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Effect of Fimasartan versus Valsartan and Olmesartan on Office and Ambulatory Blood Pressure in Korean Patients with Mild-to-Moderate Essential Hypertension: A Randomized, Double-Blind, Active Control, Three-Parallel Group, Forced Titration, Multicenter, Phase IV Study (Fimasartan Achieving Systolic Blood Pressure Target (FAST) Study)

Authors Chung WB, Ihm SH, Jang SW, Her SH, Park CS, Lee JM, Chang K, Jeon DS, Yoo KD, Seung KB

Received 17 September 2019

Accepted for publication 30 December 2019

Published 23 January 2020 Volume 2020:14 Pages 347—360

DOI https://doi.org/10.2147/DDDT.S231293

Checked for plagiarism Yes

Review by Single-blind

Peer reviewer comments 2

Editor who approved publication: Professor Jianbo Sun


Woo-Baek Chung,1 Sang-Hyun Ihm,2 Sung-Won Jang,3 Sung-Ho Her,4 Chul Soo Park,5 Jong-Min Lee,6 Kiyuk Chang,1 Doo-Soo Jeon,7 Ki-Dong Yoo,8 Ki-Bae Seung1

1Division of Cardiology, Department of Internal Medicine, Seoul St. Mary’s Hospital, The Catholic University of Korea, Seoul, Republic of Korea; 2Division of Cardiology, Department of Internal Medicine, Bucheon St. Mary’s Hospital, The Catholic University of Korea, Seoul, Republic of Korea; 3Division of Cardiology, Department of Internal Medicine, St. Paul’s Hospital; 4Daejeon St. Mary’s Hospital, The Catholic University of Korea, Seoul, Republic of Korea; 5Division of Cardiology, Department of Internal Medicine, Yeouido St. Mary’s Hospital, The Catholic University of Korea, Seoul, Republic of Korea; 6Division of Cardiology, Department of Internal Medicine, Uijeongbu St. Mary’s Hospital, The Catholic University of Korea, Seoul, Republic of Korea; 7Division of Cardiology, Department of Internal Medicine, In-Cheon St. Mary’s Hospital, The Catholic University of Korea, Seoul, Republic of Korea; 8Division of Cardiology, Department of Internal Medicine, St. Vincent’s Hospital, The Catholic University of Korea, Seoul, Republic of Korea

Correspondence: Sang-Hyun Ihm
Division of Cardiology, Department of Internal Medicine, Bucheon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, 14647, 327, Sosa-ro, Bucheon-si, Gyeonggi-do, Republic of Korea
Tel +82-32-340-7027
Fax +82-32-340-2669
Email heartihmsh@yahoo.co.kr

Ki-Bae Seung
Division of Cardiology, Department of Internal Medicine, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, 06591, 222, Banpo-daero, Seocho-gu, Seoul, Republic of Korea
Tel +82-2-2258-1134
Fax +82-2-591-1506
Email kbseung@catholic.ac.kr

Purpose: Head-to-head comparison of the blood pressure (BP) lowering effect of fimasartan versus valsartan, with olmesartan as a reference, on office blood pressure and ambulatory BP.
Patients and Methods: Of the 369 randomly assigned patients in this study, 365 hypertensive patients were referred as the full analysis set and divided into 3 groups with a 3:3:1 ratio (fimasartan group: 155, valsartan group: 157, olmesartan group: 53). After the 2-week single-blind placebo run-in period, initial standard doses of 60-mg fimasartan, 80-mg valsartan, and 10-mg olmesartan were administered for 2 weeks, then forcibly up-titrated higher doses (fimasartan 120 mg, valsartan 160 mg, olmesartan 20 mg) were given for 4 weeks. ABP was measured before and after the 6-week treatment. Primary endpoint was reduction of sitting office systolic BP (SiSBP) of fimasartan compared to valsartan after 6 weeks. Secondary endpoints were reduction of sitting office diastolic BP (SiDBP) and 24 hrs, day-time, and night-time mean systolic and diastolic ABP (ASBP, ADBP) after 6 weeks.
Results: Patients’ mean age was 58.34± 7.68 years, and 289 patients were male (79.18%). After the 6-week treatment, SiSBP reduction of fimasartan and valsartan were − 16.26± 15.07 and − 12.81± 13.87 (p=0.0298) and SiDBP were − 7.63± 9.67 and − 5.14± 8.52 (p=0.0211). Reductions in 24 hrs mean ASBP were − 15.22± 13.33 and − 9.45± 12.37 (p=0.0009), and ADBPs were − 8.74± 7.55 and − 5.98± 7.85 (p=0.0140). Reductions of night-time ASBPs were − 16.80± 15.81 and − 10.32± 14.88 (p=0.0012), and those of night-time ADBPs were − 8.89± 9.93 and − 5.55± 9.70 (p=0.0152). Reduction of BP in olmesartan group did not demonstrate significant difference with fimasartan group in all end-points.
Conclusion: Fimasartan 120-mg treatment demonstrated superior efficacy in reduction of SiSBP, SiDBP, and 24 hrs ASBP and ADBP compared to valsartan 160 mg. Reduction of night-time ASBP from baseline was largest in fimasartan group, suggesting that fimasartan may be effective for recovering dipping pattern.
NCT number: NCT02495324 (Fimasartan Achieving SBP Target (FAST) study).

Keywords: 24 hr ambulatory blood pressure monitoring, angiotensin receptor blocker, essential hypertension, antihypertensive

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