アブストラクト | Using a large health insurance database in Japan, we examined the real-world usage of budesonide enteric-coated capsules (BUD) in treating Crohn's disease. We analyzed data from the Japan Medical Data Center claims database for Crohn's disease patients prescribed BUD from April 2016 to March 2021, focusing on prescription status, adverse events (AEs), monitoring tests, and concomitant medications over 2 years following BUD initiation. Patients were categorized into two groups based on BUD usage duration: </=1 year and >1 year. Of the 7364 registered patients, 1049 (14.2%) were prescribed BUD. Among the 562 followed for 2 years, 505 (89.9%) used BUD for </=1 year and 57 (10.1%) for >1 year. Over 70% of the patients used at least one biologic, and more than 20% used at least two. The proportions of new thiopurine initiation were 22 and 9% in the </=1-year and >1-year groups, respectively (p = 0.0181). We did not identify any obvious increase in AEs from long-term BUD use within the confines of our study design. However, regardless of prescription duration, over half of the patients lacked hepatitis B virus screening, glycated hemoglobin measurement, adrenal function quantification, or bone densitometry. Usage of strong CYP3A4 inhibitors was more frequent among patients in the BUD >1-year group. This study revealed that numerous Japanese patients received long-term BUD prescriptions. Although no apparent increase in AEs from long-term BUD was detected, we identified inadequate monitoring of AEs and drug interactions, as well as insufficient use of steroid-sparing agents. |
投稿者 | Yagisawa, Keiji; Kubota, Atsuhito; Imai, Shungo; Nashimoto, Shunsuke; Sato, Yuki; Kashiwagi, Hitoshi; Maemoto, Atsuo; Sugawara, Mitsuru; Takekuma, Yoh |
組織名 | Graduate School of Life Science, Hokkaido University, Kita 10, Nishi 8, Kita-ku,;Sapporo 060-0810, Japan.;Department of Pharmacy, Sapporo-Higashi Tokushukai Hospital, 3-1 Kita 33, Higashi;14, Higashi-ku, Sapporo 065-0033, Japan.;School of Pharmaceutical Sciences, Health Sciences University of Hokkaido, 1757;Kanazawa, Tobetsu-cho, Ishikari-gun, Hokkaido 061-0293, Japan.;Keio University Faculty of Pharmacy, 1-5-30 Shibakoen, Minato-ku, Tokyo 105-8512,;Japan.;Faculty of Pharmaceutical Sciences, Hokkaido University, Kita 12, Nishi 6,;Kita-ku, Sapporo 060-0812, Japan.;Inflammatory Bowel Disease Center, Sapporo Higashi Tokushukai Hospital, Kita 33,;Higashi 14, Higashi-ku, Sapporo 065-0033, Japan.;Department of Pharmacy, Hokkaido University Hospital, Kita 14, Nishi 5, Kita-ku,;Sapporo 060-8648, Japan. |