Analysis of Prednisolone-Induced Osteoporosis Using the Japanese Adverse Drug Event Report Database

Abstract

Purpose: Osteoporosis is an adverse event of prednisolone. This study aimed to assess prednisolone-induced osteoporosis (PIO) profiles and patient backgrounds by analyzing data from the Japanese Adverse Drug Event Report (JADER) database. Methods: The current study focused only on orally administered prednisolone. PIO was defined using preferred terms from the Medical Dictionary for Regulatory Activities. Reporting odds ratio (ROR) at 95% confidence interval (CI) and the time-to-onset profile of PIO were used to evaluate adverse events. Results: The RORs (95% CI) of the female and male subgroups were 4.73 (4.17–5.38) and 2.49 (2.06–3.00), respectively. The analysis of time-to-onset profiles demonstrated that the median values (interquartile range: 25.0–75.0%) of PIO were 136 (74.0–294.0). The prednisolone treatment duration was significantly longer in the PIO patient group than in the non-PIO patient group. The findings suggest that patients with rheumatoid arthritis, systemic lupus erythematosus, and nephrotic syndrome receiving prednisolone have different age-related PIO profiles. Conclusions: Our results suggest that longer prednisolone treatment duration and larger cumulative dose might be risk factors of PIO. The potential risk for PIO should not be overlooked, and careful observation is recommended.