British Heart Foundation Glasgow, Institute of Cardiovascular and Medical Sciences, University of Glasgow, University Avenue, Glasgow, G12 8TA, UK.
Department of Clinical Science and Education, Södersjukhuset, Stockholm, Sweden.
Cardiovasc Drugs Ther. 2019 Jun;33(3):315-322. doi: 10.1007/s10557-019-06873-1.
PARADIGM-HF demonstrated the superiority of sacubitril/valsartan over enalapril in patients with heart failure and reduced ejection fraction (HF-REF). How widely applicable sacubitril/valsartan treatment is in unselected patients with HF-REF is not known. We examined eligibility of patients with HF-REF for treatment with sacubitril/valsartan, according to the criteria used in PARADIGM-HF, in the Swedish Heart Failure Registry (SwedeHF).
Patients were considered potentially eligible if they were not hospitalized, had symptoms (NYHA class II-IV) and a reduced LVEF (≤ 40%), and were prescribed an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) at a dose equivalent to enalapril ≥ 10 mg daily. In these patients, we evaluated further eligibility according to the main additional PARADIGM-HF inclusion criteria.
Of 12,866 outpatients in NYHA functional class II-IV with an LVEF ≤ 40%, 9577 were prescribed at least 10 mg of enalapril (or equivalent) daily. Complete additional data were available for 3099 of these patients (32.4%) and of them 75.5% were potentially eligible for treatment with sacubitril/valsartan. The most common reason for ineligibility was a low natriuretic peptide level (n = 462, 14.9%). Only a small proportion of patients were ineligible due to low eGFR or serum potassium level. Because only 78% of patients were taking ≥ 10 mg enalapril or equivalent daily, only 58.9% of all patients (75.5% of 78%) were eligible for sacubitril/valsartan.
Between 34 and 76% of symptomatic patients with HF-REF in a 'real world' population are eligible for treatment with sacubitril/valsartan, depending on background ACEI/ARB dose. The most common reason for ineligibility is a low natriuretic peptide level.
PARADIGM-HF 研究表明，在射血分数降低的心力衰竭（HF-REF）患者中，沙库巴曲缬沙坦优于依那普利。沙库巴曲缬沙坦在未经选择的 HF-REF 患者中的广泛适用性尚不清楚。我们根据 PARADIGM-HF 研究中的标准，在瑞典心力衰竭注册研究（SwedeHF）中检查了 HF-REF 患者接受沙库巴曲缬沙坦治疗的资格。
如果患者未住院，有症状（NYHA 心功能 II-IV 级）且左心室射血分数（LVEF）≤40%，并且正在服用相当于依那普利≥10mg 每日的剂量的血管紧张素转换酶抑制剂（ACEI）或血管紧张素受体阻滞剂（ARB），则认为患者有资格入选。在这些患者中，我们根据主要的附加 PARADIGM-HF 纳入标准进一步评估其资格。
在 NYHA 心功能 II-IV 级且 LVEF≤40%的 12866 例门诊患者中，有 9577 例患者每天至少服用 10mg 依那普利（或等效剂量）。其中 3099 例患者的完整附加数据可用（32.4%），其中 75.5%有资格接受沙库巴曲缬沙坦治疗。最常见的不合格原因是低利钠肽水平（n=462，14.9%）。仅有少数患者因肾小球滤过率或血清钾水平低而不合格。由于只有 78%的患者每天服用≥10mg 依那普利或等效剂量，因此只有 58.9%的所有患者（75.5%的 78%）有资格接受沙库巴曲缬沙坦治疗。
在“真实世界”人群中，HF-REF 有症状患者中，根据背景 ACEI/ARB 剂量，有 34%至 76%的患者有资格接受沙库巴曲缬沙坦治疗。最常见的不合格原因是低利钠肽水平。
