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

  • Global Perspectives: Original Research
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Abstract

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.

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Authors and Affiliations

  1. School of Medicine, Department of Regulatory Science of Medicine, Chiba University, 1-8-1 Inohana Chuo-ku, Chiba, 260-8677, Japan

    Nanae Tanemura PhD, Yoshiaki Uyama PhD & Hideki Hanaoka MD, PhD

  2. Division of Clinical Research Center, Chiba University Hospital, Chiba, Japan

    Nanae Tanemura PhD, Kengo Nagashima PhD & Hideki Hanaoka MD, PhD

  3. Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency (PMDA), Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyodaku, Tokyo, 100-0013, Japan

    Yoshiaki Uyama PhD

  4. Division of Medical Informatics and Management, Chiba University Hospital, Chiba, Japan

    Takahiro Suzuki MD, PhD

  5. Office of New Drugs II, Pharmaceuticals and Medical Devices Agency (PMDA), Tokyo, Japan

    Yasuko Asahina PhD

  6. Department of Cardiovascular Medicine, Graduate School of Medicine, Chiba University, Chiba, Japan

    Yoshio Kobayashi MD, PhD

  7. Division of Cardiovascular Medicine, Chiba University Hospital, Chiba, Japan

    Yoshio Kobayashi MD, PhD

  8. Department of Psychiatry, Graduate School of Medicine, Chiba University, Chiba, Japan

    Masaomi Iyo MD, PhD

  9. Division of Clinical Psychiatry, Chiba University Hospital, Chiba, Japan

    Masaomi Iyo MD, PhD

  10. Department of Clinical Cell Biology and Medicine, Graduate School of Medicine, Chiba University, Chiba, Japan

    Koutaro Yokote MD, PhD

  11. Division of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, Chiba, Japan

    Koutaro Yokote MD, PhD

Authors
  1. Nanae Tanemura PhD
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  2. Yoshiaki Uyama PhD
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  7. Masaomi Iyo MD, PhD
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  8. Koutaro Yokote MD, PhD
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Corresponding author

Correspondence to Yoshiaki Uyama PhD.

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Tanemura, N., Uyama, Y., Nagashima, K. et al. Comparison of Drug Use Between Clinical Practice and Regulatory Approval: Results in Older Japanese Patients With Rheumatoid Arthritis, Diabetes, High Blood Pressure, or Depression. Ther Innov Regul Sci 50, 743–750 (2016). https://doi.org/10.1177/2168479016648731

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  • DOI: https://doi.org/10.1177/2168479016648731

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