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      Efficacy of fimasartan/hydrochlorothiazide combination in hypertensive patients inadequately controlled by fimasartan monotherapy

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          Abstract

          Background

          The study reported here compared the blood pressure (BP)-lowering efficacy of fimasartan alone with that of fimasartan/hydrochlorothiazide (HCTZ) combination in patients whose BP goal was not achieved after 4 weeks of treatment with once-daily fimasartan 60 mg.

          Methods

          Patients with sitting diastolic blood pressure (siDBP) ≥90 mmHg with 4 weeks of once-daily fimasartan 60 mg were randomly assigned to receive either once-daily fimasartan 60 mg/HCTZ 12.5 mg or fimasartan 60 mg for 4 weeks. After 4 weeks, the dose was increased from fimasartan 60 mg/HCTZ 12.5 mg to fimasartan 120 mg/HCTZ 12.5 mg or from fimasartan 60 mg to fimasartan 120 mg if siDBP was ≥90 mmHg.

          Results

          Of the 263 randomized patients, 256 patients who had available efficacy data were analyzed. The fimasartan/HCTZ treatment group showed a greater reduction of siDBP compared to the fimasartan treatment group at Week 4 (6.88±8.10 mmHg vs 3.38±7.33, P=0.0008), and the effect persisted at Week 8 (8.67±9.39 mmHg vs 5.02±8.27 mmHg, P=0.0023). Reduction of sitting systolic BP in the fimasartan/HCTZ treatment group was also greater than that in the fimasartan treatment group (at Week 4, 10.50±13.76 mmHg vs 5.75±12.18 mmHg, P=0.0069 and, at Week 8, 13.45±15.15 mmHg vs 6.84±13.57 mmHg, P=0.0007). The proportion of patients who achieved a reduction of siDBP ≥10 mmHg from baseline and/or a mean siDBP <90 mmHg after 4 weeks of treatment was higher in the fimasartan/HCTZ treatment group than in the fimasartan treatment group (53.6% vs 39.8%, P=0.0359). The overall incidence of adverse drug reaction was 11.79% with no significant difference between the treatment groups.

          Conclusion

          The combination treatment of fimasartan and HCTZ achieved better BP control than fimasartan monotherapy, and had comparable safety and tolerance to fimasartan monotherapy.

          Most cited references23

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          Validation of the Omron 705IT (HEM-759-E) oscillometric blood pressure monitoring device according to the British Hypertension Society protocol.

          The Omron 705IT (HEM-759-E, Omron Corporation, Kyoto, Japan) is an automated oscillometric upper arm blood pressure monitor for the professional and home use markets. The aim of this study was to validate the accuracy of this device according to the British Hypertension Society and the Association for the Advancement of Medical Instrumentation SP10 validation criteria. Study participants were recruited until a total of 85 were obtained that filled the blood pressure categories specified by the British Hypertension Society protocol. Recruitment to the study was from the general medical and specialist clinics and from the staff at Guy's & St Thomas' Hospital in London, UK. Nine sequential same-arm blood pressure readings were taken from each participant by two trained observers, alternating between mercury reference sphygmomanometers and the Omron 705IT (HEM-759-E). The differences between the reference and test device readings, for both systolic and diastolic pressures, were compared with British Hypertension Society and Association for the Advancement of Medical Instrumentation criteria to determine the outcome of the study. The Omron 705IT (HEM-759-E) is graded 'A' for systolic and 'A' for diastolic blood pressures according to the British Hypertension Society criteria. The mean (standard deviation) of the difference between the observer and the device measurements was 0.60 (6.0) mmHg for systolic and -3.15 (6.6) mmHg for diastolic pressures, respectively. The device, therefore, also satisfies the Association for the Advancement of Medical Instrumentation SP10 standard, that requires differences of less than +/-5 (8) mmHg. The Omron 705IT (HEM-759-E) achieved an 'A/A' performance classification under the British Hypertension Society criteria and passes the Association for the Advancement of Medical Instrumentation requirements for the study population. It can be recommended for professional and home-use in an adult population.
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            Trends in the prevalence of major cardiovascular disease risk factors among Korean adults: results from the Korea National Health and Nutrition Examination Survey, 1998-2012.

            Mortality from coronary heart disease in Korea has increased continuously, but there are few comprehensive national data on trend in the prevalence of risk factors for cardiovascular disease in this population. We examined the trends in the prevalence of major risk factors for cardiovascular disease, including smoking, obesity, hypertension, diabetes, and hypercholesterolemia, from 1998 through 2012 in a representative Korean population. Using data from the Korea National Health and Nutrition Examination Survey I (1998) to V (2010-2012), we selected the adults aged≥30 yr who participated in both a health examination and health interview survey. From 1998 to 2012, significant decrease in the prevalence of hypertension was observed in both men (32.5 to 31.5%) and women (26.9 to 24.3%). Smoking rates decreased only in men (65.1 to 47.0%), whereas the prevalence of diabetes did not change over time. Conversely, the prevalence of hypercholesterolemia significantly increased from 7.2% to 12.6% for men and from 8.4% to 14.9% for women, whereas the rates of awareness and treatment for hypercholesterolemia were relatively lower than that of hypertension and diabetes. During the period, prevalence of obesity significantly increased from 26.8% to 38.1% only in men. The increased prevalence of hypercholesterolemia and obesity may have contributed to the increasing trend in the mortality from coronary heart disease in Korea. Further population-based surveillance of blood cholesterol levels and obesity needs to be performed, and national strategies for improvement of these factors should be established in Korea. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.
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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
                Drug Design, Development and Therapy
                Drug Design, Development and Therapy
                Dove Medical Press
                1177-8881
                2015
                02 June 2015
                : 9
                : 2847-2854
                Affiliations
                [1 ]Cardiovascular Center, Dongguk University Ilsan Hospital, Goyang, Republic of Korea
                [2 ]Catholic University of Korea, Seoul St Mary’s Hospital, Seoul, Republic of Korea
                [3 ]Cardiovascular Department of Internal Medicine, Kyung Hee University Medical Center, Seoul, Republic of Korea
                [4 ]Division of Cardiology, Guro Hospital, Korea University College of Medicine, Seoul, Republic of Korea
                [5 ]Division of Cardiology, Samsung Medical Center, Seoul, Republic of Korea
                [6 ]Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea
                [7 ]Division of Cardiology, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul, Republic of Korea
                [8 ]Division of Cardiology, Asan Medical Center, Seoul, Republic of Korea
                [9 ]Division of Cardiology, Ajou University Hospital, Suwon, Republic of Korea
                [10 ]Division of Cardiology, Wonju Severance Christian Hospital, Wonju, Republic of Korea
                [11 ]Division of Cardiology, GangNam Severance Hospital, Seoul, Republic of Korea
                [12 ]Division of Cardiology, Severance Hospital, Seoul, Republic of Korea
                [13 ]Division of Cardiology, Inje University Ilsan Hospital, Goyang, Republic of Korea
                [14 ]Department of Cardiology, Chonnam National University Hospital, Gwangju, Republic of Korea
                [15 ]Chonbuk National University Hospital, Jeonju, Republic of Korea
                [16 ]Department of Cardiology, Cheil General Hospital, Dankook University College of Medicine, Seoul, Republic of Korea
                [17 ]Department of Cardiology, Hanyang University Guri Hospital, Guri, Republic of Korea
                [18 ]Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea
                Author notes
                Correspondence: Cheol Ho Kim, Department of Internal Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Gumi-ro 173, Bundang-gu, Seongnam-si, Gyeonggi-do 463-707, Republic of Korea, Tel +82 31 787 7001, Fax +82 31 787 4052, Email cheolkim@ 123456snu.ac.kr
                Article
                dddt-9-2847
                10.2147/DDDT.S82098
                4459623
                ef3e9d56-f3c1-490f-b214-b0664565d6fb
                © 2015 Rhee et al. This work is published by Dove Medical Press Limited, and licensed under Creative Commons Attribution – Non Commercial (unported, v3.0) License

                The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

                History
                Categories
                Original Research

                Pharmacology & Pharmaceutical medicine
                blood pressure,antihypertensive,angiotensin-converting enzyme inhibitor,angiotensin-receptor blocker,angiotensin ii type 1 receptor,renin–angiotensin–aldosterone system inhibitor

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