Baseline characteristics and treatment of patients in prospective comparison of ARNI with ACEI to determine impact on global mortality and morbidity in heart failure trial (PARADIGM-HF).

Baseline characteristics and treatment of patients in prospective comparison of ARNI with ACEI to determine impact on global mortality and morbidity in heart failure trial (PARADIGM-HF).
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DOI:
10.1002/ejhf.115
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发表时间:
2014-07
影响因子:
18.2
通讯作者:
Zile, Michael R.
Zile, Michael R.
中科院分区:
医学1区
文献类型:
--
作者:
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.

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描述PARADIGM-HF(前瞻性比较ARNi与ACEi对心力衰竭全球死亡率和发病率的影响)试验中随机化患者的基线特征和治疗,检验LCZ 696 200 mg b.i.d.上级优于依那普利10 mg b.i.d.降低心力衰竭和射血分数降低患者的死亡率和发病率。报告了关键的人口统计学、临床和实验室结果沿着基线治疗,并与左心室功能障碍研究(SOLVD-T)治疗组患者以及心力衰竭和射血分数降低的更现代药物和器械试验进行了比较。PARADIGM-HF中8442例患者的平均年龄为64岁(SD 11),78%为男性,这与SOLVD-T和最近的试验相似。尽管接受了β受体阻滞剂(93%的患者)和盐皮质激素受体拮抗剂(60%)的广泛背景治疗,但PARADIGM-HF患者的症状和体征持续存在,健康相关生活质量降低,LVEF降低(平均值29 ± SD 6%),N-末端-proB型利钠肽水平升高(中位数1608,四分位数间范围886-3221 pg/mL)。PARADIGM-HF将确定LCZ 696是否比依那普利更有益,当添加到其他疾病修饰疗法时,以及内源性利钠肽的进一步增加是否会降低心力衰竭和射血分数降低的发病率和死亡率。
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.
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