results We analyzed 4774 participants from PARAGON-HF (Prospective Comparison of Angiotensin Receptor-Neprilysin Inhibitor With Angiotensin-Receptor Blockers Global Outcomes in Heart Failure With Preserved Ejection Fraction) with available screening lipids. During follow-up visits, we analyzed the treatment effect on lipid levels and assessed for interaction by baseline lipid levels. At the 16-week visit, we adjusted these treatment effects for the change in several biomarkers (including hemoglobin A1c and urinary cyclic guanosine monophosphate/creatinine [a biomarker of natriuretic peptide activation]). The average age was 73±8 years, 52% were women, 43% had diabetes mellitus, and 64% were on statin therapy. Compared with valsartan, sacubitril/valsartan reduced triglycerides -5.0% (95% CI, -6.6% to -3.5%), increased high-density lipoprotein cholesterol +2.6% (95% CI, +1.7% to +3.4%), and increased low-density lipoprotein cholesterol +1.7% (95% CI, +0.4% to +3.0%). Sacubitril/valsartan reduced triglycerides most among those with elevated baseline levels (triglycerides≥200 mg/dL) (P-interaction<0.001), and at 16 weeks by -13.0% (95% CI, -18.1% to -7.6%), or -29.9 (95% CI, -44.3 to -15.5) mg/dL, in this group. Adjusting for the change in urinary cyclic guanosine monophosphate/creatinine significantly attenuated treatment effects on triglycerides and high-density lipoprotein cholesterol, but not low-density lipoprotein cholesterol, while adjusting for other biomarkers did not significantly alter the treatment effects. Conclusions Sacubitril/valsartan significantly reduces triglycerides compared with valsartan, an effect that was nearly threefold stronger in those with elevated baseline triglycerides. Modest increases in high-density lipoprotein cholesterol and low-density lipoprotein cholesterol cholesterol were also observed with therapy. The underlying mechanism(s) of changes in high-density lipoprotein cholesterol and triglycerides are related to sacubitril/valsartan's effects on natriuretic peptide activity. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01920711.

Dataset Information

Real-World Eligibility for Sacubitril/Valsartan in Heart Failure with Reduced Ejection Fraction Patients in Korea: Data from the Korean Acute Heart Failure (KorAHF) Registry.

Background and objectives

Methods

Results

Conclusions

Publications

Real-World Eligibility for Sacubitril/Valsartan in Heart Failure with Reduced Ejection Fraction Patients in Korea: Data from the Korean Acute Heart Failure (KorAHF) Registry.

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