# A Real-World Analysis of Post-Marketing Surveillance Data Assessing the Incidence of Hyperkalemia or Acute Kidney Injury in Patients on Angiotensin-Converting Enzyme Inhibitors Versus Angiotensin-Receptor Blockers

## TL;DR

This study analyzed real-world data to compare the risks of kidney issues and high potassium levels in patients using two types of blood pressure medications.

## Contribution

The study provides new insights into the comparative safety of ACEIs and ARBs using real-world adverse event data.

## Key findings

- ARB users reported more acute kidney injury than ACEI users.
- ACEI users experienced more hyperkalemia than ARB users.
- Combining ACEI and ARB significantly increased the risk of adverse kidney events.

## Abstract

The widely used Renin-angiotensin-aldosterone system
inhibitor (RASI) may increase the risk of hyperkalemia and acute kidney injury
(AKI). We aimed to analyze the RASI-related AKI or hyperkalemia reported in the
Food and Drug Administration’s Adverse Event Reporting System (FAERS) database
to optimize patients’ treatment and provide a reference for a clinically safe
and rational prescription.

We obtained data in FAERS recorded
from January 2004 to December 2020. Disproportionality analysis
and Bayesian analysis were used in data mining to screen the suspected AKI or
hyperkalemia after RASI. The time to onset, hospitalization, and prognosis of
RASI-associated AKI or hyperkalemia were also investigated.

We
identified 11,301 RASI-related adverse events (AEs) of hyperkalemia and AKI in
the FAERS database; 4997 were due to Angiotensin-converting enzyme inhibitors (ACEIs),
5658 were due to angiotensin receptor blockers (ARBs), and 646 were
due to the combination of ACEI and ARB. AKI was more commonly reported in
patients with ARB (78.42%) than ACEI users (57.27%). Hyperkalemia cases were
reported more in ACEI users (28.70%) than ARB users (14.14%). The median time
to onset of RAS-associated AKI was 135.0 (17.0–620.0) days. RASI-associated
hyperkalemia occurred relatively later in ACEI users, with a median onset time of
261.0 (43.0–1097.7) days, compared with that of 200.5 (52.0–636.0) days in ARB
users (p < 0.001). Among all AEs, 72.39% of cases received
hospitalization. Death occurred in 6.3% of the renal AE cases. The elderly and
heart failure were potential risk factors for death in patients who developed
RASI-associated renal AEs, with an increased Odds Ratio (OR) compared with younger age
(OR = 1.32) and hypertension patients (OR = 2.55). Based on the
criteria of the four algorithms, the ACEI and ARB combination further increased
the incidence of AKI and hyperkalemia, demonstrating the highest Reporting
Odds Ratios (RORs), Proportional Reporting Ratios (PRRs) and Empirical Bayesian
Geometric Average (EBGMs).

Patients who indicated RASI for
heart failure demonstrated a higher death risk when AEs occurred. ACEI combined with
ARB can increase the incidence of hyperkalemia and AKI. Careful and individualized
management is necessary.