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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)

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          Abstract

          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).

          Related collections

          Most cited references 20

          • Record: found
          • Abstract: found
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          The comparative efficacy and safety of the angiotensin receptor blockers in the management of hypertension and other cardiovascular diseases.

          All national guidelines for the management of hypertension recommend angiotensin receptor blockers (ARBs) as an initial or add-on antihypertensive therapy. The eight available ARBs have variable clinical efficacy when used for control of hypertension. Additive blood pressure-lowering effects have been demonstrated when ARBs are combined with thiazide diuretics or dihydropyridine calcium channel blockers, augmenting hypertension control. Furthermore, therapeutic use of ARBs goes beyond their antihypertensive effects, with evidence-based benefits in heart failure and diabetic renal disease particularly among angiotensin-converting enzyme inhibitor-intolerant patients. On the other hand, combining renin-angiotensin system blocking agents, a formerly common practice among medical subspecialists focusing on the management of hypertension, has ceased, as there is not only no evidence of cardiovascular benefit but also modest evidence of harm, particularly with regard to renal dysfunction. ARBs are very well tolerated as monotherapy, as well as in combination with other antihypertensive medications, which improve adherence to therapy and have become a mainstay in the treatment of stage 1 and stage 2 hypertension.
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            • Abstract: found
            • Article: not found

            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.

            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.
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              • Record: found
              • Abstract: found
              • Article: not found

              Ambulatory blood pressure response to once-daily fimasartan: an 8-week, multicenter, randomized, double-blind, active-comparator, parallel-group study in Korean patients with mild to moderate essential hypertension.

              Fimasartan, a selective angiotensin II type 1 receptor blocker, was approved in Korea for the treatment of patients with mild to moderate hypertension.
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                Author and article information

                Journal
                Drug Des Devel Ther
                Drug Des Devel Ther
                DDDT
                dddt
                Drug Design, Development and Therapy
                Dove
                1177-8881
                23 January 2020
                2020
                : 14
                : 347-360
                Affiliations
                [1 ]Division of Cardiology, Department of Internal Medicine, Seoul St. Mary’s Hospital, The Catholic University of Korea , Seoul, Republic of Korea
                [2 ]Division of Cardiology, Department of Internal Medicine, Bucheon St. Mary’s Hospital, The Catholic University of Korea , Seoul, Republic of Korea
                [3 ]Division of Cardiology, Department of Internal Medicine, St. Paul’s Hospital
                [4 ]Daejeon St. Mary’s Hospital, The Catholic University of Korea , Seoul, Republic of Korea
                [5 ]Division of Cardiology, Department of Internal Medicine, Yeouido St. Mary’s Hospital, The Catholic University of Korea , Seoul, Republic of Korea
                [6 ]Division of Cardiology, Department of Internal Medicine, Uijeongbu St. Mary’s Hospital, The Catholic University of Korea , Seoul, Republic of Korea
                [7 ]Division of Cardiology, Department of Internal Medicine, In-Cheon St. Mary’s Hospital, The Catholic University of Korea , Seoul, Republic of Korea
                [8 ]Division of Cardiology, Department of Internal Medicine, St. Vincent’s Hospital, The Catholic University of Korea , Seoul, Republic of Korea
                Author notes
                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 KoreaTel +82-32-340-7027Fax +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 KoreaTel +82-2-2258-1134Fax +82-2-591-1506 Email kbseung@catholic.ac.kr
                Article
                231293
                10.2147/DDDT.S231293
                6986172
                32158190
                © 2020 Chung et al.

                This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms ( https://www.dovepress.com/terms.php).

                Page count
                Figures: 6, Tables: 3, References: 22, Pages: 14
                Funding
                This study was initiated and financially supported by Boryung Pharmaceutical Co. Ltd., Seoul, Republic of Korea (BR-FVO-CT-401). The sponsor supported the supply of study drugs, laboratory test, data collection, and data analysis. The funding body had no role in data interpretation and the writing of the manuscript based on the data.
                Categories
                Original Research

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