AUTHOR=Waki Takashi , Okada Yusuke , Kinoshita Yuki , Kajiyama Kazuhiro , Ishiguro Chieko , Nakazato Yuki , Kimura Ryota , Maniwa Harumi , Horiuchi Naoya , Iguchi Toyotaka , Uyama Yoshiaki 

TITLE=Prescription trend and lactic acidosis in patients prescribed metformin before and after the revision of package insert for allowing metformin administration to patients with moderately decreased kidney function based on real-world data from MID-NET® in Japan

JOURNAL=Frontiers in Medicine

VOLUME=Volume 10 - 2023

YEAR=2024

URL=https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2023.1294696

DOI=10.3389/fmed.2023.1294696

ISSN=2296-858X

ABSTRACT=Introduction : This study was conducted to understand the impact of package insert (PI) revision in Japan on June 18, 2019 to allow metformin use for patients with moderately decreased kidney function (30 < estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2).
Methods : A new user cohort design was employed to examine the prescription trend and the occurrence of lactic acidosis in patients prescribed metformin before and after the PI revision utilizing the Medical Information Database Network (MID-NET®).
Results : From May 12 , 2016 to March 31, 2020, 5,874 patients (before, n = 4,702; after, n = 1,172) were identified as new metformin users, including 1,145 patients (before, n = 914; after, n = 231) with moderately decreased kidney function. Although no marked changes in metformin prescription were observed before and after the PI revision, the daily metformin dose at the first prescription decreased after the PI revision. For both before and after the PI revision, < 10 cases of lactic acidosis occurred in all patients prescribed metformin, and no lactic acidosis was observed in patients with moderately decreased kidney function. 
Conclusion : The results of this study are useful for understanding the safety of metformin use in patients with decreased kidney function and suggest no worse impacts of the PI revision in Japan, indicating no further safety concerns on metformin use in patients with decreased kidney function under the situation with careful use and safety monitoring of metformin.