Efficacy of a digital therapeutics system in the management of essential hypertension: the HERB-DH1 pivotal trial

Figures

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  Figure 1. Overview of the digital therapeutic intervention (HERB system) for essential hypertension.

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  Figure 2. CONSORT flow diagram. *Primary endpoint. ABPM, ambulatory blood pressure monitoring; BP, blood pressure.

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  Figure 3. Changes from baseline to 12 weeks in 24-h, daytime, and nighttime systolic blood pressure based on ambulatory blood pressure monitoring, morning and evening home systolic blood pressure, and office systolic blood pressure. Values are reported as mean [95% confidence interval]. ABPM, ambulatory blood pressure monitoring; SBP, systolic blood pressure.

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  Figure 4. Change in morning home systolic blood pressure from baseline to 24 weeks. Values are reported as mean and standard error (bars). P-values are for differences between groups in the change from baseline to each time point using analysis of covariance adjusted for study site, previous antihypertensive drug use, and baseline systolic blood pressure on ambulatory blood pressure monitoring. LM, guideline-based lifestyle modification; MED, prescribed antihypertensive medications at 12 weeks. *Statistically significant between-group difference in the change from baseline.

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  Figure 5. Differences in 24-h systolic blood pressure between the digital therapeutics and control groups at 12 weeks in patient subgroups. ABPM, ambulatory blood pressure monitoring; BMI, body mass index; CI, confidence interval; DBP, diastolic blood pressure; SBP, systolic blood pressure.