|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|
|WOS标题词||Science & Technology|
|类目[WOS]||Medicine, Research & Experimental ; Pharmacology & Pharmacy|
|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|
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.
|资助机构||Novartis Pharmaceuticals (China)|
|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
|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.|