McMurray John J V, Packer Milton, Desai Akshay S, Gong Jianjian, Lefkowitz Martin, Rizkala Adel R, Rouleau Jean L, Shi Victor C, Solomon Scott D, Swedberg Karl, Zile Michael R
BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, Scotland, UK.
Eur J Heart Fail. 2014 Jul;16(7):817-25. doi: 10.1002/ejhf.115. Epub 2014 Jun 3.
To describe the baseline characteristics and treatment of the patients randomized in the PARADIGM-HF (Prospective comparison of ARNi with ACEi to Determine Impact on Global Mortality and morbidity in Heart Failure) trial, testing the hypothesis that the strategy of simultaneously blocking the renin-angiotensin-aldosterone system and augmenting natriuretic peptides with LCZ696 200 mg b.i.d. is superior to enalapril 10 mg b.i.d. in reducing mortality and morbidity in patients with heart failure and reduced ejection fraction.
Key demographic, clinical and laboratory findings, along with baseline treatment, are reported and compared with those of patients in the treatment arm of the Studies Of Left Ventricular Dysfunction (SOLVD-T) and more contemporary drug and device trials in heart failure and reduced ejection fraction.
The mean age of the 8442 patients in PARADIGM-HF is 64 (SD 11) years and 78% are male, which is similar to SOLVD-T and more recent trials. Despite extensive background therapy with beta-blockers (93% patients) and mineralocorticoid receptor antagonists (60%), patients in PARADIGM-HF have persisting symptoms and signs, reduced health related quality of life, a low LVEF (mean 29 ± SD 6%) and elevated N-terminal-proB type-natriuretic peptide levels (median 1608 inter-quartile range 886-3221 pg/mL).
PARADIGM-HF will determine whether LCZ696 is more beneficial than enalapril when added to other disease-modifying therapies and if further augmentation of endogenous natriuretic peptides will reduce morbidity and mortality in heart failure and reduced ejection fraction.
描述在PARADIGM-HF（血管紧张素受体脑啡肽酶抑制剂与血管紧张素转换酶抑制剂对心力衰竭患者全球死亡率和发病率影响的前瞻性比较）试验中随机分组患者的基线特征和治疗情况，验证以下假设：与每日两次服用10 mg依那普利相比，每日两次服用200 mg LCZ696同时阻断肾素-血管紧张素-醛固酮系统并增强利钠肽的策略，在降低射血分数降低的心力衰竭患者的死亡率和发病率方面更具优势。
报告关键的人口统计学、临床和实验室检查结果以及基线治疗情况，并与左心室功能障碍研究（SOLVD-T）治疗组患者以及射血分数降低的心力衰竭领域更近期的药物和器械试验中的患者情况进行比较。
PARADIGM-HF试验中8442例患者的平均年龄为64（标准差11）岁，78%为男性，这与SOLVD-T试验及近期试验相似。尽管广泛使用了β受体阻滞剂（93%的患者）和盐皮质激素受体拮抗剂（60%）进行背景治疗，但PARADIGM-HF试验中的患者仍有持续的症状和体征，健康相关生活质量降低，左心室射血分数较低（平均29±标准差6%），N末端B型利钠肽前体水平升高（中位数1608，四分位间距886 - 3221 pg/mL）。
PARADIGM-HF试验将确定在添加其他改善病情的治疗方法时，LCZ696是否比依那普利更有益，以及进一步增强内源性利钠肽是否会降低射血分数降低的心力衰竭患者的发病率和死亡率。
