EPIC Hospital (Unit of Vatsalya Healthcare LLP), Ahmedabad, Gujarat, India.
Deep Heart Centre, Deep Hospital Model Town, Ludhiana, Punjab, India.
Indian Heart J. 2020 Nov-Dec;72(6):535-540. doi: 10.1016/j.ihj.2020.09.016. Epub 2020 Sep 28.
To determine efficacy and safety of sacubitril/valsartan compared with enalapril in Indian patients of PARADIGM-HF trial.
A randomized, double-blind, active-controlled, phase III sub-study (NCT01035255) was conducted between April 2010 and May 2014. Patients with chronic heart failure (HF), aged >18 years with left ventricular ejection fraction ≤40% were randomized (1:1) to receive either sacubitril/valsartan 200 mg twice-daily or enalapril 10 mg twice-daily. The primary endpoint was to compare efficacy of sacubitril/valsartan to enalapril in delaying time-to-first occurrence of the composite endpoint (cardiovascular [CV] death or HF hospitalization).
The trial was stopped after a median follow-up of 27 months, because the boundary for benefit with sacubitril/valsartan had crossed. Among 637 Indian patients in PARADIGM-HF (sacubitril/valsartan, n = 322 and enalapril, n = 315), the primary outcome, CV death, and the first hospitalization for HF occurred in 21.81% and 24.76% (HR 0.89; 95% CI, 0.646-1.231), 17.45% and 20.63% (HR 0.87; 95% CI, 0.605-1.236), and 7.48% and 9.52% (HR 0.78; 95% CI, 0.461-1.350) patients in the sacubitril/valsartan and enalapril group, respectively. The all-cause mortality (19.0% vs. 21.9%) and adverse events (78.4% vs. 82.2%) were comparatively lower in the sacubitril/valsartan than enalapril group. No significant difference was seen between the benefits of treatment in Indian and the total PARADIGM-HF cohort (p value for interaction >0.05).
Results support the use of sacubitril/valsartan in Indian patients with chronic HF with reduced ejection fraction with treatment benefits similar to global PARADIGM-HF cohort.
评估沙库巴曲缬沙坦（sacubitril/valsartan）在 PARADIGM-HF 试验的印度患者中的疗效和安全性，与依那普利进行比较。
这是一项于 2010 年 4 月至 2014 年 5 月期间开展的随机、双盲、活性对照、III 期亚组研究（NCT01035255）。将年龄>18 岁且左心室射血分数（LVEF）≤40%的慢性心力衰竭（HF）患者，以 1:1 的比例随机分为沙库巴曲缬沙坦 200mg 每日两次或依那普利 10mg 每日两次。主要终点是比较沙库巴曲缬沙坦和依那普利在延迟首次发生复合终点（心血管死亡或 HF 住院）时间方面的疗效。
在中位随访 27 个月后，试验因沙库巴曲缬沙坦的获益边界已经越过而停止。在 PARADIGM-HF 的 637 例印度患者（沙库巴曲缬沙坦组，n=322；依那普利组，n=315）中，主要结局、心血管死亡和首次因 HF 住院的发生率分别为 21.81%和 24.76%（HR 0.89；95%CI，0.646-1.231）、17.45%和 20.63%（HR 0.87；95%CI，0.605-1.236）和 7.48%和 9.52%（HR 0.78；95%CI，0.461-1.350）。沙库巴曲缬沙坦组的全因死亡率（19.0% vs. 21.9%）和不良事件（78.4% vs. 82.2%）较依那普利组较低。印度人群与 PARADIGM-HF 总体人群的治疗获益之间未见显著差异（交互作用 p 值>0.05）。
结果支持在射血分数降低的慢性 HF 印度患者中使用沙库巴曲缬沙坦，其治疗获益与全球 PARADIGM-HF 队列相似。
