Lee, Hae-Young; Kim, Kwang-Il; Ihm, Sang Hyun; Rhee, Moo-Yong; Sohn, Il Suk; Park, Sungha; Jeon, Eun-Seok; Song, Jong-Min; Pyun, Wook Bum; Sung, Ki-Chul; Kim, Moo Hyun; Kim, Sang-Hyun; Kim, Seok-Yeon; Kim, Shin-Jae; Kim, Eung Ju; Shin, Jinho; Lee, Sung Yun; Chun, Kook-Jin; Jeong, Jin-Ok; Chae, Shung Chull; Yoo, Ki Dong; Choi, Young Jin; Park, Yong Hwan; Kim, Cheol-Ho
Clinical therapeutics
2021Sep ; 424 ( Pt A ) :.
PMID : 34503866
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Lee, Hae-Young - Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea. Electronic address: cheolkim@snu.ac.kr.
Kim, Kwang-Il - Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam-si, Republic of Korea.
Ihm, Sang Hyun - Department of Internal Medicine, The Catholic University of Korea Bucheon St. Mary's Hospital, Bucheon-si, Republic of Korea.
Rhee, Moo-Yong - Cardiovascular Center, Dongguk University Ilsan Hospital, Goyang-si, Republic of Korea.
Sohn, Il Suk - Department of Cardiology, Kyung Hee University Hospital at Gangdong, Seoul, Republic of Korea.
Park, Sungha - Department of Internal Medicine, Yonsei University Health System, Severance Hospital, Seoul, Republic of Korea.
Jeon, Eun-Seok - Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Song, Jong-Min - Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
Pyun, Wook Bum - Department of Internal Medicine, Ewha Womans University Seoul Hospital, Seoul, Republic of Korea.
Sung, Ki-Chul - Division of Cardiology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Kim, Moo Hyun - Department of Internal Medicine, Dong-A University Hospital, Busan, Republic of Korea.
Kim, Sang-Hyun - Department of Internal Medicine, Seoul National University Borame Medical Center, Seoul, Republic of Korea.
Kim, Seok-Yeon - Department of Internal Medicine, Seoul Medical Center, Seoul, Republic of Korea.
Kim, Shin-Jae - Department of Internal Medicine, Ulsan University Hospital, Ulsan, Republic of Korea.
Kim, Eung Ju - Department of Internal Medicine, Korea University Guro Hospital, Seoul, Republic of Korea.
Shin, Jinho - Department of Internal Medicine, Hanyang University Hospital, Seoul, Republic of Korea.
Lee, Sung Yun - Department of Internal Medicine, Inje University Ilsan Paik Hospital, Goyang-si, Republic of Korea.
Chun, Kook-Jin - Department of Internal Medicine, Pusan National University Yangsan Hospital, Yangsan-si, Republic of Korea.
Jeong, Jin-Ok - Department of Internal Medicine, Chungnam National University Hospital, Daejeon, Republic of Korea.
Chae, Shung Chull - Department of Internal Medicine, School of Medicine, Kyungpuk National University, Daegu, Republic of Korea.
Yoo, Ki Dong - Department of Internal Medicine, The Catholic University of Korea, ST. Vincent's Hospital, Suwon-si, Republic of Korea.
Choi, Young Jin - Department of Internal Medicine, Sejong Hospital, Bucheon-si, Republic of Korea.
Park, Yong Hwan - Department of Internal Medicine, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon-si, Republic of Korea.
Kim, Cheol-Ho - Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam-si, Republic of Korea. Electronic address: cheolkim@snu.ac.kr.
ABSTRACT
PURPOSE: The efficacy and tolerability of fimasartan in elderly patients have not been fully evaluated. This study was therefore conducted to determine the efficacy and tolerability of fimasartan compared with perindopril in elderly Korean patients aged >70 years with essential hypertension (defined by a mean sitting systolic blood pressure [SBP] ??40 mm Hg).
METHODS: This randomized, double-blind, active-controlled, 2 parallel-group, optional titration, multicenter, Phase IIIb trial (FITNESS [Fimasartan in the Senior Subjects]) enrolled 241 patients from 23 cardiac centers in the Republic of Korea between August 2017 and December 2019. After the placebo run-in period, treatment started with fimasartan 30 mg or perindopril arginine 2.5 mg once daily at a 1:1 ratio; if BP was not controlled at week 4, the dose was doubled. If BP was not controlled at week 8, a diuretic combination (fimasartan 60 mg/hydrochlorothiazide 12.5 mg or perindopril arginine 5 mg/indapamide 1.25 mg) was administered. After 16 weeks of the double-blind treatment, the patients with controlled BP participated in an 8-week open-label extension study, with the 2 groups unified by fimasartan 60 mg with or without hydrochlorothiazide 12.5 mg for 8 weeks. The primary outcome was a change in SBP for 8 weeks. The secondary outcomes included a change in sitting diastolic BP (DBP) for 8 weeks and changes in SBP and DBP for 4, 16, and 24 weeks. FINDINGS: At week 8, mean SBP significantly decreased from baseline in both groups: -14.2 (14.4) mm Hg in the fimasartan group and -9.0 (16.1) mm Hg in the perindopril group. The difference between the 2 groups was 5.4 (2.1) mm Hg, indicating the noninferiority of fimasartan to perindopril. Moreover, fimasartan exhibited a higher BP-lowering effect than perindopril (P?=?0.0108). In addition, reductions in SBP and DBP from baseline to weeks 4, 8, and 16 were significantly greater in the fimasartan group than in the perindopril group, although the SBP reduction was comparable at week 16. Both groups reported an excellent mean compliance rate of 97.4% (4.7%) through week 16. During the study period, 82 adverse events were reported in 52 patients, 40 in the fimasartan group and 42 in the perindopril group (P?=?0.4647). Dizziness was the most commonly reported adverse event (7 cases). Remarkably, only 1 case of orthostatic hypotension was reported during the study period. IMPLICATIONS: In elderly patients with essential hypertension, fimasartan 30 to 60 mg with a possible hydrochlorothiazide 12.5-mg combination was noninferior to perindopril 2.5 to 5 mg with a possible indapamide 1.25-mg combination. Furthermore, fimasartan exhibited higher BP-lowering efficacy than perindopril. There was no difference in tolerability between the 2 groups. Clinicaltrials.gov Identifier: NCT03246555. CI - Copyright ??2021 Elsevier Inc. All rights reserved.
keyword
angiotensin receptor blocker; angiotensin-converting enzyme inhibitor; elderly; fimasartan; hypertension; perindopril
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