Nobuaki Ochi    Department   Kawasaki Medical School  Kawasaki Medical School, Department of General Internal Medicine 4,    Position   Assistant Professor
Article types	原著
Language	English
Peer review	Peer reviewed
Title	Cisplatin-induced hyponatremia in malignancy:comparison between brand-name and generic formulation
Journal	Formal name：Drug Design, Development and Therapy Abbreviation：Drug Des Devel Ther
Domestic / Foregin	Foregin
Publisher	Dove press
Volume, Issue, Page	8,pp.2401-2408
Author and coauthor	Nobuaki ochi, Hiromichi Yamane, Katsuyuki Hotta, Hiromi Fujii, Hideko Isozaki, Yoshihiro Honda, Tomoko Yamagishi, Toshio Kubo, Mitsune Tanimoto, Katsuyuki Kiura, Nagio Takigawa
Authorship	Lead author
Publication date	2015/01
Summary	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.