OBJECTIVES: According to the Centers for Disease Control and Prevention, a deadly consequence of the opioid crisis is the increased incidence of blood-borne infections, including those related to bacteria/fungi causing endocarditis, a life-threatening infection of the heart's inner lining that disproportionally affects patients with all forms of opioid use disorder (OUD). Its significant morbidity and mortality burdens the healthcare system through prolonged, high-complexity episodes of acute hospitalization. This study compared bacteremia/sepsis/endocarditis rates between patients prescribed an FDA-authorized prescription digital therapeutic (PDT) and controls.

METHODS: Analysis of closed-claims data from OUD-diagnosed adults one year before (pre-index) and after (post-index) PDT prescription/fill (index). Cases filled the PDT prescription, while controls did not. Outcomes assessed were claims for bacteremia/sepsis, endocarditis, or the composite endpoint (any bacteremia/sepsis/endocarditis). Incidence rate ratios (IRRs) were compared pre- and post-index, and between cases and controls (post-index only) using a repeated-measures negative binomial model of patient counts, adjusting for duration of each period (pre-post analysis), and for baseline demographic and clinical characteristics (cases vs. control analysis).

RESULTS: Among 901 cases and 978 controls, cases showed a decrease in bacteremia/sepsis, endocarditis, and the composite endpoint [IRR 0.85, 0.92, and 0.93, respectively; all P>0.6] in the pre- vs. post-index period; controls showed a decrease in bacteremia/sepsis, and an increase of endocarditis and the composite endpoint [IRR 0.96, 1.41, and 1.06, respectively; all P>0.4]. Cases showed a 12% lower incidence of bacteremia/sepsis and a 2% lower incidence of the composite endpoint vs. controls [IRR 0.88 and 0.98 respectively, both P>0.7; model could not be fit for endocarditis]. Rate of acute and subacute infective endocarditis decreased 41% pre-post in cases (P=0.4), and increased 34% in controls (P=0.6).

CONCLUSIONS: Treatment with an FDA-authorized PDT for OUD was associated with reduced rates of bacteremia, sepsis, and endocarditis, findings that merit further investigation.