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

BACKGROUND: infection. Although well tolerated, heart failure (HF) exacerbations have been reported as adverse events in clinical trials. This study evaluates the incidence and predictors of HF exacerbation following bezlotoxumab. METHODS: We used the TriNetX research database to identify U.S. adults who received bezlotoxumab and stratified them into three groups based on HF history: no HF, HF with preserved ejection fraction (HFpEF), and HF with reduced ejection fraction (HFrEF). The 90-day cumulative incidence of HF events and mortality were assessed. Cox proportional hazard models identified predictors of HF events. RESULTS: < 0.001). Independent positive predictors of HF events included HFrEF (aHR 19.400), HFpEF (adjusted hazard ratio [aHR] 8.632), heart transplant (aHR 7.485), hyperlipidemia (aHR 3.184), valvular heart disease (aHR 2.267), chronic kidney disease stage ≥ 3 (aHR 1.715), and ischemic heart disease (aHR 1.987). Protective factors included non-cardiac solid organ transplant (aHR 0.333). CONCLUSIONS: Bezlotoxumab appears safe in patients without HF history but is associated with a significantly increased risk of HF exacerbation in those with pre-existing HF, especially HFrEF.