PP.16.35

Abstract

Objective: Despite the availability of numerous therapeutic agents and management tools, nearly half of all hypertensive patients do not have their blood pressure (BP) at goal (HSCIC data). Proteus captures and shares information about medication-taking, rest and activity patterns through an FDA-cleared and CE-marked ingestible sensor (IS), a wearable sensor adhesive patch and a mobile device and app. This platform supports provider decision-making for treating patients to goal. An open-label, observational real-world registry study evaluated this product in patients with uncontrolled hypertension. Design and method: The target sample size of the registry study is 150 patients with uncontrolled hypertension prescribed at least 2 antihypertensives. Patients co-ingested the IS with prescribed BP medications while simultaneously wearing the patch for 2 weeks. Clinic BP was measured on days 1 and 14. Adherence, activity and rest patterns, were measured via the Proteus patch and IS. Subjects returned to the clinic at week 4 to discuss the next steps in therapy based on the Proteus data. Results: In this interim analysis, 46 patients met the inclusion/exclusion criteria. The mean age was 68, 51% were male, and 36% also had diabetes. The root cause of persistent hypertension was identified for 100% of subjects; 46% had pharmacological resistance and 54% had inadequate medication use. BP control was achieved in 37% of patients after 2 weeks. The mean systolic BP decreased from 158 ± 16 to 143 ± 16, and the mean diastolic BP decreased from 83 ± 12 to 77 ± 10 after 2 weeks. BP management changes included medication reviews and/or adherence counseling in 88%, and medication changes in 24% of patients. Most patients (84%) had a good experience and thought the Proteus platform was easy to understand and convenient to use as measured by a patient satisfaction survey. Conclusions: In patients with a history of uncontrolled hypertension, the Proteus platform was able to help identify the root cause of persistent hypertension and help 37% achieve BP control within 2 weeks. The Proteus platform demonstrates the potential to help providers identify specific factors contributing to uncontrolled hypertension and facilitates interventions to improve disease management.