App-based Digital therapeutics bests lifestyle modifications alone for high BP control: Study

Digital therapeutics is a new approach to facilitate the non-pharmacological treatment of hypertension using software programmes such as smartphone applications and/or device algorithms.

Based on promising findings from a small pilot trial, the HERB Digital Hypertension 1 (HERB-DH1) pivotal trial investigated the efficacy of digital therapeutics in patients with hypertension not receiving antihypertensive medication.

This prospective, open-label, randomized controlled study was performed at 12 sites in Japan. Patients with hypertension were randomly assigned 1:1 to the digital therapeutics group (HERB system + standard lifestyle modification) or control group (standard lifestyle modification alone).

The primary efficacy endpoint was the mean change in 24 h ambulatory SBP from baseline to 12 weeks; key secondary efficacy endpoints were mean changes in office and home blood pressure (BP) from baseline to 12 weeks. All analyses were conducted in the full analysis set population.

The results of the study are as follows:

· Between December 2019 and June 2020, 390 patients were randomly assigned to the digital therapeutics group or control group.

· Between-group differences in 24-h ambulatory, home, and office SBPs at 12 weeks were −2.4 mmHg, respectively.

· No major programme-related safety events occurred up to 24 weeks.

Thus, the researchers concluded that the HERB-DH1 pivotal study showed the superiority of digital therapeutics compared with standard lifestyle modification alone to reduce 24-h ambulatory, home, and office BPs in the absence of antihypertensive medications.

Although there is some older literature investigating the use of digital interventions in patients with hypertension,11 the novelty of this HERB-DH1 pivotal trial is the randomized, controlled evaluation of the office, home, and ambulatory BP-lowering effects of adding a comprehensive digital therapeutic intervention to standard lifestyle modification alone in patients with hypertension not currently receiving antihypertensive medication. 

Reference:

Efficacy of a digital therapeutics system in the management of essential hypertension: the HERB-DH1 pivotal trial by Kario K et. al published in the European Heart Journal.

https://doi.org/10.1093/eurheartj/ehab559