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      Efficacy of a digital therapeutics system in the management of essential hypertension: the HERB-DH1 pivotal trial


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          Digital therapeutics is a new approach to facilitate the non-pharmacological treatment of hypertension using software programmes such as smartphone applications and/or device algorithms. Based on promising findings from a small pilot trial, the HERB Digital Hypertension 1 (HERB-DH1) pivotal trial investigated the efficacy of digital therapeutics in patients with hypertension not receiving antihypertensive medication.

          Methods and results

          This prospective, open-label, randomized controlled study was performed at 12 sites in Japan. Patients with hypertension [office systolic blood pressure (SBP) 140 to <180 mmHg and 24 h SBP ≥130 mmHg] were randomly assigned 1:1 to the digital therapeutics group (HERB system + standard lifestyle modification) or control group (standard lifestyle modification alone). The primary efficacy endpoint was the mean change in 24 h ambulatory SBP from baseline to 12 weeks; key secondary efficacy endpoints were mean changes in office and home blood pressure (BP) from baseline to 12 weeks. All analyses were conducted in the full analysis set population. Between December 2019 and June 2020, 390 patients were randomly assigned to the digital therapeutics group ( n = 199) or control ( n = 191) group. Between-group differences in 24-h ambulatory, home, and office SBPs at 12 weeks were −2.4 (95% confidence interval −4.5 to −0.3), −4.3 (−6.7 to −1.9), and −3.6 (−6.2 to −1.0) mmHg, respectively. No major programme-related safety events occurred up to 24 weeks.


          The HERB-DH1 pivotal study showed the superiority of digital therapeutics compared with standard lifestyle modification alone to reduce 24-h ambulatory, home, and office BPs in the absence of antihypertensive medications.

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          Most cited references29

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          2018 ESC/ESH Guidelines for the management of arterial hypertension

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            Global Burden of Cardiovascular Diseases and Risk Factors, 1990–2019

            Cardiovascular diseases (CVDs), principally ischemic heart disease (IHD) and stroke, are the leading cause of global mortality and a major contributor to disability. This paper reviews the magnitude of total CVD burden, including 13 underlying causes of cardiovascular death and 9 related risk factors, using estimates from the Global Burden of Disease (GBD) Study 2019. GBD, an ongoing multinational collaboration to provide comparable and consistent estimates of population health over time, used all available population-level data sources on incidence, prevalence, case fatality, mortality, and health risks to produce estimates for 204 countries and territories from 1990 to 2019. Prevalent cases of total CVD nearly doubled from 271 million (95% uncertainty interval [UI]: 257 to 285 million) in 1990 to 523 million (95% UI: 497 to 550 million) in 2019, and the number of CVD deaths steadily increased from 12.1 million (95% UI:11.4 to 12.6 million) in 1990, reaching 18.6 million (95% UI: 17.1 to 19.7 million) in 2019. The global trends for disability-adjusted life years (DALYs) and years of life lost also increased significantly, and years lived with disability doubled from 17.7 million (95% UI: 12.9 to 22.5 million) to 34.4 million (95% UI:24.9 to 43.6 million) over that period. The total number of DALYs due to IHD has risen steadily since 1990, reaching 182 million (95% UI: 170 to 194 million) DALYs, 9.14 million (95% UI: 8.40 to 9.74 million) deaths in the year 2019, and 197 million (95% UI: 178 to 220 million) prevalent cases of IHD in 2019. The total number of DALYs due to stroke has risen steadily since 1990, reaching 143 million (95% UI: 133 to 153 million) DALYs, 6.55 million (95% UI: 6.00 to 7.02 million) deaths in the year 2019, and 101 million (95% UI: 93.2 to 111 million) prevalent cases of stroke in 2019. Cardiovascular diseases remain the leading cause of disease burden in the world. CVD burden continues its decades-long rise for almost all countries outside high-income countries, and alarmingly, the age-standardized rate of CVD has begun to rise in some locations where it was previously declining in high-income countries. There is an urgent need to focus on implementing existing cost-effective policies and interventions if the world is to meet the targets for Sustainable Development Goal 3 and achieve a 30% reduction in premature mortality due to noncommunicable diseases.
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              2020 International Society of Hypertension Global Hypertension Practice Guidelines


                Author and article information

                Eur Heart J
                Eur Heart J
                European Heart Journal
                Oxford University Press
                21 October 2021
                29 August 2021
                29 August 2021
                : 42
                : 40 , Focus Issue on Epidemiology and Prevention
                : 4111-4122
                [1 ] Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine , 3311-1, Yakushiji, Shimotsuke, Tochigi 329-0498, Japan
                [2 ] Innovative Clinical Research Center, Kanazawa University , 13-1 Takaramachi, Kanazawa, Ishikawa 920-8641, Japan
                [3 ] Department of Cardiovascular Medicine, Kanazawa University Graduate School of Medical Sciences , 13-1 Takaramachi, Kanazawa, Ishikawa, 920-8641, Japan
                [4 ] Department of Biomedical Informatics, CureApp Institute , 4136-1 Azayakozawa, Nagakutra, Kitasaku-Gun, Karuizawa, Nagano 389-0111, Japan
                [5 ] CureApp, Inc. , . Kodenma-Cho YS building 4th floor, 12-5 Nihonbashi kodenma-Cho, Chuo-ku, Tokyo 103-0001, Japan
                [6 ] Department of Biostatistics and Data Science, Osaka University Graduate School of Medicine , Yamadaoka 2-2, Suita-Shi, Osaka 565-0871, Japan
                Author notes
                Corresponding author. Tel: +81 285 58 7538, Fax: +81 285 44 4311, Email: kkario@ 123456jichi.ac.jp
                Author information
                © The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial License ( https://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com

                : 25 June 2021
                : 07 July 2021
                : 04 August 2021
                : 02 August 2021
                : 21 October 2021
                Page count
                Pages: 12
                Funded by: CureApp Inc.;
                Fast Track Clinical Research
                Epidemiology and Prevention

                Cardiovascular Medicine
                hypertension,digital therapeutics,lifestyle modification,ambulatory blood pressure,home blood pressure


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