PMID- 29248384
OWN - NLM
STAT- MEDLINE
DCOM- 20180710
LR  - 20181202
IS  - 1879-114X (Electronic)
IS  - 0149-2918 (Linking)
VI  - 40
IP  - 1
DP  - 2018 Jan
TI  - Efficacy and Tolerability of Telmisartan/Amlodipine + Hydrochlorothiazide Versus 
      Telmisartan/Amlodipine Combination Therapy for Essential Hypertension 
      Uncontrolled With Telmisartan/Amlodipine: The Phase III, Multicenter, Randomized, 
      Double-blind TAHYTI Study.
PG  - 50-63.e3
LID - S0149-2918(17)31070-6 [pii]
LID - 10.1016/j.clinthera.2017.11.006 [doi]
AB  - PURPOSE: This 8-week study in Korea aimed to evaluate the efficacy and 
      tolerability of a telmisartan/amlodipine + hydrochlorothiazide (TAH) combination 
      versus telmisartan/amlodipine (TA) combination in patients with essential 
      hypertension that did not respond appropriately to 4-week treatment with TA. 
      METHODS: All patients who met the inclusion criteria received TA (40/5 mg) during 
      a 4-week run-in period (period 1). Patients who met the criteria for essential 
      hypertension (mean sitting systolic blood pressure [MSSBP], >/=140 and <200 mm Hg, 
      or >/=130 and<200 mm Hg in those with diabetes mellitus or chronic kidney disease) 
      after period 1 were randomly assigned to receive TA 40/5 mg + hydrochlorothiazide 
      12.5 mg (test group) or TA only (control group). The test and control drugs were 
      administered in each group for 2 weeks (period 2). Patients who completed period 
      2 underwent 6-week treatment (period 3) with a TAH and TA dose twice that in 
      period 2. The primary end point was the change in MSSBP at week 8 of treatment. 
      Secondary end points were the change in MSSBP at week 2 and MS diastolic BP, BP 
      control rate, and BP response rate at weeks 2 and 8. Treatment tolerability was 
      assessed based on adverse events (AEs), laboratory evaluations (chemistry, 
      hematology, and urinalysis), 12-lead ECG, and physical examination including 
      vital sign measurements. FINDINGS: We randomized 310 patients to the treatment 
      groups. The mean (SD) ages of the TAH and TA groups were 62.0 (10.8) and 63.4 
      (10.4) years, respectively. The least squares mean change in MSSBP was 
      significantly greater in the TAH group than in the TA group after 8 weeks (-18.7 
      vs -12.2 mm Hg; P < 0.001). Similar results were obtained on changes in MSSBP 
      after 2 weeks and changes in sitting diastolic BP, BP control rate, and BP 
      response rate at weeks 2 and 8 compared with the respective baseline values. The 
      prevalences of treatment-emergent AEs (29.0% vs 16.3%; P = 0.008) and adverse 
      drug reactions (20.0% vs 10.5%; P = 0.020) were significantly greater in the TAH 
      group than in the TA group. Most treatment-emergent AEs were mild or moderate; 
      none were severe. The most frequently reported AEs were dizziness and headache. 
      IMPLICATION: TAH triple therapy was more effective than was TA double therapy in 
      reducing BP in these patients in Korea with essential hypertension that did not 
      adequately respond to TA. ClinicalTrials.gov identifier: NCT02738632.
CI  - Copyright (c) 2018 The Authors. Published by Elsevier Inc. All rights reserved.
FAU - Sung, Ki-Chul
AU  - Sung KC
AD  - Kangbuk Samsung Hospital, Sungkyunkwan University, School of Medicine, Seoul, 
      Korea; Seoul National University Hospital, Seoul, Korea.
FAU - Oh, Yong-Seog
AU  - Oh YS
AD  - Seoul St. Mary's Hospital of the Catholic University, Seoul, Korea.
FAU - Cha, Dong-Hun
AU  - Cha DH
AD  - CHA Bundang Medical Center CHA University, Seongnam, Korea.
FAU - Hong, Soon-Jun
AU  - Hong SJ
AD  - Korea University Anam Hospital, Seoul, Korea.
FAU - Won, Kyung-Heon
AU  - Won KH
AD  - Seoul Medical Center, Seoul, Korea.
FAU - Yoo, Ki-Dong
AU  - Yoo KD
AD  - Catholic University of Korea St. Vincent's Hospital, Suwon, Korea.
FAU - Rha, Seung-Woon
AU  - Rha SW
AD  - Korea University Guro Hospital, Seoul, Korea.
FAU - Ahn, Young-Keun
AU  - Ahn YK
AD  - Chonnam National University Hospital, Gwangju, Korea.
FAU - Ahn, Jeong-Cheon
AU  - Ahn JC
AD  - Korea University Ansan Hospital, Ansan, Korea.
FAU - Jang, Ji-Yong
AU  - Jang JY
AD  - Konkuk University Chungju Hospital, Chungju, Korea.
FAU - Hong, Tack-Jong
AU  - Hong TJ
AD  - Pusan National University Hospital, Busan, Korea.
FAU - Cho, Sang-Kyoon
AU  - Cho SK
AD  - Daejin Medical Center, Seongnam, Korea.
FAU - Park, Sang-Ho
AU  - Park SH
AD  - Sooncheonhyang University Hospital Cheonan, Cheonan, Korea.
FAU - Hyon, Min-Su
AU  - Hyon MS
AD  - Soon Chun Hyang University Hospital Seoul, Seoul, Korea.
FAU - Nam, Chang-Wook
AU  - Nam CW
AD  - Keimyung University Dongsan Medical Center, Daegu, Korea.
FAU - Chae, In-Ho
AU  - Chae IH
AD  - Seoul National University Bundang Hospital, Seongnam, Korea.
FAU - Yoo, Byung-Su
AU  - Yoo BS
AD  - Wonju Severance Christian Hospital, Wonju, Korea.
FAU - Song, Jong-Min
AU  - Song JM
AD  - Asan Medical Center, Seoul, Korea.
FAU - Jeong, Jin-Ok
AU  - Jeong JO
AD  - Chungnam National University Hospital, Daejeon, Korea.
FAU - Yoon, Young Won
AU  - Yoon YW
AD  - Gangnam Severance Hospital, Seoul, Korea.
FAU - Kim, Byung-Soo
AU  - Kim BS
AD  - Daedong Hospital, Busan, Korea.
FAU - Yang, Tae-Hyun
AU  - Yang TH
AD  - Inje University Busan Paik Hospital, Busan, Korea.
FAU - Cho, Deok-Kyu
AU  - Cho DK
AD  - Gwandong University Myungji Hospital, Goyang, Korea.
FAU - Kim, Sang-Hyun
AU  - Kim SH
AD  - Boramae Medical Center, Seoul, Korea.
FAU - Choi, Yu-Jeong
AU  - Choi YJ
AD  - Daejeon Eulji University Hospital, Daejeon, Korea.
FAU - Ahn, Ji-Hun
AU  - Ahn JH
AD  - Sooncheonhyang University Hospital Gumi, Gumi, Korea.
FAU - Jeon, Dong-Woon
AU  - Jeon DW
AD  - Health Insurance Service Ilsan Hospital, Goyang, Korea.
FAU - Kim, Hyo-Soo
AU  - Kim HS
AD  - Kangbuk Samsung Hospital, Sungkyunkwan University, School of Medicine, Seoul, 
      Korea; Seoul National University Hospital, Seoul, Korea. Electronic address: 
      usahyosoo@gmail.com.
LA  - eng
SI  - ClinicalTrials.gov/NCT02738632
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20171214
PL  - United States
TA  - Clin Ther
JT  - Clinical therapeutics
JID - 7706726
RN  - 0 (Antihypertensive Agents)
RN  - 0 (Benzimidazoles)
RN  - 0 (Benzoates)
RN  - 0 (Drug Combinations)
RN  - 0 (telmisartan amlodipine combination)
RN  - 0J48LPH2TH (Hydrochlorothiazide)
RN  - 1J444QC288 (Amlodipine)
RN  - U5SYW473RQ (Telmisartan)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Amlodipine/*administration & dosage/adverse effects/therapeutic use
MH  - Antihypertensive Agents/*administration & dosage/adverse effects/therapeutic use
MH  - Benzimidazoles/*administration & dosage/adverse effects/therapeutic use
MH  - Benzoates/*administration & dosage/adverse effects/therapeutic use
MH  - Blood Pressure/drug effects
MH  - Dizziness/chemically induced
MH  - Double-Blind Method
MH  - Drug Combinations
MH  - Drug Therapy, Combination
MH  - Essential Hypertension/*drug therapy
MH  - Female
MH  - Headache/chemically induced
MH  - Humans
MH  - Hydrochlorothiazide/*administration & dosage/adverse effects/therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Telmisartan
MH  - Treatment Outcome
MH  - Young Adult
OTO - NOTNLM
OT  - amlodipine
OT  - blood pressure control
OT  - hydrochlorothiazide
OT  - hypertension
OT  - telmisartan
OT  - triple combination
EDAT- 2017/12/19 06:00
MHDA- 2018/07/11 06:00
CRDT- 2017/12/18 06:00
PHST- 2017/07/20 00:00 [received]
PHST- 2017/11/13 00:00 [revised]
PHST- 2017/11/13 00:00 [accepted]
PHST- 2017/12/19 06:00 [pubmed]
PHST- 2018/07/11 06:00 [medline]
PHST- 2017/12/18 06:00 [entrez]
AID - S0149-2918(17)31070-6 [pii]
AID - 10.1016/j.clinthera.2017.11.006 [doi]
PST - ppublish
SO  - Clin Ther. 2018 Jan;40(1):50-63.e3. doi: 10.1016/j.clinthera.2017.11.006. Epub 
      2017 Dec 14.