دورية أكاديمية
A Randomized, Double-blind, Active-controlled, Two Parallel-Group, Optional Titration, Multicenter, Phase IIIb Study to Evaluate the Efficacy and Safety of Fimasartan Versus Perindopril Monotherapy With and Without a Diuretic Combination in Elderly Patients With Essential Hypertension
| العنوان: | A Randomized, Double-blind, Active-controlled, Two Parallel-Group, Optional Titration, Multicenter, Phase IIIb Study to Evaluate the Efficacy and Safety of Fimasartan Versus Perindopril Monotherapy With and Without a Diuretic Combination in Elderly Patients With Essential Hypertension |
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| المساهمون: | Hae-Young Lee, Kwang-Il Kim, Sang Hyun Ihm, Moo-Yong Rhee, Il Suk Sohn, Sungha Park, Eun-Seok Jeon, Jong-Min Song, Wook Bum Pyun, Ki-Chul Sung, Moo Hyun Kim, Sang-Hyun Kim, Seok-Yeon Kim, Shin-Jae Kim, Eung Ju Kim, Jinho Shin, Sung Yun Lee, Kook-Jin Chun, Jin-Ok Jeong, Shung Chull Chae, Ki Dong Yoo, Young Jin Choi, Yong Hwan Park, Cheol-Ho Kim, Park, Sung Ha |
| بيانات النشر: | Excerpta Medica |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | Aged, Antihypertensive Agents / adverse effects, Biphenyl Compounds* / adverse effects, Blood Pressure, Diuretics / therapeutic use, Double-Blind Method, Drug Therapy, Combination, Essential Hypertension* / drug therapy, Humans, Perindopril* / adverse effects, Pyrimidines* / adverse effects, Tetrazoles* / adverse effects, Treatment Outcome, angiotensin receptor blocker, angiotensin-converting enzyme inhibitor, elderly, fimasartan, hypertension, perindopril |
| الوصف: | 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] ≥140 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 ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| تدمد: | 0149-2918 1879-114X |
| العلاقة: | CLINICAL THERAPEUTICS; J00614; OAK-2022-04453; https://ir.ymlib.yonsei.ac.kr/handle/22282913/190570Test; https://www.sciencedirect.com/science/article/pii/S0149291821003003Test; T202126182; CLINICAL THERAPEUTICS, Vol.43(10) : 1746-1756, 2021-10 |
| DOI: | 10.1016/j.clinthera.2021.08.003 |
| الإتاحة: | https://doi.org/10.1016/j.clinthera.2021.08.003Test https://ir.ymlib.yonsei.ac.kr/handle/22282913/190570Test https://www.sciencedirect.com/science/article/pii/S0149291821003003Test |
| حقوق: | CC BY-NC-ND 2.0 KR |
| رقم الانضمام: | edsbas.BC0F1B75 |
| قاعدة البيانات: | BASE |
| تدمد: | 01492918 1879114X |
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| DOI: | 10.1016/j.clinthera.2021.08.003 |