Pharmaceutical and therapeutic equivalence study of the generic drug containing bezafibrate

Susumu Kaneshige, Yuusuke Ikeda, Matsunaga Naoya, Koyanagi Satoru, Shigehiro Ohdo, Hidetoshi Kamimura

研究成果: Contribution to journalArticle査読

1 被引用数 (Scopus)

抄録

Objectives: The use of generic drugs is recommended in order to reduce medical costs. However, many doctors and pharmacists do not trust the quality, efficacy and safety of some generic drugs. Bezator® SR containing bezafibrate is widely used for the treatment of hyperlipidemia, and besastar® SR is the generic drug of bezator® SR. We herein compared the pharmaceutical and therapeutic equivalence of besastar® SR with those of bezator® SR. Methods: The elution rate of bezafibrate from besastar® SR was compared to that of bezator® SR. In addition, the clinical data of the patients treated with besastar® SR at Fukuoka Memorial Hospital were compared with those treated with bezator® SR at Fukuoka University Chikushi Hospital. Results: One of six lots of besastar® SR did not satisfy the standards of elution of bezafibrate. However, the effect of besastar® SR on the blood triglyceride concentration after 4-12 weeks was equivalent to that of bezator® SR. In addition, in a manner similar to that of bezator® SR, besastar® SR did not induce hematopoietic injury, hepatic dysfunction, renal dysfunction or rhabdomyolysis during the period from 4-12 weeks after the initiation of treatment. Conclusions: Although besastar® SR is not 100% pharmaceutically equivalent to bezator® SR, the efficacy and safety of this generic drug are considered to be equivalent to those of bezator® SR.

本文言語英語
ページ(範囲)91-100
ページ数10
ジャーナルJapanese Pharmacology and Therapeutics
39
1
出版ステータス出版済み - 1 20 2011

All Science Journal Classification (ASJC) codes

  • 薬理学(医学)
  • 薬理学

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