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Efficacy and Safety of Valsartan/Amlodipine Single-Pill Combination in 11,422 Chinese Patients with Hypertension: an Observational Study
Hu, Dayi1; Liu, Lisheng2,3; Li, Weimin4
关键词Amlodipine Blood pressure Cardiology Hypertension Single-pill combination Valsartan
刊名ADVANCES IN THERAPY
2014-07-01
DOI10.1007/s12325-014-0132-x
31期:7页:762-775
收录类别SCI
文章类型Article
WOS标题词Science & Technology
类目[WOS]Medicine, Research & Experimental ; Pharmacology & Pharmacy
资助者Novartis Pharmaceuticals (China) ; Novartis Pharmaceuticals (China)
研究领域[WOS]Research & Experimental Medicine ; Pharmacology & Pharmacy
关键词[WOS]FIXED-DOSE COMBINATIONS ; VALSARTAN 160 MG ; BLOOD-PRESSURE ; AMLODIPINE MONOTHERAPY ; STAGE-2 HYPERTENSION ; ARTERIAL-HYPERTENSION ; ADULT PATIENTS ; DOUBLE-BLIND ; THERAPY ; TOLERABILITY
英文摘要

Single-pill combination (SPC) therapy of two drugs is recommended by international guidelines, including the Chinese guidelines (2010), for the treatment of hypertension in high-risk patients who require marked blood pressure (BP) reductions. Real-world data on the efficacy and safety of valsartan/amlodipine (Val/Aml) SPC are scarce. The present study is the first observational study in China to evaluate the efficacy (primary endpoint) and safety of Val/Aml (80/5 mg) SPC in Chinese patients with hypertension whose BP was not adequately controlled by monotherapy in a real-world setting.

This prospective, multicenter, open-label, post-marketing observational study included 11,422 Chinese adults (a parts per thousand yen18 years) with essential hypertension from 238 sites of 29 provinces who were prescribed once-daily Val/Aml (80/5 mg) SPC. Patients were treated for 8 weeks. The primary efficacy variable of the study included changes in mean sitting systolic BP (MSSBP) and mean diastolic BP (MSDBP) from baseline to week 8 (end point). The secondary efficacy variable of the study included BP control rate and response rate at week 4 and 8. Safety assessments included recording and measurement of all adverse events (AEs) and vital signs in the safety population.

A significant reduction of 27.1 mmHg in MSSBP (159.6 vs. 132.5 mmHg; P < 0.0001) and 15.2 mmHg in MSDBP (95.6 vs. 80.4 mmHg; P < 0.0001) from baseline was observed at week 8. The BP-lowering efficacy of Val/Aml SPC was independent of age and comorbidities. BP control of < 140/90 mmHg was achieved in 76.8% (n = 8,692) of the patients. The most frequently reported AEs were dizziness (0.2%), headache (0.2%), upper respiratory tract infection (0.2%), and edema (0.2%). Only three serious AEs were reported and they were not drug-related.

This is the first evidence-based real-world data in Chinese hypertensive patients which demonstrate the efficacy and safety of Val/Aml (80/5 mg) SPC.

语种英语
资助者Novartis Pharmaceuticals (China) ; Novartis Pharmaceuticals (China)
WOS记录号WOS:000339736200008
引用统计
被引频次:11[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/400002259/66227
专题北京大学第二临床医学院_心血管内科
作者单位1.Peking Univ Peoples Hosp, Dept Cardiol, Beijing 100044, Peoples R China
2.Chinese Acad Med Sci, Fuwai Hosp, Beijing 100037, Peoples R China
3.Chinese Acad Med Sci, Cardiovasc Inst, Beijing 100037, Peoples R China
4.Harbin Med Univ, Affiliated Hosp 1, Dept Cardiol, Harbin 150001, Peoples R China
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GB/T 7714
Hu, Dayi,Liu, Lisheng,Li, Weimin. Efficacy and Safety of Valsartan/Amlodipine Single-Pill Combination in 11,422 Chinese Patients with Hypertension: an Observational Study[J]. ADVANCES IN THERAPY,2014,31(7):762-775.
APA Hu, Dayi,Liu, Lisheng,&Li, Weimin.(2014).Efficacy and Safety of Valsartan/Amlodipine Single-Pill Combination in 11,422 Chinese Patients with Hypertension: an Observational Study.ADVANCES IN THERAPY,31(7),762-775.
MLA Hu, Dayi,et al."Efficacy and Safety of Valsartan/Amlodipine Single-Pill Combination in 11,422 Chinese Patients with Hypertension: an Observational Study".ADVANCES IN THERAPY 31.7(2014):762-775.
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