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Efficacy and Safety of LCZ696, a First-in-Class Angiotensin Receptor Neprilysin Inhibitor, in Asian Patients With Hypertension
Kario, Kazuomi1; Sun, Ningling2; Chiang, Fu-Tien3; Supasyndh, Ouppatham4; Baek, Sang Hong5; Inubushi-Molessa, Akiko6; Zhang, Ying6; Gotou, Hiromi7; Lefkowitz, Martin6; Zhang, Jack6
关键词Asia Blood Pressure Monitoring Ambulatory Hypertension Randomized Controlled Trial
刊名HYPERTENSION
2014-04-01
DOI10.1161/HYPERTENSIONAHA.113.02002
63期:4页:698-705
收录类别SCI
文章类型Article
WOS标题词Science & Technology
类目[WOS]Peripheral Vascular Disease
资助者Novartis AG, Basel ; Novartis AG, Basel
研究领域[WOS]Cardiovascular System & Cardiology
关键词[WOS]AMBULATORY BLOOD-PRESSURE ; CARDIOVASCULAR-DISEASE ; NATRIURETIC PEPTIDE ; CIRCADIAN-RHYTHM ; PULSE PRESSURE ; MORNING SURGE ; RISK-FACTORS ; MANAGEMENT ; JAPANESE ; OMAPATRILAT
英文摘要

LCZ696 (Japanese adopted name: sucabitril valsartan sodium hydrate), a first-in-class angiotensin receptor neprilysin inhibitor, concomitantly inhibits neprilysin and blocks angiotensin type 1 receptor. This randomized, double-blind, placebo-controlled study, the first in Asia for this drug, evaluated the dose-related efficacy and safety of LCZ696 in patients with hypertension using 24-hour ambulatory blood pressure (BP) monitoring. Asian patients aged 18 years (n=389) with hypertension were randomized to receive LCZ696 100 mg (n=100), 200 mg (n=101), 400 mg (n=96), or placebo (n=92) for 8 weeks. The primary end point was mean difference across the 3 single-dose pairwise comparisons of LCZ696 versus placebo in clinic diastolic BP after 8-week treatment. Key secondary efficacy variables included changes in clinic systolic BP and pulse pressure and changes in 24-hour, daytime, and nighttime ambulatory BPs and pulse pressure. Safety assessments included recording all adverse events and serious adverse events. A total of 362 patients completed the study. Reductions in clinic systolic BP, diastolic BP (P<0.0001), and pulse pressure (P<0.001) were significantly greater with all doses of LCZ696 than with placebo. There were also significant reductions in 24-hour, daytime, and nighttime ambulatory systolic BP, diastolic BP, and pulse pressure for all doses of LCZ696 compared with placebo (P<0.0001). LCZ696 was well tolerated, and no cases of angioedema were reported. In conclusion, LCZ696 is effective for the treatment of hypertension in Asian population and, in general, is safe and well tolerated.

Clinical Trial Information URL: http://www.clinicaltrials.gov. Unique identifier: NCT01193101.

语种英语
资助者Novartis AG, Basel ; Novartis AG, Basel
WOS记录号WOS:000332685500027
引用统计
被引频次:67[WOS]   [WOS记录]     [WOS相关记录]
文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/51569
专题北京大学第二临床医学院
作者单位1.Novartis Pharmaceut, E Hanover, NJ USA
2.Novartis Pharma KK, Tokyo, Japan
3.Peking Univ, Peoples Hosp, Beijing 100871, Peoples R China
4.Natl Taiwan Univ Hosp, Taipei, Taiwan
5.Phramongkutklao Hosp, Bangkok, Thailand
6.Jichi Med Univ, Sch Med, Dept Med, Div Cardiovasc Med, Shimotsuke, Tochigi 3290498, Japan
7.Catholic Univ Korea, Seoul St Marys Hosp, Seoul, South Korea
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GB/T 7714
Kario, Kazuomi,Sun, Ningling,Chiang, Fu-Tien,et al. Efficacy and Safety of LCZ696, a First-in-Class Angiotensin Receptor Neprilysin Inhibitor, in Asian Patients With Hypertension[J]. HYPERTENSION,2014,63(4):698-705.
APA Kario, Kazuomi.,Sun, Ningling.,Chiang, Fu-Tien.,Supasyndh, Ouppatham.,Baek, Sang Hong.,...&Zhang, Jack.(2014).Efficacy and Safety of LCZ696, a First-in-Class Angiotensin Receptor Neprilysin Inhibitor, in Asian Patients With Hypertension.HYPERTENSION,63(4),698-705.
MLA Kario, Kazuomi,et al."Efficacy and Safety of LCZ696, a First-in-Class Angiotensin Receptor Neprilysin Inhibitor, in Asian Patients With Hypertension".HYPERTENSION 63.4(2014):698-705.
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