Heart Failure Incidence and Risk Factors in U.S. Adults Receiving Bezlotoxumab: A Large Database Analysis

Area of Science:

• Infectious Diseases
• Cardiology
• Pharmacology

Background:

• Bezlotoxumab prevents recurrent Clostridioides difficile infection.
• Adverse events in trials reported heart failure (HF) exacerbations.
• This study assesses HF exacerbation incidence and predictors post-bezlotoxumab.

Purpose of the Study:

• Evaluate HF exacerbation incidence after bezlotoxumab.
• Identify predictors of HF exacerbation in patients receiving bezlotoxumab.
• Assess HF event and mortality rates stratified by HF history.

Main Methods:

• Utilized the TriNetX research database for U.S. adult patients receiving bezlotoxumab.
• Stratified patients into three groups: no HF, HF with preserved ejection fraction (HFpEF), and HF with reduced ejection fraction (HFrEF).
• Assessed 90-day cumulative incidence of HF events and mortality using Cox proportional hazard models.

Main Results:

• Among 2515 patients, 89% had no HF history, 4% HFpEF, and 7% HFrEF.
• 90-day HF event rates were 1% (no HF), 29% (HFpEF), and 52% (HFrEF).
• Independent predictors of HF events included HFrEF, HFpEF, heart transplant, hyperlipidemia, valvular heart disease, CKD stage ≥ 3, and ischemic heart disease.

Conclusions:

• Bezlotoxumab is associated with a significantly increased risk of HF exacerbation in patients with pre-existing HF.
• The risk is especially pronounced in patients with HFrEF.
• Bezlotoxumab appears safe in patients without a history of HF.