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The first software as medical device of evidence-based hypertension digital therapeutics for clinical practice

Hypertension Research volume 45, pages 1899–1905 (2022)Cite this article

Abstract

In 2021, the open-label randomized HERB-Digital Hypertension 1 (HERB-DH1) trial showed for the first time that hypertension digital therapeutics (a hypertension treatment app) successfully reduced blood pressure (BP) in patients with hypertension. Patients in the digital therapeutics group who used the app and home BP monitoring (HBPM) showed significant and persistent decreases in office, home and ambulatory BP values compared with the control group (who were under physician management using HBPM and lifestyle modifications). The results of the pivotal study led to the first global approval of this app for the treatment of hypertension in Japan in 2022, including medical insurance reimbursement. As a result, this hypertension app is expected to become widely used in the clinical management of all stages of hypertension. The most important remaining research issues include the identification of patients likely to respond to this therapeutic approach and the development of clinical efficacy indices. In addition, guidelines for the appropriate use of hypertension apps in the treatment of hypertension are needed. Next steps include the development and research of digital tools to facilitate the behavioral modifications required to prevent hypertension.

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References

  1. Kario K. Essential Manual on Perfect 24-hour Blood Pressure Management from Morning to Nocturnal Hypertension: Up-to-date for Anticipation Medicine.). Tokyo: Wiley; 2018. p. 1–309.

  2. Kario K, Harada N, Okura A. Digital therapeutics in hypertension: evidence and perspectives. Hypertension. 2022;79:2148–58. https://doi.org/10.1161/HYPERTENSIONAHA.1122.19414.

  3. Kario K, Harada N, Okura A. State-of-the-art rapid review of the current landscape of digital hypertension. Conn Health. 2022;1:46–58.

    Google Scholar 

  4. Omboni S, McManus RJ, Bosworth HB, Chappell LC, Green BB, Kario K, et al. Evidence and Recommendations on the Use of Telemedicine for the Management of Arterial Hypertension: An International Expert Position Paper. Hypertension 2020;76:1368–83.

    Article  CAS  PubMed  Google Scholar 

  5. Kario K, Hoshide S, Mogi M. Digital hypertension 2023: concept, hypothesis, and new technology. Hypertens Res. 2022;45:1529–30.

  6. Kario K. Management of Hypertension in the Digital Era: Small Wearable Monitoring Devices for Remote Blood Pressure Monitoring. Hypertension 2020;76:640–50.

    Article  CAS  PubMed  Google Scholar 

  7. Kario K, Mogi M, Hoshide S. Latest hypertension research to inform clinical practice in Asia. Hypertens Res. 2022;45:555–72.

    Article  PubMed  Google Scholar 

  8. Pellegrini D, Torlasco C, Ochoa JE, Parati G. Contribution of telemedicine and information technology to hypertension control. Hypertens Res. 2020;43:621–8.

    Article  PubMed  Google Scholar 

  9. Waki T, Miura K, Tanaka-Mizuno S, Ohya Y, Node K, Itoh H, et al. Prevalence of hypertensive diseases and treated hypertensive patients in Japan: A nationwide administrative claims database study. Hypertens Res. 2022;45:1123–33.

    Article  PubMed  Google Scholar 

  10. Yatabe J, Yatabe MS, Ichihara A. The current state and future of internet technology-based hypertension management in Japan. Hypertens Res. 2021;44:276–85.

    Article  PubMed  Google Scholar 

  11. Node K, Kishi T, Tanaka A, Itoh H, Rakugi H, Ohya Y, et al. The Japanese Society of Hypertension-Digest of plan for the future. Hypertens Res. 2018;41:989–90.

    Article  PubMed  Google Scholar 

  12. Matsuoka R, Akazawa H, Kodera S, Komuro I. The dawning of the digital era in the management of hypertension. Hypertens Res. 2020;43:1135–40.

    Article  PubMed  Google Scholar 

  13. Nakagami H. New wave of digital hypertension management for clinical applications. Hypertens Res. 2022;45:1549–51; https://doi.org/10.1038/s41440-022-00977-2.

  14. Rakugi H. Further promotion of “the JSH plan for the future” conscious of new normal after/with COVID-19: message from the new president of the Japanese Society of Hypertension. Hypertens Res. 2021;44:4–6.

    Article  CAS  PubMed  Google Scholar 

  15. Kario K, Nomura A, Harada N, Okura A, Nakagawa K, Tanigawa T, et al. Efficacy of a digital therapeutics system in the management of essential hypertension: the HERB-DH1 pivotal trial. Eur Heart J. 2021;42:4111–22.

    Article  PubMed  PubMed Central  Google Scholar 

  16. Kario K, Nomura A, Harada N, Tanigawa T, So R, Nakagawa K, et al. A multicenter clinical trial to assess the efficacy of the digital therapeutics for essential hypertension: Rationale and design of the HERB-DH1 trial. J Clin Hypertens (Greenwich). 2020;22:1713–22.

    Article  Google Scholar 

  17. Kario K, Nomura A, Kato A, Harada N, Tanigawa T, So R, et al. Digital therapeutics for essential hypertension using a smartphone application: a randomized, open-label, multicenter pilot study. J Clin Hypertens (Greenwich). 2021;23:923–34.

    Article  Google Scholar 

  18. Nomura A, Tanigawa T, Kario K, Igarashi A. Cost-effectiveness of digital therapeutics for essential hypertension. Hypertens Res. 2022;45:1538–48; https://doi.org/10.1038/s41440-022-00952-x.

  19. Umemura S, Arima H, Arima S, Asayama K, Dohi Y, Hirooka Y, et al. The Japanese Society of Hypertension Guidelines for the Management of Hypertension (JSH 2019). Hypertens Res. 2019;42:1235–481.

    Article  PubMed  Google Scholar 

  20. Whelton PK, Carey RM, Aronow WS, Casey DE Jr., Collins KJ, Dennison Himmelfarb C, et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension 2018;71:1269–324.

    Article  CAS  PubMed  Google Scholar 

  21. Williams B, Mancia G, Spiering W, Agabiti Rosei E, Azizi M, Burnier M, et al. 2018 ESC/ESH Guidelines for the management of arterial hypertension. Eur Heart J. 2018;39:3021–104.

    Article  PubMed  Google Scholar 

  22. Tucker KL, Sheppard JP, Stevens R, Bosworth HB, Bove A, Bray EP, et al. Self-monitoring of blood pressure in hypertension: a systematic review and individual patient data meta-analysis. PLoS Med. 2017;14:e1002389.

    Article  PubMed  PubMed Central  Google Scholar 

  23. Kario K, Park S, Chia YC, Sukonthasarn A, Turana Y, Shin J, et al. 2020 Consensus summary on the management of hypertension in Asia from the HOPE Asia Network. J Clin Hypertens (Greenwich) 2020;22:351–62.

    Article  Google Scholar 

  24. Parati G, Stergiou GS, Bilo G, Kollias A, Pengo M, Ochoa JE, et al. Home blood pressure monitoring: methodology, clinical relevance and practical application: a 2021 position paper by the Working Group on Blood Pressure Monitoring and Cardiovascular Variability of the European Society of Hypertension. J Hypertens. 2021;39:1742–67.

    Article  CAS  PubMed  Google Scholar 

  25. Kario K. Home blood pressure monitoring: current status and new developments. Am J Hypertens. 2021;34:783–94.

    Article  PubMed  PubMed Central  Google Scholar 

  26. Zhang W, Zhang S, Deng Y, Wu S, Ren J, Sun G, et al. Trial of Intensive Blood-Pressure Control in Older Patients with Hypertension. N. Engl J Med. 2021;385:1268–79.

    Article  CAS  PubMed  Google Scholar 

  27. Hoshide S, Yano Y, Haimoto H, Yamagiwa K, Uchiba K, Nagasaka S, et al. Morning and Evening Home Blood Pressure and Risks of Incident Stroke and Coronary Artery Disease in the Japanese General Practice Population: The Japan Morning Surge-Home Blood Pressure Study. Hypertension 2016;68:54–61.

    Article  CAS  PubMed  Google Scholar 

  28. Kario K. Morning Surge in Blood Pressure and Cardiovascular Risk. Hypertension 2010;56:765–73.

    Article  CAS  PubMed  Google Scholar 

  29. Kario K, Saito I, Kushiro T, Teramukai S, Tomono Y, Okuda Y, et al. Morning Home Blood Pressure Is a Strong Predictor of Coronary Artery Disease: The HONEST Study. J Am Coll Cardiol. 2016;67:1519–27.

    Article  PubMed  Google Scholar 

  30. Burnier M, Egan BM. Adherence in Hypertension. Circ Res. 2019;124:1124–40.

    Article  CAS  PubMed  Google Scholar 

  31. Rea F, Corrao G, Merlino L, Mancia G. Initial Antihypertensive Treatment Strategies and Therapeutic Inertia. Hypertension 2018;72:846–53.

    Article  CAS  PubMed  Google Scholar 

  32. Newby K, Teah G, Cooke R, Li X, Brown K, Salisbury-Finch B, et al. Do automated digital health behaviour change interventions have a positive effect on self-efficacy? A systematic review and meta-analysis. Health Psychol Rev. 2021;15:140–58.

    Article  PubMed  Google Scholar 

  33. Fujiwara T, McManus RJ, Kario K. Management of hypertension in the digital era: Perspectives and future directions. Hipertens Riesgo Vasc. 2022;39:79–91.

    Article  CAS  PubMed  Google Scholar 

  34. Kario K, Chia YC, Siddique S, Turana Y, Li Y, Chen CH, et al. Seven-action approaches for the management of hypertension in Asia - The HOPE Asia network. J Clin Hypertens (Greenwich). 2022;24:213–23.

    Article  Google Scholar 

  35. Kario K, Morisawa Y, Sukonthasarn A, Turana Y, Chia YC, Park S, et al. COVID-19 and hypertension-evidence and practical management: Guidance from the HOPE Asia Network. J Clin Hypertens (Greenwich). 2020;22:1109–19.

    Article  CAS  Google Scholar 

  36. Khan NA, Stergiou GS, Omboni S, Kario K, Renna N, Chapman N, et al. Virtual management of hypertension: lessons from the COVID-19 pandemic-International Society of Hypertension position paper endorsed by the World Hypertension League and European Society of Hypertension. J Hypertens. 2022;40:1435–48.

    Article  CAS  PubMed  Google Scholar 

  37. Narita K, Hoshide S, Tsoi K, Siddique S, Shin J, Chia YC, et al. Disaster hypertension and cardiovascular events in disaster and COVID-19 pandemic. J Clin Hypertens (Greenwich). 2021;23:575–83.

    Article  CAS  Google Scholar 

  38. Omboni S, Padwal RS, Alessa T, Benczúr B, Green BB, Hubbard I, et al. The worldwide impact of telemedicine during COVID-19: current evidence and recommendations for the future. Connect Health. 2022;1:7–35.

    PubMed  PubMed Central  Google Scholar 

  39. Shibata S, Arima H, Asayama K, Hoshide S, Ichihara A, Ishimitsu T, et al. Hypertension and related diseases in the era of COVID-19: a report from the Japanese Society of Hypertension Task Force on COVID-19. Hypertens Res. 2020;43:1028–46.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  40. Wang JG, Li Y, Chia YC, Cheng HM, Minh HV, Siddique S, et al. Telemedicine in the management of hypertension: evolving technological platforms for blood pressure telemonitoring. J Clin Hypertens (Greenwich). 2021;23:435–9.

    Article  Google Scholar 

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Acknowledgements

English language editing support was provided by Nicola Ryan, independent medical writer, funded by Jichi Medical University.

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Authors and Affiliations

  1. Division of Cardiovascular Medicine, School of Medicine, Jichi Medical University, Tochigi, Japan

    Kazuomi Kario, Noriko Harada & Ayako Okura

Authors
  1. Kazuomi Kario
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  2. Noriko Harada
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  3. Ayako Okura
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K Kario conceptualized this review. All authors contributed to the writing of the final article.

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Correspondence to Kazuomi Kario.

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KK reports lecture fees from CureApp outside the submitted work. All other authors report no potential competing interests in relation to this paper.

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Kario, K., Harada, N. & Okura, A. The first software as medical device of evidence-based hypertension digital therapeutics for clinical practice. Hypertens Res 45, 1899–1905 (2022). https://doi.org/10.1038/s41440-022-01016-w

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