Cisplatin-induced hyponatremia in malignancy: Comparison between brand-name and generic formulation

Nobuaki Ochi, Hiromichi Yamane, Katsuyuki Hotta, Hiromi Fujii, Hideko Isozaki, Yoshihiro Honda, Tomoko Yamagishi, Toshio Kubo, Mitsune Tanimoto, Katsuyuki Kiura, Nagio Takigawa

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

Introduction: Widespread use of generic drugs is considered to be indispensable if reductions in total health care 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 Student's 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 interval =1.403-22.839; P=0.015).

Conclusion: Oncologists should be aware that use of a generic CDDP might be associated with more hyponatremia than would use of brand-name CDDP.

Original languageEnglish
Pages (from-to)2401-2408
Number of pages8
JournalDrug Design, Development and Therapy
Volume8
DOIs
Publication statusPublished - Dec 3 2014

Fingerprint

Hyponatremia
Cisplatin
Names
Generic Drugs
Neoplasms
Incidence
Odds Ratio
Terminology
Pharmaceutical Preparations
Health Care Costs
Medical Records
Creatinine
Multivariate Analysis
Logistic Models
Regression Analysis
Confidence Intervals
Students
Kidney
Drug Therapy
Serum

Keywords

  • Brand-name
  • Cisplatin
  • Generic drug
  • Hyponatremia

ASJC Scopus subject areas

  • Pharmaceutical Science
  • Pharmacology
  • Drug Discovery

Cite this

Cisplatin-induced hyponatremia in malignancy : Comparison between brand-name and generic formulation. / Ochi, Nobuaki; Yamane, Hiromichi; Hotta, Katsuyuki; Fujii, Hiromi; Isozaki, Hideko; Honda, Yoshihiro; Yamagishi, Tomoko; Kubo, Toshio; Tanimoto, Mitsune; Kiura, Katsuyuki; Takigawa, Nagio.

In: Drug Design, Development and Therapy, Vol. 8, 03.12.2014, p. 2401-2408.

Research output: Contribution to journalArticle

Ochi, Nobuaki ; Yamane, Hiromichi ; Hotta, Katsuyuki ; Fujii, Hiromi ; Isozaki, Hideko ; Honda, Yoshihiro ; Yamagishi, Tomoko ; Kubo, Toshio ; Tanimoto, Mitsune ; Kiura, Katsuyuki ; Takigawa, Nagio. / Cisplatin-induced hyponatremia in malignancy : Comparison between brand-name and generic formulation. In: Drug Design, Development and Therapy. 2014 ; Vol. 8. pp. 2401-2408.
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AU - Ochi, Nobuaki

AU - Yamane, Hiromichi

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AU - Fujii, Hiromi

AU - Isozaki, Hideko

AU - Honda, Yoshihiro

AU - Yamagishi, Tomoko

AU - Kubo, Toshio

AU - Tanimoto, Mitsune

AU - Kiura, Katsuyuki

AU - Takigawa, Nagio

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AB - Introduction: Widespread use of generic drugs is considered to be indispensable if reductions in total health care 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 Student's 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 interval =1.403-22.839; P=0.015).Conclusion: Oncologists should be aware that use of a generic CDDP might be associated with more hyponatremia than would use of brand-name CDDP.

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