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      Long-Term Safety of a Novel Angiotensin Receptor Blocker, Fimasartan, According to the Absence or Presence of Underlying Liver Disease in Korean Hypertensive Patients: A Prospective, 12-Month, Observational Study

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          Abstract

          Purpose

          Fimasartan, the ninth and most recent angiotensin receptor blocker (ARB) approved by the Korea Food and Drug Administration, has shown similar efficacy and safety profiles compared to other ARBs. However, due to being predominantly excreted by the hepatobiliary system, concerns on safety have been raised regarding its use in patients with underlying liver disease.

          Patients and Methods

          This prospective, 12-month, observational study evaluated patients with essential hypertension (HTN) receiving ≥1 dose of fimasartan. Self-reported and physician-reported events were recorded and classified according to organ class and severity. Outcomes were compared according to the absence and presence of underlying liver disease.

          Results

          A total of 601 patients were screened, and 566 patients who met predefined inclusion criteria were grouped according to the presence of underlying liver disease. Adverse events (AE) were reported in 28.7% (128/446) of patients without prior liver disease, while 42.5% (51/120) experienced events in the group with chronic liver disease. There was no difference in discontinuations due to liver function between patients with and without baseline liver disease (1.1% [5] vs 2.5% [3], p=0.376), and only a non-significant increase was observed in events associated to the hepatobiliary system in patients with chronic liver disease (9.7% [7] vs 2.7% [9], p=0.061). There were no deaths or serious adverse drug reactions (SADR) during the study period. In multivariate regression analysis, the presence of chronic liver disease (OR 2.01), female sex (OR 1.49) and old age (OR 1.12 for every 5-year increase) were independent predictors for the development of AE. Finally, no significant difference was observed in the reduction of systolic blood pressure after 12 months of treatment (least square mean change −6.57 ± 0.80 mmHg for normal liver function group; −7.65 ± 1.59 mmHg for chronic liver disease group; p=0.546).

          Conclusion

          Long-term use of fimasartan for treatment of HTN was associated with a low rate of adverse events overall, especially in the absence of underlying liver disease. Even for patients with chronic liver disease, fimasartan treatment was well tolerated. Fimasartan could be a safe option for long-term treatment of essential HTN. ClinicalTrials.gov identifier: NCT02385721.

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          Most cited references 22

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          Korea hypertension fact sheet 2018

          Background The Korea Hypertension Fact Sheet 2018 aims to overview the magnitude and management status of hypertension, and their trends in Korea. Methods The Hypertension Epidemiology Research Group analyzed the 1998–2016 Korea National Health and Nutrition Examination Survey data and the 2002–2016 Korea National Health Insurance Big Data. Results The population average of systolic/diastolic blood pressure was 118/77 mmHg among Korean adults (age 30+) in 2016, showing little change in recent 10 years. However, the number of people with hypertension increased steadily, exceeding 11 million. The number of people diagnosed with hypertension increased from 3 million in 2002 to 8.9 million in 2016. The number of people using antihypertensive medication increased from 2.5 million in 2002 to 8.2 million in 2016. However, only 5.7 million people are being treated constantly. Hypertension awareness, treatment, and control rates increased fast until 2007, but showed a plateau thereafter. More than half of the young hypertensive patients (30–49 years) did not know about and treat for their hypertension. Among patients prescribed antihypertensive medications, 45% was elderly people over the age of 65 years, 57% used anti-diabetic or cholesterol-lowering medications, and 60% were prescribed two or more class of antihypertensive medications simultaneously. Conclusions In Korea, the level of hypertension management has considerably improved over the last 20 years. In order to achieve further improvement in hypertension management status, we need to find the vulnerable subgroups and develop subgroup-specific intervention strategies. It is also becoming more important to manage hypertensive patients at older age and those with concurrent chronic diseases. Electronic supplementary material The online version of this article (10.1186/s40885-018-0098-0) contains supplementary material, which is available to authorized users.
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            2018 Korean Society of Hypertension Guidelines for the management of hypertension: part II-diagnosis and treatment of hypertension

            The standardized techniques of blood pressure (BP) measurement in the clinic are emphasized and it is recommended to replace the mercury sphygmomanometer by a non-mercury sphygmomanometer. Out-of-office BP measurement using home BP monitoring (HBPM) or ambulatory BP monitoring (ABPM) and even automated office BP (AOBP) are recommended to correctly measure the patient’s genuine BP. Hypertension (HTN) treatment should be individualized based on cardiovascular (CV) risk and the level of BP. Based on the recent clinical study data proving benefits of intensive BP lowering in the high risk patients, the revised guideline recommends the more intensive BP lowering in high risk patients including the elderly population. Lifestyle modifications, mostly low salt diet and weight reduction, are strongly recommended in the population with elevated BP and prehypertension and all hypertensive patients. In patients with BP higher than 160/100 mmHg or more than 20/10 mmHg above the target BP, two drugs can be prescribed in combination to maximize the antihypertensive effect and to achieve rapid BP control. Especially, single pill combination drugs have multiple benefits, including maximizing reduction of BP, minimizing adverse effects, increasing adherence, and preventing cardiovascular disease (CVD) and target organ damage.
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              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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                Author and article information

                Journal
                Drug Des Devel Ther
                Drug Des Devel Ther
                DDDT
                dddt
                Drug Design, Development and Therapy
                Dove
                1177-8881
                03 April 2020
                2020
                : 14
                : 1341-1349
                Affiliations
                [1 ]Division of Cardiology, Department of Internal Medicine, Seoul National University Hospital , Seoul, Korea
                [2 ]Division of Nephrology, Department of Internal Medicine, Seoul National University Hospital , Seoul, Korea
                [3 ]Division of Cardiology, Department of Internal Medicine, Seoul Metropolitan Government Boramae Hospital , Seoul, Korea
                [4 ]Division of Cardiology, Department of Internal Medicine, Seoul National University Bundang Hospital , Seongnam, Korea
                [5 ]Division of Hepatology, Department of Internal Medicine, Seoul National University Hospital , Seoul, Korea
                Author notes
                Correspondence: Hae-Young Lee; Yoon Jun Kim 101 Daehak-ro, Jongno-gu, Seoul, KoreaTel +82 2 2072 0698; +82 2 2072 3081Fax +82 2 3674 0805 Email hylee612@snu.ac.kr; yoonjun@snu.ac.kr
                Article
                233174
                10.2147/DDDT.S233174
                7138630
                © 2020 Oh 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: 3, Tables: 4, References: 32, Pages: 9
                Categories
                Original Research

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