Increasing the Precision of Hypertension Treatment Through Personalized Trials: a Pilot Study

Abstract

Background: There are substantial differences in the effects of blood pressure (BP) medications in individual patients. Yet, the current standard approach to prescribing BP medications is not personalized.

Objective: To determine the feasibility of individualizing the selection of BP medications through pragmatic personalized (i.e., N-of-1) trials.

Design: Series of N-of-1 trials.

Setting: Outpatient.

Patients: Hypertensive adults prescribed none or one BP medication.

Intervention: Participation in a flexible, open-label personalized trial of two to three BP medications (NCT02744456).

Measurements: BP was measured twice per day with a validated home BP device. Frequency and severity of side effects were assessed at the end of the day via an electronic questionnaire. Patients' BP medication preference was assessed after reviewing BP lowering and side effect results with a study clinician. Feasibility was assessed by determining the proportion of patients who adhered to self-assessments. Benefit was assessed by asking patients to rate the helpfulness of participation and whether they would recommend personalized trials to other hypertensive patients.

Key results: Of ten patients enrolled, two dropped out prior to initiation, one discovered white coat hypertension through ambulatory BP monitoring, and seven (mean age 58 years, 71% of women) completed personalized trials. All seven were compliant with home BP monitoring and side effect tracking. All seven recommended personalized trials of BP medications to others. Thiazides were preferred by three patients, renin-angiotensin system-blocking agents by two patients, a combination of thiazide and beta-blocker by one patient, and any of three classes by one patient.

Conclusions: Personalized trials of BP medications were feasible and led to improved treatment precision. Heterogeneity of patient preferences and of therapeutic BP response for first-line BP medications can be determined through a personalized trial approach.

Keywords: clinical trials; disease management; health care delivery; hypertension; primary care.

Conflict of interest statement

The authors declare that they do not have a conflict of interest.

Figures

Fig. 1

Morning/night and overall mean systolic blood pressure during each personalized trial. The black circles and triangles show the average of morning (a.m.) and night (p.m.) systolic blood pressure (BP) readings, respectively, that were self-measured using a home BP device. These readings came from the second week of taking each medication. The gaps between the columns reflect the time period during which BP was not measured. This gap allowed for the time on the prior medication to wash out and the time for the new medication to have an onset of action. The columns reflect the mean of all systolic BP readings taken during that time period for each medication. The dashed line refers to goal BP according to the 2017 American College of Cardiology/American Heart Association high BP guidelines.