| アブストラクト | BACKGROUND: Medication-related osteonecrosis of the jaw is a serious adverse event associated with bone-modifying agents, such as injectable bisphosphonate (zoledronic acid) and the anti-receptor activator of nuclear factor-kappaB ligand antibody (denosumab). OBJECTIVE: This study aims to evaluate and compare the time-to-onset profile for medication-related osteonecrosis of the jaw associated with denosumab between treatment-naive (naive group) and pre-treatment with zoledronic acid (post-zoledronic acid group) patients using the Japanese Adverse Drug Event Report database. METHODS: Medication-related osteonecrosis of the jaw was defined according to the Medical Dictionary for Regulatory Activities. The medication-related osteonecrosis of the jaw onset profiles were evaluated using the Weibull shape parameter and the log-rank test. RESULTS: The Japanese Adverse Drug Event Report database contains 632,409 reports published between April 2004 and March 2020. In the time-to-onset analysis, after extracting the combinations with complete information for the treatment start date and the medication-related osteonecrosis of the jaw onset date, 272 reports of the naive group and 86 reports of the post-zoledronic acid group were analyzed. The median onset in the naive and post-zoledronic acid groups was 487.0 (25-75%: 274.0-690.8) and 305.5 (25-75%: 158.3-508.5) days, respectively. Medication-related osteonecrosis of the jaw occurred earlier in the post-zoledronic acid group than in the naive group, and the log-rank test demonstrated a significant difference in their time transitions (p < 0.0001). CONCLUSIONS: The results indicated a risk of medication-related osteonecrosis of the jaw in naive and post-zoledronic acid groups and a shorter onset time in the latter than in the former. Thus, healthcare professionals should take the early risk of medication-related osteonecrosis of the jaw into account when switching patients from zoledronic acid to denosumab treatment. |
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| ジャーナル名 | Drugs - real world outcomes |
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| 投稿日 | 2022/8/7 |
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| 投稿者 | Hasegawa, Shiori; Ikesue, Hiroaki; Satake, Riko; Inoue, Misaki; Yoshida, Yu; Tanaka, Mizuki; Matsumoto, Kiyoka; Wakabayashi, Wataru; Oura, Keita; Muroi, Nobuyuki; Hashida, Tohru; Iguchi, Kazuhiro; Nakamura, Mitsuhiro |
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| 組織名 | Laboratory of Drug Informatics, Gifu Pharmaceutical University, 1-25-4;Daigaku-Nishi, Gifu, 501-1198, Japan.;Kaneichi Pharmaceutical. Co., Ltd, 3-5-23, Himejima, Nishiyodogawa-ku, Osaka,;555-0033, Japan.;Department of Pharmacy, Kobe City Medical Center General Hospital, Kobe, Japan.;Laboratory of Community Pharmacy, Gifu Pharmaceutical University, Gifu, Japan.;Daigaku-Nishi, Gifu, 501-1198, Japan. mnakamura@gifu-pu.ac.jp. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/35933498/ |
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