Objective: Risedronate Enteric-Coated (EC) is the only oral-bisphosphonate which can be taken with food, while preserving a higher bioavailability compared to immediate-release risedronate. Whether this formulation can further reduce the risk of fracture when compared to other Immediate-Release Bisphosphonate (IRB) remains unclear. Thus this study compared fracture rates and economic outcomes between women with osteoporosis treated with EC vs. IRB.
Methods: Women with osteoporosis were selected from a large US claims database (2009-2019). Patients were classified into EC or IRB cohorts based on the treatment initiated on the index date (first dispensing date for an oral bisphosphonate), matched 1:1 based on demographic and clinical characteristics, and observed for ≥2 years. Incidence rates (IRs) of fractures and healthcare resource utilization per 1,000 patient-years were compared between cohorts using IR ratios (IRRs). Outcomes were assessed overall and by age-groups (<65 yrs, ≥65 yrs and ≥75 yrs).
Results: Cohorts (n=2,726, median age: 60.0 yrs) were observed on average 4.5 yrs. The IR of fractures was significantly lower in the EC vs. the IRB cohort for any fracture site (EC: 34.65, IRB: 42.13; IRR=0.83, p<0.05) and spine fractures (EC: 10.84, IRB: 15.13; IRR=0.71, p<0.05). When stratified by age-group results persisted (table). Across the observation period, the IR of fracture was lower in the EC vs. the IRB cohort, reaching statistical significance at 36-months (fracture rate; EC=7.08%; IRB=8.67%, p=0.04). IR of hospitalizations was lower in the EC vs. the IRB cohort (EC: 106.74, IRB: 124.20; IRR=0.86, p<0.05) leading to significantly lower hospitalization costs among EC patients (average per-patient-per-year; EC: US$3,611; IRB: US$4,603, p<0.05).
Conclusion: Women with osteoporosis treated with EC have a lower incidence of fracture when compared to IRB. Potentially indicating that the bioavailability and therefore the efficacy of EC is higher than IRB, independent of food intake.