Abstract P208: Association of Baseline Medication Burden With Blood Pressure Control, Patient-Reported Outcomes, and Serious Adverse Events: Findings from the SPRINT Trial

Abstract

Background: Achieving intensive systolic blood pressure (SBP) control (<120 mmHg) requires more antihypertensive medications than standard control (<140 mmHg). It is unclear how total medication burden impacts hypertension outcomes. Objective: To evaluate the association of total medication burden at baseline and SBP control, serious adverse events (SAEs), medication adherence, and treatment satisfaction in the Systolic Blood Pressure Intervention Trial (SPRINT). Methods: Baseline medication data were obtained by pill bottle review at randomization and categorized as high (≥ 5 prescription medications) vs low (< 5 medications) medication burden. SBP control per randomization goal, eight item Morisky Medication Adherence Scale (MMAS 8), and Treatment Satisfaction Questionnaire were evaluated at 1-year. SAEs were collected over the trial. We calculated adjusted risk ratios (RR) and hazard ratios (HR) for each outcome associated with medication burden using multivariable regression models stratified by randomized group. Results: Among 8454 participants with available data at 1-year follow up, 4797 (57%) and 3657 (43%) had high and low medication burden, respectively (mean medications ± SD; 8 ± 3 vs 3 ± 1). High medication burden was associated with reduced SBP control in the intensive arm (RR, 95%CI; intensive 0.92, 0.87-0.98; standard 0.98, 0.94-1.03; interaction p 0.01) and increased SAEs in both arms (HR, 95%CI; intensive 1.57, 1.40-1.77; standard 1.59, 1.41-1.78; interaction p 0.54). High medication burden was associated with worse medication adherence in the intensive arm and improved adherence in the standard arm (RR for MMAS 8 ≥6, 95%CI; intensive 0.97, 0.94-1.00; standard 1.05, 1.02-1.09; interaction p <0.01). High medication burden was not associated with hypertension treatment satisfaction (RR for satisfied/very satisfied, 95%CI; intensive 0.99, 0.98-1.00; standard 0.98, 0.97-1.00; interaction p 0.50). Conclusion: In SPRINT, high medication burden at baseline was associated with higher risk of SAEs. The association of high medication burden on the likelihood of achieving SBP goal and medication adherence at 1 year was different by treatment arm; medication burden was not associated with hypertension treatment satisfaction.