Aldosterone Dysregulation After Antihypertensive Treatments Among Patients With Hypertension in the United States: Findings From the Breakthrough Aldosterone Real-World Study
Abstract Body: Background: Conventional anti-hypertensive (anti-HTN) therapies, including renin-angiotensin-aldosterone system inhibitors, don’t fully address excess aldosterone production, leaving unresolved aldosterone dysregulation in some hypertensive patients. To understand the extent of this problem, this study describes aldosterone dysregulation after anti-HTN treatment.
Methods: We used IQVIA PharMetrics® Plus and Ambulatory EMR-US data (01/01/2017–10/31/2024) to identify adults with essential HTN and ≥1 circulating aldosterone or renin (A/R) assessment. We marked the index date as the first anti-HTN prescription after diagnosis and ≤1 year before the A/R measure. Continuous enrollment for 6 months pre-index was the baseline period to capture comorbidities. Follow-up spanned from index to the first A/R measure. Patients were grouped into mono, dual, and triple+ therapy based on their index anti-HTN regimen. Patient characteristics and presence of aldosterone dysregulation (aldosterone ≥10 ng/dL or renin ≤1 ng/mL/h) were compared across cohorts using Wilcoxon rank sum and Chi-square tests. Subgroup analyses included patients with uncontrolled HTN (systolic blood pressure [SBP] ≥130 mmHg; ≥1 baseline SBP measure required).
Results: Of the 1,183 eligible patients, 539 (46%), 377 (32%), 267 (22%) received mono, dual, and triple+ therapy, respectively (mean age: 57 years; 56% female; 69% White). Beta blockers (36%) and dihydropyridine calcium channel blockers (33%) were the most common therapies at index. Most patients were obese (53%) and had uncontrolled HTN (69%). Relative to monotherapy, triple+ therapy patients were older, and more likely to be male, non-White, obese, and have comorbidities (all p<0.05). Over 10 months of median follow-up, 50% of patients had aldosterone dysregulation, with no significant differences across cohorts (47%, 52%, and 54%, in mono, dual, and triple+ therapy, respectively). Similar results were seen in patients with A/R measures ≤3 months of index (50%, 54%, 57%) and baseline uncontrolled HTN (48%, 54%, 50%; all p≥0.05). Limitations include selection bias on testing and limited generalizability.
Conclusions: Aldosterone dysregulation was seen in half of treated hypertensive patients with an A/R measure regardless of therapy intensity (i.e., number of unique anti-HTN classes). These findings highlight the need for additional population-based studies of aldosterone dysregulation in hypertension and other cardiovascular diseases.
Rader, Florian
( Cedars-Sinai Medical Center
, Los Angeles
, California
, United States
)
Chertow, Glenn
( Stanford University School of Medicine
, Palo Alto
, California
, United States
)
Agiro, Abiy
( AstraZeneca
, Wilmington
, Delaware
, United States
)
Satija, Ambika
( Analysis Group, Inc.
, Boston
, Massachusetts
, United States
)
Chen, Jingyi
( Analysis Group, Inc.
, Boston
, Massachusetts
, United States
)
Lemus Wirtz, Esteban
( Analysis Group, Inc.
, Boston
, Massachusetts
, United States
)
Brahmbhatt, Ashish
( AstraZeneca
, Wilmington
, Delaware
, United States
)
Luan, Shan
( AstraZeneca
, Wilmington
, Delaware
, United States
)
Kang, Zoey
( Analysis Group, Inc.
, Boston
, Massachusetts
, United States
)
Mu, Fan
( Analysis Group, Inc.
, Boston
, Massachusetts
, United States
)