Impact of Japanese regulatory action on metformin-associated lactic acidosis in type II diabetes patients

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• 作者：Tadaaki Hanatani ; Kimie Sai ; Masahiro Tohkin…
• 关键词：Boxed warning ; Drug safety ; Japan ; Lactic acidosis ; Medical information ; Metformin ; Regulatory action
• 刊名：Pharmacy World Science
• 出版年：2015
• 出版时间：June 2015
• 年：2015
• 卷：37
• 期：3
• 页码：537-545
• 全文大小：793 KB
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• 作者单位：Tadaaki Hanatani (1) (2)
  Kimie Sai (1)
  Masahiro Tohkin (2)
  Katsunori Segawa (1)
  Yoshiro Saito (1)
  
  1. Division of Medicinal Safety Science, National Institute of Health Sciences, Kamiyoga 1-18-1, Setagaya-ku, Tokyo, 158-8501, Japan
  2. Department of Regulatory Science, Graduate School of Pharmaceutical Sciences, Nagoya City University, Tanabedori 3-1, Mizuho-ku, Nagoya, 467-8603, Japan
  
• 刊物类别：Medicine
• 刊物主题：Medicine & Public Health
  Internal Medicine
  Pharmacy
  
• 出版者：Springer Netherlands
• ISSN：2210-7711

文摘

Background The March 2012 regulatory action issued by the Japanese government signalled the rare but serious complication of lactic acidosis that can occur during metformin treatment, especially with the high dose formulation, h-metformin, and in those above 75?years old. Objective To assess quantitatively the impact of this regulatory action on patient management using a medical information database (MID). Setting Eight hospitals in Japan. Method Using a commercial MID, we collected data on adult outpatients treated with metformin, including h-metformin, during a 2-year study period between April 1, 2011 and March 31, 2013. The 2-year study period spanned 1?year before and after the regulatory action. The frequencies of lactate measurement in all metformin users, h-metformin users, and new users (started on metformin during the study period) were compared between the periods before and after the regulatory action, using generalized estimating equations. Trends in metformin prescription for elderly patients were analysed month-wise by regression analysis using an interrupted time series design. Main outcome measure The rate ratios (RR) of lactate testing before and after the regulatory action. Results Of 4347 metformin users, 784 patients were >75?years old. A significant increase in lactate measurement was observed after the regulatory action than before in the overall study population, with an adjusted RR of 2.14 (95?% confidence interval 1.24-.68). No significant change was found in h-metformin users and new users because lactate measurements were being performed as frequently in these subgroups before the regulatory action. There were no meaningful changes in the proportion of elderly metformin users in the overall population. Conclusion The regulatory action led to increased lactate measurement in the overall metformin users, but did not affect metformin prescription rate in the elderly patients. Our findings probably reflect the doctors-judgement that the benefits of metformin use outweigh the risk of lactic acidosis if lactate testing is performed regularly.