Randomized Controlled Trial of a Digital Therapeutics System for Treating New-onset Mild Hypertension (Preprint)

Abstract

Hypertension is the single most significant modifiable risk factor for all-cause morbidity and mortality worldwide.Lifestylechanges are the cornerstone of prevention and treatment of hypertension，Traditional lifestyle intervention depends on the hospital visit follow-up, patients with poor execution and poor compliance.However, the therapeutic effect of LIAN digital therapy with Internet technology in patients with mild hypertension is not yet established.

We aim to evaluate the therapeutic efficacy of LIAN digital therapeutics in patients with new-onset mild hypertension who did not receive antihypertensive medication.

This randomized controlled clinical trial included 1525 individuals with new-onset mild hypertension who were admitted to our Health Management Medicine Center between January 2022 and March 2023. They were randomly assigned 1:1 to the digital therapeutics group (n=756) or the control group (n = 769). The primary efficacy endpoint was the mean change in office blood pressure (BP) from baseline to 12 weeks. The key secondary efficacy endpoints were the mean changes in lipoprotein indices and lifestyle factors from baseline to 12 weeks.

The mean office BP decreased from 142.03 (SD 8.05)/90.39 (SD 5.69) to 136.19 (SD 10.60)/85.44 (SD 7.62) mmHg in the digital therapeutics group and from 141.91 (SD 7.25)/90.28 (SD 5.57) to 139.78 (SD12.33)/89.00 (SD 8.84) mmHg in the control group, with a mean difference in systolic BP and diastolic BP of –5.85 mmHg (95% CI –6.64 to –5.05 mmHg; P<0.001) and –4.95 mmHg (95% CI –5.50 to –4.40 mmHg; P<0.001), respectively. From baseline to 12 weeks, office BP control (<140/90 mmHg) was achieved in 423 (56.0%) patients in the digital therapeutics group and 308 (40.1%) patients in the control group (P<0.001). At 12 weeks, no group differences existed in high-density lipoprotein cholesterol (P=0.082), total cholesterol (P=0.055) or low-density lipoprotein (P=0.222) concentrations. However, changes in the total cholesterol/high-density lipoprotein cholesterol ratio and lifestyle factors were statistically significant (P<0.001). At 12 weeks, there were significant differences in lifestyle factors, including limiting oil consumption (P<0.001), limiting salt consumption (P<0.001), smoking status (P<0.001), drinking status (P<0.001), and exercise status (P<0.001), between the digital therapeutics group and the control group.

Our study confirmed the superiority of digital therapeutics for improving BP and lifestyle factors in people with new-onset mild hypertension without antihypertensive medications.