PMID- 24985411
OWN - NLM
STAT- MEDLINE
DCOM- 20160309
LR  - 20221207
IS  - 1865-8652 (Electronic)
IS  - 0741-238X (Print)
IS  - 0741-238X (Linking)
VI  - 31
IP  - 7
DP  - 2014 Jul
TI  - Efficacy and safety of valsartan/amlodipine single-pill combination in 11,422 
      Chinese patients with hypertension: an observational study.
PG  - 762-75
LID - 10.1007/s12325-014-0132-x [doi]
AB  - INTRODUCTION: 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. METHODS: 
      This prospective, multicenter, open-label, post-marketing observational study 
      included 11,422 Chinese adults (>/=18 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. RESULTS: 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. CONCLUSION: 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.
FAU - Hu, Dayi
AU  - Hu D
AD  - Department of Cardiology, Peking University People's Hospital, Beijing, 100044, 
      China, hudayi1@163.com.
FAU - Liu, Lisheng
AU  - Liu L
FAU - Li, Weimin
AU  - Li W
LA  - eng
PT  - Journal Article
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20140702
PL  - United States
TA  - Adv Ther
JT  - Advances in therapy
JID - 8611864
RN  - 0 (Amlodipine, Valsartan Drug Combination)
RN  - 0 (Antihypertensive Agents)
RN  - 0 (Drug Combinations)
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Amlodipine, Valsartan Drug Combination/administration & dosage/adverse 
      effects/*therapeutic use
MH  - Antihypertensive Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Asian People
MH  - Blood Pressure/drug effects
MH  - China
MH  - Double-Blind Method
MH  - Drug Combinations
MH  - Edema/chemically induced
MH  - Female
MH  - Headache/chemically induced
MH  - Humans
MH  - Hypertension/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
PMC - PMC4115183
EDAT- 2014/07/06 06:00
MHDA- 2016/03/10 06:00
PMCR- 2014/07/02
CRDT- 2014/07/03 06:00
PHST- 2014/02/25 00:00 [received]
PHST- 2014/07/03 06:00 [entrez]
PHST- 2014/07/06 06:00 [pubmed]
PHST- 2016/03/10 06:00 [medline]
PHST- 2014/07/02 00:00 [pmc-release]
AID - 132 [pii]
AID - 10.1007/s12325-014-0132-x [doi]
PST - ppublish
SO  - Adv Ther. 2014 Jul;31(7):762-75. doi: 10.1007/s12325-014-0132-x. Epub 2014 Jul 2.