Senior Research Specialist ALNAS Hospital cairo, Egypt
Background: Angiotensin Receptor-Neprilysin Inhibitor (ARNi) is a novel pharmacological class that reduce all-cause mortality and heart failure (HF) hospitalization compared to enalapril in symptomatic heart failure with reduced ejection fraction (HFrEF) patients. Long-term safety evaluation using real-world data is crucial to assess unexpected adverse events, providing a more comprehensive understanding of the treatment's safety profile.
Objectives: The study aims to assess the long-term safety of ARNi and ACEi/ARBs after market approval from July 2015 to August 2021 using electronic medical records. The study also evaluates the difference in hospital length of stay between the groups, providing a comprehensive evaluation of the clinical outcomes associated with these drugs.
Methods: This retrospective comparative longitudinal cohort study was done using Brigham and Women's Hospital (BWH) records. Patients were divided into those taking ARNis or ACEi/ARB. To reduce bias, a propensity score matching was conducted. Lab reports were analyzed using chi-square test to compare the incidence of adverse events (AE) between drug cohorts. We’ve assessed the risks of serum creatinine (Scr>1.4 mg/dl), hyperkalemia > 5.5 mmol/liter, low systolic blood pressure (SBP < 90 mmHg), as well as patient encounters to detect angioedema (ICD-10 T78.3XXD), and acute tubular necrosis-ATN (N17.0). Additionally, HF related hospital stay was calculated using Mann-Whitney test .
Results: Results showed that ARNi group had lower incidence of some AE compared to the ACEi/ARB Cohort. Specifically, the incidence of hyperkalemia (7.7% in the ARNi vs 29.8% in the enalapril ), low systolic blood pressure (38.4% vs. 47.1%), and high serum creatinine levels (42.2% vs 59.4%) were all statistically significant lower in the ARNi group. However, the incidence of angioedema and acute tubular necrosis did not show statistical significance between the two groups. Additionally, patients in the ARNi group stayed less in the hospital (median = 11 days) than patients in the ACEi/ARBs group (median = 17 days). The Z-score=-6.147,p < 0.001.
Conclusions: These safety analyses showed that the ARNi administration may be associated with a lower risk of certain AE compared to the ACEi/ARB administration. Additionally, patients treated with ARNi stayed less time in the hospital compared to patients treated with ACEi/ARBs. Furthermore, this study provides a valuable contribution to the literature on the safety of ARNi, which will be beneficial for a better-informed prescribing decision and future research and for the development of guidelines for the safe use of these drugs.
