International journal of clinical pharmacology and therapeutics · 2026
Time to onset of amiodarone-induced interstitial lung disease is correlated with the percentage body fat: An analysis of data from the FAERS and JADER databases.
СтатьяНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Uno Takaya, Hosomi Kouichi, Yokoyama Satoshi
Аннотация
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.
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.