| アブストラクト | OBJECTIVES: To identify the time-to-onset profiles of amiodarone-induced interstitial lung disease using two spontaneous adverse event reporting databases. MATERIALS AND METHODS: Data were obtained from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS; JAPIC AERS) and the Japanese Adverse Drug Event Report database (JADER). Time-to-onset profiles of amiodarone-induced interstitial lung disease were analyzed using the generalized Wilcoxon test. Additionally, because JADER allows estimation of body fat percentage (eBF%), a one-sided Jonckheere-Terpstra test was conducted to evaluate the relationship between eBF% and time-to-onset of amiodarone-induced interstitial lung disease. RESULTS: In FAERS, sex was not significantly associated with the median time-to-onset of interstitial lung disease (male: 187 days; female: 190 days; p = 0.8457). Conversely, in JADER, female patients demonstrated a significantly longer median time-to-onset than male patients (male: 175 days; female: 273 days; p = 0.0214). Furthermore, in the Jonckheere-Terpstra test, patient stratification into healthy weight, overweight, and obesity categories based on eBF% showed a significant increase in median onset time with increasing obesity level in male patients (healthy weight: 96 days; overweight: 185 days; obesity: 272 days; p = 0.0126) but not in female patients (healthy weight: 253 days; overweight: 273 days; obesity: 428.5 days; p = 0.4123). CONCLUSION: To prevent fatal outcomes, pulmonary function may need to be monitored according to race, sex, and obesity level. |
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