PMID- 22381711
OWN - NLM
STAT- MEDLINE
DCOM- 20120716
LR  - 20220321
IS  - 1879-114X (Electronic)
IS  - 0149-2918 (Linking)
VI  - 34
IP  - 3
DP  - 2012 Mar
TI  - Efficacy and tolerability of fimasartan, a new angiotensin receptor blocker, 
      compared with losartan (50/100 mg): a 12-week, phase III, multicenter, 
      prospective, randomized, double-blind, parallel-group, dose escalation clinical 
      trial with an optional 12-week extension phase in adult Korean patients with 
      mild-to-moderate hypertension.
PG  - 552-568, 568.e1-9
LID - 10.1016/j.clinthera.2012.01.024 [doi]
AB  - BACKGROUND: Angiotensin receptor blockers (ARBs) is an effective and well 
      tolerated first-line antihypertensive drug. Fimasartan is a newly developed ARB 
      that has not been compared with other ARBs with regard to its efficacy and 
      tolerability. OBJECTIVE: The goal of this study was to determine the 
      noninferiority of fimasartan to losartan with regard to its efficacy and 
      tolerability in adult Korean patients with mild-to-moderate hypertension. 
      METHODS: This was a randomized, multicenter, double-blind, parallel group, dose 
      escalation, Phase III, noninferiority clinical trial. Patients aged 18 to 70 
      years with mild-to-moderate hypertension were randomized to receive either 
      fimasartan 60/120 mg daily or losartan 50/100 mg daily with optional titration. 
      Antihypertensive efficacy and tolerability were evaluated for 12 weeks. The 
      primary end point was noninferiority of improvement in mean siDBP from baseline 
      to week 12 for fimasartan compared with losartan. The incidence and severity of 
      adverse events (AEs) and adverse drug reactions (ADRs) were evaluated to assess 
      their tolerability. In addition, some patients whose blood pressure reached goal 
      levels participated in a 24-week extension study for additional assessment of 
      tolerability and efficacy. RESULTS: Five hundred six patients were randomly 
      allocated to receive fimasartan (n = 256) or losartan (n = 250). There was no 
      significant difference in baseline demographic characteristics between the 2 
      treatment groups (fimasartan-treated group-mean age, 53.96 [8.79] years; mean 
      weight, 70.58 [11.73] kg; male, 68.02%; losartan-treated group-mean age, 53.58 
      [9.61] years; mean weight, 69.80 [11.08] kg; male, 70.17%). At week 12, siDBP was 
      significantly decreased from baseline in both groups (-11.26 [7.53] mm Hg in the 
      fimasartan group and -8.56 [7.72] mm Hg in the losartan group [P < 0.0001]). The 
      between-group difference was 2.70 mm Hg (P = 0.0002), and the lower limit of the 
      2-sided 95% CI (1.27 mm Hg) was higher than the prespecified noninferiority 
      margin (-2.5 mm Hg). The incidence of ADRs were 7.84% and 10.40% in the 
      fimasartan and losartan groups, respectively (chi(2) test, P = 0.3181). The 
      efficacy of fimasartan was maintained over 24 weeks, and its tolerability was 
      comparable with losartan in the extension study. CONCLUSIONS: In this study with 
      eligible adult Korean patients who had mild-to-moderate hypertension, the 
      reduction of siDBP after 12 weeks of treatment with fimasartan 60/120 mg was 
      noninferior to that of losartan 50/100 mg. By post hoc comparison, between-group 
      differences in siDBP were significant in favor of fimasartan, suggesting 
      superiority to losartan. There was no statistically significant difference in 
      tolerability between the groups. This efficacy and tolerability were maintained 
      throughout the additional 12-week extension study.
CI  - Copyright A(c) 2012 Elsevier HS Journals, Inc. All rights reserved.
FAU - Lee, Sang Eun
AU  - Lee SE
AD  - Department of Internal Medicine, Seoul National University College of Medicine, 
      Seoul National University Hospital, Seoul, Korea.
FAU - Kim, Yong-Jin
AU  - Kim YJ
FAU - Lee, Hae-Young
AU  - Lee HY
FAU - Yang, Han-Mo
AU  - Yang HM
FAU - Park, Chang-Gyu
AU  - Park CG
FAU - Kim, Jae-Joong
AU  - Kim JJ
FAU - Kim, Soon-Kil
AU  - Kim SK
FAU - Rhee, Moo-Yong
AU  - Rhee MY
FAU - Oh, Byung-Hee
AU  - Oh BH
CN  - Investigators
LA  - eng
SI  - ClinicalTrials.gov/NCT00922480
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20120303
PL  - United States
TA  - Clin Ther
JT  - Clinical therapeutics
JID - 7706726
RN  - 0 (Angiotensin Receptor Antagonists)
RN  - 0 (Antihypertensive Agents)
RN  - 0 (Biphenyl Compounds)
RN  - 0 (Pyrimidines)
RN  - 0 (Tetrazoles)
RN  - JMS50MPO89 (Losartan)
RN  - P58222188P (fimasartan)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Angiotensin Receptor Antagonists/administration & dosage/adverse 
      effects/pharmacology/*therapeutic use
MH  - Antihypertensive Agents/administration & dosage/adverse 
      effects/pharmacology/*therapeutic use
MH  - Biphenyl Compounds/adverse effects/pharmacology/*therapeutic use
MH  - Blood Pressure/drug effects
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Hypertension/diagnosis/*drug therapy
MH  - Losartan/administration & dosage/adverse effects/pharmacology/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Pyrimidines/adverse effects/pharmacology/*therapeutic use
MH  - Republic of Korea
MH  - Severity of Illness Index
MH  - Tetrazoles/adverse effects/pharmacology/*therapeutic use
MH  - Treatment Outcome
MH  - Young Adult
FIR - Ahn, Taehoon
IR  - Ahn T
FIR - Bae, Jang-Ho
IR  - Bae JH
FIR - Chae, Jei Keon
IR  - Chae JK
FIR - Cho, Myeong Chan
IR  - Cho MC
FIR - Choi, Dongju
IR  - Choi D
FIR - Hur, Seung Ho
IR  - Hur SH
FIR - Jeong, Jin-Ok
IR  - Jeong JO
FIR - Kang, Jin Ho
IR  - Kang JH
FIR - Kang, Seok-Min
IR  - Kang SM
FIR - Kwan, Jun
IR  - Kwan J
FIR - Lee, Seung-Hwan
IR  - Lee SH
FIR - Park, Jeong Bae
IR  - Park JB
FIR - Park, Jong-Seon
IR  - Park JS
FIR - Rim, Se-Joong
IR  - Rim SJ
FIR - Ryu, Kyu-Hyung
IR  - Ryu KH
FIR - Seung, Ki-Bae
IR  - Seung KB
FIR - Youn, Ho-Joong
IR  - Youn HJ
FIR - Shin, Joon-Han
IR  - Shin JH
FIR - Sung, Jidong
IR  - Sung J
EDAT- 2012/03/03 06:00
MHDA- 2012/07/17 06:00
CRDT- 2012/03/03 06:00
PHST- 2012/01/25 00:00 [accepted]
PHST- 2012/03/03 06:00 [entrez]
PHST- 2012/03/03 06:00 [pubmed]
PHST- 2012/07/17 06:00 [medline]
AID - S0149-2918(12)00070-7 [pii]
AID - 10.1016/j.clinthera.2012.01.024 [doi]
PST - ppublish
SO  - Clin Ther. 2012 Mar;34(3):552-568, 568.e1-9. doi: 
      10.1016/j.clinthera.2012.01.024. Epub 2012 Mar 3.