FACTORS ASSOCIATED WITH BLOOD PRESSURE CHANGES IN RESPONSE TO DIGITAL THERAPEUTICS SYSTEM: a RETROSPECTIVE ANALYSIS OF THE HERB-DH1 TRIAL

Digital therapeutics are evidence‐based therapeutic interventions driven by software. Recently, the HERB Digital Hypertension 1 (HERB‐DH1) pivotal trial was conducted to investigate the efficacy of the digital therapeutics in patients with hypertension. It has demonstrated that the difference between digital therapeutics group and control group in mean change in 24 h ambulatory SBP from baseline to 12 weeks was ‐2.4 (95% confidence interval [CI]: ‐4.5 to ‐0.3). However, The mechanism that led to the decrease in blood pressure has not been elucidated. We retrospectively analyzed the digital therapeutics group (HERB system + standard lifestyle modification) of the HERB‐DH1 trial. Spearman's correlation test between the blood pressure change from baseline to 12 weeks and clinical variables in patients with hypertension was performed. Of the 199 patients, 148 patients with available data for initial and final blood pressures were included. In the univariate analysis, age (r = ‐0.1761; 95% CI: ‐0.3324 to ‐0.01033; P = 0.0323), baseline blood pressure (r = ‐0.3697; 95% CI: ‐0.5048 to ‐0.2170; P < 0.0001), body weight change (r = 0.1704; 95% CI: 0.004451 to 0.3271; P = 0.0385), baseline BMI (r = ‐0.1738; 95% CI: ‐0.3303 to ‐0.008007; P = 0.0346) and BMI change (r = 0.1653; 95% CI: ‐0.0007627 to 0.3225; P = 0.0447) were related to blood pressure change. In conclusion, it is indicated that intervention in the digital therapeutics group of HERB‐DH1 trial leads to lifestyle modification and body weight change, which impact on effective blood pressure control.