PMID- 30880492
OWN - NLM
STAT- MEDLINE
DCOM- 20200609
LR  - 20200609
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 35
IP  - 8
DP  - 2019 Aug
TI  - China STudy of valsartan/amlodipine fixed-dose combination-bAsed long-Term blood 
      pressUre management in HypertenSive patients: a one-year registry (China STATUS 
      III).
PG  - 1441-1449
LID - 10.1080/03007995.2019.1596630 [doi]
AB  - 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.
FAU - Huo, Yong
AU  - Huo Y
AD  - a Peking University First Hospital , Beijing , China.
FAU - Gu, Ye
AU  - Gu Y
AD  - b Wuhan Puai Hospital , Wuhan , China.
FAU - Ma, Genshan
AU  - Ma G
AD  - c Zhongda Hospital Southeast University , Nanjing , China.
FAU - Guo, Jincheng
AU  - Guo J
AD  - d Beijing Luhe Affiliated Hospital of the Capital Medical University , Beijing , 
      China.
FAU - Xiong, Longgen
AU  - Xiong L
AD  - e The Second Affiliated Hospital of Guangzhou Medical University , Guangzhou , 
      China.
FAU - Luo, Zhurong
AU  - Luo Z
AD  - f Fuzhou General Hospital of Nanjing Military Command , Fuzhou , China.
FAU - Xie, Jianhong
AU  - Xie J
AD  - g Zhejiang Provincial People's Hospital , Hangzhou , China.
FAU - Li, Weimin
AU  - Li W
AD  - h First Affiliated Hospital of Harbin Medical University , Harbin , China.
FAU - Zhao, Jianrong
AU  - Zhao J
AD  - i Lu Wan Branch of Ruijin Hospital, Shanghai Jiao Tong University School of 
      Medicine , Shanghai , China.
FAU - Yan, Xiaowei
AU  - Yan X
AD  - j Chinese Academy of Medical Sciences Peking Union Medical College Hospital , 
      Beijing , China.
FAU - Liu, Wei
AU  - Liu W
AD  - k Beijing Hospital , Beijing , China.
FAU - Xu, Yawei
AU  - Xu Y
AD  - l Shanghai Tenth People's Hospital , Shanghai , China.
FAU - Bao, Xiaomei
AU  - Bao X
AD  - m Shanghai Xuhui Hospital , Shanghai , China.
FAU - Zhao, Luosha
AU  - Zhao L
AD  - n The First Affiliated Hospital of Zhengzhou University , Zhengzhou , China.
FAU - Yang, Ming
AU  - Yang M
AD  - o Beijing Fuxing Hospital , Beijing , China.
FAU - Wang, Bei
AU  - Wang B
AD  - p Novartis Pharmaceuticals (China) , Beijing , China.
FAU - Iii Study Group, The China Status
AU  - Iii Study Group TCS
LA  - eng
SI  - ChiCTR/ChiCTR1900021324
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20190513
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Antihypertensive Agents)
RN  - 0 (Drug Combinations)
RN  - 1J444QC288 (Amlodipine)
RN  - 80M03YXJ7I (Valsartan)
SB  - IM
MH  - Aged
MH  - *Amlodipine/administration & dosage/adverse effects/therapeutic use
MH  - *Antihypertensive Agents/administration & dosage/adverse effects/therapeutic use
MH  - China
MH  - Drug Combinations
MH  - Female
MH  - Humans
MH  - Hypertension/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - *Valsartan/administration & dosage/adverse effects/therapeutic use
OTO - NOTNLM
OT  - Antihypertensive agents
OT  - hypertension
OT  - long-term
OT  - observational study
OT  - single-pill combination
OT  - valsartan/amlodipine
EDAT- 2019/03/19 06:00
MHDA- 2020/06/10 06:00
CRDT- 2019/03/19 06:00
PHST- 2019/03/19 06:00 [pubmed]
PHST- 2020/06/10 06:00 [medline]
PHST- 2019/03/19 06:00 [entrez]
AID - 10.1080/03007995.2019.1596630 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2019 Aug;35(8):1441-1449. doi: 10.1080/03007995.2019.1596630. 
      Epub 2019 May 13.