Comparison of Drug Use Between Clinical Practice and Regulatory Approval: Results in Older Japanese Patients With Rheumatoid Arthritis, Diabetes, High Blood Pressure, or Depression

Nanae Tanemura, Yoshiaki Uyama, Kengo Nagashima, Takahiro Suzuki, Yasuko Asahina, Yoshio Kobayashi, Masaomi Iyo, Koutaro Yokote, Hideki Hanaoka

研究成果: Article査読

1 被引用数 (Scopus)

抄録

Background: In this study, differences in older patients between drug use as reported in clinical practice and in clinical trials for regulatory approval were examined. Methods: Electronic medical record (EMR) data such as patient background (age, sex), concomitant drugs, data on laboratory tests, and prescribed doses of drugs from outpatients with rheumatoid arthritis, diabetes, high blood pressure, or depression at Chiba University Hospital were obtained for the period from January 2003 to December 2012. These data were compared with data from relevant clinical trials for regulatory approval in order to examine differences in drug use. Results: There were 5134 eligible patients. The prescribed doses of drugs were lower than the standard approved doses for depression and rheumatoid arthritis but were generally within the approved dose range for type 2 diabetes mellitus and hypertension. When comparing the characteristics of older patients taking tacrolimus, 5.6% to 17.0% of those would not be able to participate in clinical trials because of liver or renal abnormality, and the incidence rates of some adverse drug events (ADEs) differed significantly between clinical practice and clinical trials. Conclusions: Appropriate doses of drugs for older patients may differ from approved doses in certain diseases. Complex situations such as a lot of polypharmacy, comorbidity, and functional impairment in older patients in clinical practice make it difficult to evaluate safety based on data from clinical trials. In the future, utilization of a database created from the EMR of older patients should be considered for assessment of drug safety in older patients in clinical practice.

本文言語English
ページ(範囲)743-750
ページ数8
ジャーナルTherapeutic Innovation and Regulatory Science
50
6
DOI
出版ステータスPublished - 2016 11月 1
外部発表はい

ASJC Scopus subject areas

  • 薬理学、毒性学および薬学(その他)
  • 公衆衛生学、環境および労働衛生
  • 薬理学(医学)

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