PMID- 29032666
OWN - NLM
STAT- MEDLINE
DCOM- 20180709
LR  - 20181113
IS  - 2005-6648 (Electronic)
IS  - 1226-3303 (Print)
IS  - 1226-3303 (Linking)
VI  - 32
IP  - 6
DP  - 2017 Nov
TI  - 24-Hour blood pressure response to lower dose (30 mg) fimasartan in Korean 
      patients with mild to moderate essential hypertension.
PG  - 1025-1036
LID - 10.3904/kjim.2016.094 [doi]
AB  - BACKGROUND/AIMS: Fimasartan is an angiotensin type 1 receptor blocker (ARB) which 
      has comparable efficacy and tolerability with other ARBs. The aim of this study 
      was to evaluate 24-hour blood pressure (BP) lowering efficacy and the 
      tolerability of the low dose fimasartan compared with valsartan in patients with 
      mild to moderate hypertension. METHODS: This study was a phase II, prospective, 
      multicenter, randomized, double-blind, parallel-grouped trial. A total of 75 
      hypertensive patients, whose mean ambulatory BP monitoring values were >/= 135/85 
      mmHg, were randomized to either fimasartan 30 mg or valsartan 80 mg daily. The 
      primary efficacy endpoint was the change in the mean 24-hour systolic BP (SBP) 
      values from the baseline and at the week 8. Secondary endpoints included the 
      change in the mean 24-hour diastolic BP values, the daytime and the nighttime 
      mean BP values at week 8, the trough-to-peak (T/P) ratio and the smoothness 
      index. RESULTS: At week 8, the mean 24-hour SBP values significantly decreased in 
      both groups; -10.5 +/- 11.9 mmHg (p < 0.0001) in the fimasartan group and -5.5 +/- 
      11.6 mmHg (p = 0.0307) in the valsartan group. The difference between two groups 
      was 4.3 +/- 2.9 mmHg but there was no statistical significance (p = 0.1392). The 
      global T/P ratio in the fimasartan 30 mg groups were 0.48 and 0.40 in the 
      valsartan 80 mg group, respectively (p = 0.3411). The most frequent adverse 
      events (AEs) were acute pharyngitis and there were no cases of severe AEs. 
      CONCLUSIONS: In mild-to-moderate hypertensive patients, low dose (30 mg) 
      fimasartan showed comparable 24-hour BP lowering efficacy compared with valsartan 
      (80 mg). There was no difference in tolerability between two groups.
FAU - Lee, Hae-Young
AU  - Lee HY
AD  - Department of Internal Medicine, Seoul National University Hospital, Seoul, 
      Korea.
FAU - Kim, Cheol-Ho
AU  - Kim CH
AD  - Department of Internal Medicine, Seoul National University Bundang Hospital, 
      Seongnam, Korea.
FAU - Song, Jae-Kwan
AU  - Song JK
AD  - Department of Internal Medicine, Asan Medical Center, University of Ulsan College 
      of Medicine, Seoul, Korea.
FAU - Chae, Shung Chull
AU  - Chae SC
AD  - Department of Internal Medicine, Kyungpook National University Hospital, Daegu, 
      Korea.
FAU - Jeong, Myung Ho
AU  - Jeong MH
AD  - Department of Internal Medicine, The Heart Center of Chonnam National University 
      Hospital, Gwangju, Korea.
FAU - Kim, Dong-Soo
AU  - Kim DS
AD  - Department of Internal Medicine, Inje University Busan Paik Hospital, Busan, 
      Korea.
FAU - Oh, Byung-Hee
AU  - Oh BH
AD  - Department of Internal Medicine, Seoul National University Hospital, Seoul, 
      Korea.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20171017
PL  - Korea (South)
TA  - Korean J Intern Med
JT  - The Korean journal of internal medicine
JID - 8712418
RN  - 0 (Antihypertensive Agents)
RN  - 0 (Biphenyl Compounds)
RN  - 0 (Pyrimidines)
RN  - 0 (Tetrazoles)
RN  - 80M03YXJ7I (Valsartan)
RN  - P58222188P (fimasartan)
SB  - IM
MH  - Aged
MH  - Antihypertensive Agents/*administration & dosage
MH  - Biphenyl Compounds/*administration & dosage
MH  - Blood Pressure/*drug effects
MH  - Blood Pressure Monitoring, Ambulatory
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Hypertension/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Pyrimidines/*administration & dosage
MH  - Tetrazoles/*administration & dosage
MH  - Valsartan/administration & dosage
PMC - PMC5668394
OTO - NOTNLM
OT  - Angiotensin II type 1 receptor blockers
OT  - Blood pressure monitoring, ambulatory
OT  - Hypertension
COIS- This study was sponsored by Boryung pharmaceutical, Seoul, Korea. The sponsor 
      supported the supply of the investigational products, laboratory test, and 
      clinical research coordinator expenses.
EDAT- 2017/10/17 06:00
MHDA- 2018/07/10 06:00
PMCR- 2017/11/01
CRDT- 2017/10/17 06:00
PHST- 2016/03/20 00:00 [received]
PHST- 2016/07/06 00:00 [revised]
PHST- 2016/08/23 00:00 [accepted]
PHST- 2017/10/17 06:00 [pubmed]
PHST- 2018/07/10 06:00 [medline]
PHST- 2017/10/17 06:00 [entrez]
PHST- 2017/11/01 00:00 [pmc-release]
AID - kjim.2016.094 [pii]
AID - kjim-2016-094 [pii]
AID - 10.3904/kjim.2016.094 [doi]
PST - ppublish
SO  - Korean J Intern Med. 2017 Nov;32(6):1025-1036. doi: 10.3904/kjim.2016.094. Epub 
      2017 Oct 17.