Observational Study
Copyright ©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. Nov 26, 2021; 9(33): 10198-10207
Published online Nov 26, 2021. doi: 10.12998/wjcc.v9.i33.10198
Impacts of statin and metformin on neuropathy in patients with type 2 diabetes mellitus: Korean Health Insurance data
Hong Ki Min, Se Hee Kim, Jong Han Choi, Kyomin Choi, Hae-Rim Kim, Sang-Heon Lee
Hong Ki Min, Se Hee Kim, Jong Han Choi, Department of Internal Medicine, Konkuk University Medical Center, Seoul KS013, South Korea
Kyomin Choi, Department of Neurology, Konkuk University Medical Center, Seoul KS013, South Korea
Hae-Rim Kim, Sang-Heon Lee, Division of Rheumatology, Department of Internal Medicine, Konkuk University School of Medicine, Seoul KS013, South Korea
Author contributions: Min HK and Kim SH designed the research study; Min HK, Kim SH, Choi JH, Choi K and Kim HR performed the research; Min HK contributed analytic tools; Min HK analyzed the data and wrote the manuscript; all authors have read and approve the final manuscript.
Supported by the Konkuk University Medical Center Research Grant 2020.
Institutional review board statement: This study was approved by the Institutional Review Board of Konkuk University Medical Center (approval number: 2021-01-004).
Informed consent statement: The HIRA database is accessible to all researchers and holds anonymized patient information to protect the privacy of individuals. The HIRA database can be accessed by any researchers whose study protocols have been approved by an official review committee, and Informed consent of HIRA data is omitted. Therefore, written informed consent for enrollment was waived because the data were provided by HIRA.
Conflict-of-interest statement: The authors have no potential conflicts of interest to disclose.
Data sharing statement: The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
STROBE statement: The authors have read the STROBE Statement—checklist of items, and the manuscript was prepared and revised according to the STROBE Statement—checklist of items.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Sang-Heon Lee, MD, Professor, Division of Rheumatology, Department of Internal Medicine, Konkuk University School of Medicine, 120 Neung-dong Ro, Gwangjin-gu, Seoul KS013, South Korea. shlee@kuh.ac.kr
Received: July 9, 2021
Peer-review started: July 9, 2021
First decision: August 8, 2021
Revised: August 9, 2021
Accepted: September 10, 2021
Article in press: September 10, 2021
Published online: November 26, 2021
Research background

Statin and metformin are widely used medications in patients with type 2 diabetes mellitus (T2DM). These medications have been claimed as causative agents for neuropathy.

Research motivation

To identify the incidence and risk of statin, metformin and statin + metformin therapy on new onset neuropathy.

Research objectives

The incidence of neuropathy was evaluated and compared between T2DM patients who used or did not use statin/metformin/statin + metformin by using Korean Health Insurance Review and Assessment - national patient sample data.

Research methods

The prospective cohort study used nation-wide health insurance data.

Research results

Statin therapy showed a positive association (odds ratio = 1.22, 95% confidence interval: 1.08-1.38], whereas metformin therapy showed a negative association with new onset neuropathy (odds ratio = 0.30, 95% confidence interval: 0.21-0.42) in patients with T2DM. Combination therapy of statin and metformin did not have an effect on new onset neuropathy of T2DM patients.

Research conclusions

The widely used medications in T2DM, statin and metformin, could have an effect on neuropathy development in T2DM patients. Physicians should pay attention to new onset neuropathy when using statin in T2DM patients.

Research perspectives

Nevertheless, further studies are required to reveal underlying mechanisms of statin and metformin on new onset neuropathy of T2DM.