Real-world effectiveness of digital therapeutics for hypertension management

Background Hypertension is a major modifiable risk factor for cardiovascular disease that affects approximately 43 million people in Japan. Although lifestyle modifications are recommended as first-line interventions, their implementation within clinical settings remains challenging. Following regulatory approval of a digital therapeutic (DTx) for hypertension in Japan in 2022, we evaluated its real-world effectiveness, particularly among demographics previously excluded from clinical trials. Methods Practice-based, real-world data from patients prescribed CureApp HT between September 2022 and December 2023 were analyzed. Participants who were ≥18 years old and had at least one baseline morning blood pressure recording were included and followed for 24 weeks. The primary outcome was a change in the morning home systolic blood pressure (SBP), whereas the secondary outcomes included other blood pressure parameters and app usage metrics such as individual app engagement proportion and in-app program durations. Statistical analyses included multivariable linear regression models to evaluate between-subgroup differences while adjusting for baseline characteristics including baseline SBP levels and seasonal timing of DTx initiation. Results Among the 2038 eligible patients, mean age was 55.8 ± 11.4 years and 48.8% were female. Morning home SBP decreased from baseline at week 12 (−4.8 mmHg; 95% confidence interval [CI], −5.3 to −4.4) and week 24 (−6.0 mmHg; 95% CI, −6.6 to −5.4), with corresponding reductions in other blood pressure parameters. Consistent benefits were observed across subgroups, including older adults (≥65 years; −6.6 mmHg at week 24) and those on antihypertensive medication (−5.2 mmHg) who had previously been excluded from clinical trials. Multivariable analyses identified baseline SBP and seasonal timing of DTx initiation as determinants of treatment response, with smaller reductions having been observed with summer initiation than with spring initiation. Furthermore, good app usage metrics, including high individual app engagement and reduced in-app program durations, promoted increased SBP reductions. Conclusions Real-world evidence demonstrates that a DTx designed for individuals with hypertension effectively reduced blood pressure across diverse patient populations, with baseline SBP, seasonal factors, and patient engagement significantly influencing treatment efficacy. These findings provide important clinical insights for optimizing daily digital hypertension management.