所属 川崎医科大学 医学部 臨床医学 総合内科学４ 職種 教授
|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
|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|
|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.