School of Cardiology, University of Bari, Piazza Giulio Cesare 11, Bari, 70124, Italy.
Cardiology Unit, Hospital of Brindisi, S.S. 7 per Mesagne, Brindisi, 72100, Italy.
ESC Heart Fail. 2021 Aug;8(4):2951-2958. doi: 10.1002/ehf2.13380. Epub 2021 May 15.
Sodium-glucose co-transporter-2 inhibitors (SGLT2i) have been shown to have a relevant role in the prevention of hospitalizations for heart failure and improvement in the life expectancy of patients with diabetes and outpatients with chronic heart failure (CHF) with reduced left ventricular ejection fraction, independently from the presence of type 2 diabetes mellitus (T2DM). The aim of our study was to evaluate in a real-world population the number of outpatients with CHF who meet the enrolment criteria of the main randomized controlled trials (RCT) published in the last 5 years and consequently identify the percentage of patients who could potential benefit from SGLT2i therapy.
We retrospectively evaluated all consecutive outpatients referred for CHF. The diagnosis of T2DM was according to the latest European Society of Cardiology Guidelines. Clinical characteristics considered for the enrolment in the RCTs were recorded. We enrolled 515 patients, 384 (75%) of whom had a left ventricular ejection fraction (LVEF) ≤ 40%, 82 (16%) had pre-diabetes, and 187 (36%) had diabetes. Most of the patients with LVEF ≤ 40% met the criteria for the DAPA-HF trial (65%), and this percentage was even higher if the serum level of N-terminal pro-brain natriuretic peptide was not considered. A high percentage of patients with diabetes and LVEF > 40% met the criteria for the DECLARE (39%), CANVAS (47%), and EMPA-REG (30%) trials. Patients meeting the enrolment criteria of RCTs evaluating SGLT2i were also characterized by a high risk of heart failure events during follow-up.
In spite of a low number of patients actually treated with SGLT2i, we observed that a high prevalence of patients with CHF met the clinical characteristics of RCTs that have demonstrated a beneficial effect of SGLT2i.
钠-葡萄糖协同转运蛋白 2 抑制剂(SGLT2i)已被证明在预防心力衰竭住院和改善糖尿病患者和慢性心力衰竭(CHF)伴左心室射血分数降低的门诊患者的预期寿命方面发挥重要作用,独立于 2 型糖尿病(T2DM)的存在。我们的研究目的是在真实世界人群中评估符合过去 5 年发表的主要随机对照试验(RCT)入组标准的 CHF 门诊患者数量,并确定可能从 SGLT2i 治疗中获益的患者比例。
我们回顾性评估了所有因 CHF 就诊的连续门诊患者。T2DM 的诊断依据最新的欧洲心脏病学会指南。记录了用于 RCT 入组的临床特征。我们共纳入了 515 例患者,其中 384 例(75%)左心室射血分数(LVEF)≤40%,82 例(16%)为糖尿病前期,187 例(36%)患有糖尿病。大多数 LVEF≤40%的患者符合 DAPA-HF 试验的标准(65%),如果不考虑脑钠肽前体 N 端水平,这一比例甚至更高。较高比例的 LVEF>40%和糖尿病患者符合 DECLARE(39%)、CANVAS(47%)和 EMPA-REG(30%)试验的标准。符合 RCT 评估 SGLT2i 入组标准的患者在随访期间也具有较高的心力衰竭事件风险。
尽管实际接受 SGLT2i 治疗的患者数量较少,但我们观察到大量 CHF 患者符合已证明 SGLT2i 有益作用的 RCT 的临床特征。