Polyclinic "Dr. Nabil", Sarajevo, Bosnia and Herzegovina.
Faculty of Medicine, University of Sarajevo, Sarajevo, Bosnia and Herzegovina.
Med Arch. 2023 Apr;77(2):105-111. doi: 10.5455/medarh.2023.77.105-111.
Heart failure remains one of the most prevalent clinical syndromes associated with significant morbidity and mortality. According to current guidelines, the prescription of a MRA is recommended to reduce the risk of HF hospitalization and death in all patients with symptomatic heart failure and no contraindications for this therapy.
The aim of our study was to determine the efficacy of eplerenone vs. spironolactone on left ventricular systolic function by measuring left ventricle ejection fraction (LVEF) in patients with chronic heart failure, especially their effect on preventing hospitalization, reducing mortality, and improving clinical status among patients with chronic HF.
From June 2021 to June 2022, the study was a randomized, prospective clinical trial single blind study. A total of 142 patients of chronic heart failure with reduced ejection fraction were selected by random sampling. Each patient was randomly allocated into either of the two groups and was continued receiving treatment with either spironolactone (Spiron-HF group) or eplerenone (Epler-HF group). Patients in Epler-HF group were compared with an arm of the same size and matched by age and gender patients in Spiron-HF group for management of chronic HFrEF. Each patient was evaluated clinically, biochemically, and echocardiographically at the beginning of treatment (baseline) after 6 months and at the end of 12th month. Echocardiography was performed to find out change in left ventricular systolic function.
After 12 months of treatment, significant improvement of left ventricular ejection fraction was observed in eplerenone treated arm (37.9 ± 3.8 ± 4.6 in Spiron-HF group versus 40.1 ± 5.7 in Epler-HF group; P < 0.05). A significant reduction in left ventricular end-systolic volume (6.3 ± 2.5ml in Spiron-HF versus 17.8± 4.4ml in Epler-HF group; P < 0.05) and left ventricular systolic diameter volume (2.7 ± 0.5ml in Spiron-HF versus 6.7 ± 0.2ml in Epler-HF group; P < 0.05), occurred after 12 months of treatment. Left ventricular global longitudinal strain (LV GLS) was significantly improved in Epler-HF group compared with Spiron-HF group (0.6 ± 0.4 versus 3.4 ± 0.9; P < 0.05). There were no significant differences observed in reduction of left ventricular end-diastolic volume (2.2 ± 0.5 ml versus 4.7 ± 1.1ml; P =0.103) and left ventricular diastolic diameter (1.2 ± 0.6 versus 1.7 ± 0.3; P=0.082) in both arms. The effects of both MRA agents spironolactone and eplerenone on the primary composite outcome, each of the individual mortality and hospital admission outcomes are shown in Figure 1 and 2. Patients of the Epler-HF group showed statistically significant lower cardiovascular mortality (HR 0.53; 95% CI 0.34-0.82; p= 0.007) and all-cause mortality (HR 0.64; 95% CI 0.44-0.93; p= 0.022) than patients of the Spiron-HF group. The statistical analysis did not show a statistically significant difference between Epler -HF and Spiron-HF study groups regarding the risk of the primary composite outcome; cardiovascular death or hospitalization due to HF (Hazard Ratio (HR) eplerenone vs. spironolactone = 0.95; 95% Confidence Interval (CI) 0.73- 1.27; p= 0.675).
Our study has demonstrated favorable effects of eplerenone on cardiac remodeling parameters and reduction of cardiovascular mortality and all-cause mortality compared with spironolactone in the treatment of HFrEF. The ability of eplerenone to effectively block the mineralocorticoid receptor while minimizing side effects and a significant reduction in the risk of hospitalization and cardiovascular death confirms its key role in the treatment of patients with chronic HFrEF.
心力衰竭仍然是与高发病率和死亡率相关的最常见临床综合征之一。根据现行指南,建议所有有症状心力衰竭且无该治疗禁忌证的患者使用 MRA 以降低心力衰竭住院和死亡的风险。
我们的研究旨在通过测量左心室射血分数(LVEF)来确定依普利酮与螺内酯对慢性心力衰竭患者左心室收缩功能的疗效,特别是它们在预防住院、降低死亡率和改善慢性心力衰竭患者临床状况方面的作用。
从 2021 年 6 月至 2022 年 6 月,该研究是一项随机、前瞻性临床试验单盲研究。通过随机抽样选择了 142 例慢性射血分数降低性心力衰竭患者。每位患者随机分配到两组中的一组,并继续接受螺内酯(Spiron-HF 组)或依普利酮(Epler-HF 组)治疗。Epler-HF 组的患者与 Spiron-HF 组相同大小且年龄和性别相匹配的患者进行慢性 HFrEF 的管理。每位患者在治疗开始时(基线)、治疗 6 个月后和治疗 12 个月末进行临床、生化和超声心动图评估。超声心动图用于发现左心室收缩功能的变化。
治疗 12 个月后,依普利酮治疗组左心室射血分数明显改善(Spiron-HF 组 37.9±3.8±4.6,Epler-HF 组 40.1±5.7;P<0.05)。左心室收缩末期容积(Spiron-HF 组 6.3±2.5ml 与 Epler-HF 组 17.8±4.4ml;P<0.05)和左心室收缩末期直径容积(Spiron-HF 组 2.7±0.5ml 与 Epler-HF 组 6.7±0.2ml;P<0.05)在治疗 12 个月后显著降低。与 Spiron-HF 组相比,Epler-HF 组左心室整体纵向应变(LV GLS)明显改善(0.6±0.4 与 3.4±0.9;P<0.05)。两组左心室舒张末期容积(Spiron-HF 组 2.2±0.5ml 与 Epler-HF 组 4.7±1.1ml;P=0.103)和左心室舒张末期直径(Spiron-HF 组 1.2±0.6 与 Epler-HF 组 1.7±0.3;P=0.082)降低无显著差异。螺内酯和依普利酮两种 MRA 药物对主要复合结局、每个死亡率和住院结局的影响如图 1 和图 2 所示。Epler-HF 组患者心血管死亡率(HR 0.53;95%CI 0.34-0.82;p=0.007)和全因死亡率(HR 0.64;95%CI 0.44-0.93;p=0.022)均显著低于 Spiron-HF 组患者。统计学分析未显示 Epler-HF 和 Spiron-HF 研究组之间主要复合结局(心血管死亡或因心力衰竭住院)的风险存在统计学差异(依普利酮与螺内酯的风险比(HR)=0.95;95%置信区间(CI)0.73-1.27;p=0.675)。
与螺内酯相比,我们的研究表明依普利酮在治疗 HFrEF 时对心脏重塑参数以及降低心血管死亡率和全因死亡率有良好的作用。依普利酮能够有效阻断盐皮质激素受体,同时最大限度地减少副作用,并显著降低住院和心血管死亡的风险,这证实了它在治疗慢性 HFrEF 患者中的关键作用。