Fractures among older patients receiving mirogabalin versus pregabalin: A retrospective cohort study using a large claims database in Japan

Purpose: Mirogabalin has a mechanism similar to that of pregabalin in the treatment of neuropathic pain. However, it remains unclear whether these drugs differ in terms of serious side effects, such as fall-related fractures, in older patients. This study aimed to investigate whether mirogabalin is associated with a decrease in fractures compared with pregabalin. Methods: We performed a retrospective cohort study using the DeSC database, a large administrative claims database in Japan. This study involved 49,393 patients ≥ 65 years taking mirogabalin or pregabalin between April 2019 and March 2020.The cumulative incidence of fractures was compared between those receiving mirogabalin and those receiving pregabalin using Kaplan-Meier curves and multivariable Cox proportional hazards models. A sensitivity analysis was performed for patients who received mirogabalin or pregabalin without other analgesic medications at the initial dose. Results: During a median follow-up of 20 months, 8,152 (16.5%) and 41,241(83.5%) received pregabalin, respectively. The proportions of fractures in the mirogabalin and pregabalin groups were 24.2% and 25.5%, respectively. Cox regression analysis showed that mirogabalin was associated with a lower risk of fractures (hazard ratio, 0.88; 95% confidence interval, 0.84–0.93). Sensitivity analysis also demonstrated a significant difference in fracture events between the mirogabalin and pregabalin groups without other analgesic medications (hazard ratio, 0.88; 95% confidence interval, 0.82–0.96). Conclusions: Our analyses suggest that the administration of MGB was associated with a decreased probability of fracture compared with PGB, although further studies are warranted to confirm these findings.