ヤマネ　ヒロミチ   Hiromichi Yamane   山根　弘路    所属   川崎医科大学  医学部 臨床医学　総合内科学４    職種   准教授
論文種別	原著
言語種別	英語
査読の有無	査読あり
表題	Cisplatin-induced hyponatremia in malignancy:comparison between brand-name and generic formulation
掲載誌名	正式名：Drug Design, Development and Therapy 略　 称：Drug Des Devel Ther
掲載区分	国外
出版社	Dove press
巻・号・頁	8,pp.2401-2408
著者・共著者	Nobuaki ochi, Hiromichi Yamane, Katsuyuki Hotta, Hiromi Fujii, Hideko Isozaki, Yoshihiro Honda, Tomoko Yamagishi, Toshio Kubo, Mitsune Tanimoto, Katsuyuki Kiura, Nagio Takigawa
担当区分	2nd著者
発行年月	2015/01
概要	Introduction: Widespread use of generic drugs is considered to be indispensable if reductions in total healthcare costs are to be achieved, but the market share of such drugs remains low. In general, generic drugs have the same active ingredients as brand-name drugs, but this is not always the case. Thus, toxicity profiles may vary when brand-name and generic drugs are compared. We retrospectively investigated the incidence of hyponatremia in patients receiving brand-name cisplatin (CDDP) and a generic counterpart thereof. Methods: We reviewed the medical records of patients treated with brand-name CDDP (n=53) and a generic formulation (n=26), and compared the incidences of hyponatremia and renal toxicity. Toxicities were graded using the Common Terminology Criteria for Adverse Events, version 4.0. Differences between groups were evaluated using the t-test, and the odds ratio for hyponatremia was estimated via logistic regression analysis. Results: Serum creatinine levels after chemotherapy increased significantly in both the brand-name and generic CDDP groups; no significant difference was evident between the two groups. Hyponatremia of grade 3 or above developed in 30.7% of the generic CDDP group compared to 15.1% of the brand-name CDDP group (p=0.011). Multivariate analysis showed that the use of generic CDDP increased the incidence of hyponatremia (odds ratio: 5.661; 95% confidence intervals, 1.403 to 22.839; p=0.015). Conclusion: Oncologists should be aware that use of a generic CDDP might be associated with more hyponatremia than use of brand-name CDDP.