SummaryBackgroundEssential hypertension patients who utilized a new digital therapeutics (DTx) application for hypertension for up to 6 months achieved notable decreases in ambulatory, home, and office blood pressures, per the HERB-DH1 randomized controlled trial. Nevertheless, the extent of its effectiveness in clinical settings is not yet fully understood. This study seeks to evaluate blood pressure changes among the initial 1,000 hypertensive patients prescribed the DTx app in a practice-based real-world data (RWD) cohort.MethodsDeidentified data from the CureApp HT clinical information database was examined. The primary outcome measure evaluated the difference in morning systolic blood pressure (SBP) at home between week 12 and baseline. Variations in morning home SBP from week 24 (measured from baseline) and app engagement rates from weeks 12 and 24 (measured from baseline) were significant secondary outcomes. We also used analysis of covariance to compare home morning SBPs between the RWD cohort and the historical HERB-DH1 control group.FindingsThe practice-based RWD cohort had a mean age of 54·8 ± 11·6 years, and 48·9% of them were female. Their baseline morning home SBP was 132·8 ± 12·9 mmHg, and 91·7% of them used the app. At week 12, their morning home SBP decreased by −4·9 mmHg (confidence interval (CI), −5·6 to −4·2), and at week 24, it dropped by −6·1 mmHg (CI, −7·3 to −5·0). These declines were much greater than those seen in the HERB-DH1 control group. Subgroup analysis showed pragmatic SBP reductions with DTx in patients aged 265 years or on medication at baseline, a cohort previously excluded from the HERB-DH1 trial.InterpretationThe initial 1,000 hypertensive patients prescribed the DTx app showed significant decreases in morning home SBP. These results may suggest importance of the DTx app’s engagement and effectiveness that could extend to older adult patients and those on medication.FundingCureApp, Inc.