Background: Non-guideline-endorsed posttreatment courses of antibiotics for post-Lyme disease syndrome (PLDS) have been linked to adverse patient outcomes, but these findings have yet to be validated in large systematic evaluations.
Methods: A retrospective cohort analysis of medical and pharmacy claims derived from the Truven Health Market Scan Commercial Claims and Encounters Database assessed 90-day incidence rates of adverse events (AEs) associated with PLDS treatment (PLDS-Tx). Patients were diagnosed with PLDS ≥6 months after initial diagnosis and standard antibiotic treatment for Lyme disease. Comparison cohorts included intravenous (IV) PLDS-Tx with or without oral antibiotics; oral antibiotic-only PLDS-Tx; or neither.
Results: Composite AE incidence rates were higher for patients treated with IV or oral PLDS-Tx than for patients not receiving either treatment (18.7%, 16.8%, and 13.4%, respectively; P = .019). Significant between-group differences in AE incidence rates were noted for electrolyte imbalance (4.0%, 1.5%, and 0.7%, respectively; P = .001) and infection (14.0%, 12.7%, and 9.3%; P = .006). Infection prevalence increased by 22.0% in the IV treatment group and 17.7% in the oral group. Incidence rates for all-cause and AE-related hospital stays and emergency department visits were higher for treated than nontreated patients, particularly when treatment was IV (all P < .01). Of IV-treated patients, 7.3% experienced an incident all-cause inpatient stay and 11.3% an incident all-cause emergency department visit, compared with, respectively, 2.2% and 3.4% of those treated with oral antibiotics and 0.9% and 1.9% of nontreated patients.
Conclusions: Use of IV therapies or oral antibiotics for PLDS was associated with increased patient morbidity within 90 days.