Sun Ningling, Feng Yingqing, Gao Pingjin, Chen Xiaoping, Qi Litong, Zhang Shuyang, Dong Yugang, Yang Xinchun, Li Xinli, Chen Yundai, Liu Lingli
Department of Cardiology, Peking University People's Hospital, Beijing 100044, P.R. China.
Department of Cardiology, Guangdong General Hospital, Guangdong Cardiovascular Institute, Guangzhou, Guangdong 510080, P.R. China.
Exp Ther Med. 2017 Mar;13(3):1109-1116. doi: 10.3892/etm.2017.4051. Epub 2017 Jan 17.
The present multicentre, prospective, open-label, single treatment arm study (Val-Perfect) examined the efficacy and tolerability of once-daily valsartan monotherapy (80 mg for two weeks, followed by 160 mg for eight weeks) in 195 Chinese patients with mild to moderate hypertension, using office, home, and ambulatory blood pressure (BP) monitoring. Significant mean reductions (P<0.0001) were observed in office BP from baseline to week 10, with mean sitting systolic BP (MSSBP) and mean sitting diastolic BP (MSDBP) values of 15.6±12.3 and 11.1±8.6 mmHg, respectively. The office BP control rate at week 10 was 56.9% (target MSSBP/MSDBP <130/80 mmHg for patients with type 2 diabetes or chronic kidney disease, <140/90 mmHg for others). Valsartan treatment significantly reduced mean 24-h SBP/DBP (-6.1/-4.4 mmHg; both P<0.0001) and mean home-monitored SBP/DBP (-13.3/-9.1 mmHg; both P<0.0001) at week 10. The incidence of adverse events (AEs) leading to discontinuation (1.5%) or drug-related AEs (3.1%) was low, with no instances of mortality or drug-related serious AEs. These results indicate that 160 mg valsartan is safe and effective at lowering BP in Chinese patients with mild to moderate hypertension. The significant reductions in office-based and out-of-office BP measures support the clinical relevance of moderate-dose valsartan monotherapy for effective 24-h BP control.
本多中心、前瞻性、开放标签、单治疗组研究（Val-Perfect）使用诊室、家庭和动态血压监测，考察了每日一次缬沙坦单药治疗（80mg治疗两周，随后160mg治疗八周）对195例轻至中度高血压中国患者的疗效和耐受性。从基线到第10周，诊室血压有显著的平均降低（P<0.0001），平均坐位收缩压（MSSBP）和平均坐位舒张压（MSDBP）值分别为15.6±12.3和11.1±8.6mmHg。第10周时诊室血压控制率为56.9%（2型糖尿病或慢性肾脏病患者的目标MSSBP/MSDBP<130/80mmHg，其他患者<140/90mmHg）。在第10周时，缬沙坦治疗显著降低了平均24小时收缩压/舒张压（-6.1/-4.4mmHg；均P<0.0001）和平均家庭监测收缩压/舒张压（-13.3/-9.1mmHg；均P<0.0001）。导致停药的不良事件（AE）发生率（1.5%）或药物相关AE发生率（3.1%）较低，无死亡或药物相关严重AE的病例。这些结果表明，160mg缬沙坦对降低轻至中度高血压中国患者的血压安全有效。基于诊室和诊室外血压测量的显著降低支持了中等剂量缬沙坦单药治疗对有效24小时血压控制的临床相关性。
