| Title | China STudy of valsartan/amlodipine fixed-dose combination-bAsed long-Term blood pressUre management in HypertenSive patients: a one-year registry (China STATUS III) |
| Authors | Huo, Yong Gu, Ye Ma, Genshan Guo, Jincheng Xiong, Longgen Luo, Zhurong Xie, Jianhong Li, Weimin Zhao, Jianrong Yan, Xiaowei Liu, Wei Xu, Yawei Bao, Xiaomei Zhao, Luosha Yang, Ming Wang, Bei Yan, Xiaowei Guo, Jincheng Ma, Changsheng Wang, Mingsheng Ding, Shenghua Du, Xinping Lin, Shan Cong, Hongliang Li, Weimin Dong, Yumei Gu, Ye Chen, De Ruan, Changwu Zhao, Jianrong Feng, Liuliu Bao, Xiaomei Mao, Wei Xie, Jianhong He, Qiang Wang, Ningfu Wu, Wei Xiong, Longgen Luo, Zhurong Zhao, Luosha Ma, Genshan Xu, Yawei Wang, Jiguang Feng, Yinqing Xie, Liangdi Li, Nanfang Li, Xinli Chen, Luyuan Wang, Wen Zhu, Dingliang Zhang, Xinhua Yu, Jinming Sun, Ningling Zhang, Weizhong |
| Affiliation | Peking Univ, Hosp 1, Beijing, Peoples R China Wuhan Puai Hosp, Wuhan, Hubei, Peoples R China Southeast Univ, Zhongda Hosp, Nanjing, Jiangsu, Peoples R China Capital Med Univ, Beijing Luhe Affiliated Hosp, Beijing, Peoples R China Guangzhou Med Univ, Affiliated Hosp 2, Guangzhou, Guangdong, Peoples R China Nanjing Mil Command, Fuzhou Gen Hosp, Fuzhou, Fujian, Peoples R China Zhejiang Prov Peoples Hosp, Hangzhou, Zhejiang, Peoples R China Harbin Med Univ, Affiliated Hosp 1, Harbin, Heilongjiang, Peoples R China Shanghai Jiao Tong Univ, Sch Med, Ruijin Hosp, Lu Wan Branch, Shanghai, Peoples R China Chinese Acad Med Sci, Peking Union Med Coll Hosp, Beijing, Peoples R China Beijing Hosp, Beijing, Peoples R China Shanghai Tenth Peoples Hosp, Shanghai, Peoples R China Shanghai Xuhui Hosp, Shanghai, Peoples R China Zhengzhou Univ, Affiliated Hosp 1, Zhengzhou, Henan, Peoples R China Beijing Fuxing Hosp, Beijing, Peoples R China Novartis Pharmaceut China, Beijing, Peoples R China |
| Keywords | Antihypertensive agents valsartan amlodipine observational study long-term hypertension single-pill combination |
| Issue Date | 2019 |
| Publisher | CURRENT MEDICAL RESEARCH AND OPINION |
| Abstract | Objective: The present observational study evaluated long-term management of hypertension in patients who received treatment with valsartan and amlodipine in a single-pill combination (Val/Aml SPC) in a real-world setting in China (Chinese Clinical Trial Registry number ChiCTR1900021324). Methods: This was a prospective, observational, multicenter, real-world registry study wherein patients with hypertension who had already received Val/Aml SPC (80/5 mg) for at least 4 weeks before study enrollment were observed for 1 year. Investigators recorded patient data every 3 months and essentially five times during the 1 year follow-up period. Effectiveness was assessed by the blood pressure (BP) control rate and average duration of treatment at the end of the study. Safety was monitored by the incidence of adverse events (AEs) and serious adverse events (SAEs). Results: Overall, 985 patients were enrolled (mean +/- standard deviation [SD] age: 60.3 +/- 11.5 years); of these, 894 were included in the full analysis set, 758 of whom completed the study. At baseline, BP was controlled (<140/90 mmHg) in 64.3% of patients on Val/Aml SPC for at least 4 weeks before enrollment. Office BP control rates significantly improved from baseline in 74.1% of patients at 1 year (p < .0001). Overall, 575 (87.0%) patients remained on Val/Aml SPC at 1 year (average exposure: 311.5 days). AEs were reported in 23.3% of patients. The majority of AEs were mild to moderate, and 0.6% of patients discontinued Val/Aml SPC because of SAEs. Conclusion: This study provides evidence that Val/Aml SPC effectively reduced BP over the long term among Chinese hypertensive patients, with a good adherence and tolerability profile, and that most hypertensive patients may benefit from this combination. |
| URI | http://hdl.handle.net/20.500.11897/548324 |
| ISSN | 0300-7995 |
| DOI | 10.1080/03007995.2019.1596630 |
| Indexed | SCI(E) |
| Appears in Collections: | 第一医院 |
