World’s first real-world data on the hypotensive effects of digital therapeutics
World’s first real-world data on the hypotensive effects of digital therapeutics
Introducing a smart antihypertensive therapy using a “hypertension digital therapeutic app” covered by insurance
Allows for continuous use in patients aged 65 years and up, reducing morning systolic blood pressure by -8.8mmHg after 12 weeks
CureApp, Inc. (Head Office: Chuo-ku, Tokyo; CEO: Kohta Satake; hereafter, “the Company”) presented*1 the results of a study into the hypotensive effects in patients undergoing a smart antihypertensive therapy using a hypertension digital therapeutic app (hereafter “DTx app”) at The 45th Annual Scientific Meeting of the Japanese Society of Hypertension.
Analysis results based on blood pressure data entered into the DTx app prescribed at medical institutions nationwide show a change in systolic blood pressure after 12 weeks across the whole population*2 of -8.8mmHg on waking (morning blood pressure), and -8.5mmHg before sleeping (bedtime blood pressure). The study demonstrates the efficacy of smart antihypertensive therapy, using a DTx app with pharmaceutical approval and insurance coverage, across a broad patient population including patients 65 years and older (the eldest being 87 years old), who were not included in the clinical trial*3. This is the world’s first real-world data obtained in a clinical setting on the hypotensive effect of smart antihypertensive therapy.
Background and Purpose
While the importance for all patients with hypertension to make lifestyle changes was outlined in the Guidelines for the Management of Hypertension 2019, providing lifestyle change guidance tailored to individual patients within the limited consultation time available is no easy task. This smart antihypertensive therapy using our hypertension DTx app is intended for use in conjunction with doctor advice during consultations, promoting awareness and behavioral changes in patients outside of a clinical setting, while assisting patients with high blood pressure in establishing proper lifestyle habits.
While DTx apps are garnering attention for data that gives a clearer view of how patients are taking to treatments outside of a clinical setting, an area which was previously unknown, information on their efficacy in a real-world clinical setting has rarely been seen.
Since the launch of the world’s first smart antihypertensive therapy using a hypertension DTx app in September 2022, thousands of medical facilities across Japan have adopted the treatment, prescribing the hypertension DTx app to many critically hypertensive patients in collaboration with their doctors. In order to gain further insight into the optimal targets and method of use of the hypertension DTx app, we studied its antihypertensive effect in a real-world clinical setting using data entered into the app.
Study Outline
This was a retrospective study using data entered into the hypertension DTx app conducted under the following conditions:
Eligibility criteria:
Patients prescribed with the app from September 2022 to April 2023
Patients who entered in their at-home blood pressure at least once
Patients who did not refuse to allow their information to be used for the study
Primary evaluation items:
Decrease in blood pressure over a 12-week period after starting use of the hypertension DTx app (patients entering their blood pressure reading for five days or more in the baseline week, and in the week 12 weeks after starting app use)
Differential analysis based on age, use of medication at the time of starting app use, salt checksheet score, and BMI (body mass index)
As a result, after 12 weeks of app use across the entire population*1, the change in morning systolic blood pressure was -8.8mmHg, and the change in bedtime systolic blood pressure was -8.5mmHg. Further, patients 65 years of age and older, which were not included in the patient population for the clinical trial, accounted for 21% of this patient population. The change in morning systolic blood pressure after 12 weeks for patients aged 65 years and up (the eldest being 87 years old) was -11.8mmHg, while the change in bedtime systolic blood pressure was -10.1mmHg. The average systolic blood pressure at the start of app use (baseline) was 133.6mmHg in the morning, and 129.7mmHg at bedtime. These results trended lower than the values for the patient population using the app in the clinical trial (Japan phase III clinical trial HERB-DH1*3), which were 149.3mmHg in the morning, and 143.3mmHg at bedtime. Additionally, there were no health hazards to report as of August 2023.
This study demonstrated the efficacy of the hypertension DTx app across a broad patient population, including patients 65 years and older who were not included in the clinical trial. Looking ahead, further studies are needed into the efficacy and proper methods of use of the DTx app from various perspectives covering a wider range of cases, in addition to reviewing key clinical issues as part of prospective clinical studies.
Clinical Trial Data (Japan Phase III Clinical Trial HERB-DH1) (Reference)
The clinical trial for the hypertension DTx app evaluated blood pressure across two patient populations: patients who only received treatment at a medical institution, and patients who used the app in addition to receiving treatment at a medical institution. Change in systolic blood pressure at home for patients using the app 12 weeks after registration was -10.6mmHg in the morning, and -8.5mmHG at bedtime, while the change in the group not using the app was -4.3㎜Hg in the morning, and -3.6㎜Hg at bedtime. This effect remained until 24 weeks after registration. The J-HOP study*4 of patients at cardiovascular risk in Japan demonstrated that morning systolic blood pressure at home was an independent risk factor for stroke, with a 10mmHg increase in systolic blood pressure increasing the risk of a stroke by 36%. The reduction in morning systolic blood pressure at home of around 10mmHg using this app during the clinical trial is clinically significant in reducing cardiovascular disease, and demonstrates the effectiveness of the DTx app as a future option in hypertension treatments.
Hypertension and Its Treatment
Currently, the options for treating hypertension include (1) the patients themselves implementing lifestyle improvements, (2) drug treatments, and (3) smart antihypertensive therapy that combines the use of a smartphone (DTx apps covered by insurance, etc.) with advice from doctors. Hypertension is highly prevalent in Japan, with some 43 million*5 patients nationwide, and medical costs associated with hypertension upwards of 1.8 trillion yen*6. Hypertension is the highest risk factor for cardiovascular and cerebrovascular diseases (stroke and heart disease), and an estimated 100,000 people*7 die of hypertension-induced cardiovascular and cerebrovascular diseases every year in Japan. Despite this, only 10 million people*8 receive continuous treatment for hypertension, and mild stage medical intervention remains inadequate, with 70% of patients failing to meet their target blood pressure, and/or left untreated. While the importance of the early adoption of sustainable lifestyle changes outside medical clinics and at home in order to maximize the benefit of treatments is recognized there are large numbers of patients that are not receiving treatment at a medical clinic and, even for patients that are receiving treatment, there are limits to what doctors can achieve by providing individually-tailored lifestyle guidance within a limited consultation time frame.
*1 Takagi Y. et al., Antihypertensive Effect of CureApp HT in Real World Applications For Patients Using the Hypertension Treatment App, 45th Annual Scientific Meeting of the Japanese Society of Hypertension, LB2-4,2023
*2 Patients entering their blood pressure reading for five days or more in the baseline week and in the week 12 weeks after starting app use N=257 (at wakeup), N=200 (before sleep)
*3 Kario K. Nomura A. Satake 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(9):1713-1722 https://doi.org/10.1111/jch.13993
*4Hoshide S, Yano Y, Haimoto H, 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. J-HOP Study Group. Hypertension. 2016;68:54-61.
*5 Guidelines for the Management of Hypertension 2019 [JSH2019] The Japanese Society of Hypertension（2019) https://www.jpnsh.jp/guideline.htm
*6 “Medical Care Expenditure Summary” 2018 Study (Ministry of Health, Labour and Welfare)
https://www.mhlw.go.jp/toukei/saikin/hw/k-iryohi/18/index.html
*7 “Vital Statistics Summary”2019 Study (Ministry of Health, Labour and Welfare)
https://www.mhlw.go.jp/toukei/saikin/hw/jinkou/kakutei19/dl/15_all.pdf
*8 “Patient Study” 2017 Study (Ministry of Health, Labour and Welfare)
https://www.mhlw.go.jp/toukei/saikin/hw/kanja/17/dl/05.pdf
About CureApp, Inc.
Founded in 2014 by two physicians, CureApp, Inc. is a MedTech venture, a manufacturer of medical devices that is involved in the research and development, production, and sale of therapeutic apps which have demonstrated their effectiveness in a clinical trial, and are prescribed by doctors to patients at medical clinics.
In 2020, CureApp developed the world’s first smartphone-based medical device program for disease treatment to receive regulatory approval and insurance coverage in the field of smoking cessation. The Company later was the first to receive regulatory approval in the field of hypertension in April 2022, followed by insurance coverage in September of the same year. CureApp is also proceeding with the development of a number of other therapeutic apps for other diseases, including NASH, alcohol addiction, cancer, chronic heart failure, and chronic low back pain. CureApp also operates the ascure mobile health program for private companies, and the ascure Smoking Cessation program, which has been implemented at 300 corporations (including 230 partnership agreements with health insurance associations). In addition, the Company launched the ascure Dr. Checkup Reminder (Hypertension), a program to help patients with hypertension to schedule checkups, on April 1, 2023, as well as introducing the ascure Aggravation Prevention (Blood Pressure Course) on June 1.
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