Scientific Poster Session IV - Original Research

Original Research
  Tuesday, November 14, 2023
  08:30 AM–10:00 AM

Abstract

Introduction:

While the REDUCE-IT trial demonstrated the cardiovascular benefit of icosapent ethyl (IPE), potential safety signals for atrial fibrillation (AF) and serious bleeding outcomes were of concern.

Research Question or Hypothesis:

What is the real-world safety of IPE vs. mixed omega-3 polysaturated fatty acid (OM-3) formulations?

Study Design: Retrospective active comparator new-user cohort study

Methods:

We compared rates of new-onset AF and major bleeding (MB) among adult new users of IPE vs OM-3 in 2020-2023 US Veterans Affairs data. We determined daily drug exposure via prescription dispensing dates. We identified outcomes via validated ICD-10-CM-based algorithms. We addressed measured confounding via nearest-neighbor pairwise propensity score (PS) matching. The PS, constructed via logistic regression, was informed by expert-identified variables meeting the disjunctive cause criterion. We used Cox regression to estimate hazard ratios (HRs), interpretable as average treatment effects for the treated.

Results:

Cohorts for analyses of AF and MB endpoints included 1,927 and 2,015 patients, respectively, in each of IPE and OM-3 exposure groups. Mean age was ~67 years with ~93% male and ~80% white population. Overall mean follow up time was ~6 months. Baseline covariates were generally well-balanced after PS matching. Incidence rates (IRs) for AF were 7.28 vs 7.47 per 100 person-years among new-users of IPE vs. OM-3. The adjusted HR was 1.15 (95% CI 0.82-1.63). Incidence rates for MB were 3.37 vs 3.36 per 100 person-years among new-users of IPE vs. OM-3. The adjusted HR was 1.62 (95% CI 0.87-3.02).

Conclusion:

While our measures of association were consistent with the null, we were unable to rule out harms of IPE (vs. OM-3) more modest than a 63% increased rate of AF and 3-fold increased rate of MB. Follow-up studies that can generate more precise estimates are warranted, spurred by increasing use of IPE.

Presenting Author

Tanvi Patil PharmD, BCPS
Salem Veterans Affair Medical Center

Authors

Charles E. Leonard PharmD, MSCE
University of Pennsylvania Perelman School of Medicine

Michael Gregory PharmD
SALEM VA MEDICAL CENTER

Nabil Jarmukli MD
Salem VA Medical Center

Natalie Savona PharmD
SALEM VA MEDICAL CENTER