Yoshihiro Noguchi
Miao Yan
Satoshi Yokoyama
Elisabetta Poluzzi- 1Laboratory of Clinical Pharmacy, Gifu Pharmaceutical University, Gifu, Japan
- 2Department of Pharmacy, The Second Xiangya Hospital of Central South University, Changsha, Hunan, China
- 3Toxicology Counseling Center of Hunan Province, Changsha, Hunan, China
- 4International Research Center for Precision Medicine, Transformative Technology and Software Services, Changsha, Hunan, China
- 5Division of Drug Informatics, School of Pharmacy, Kindai University, Higashi-osaka, Japan
- 6Pharmacology Unit, Department of Medical and Surgical Sciences (DIMEC), Alma Mater Studiorum-University of Bologna, Bologna, Italy
Editorial on the Research Topic
Pharmacovigilance and drug repositioning research using pharmacoepidemiology
Introduction
Pharmacoepidemiology, the study of the use and effects of medicines in large human populations, is a bridging science between clinical pharmacology and epidemiology. Pharmacovigilance is “the science and activities related to the detection, evaluation, understanding, and prevention of adverse effects or other problems associated with medicines."
This Research Topic contains six manuscripts using pharmacoepidemiological methods, five original research papers, and one perspective paper, including one paper using electronic health records as an information source, two papers using spontaneous reporting systems, and three papers using nationwide medical information based on claims data.
First, a retrospective cohort study using electronic medical records was reported by (Alsowaida et al.). The global epidemic of COVID-19 has made the development of effective drugs for the treatment and prevention of COVID-19 a global priority. Several post-marketing studies have reported significant bradycardia with remdesivir administration, and this article provides validation in an evidence-based source.
The spontaneous reporting system is one of the most important sources of information in pharmacovigilance, enabling the detection of unknown adverse events, and many safety signals have been reported through the spontaneous reporting system (Fusaroli et al, 2022; Xia et al, 2023). However, many cases registered in the spontaneous reporting system are spontaneously reported and therefore contain various reporting biases (Noguchi et al, 2021). In addition, the use of patient background information is controversial.
Although the risk of adverse events from drug exposure during pregnancy is usually investigated in study designs that include a control group, such as cohort studies, these studies require a sufficient number of cases. They can be time-consuming and labor-intensive to conduct. In some cases, there are few studies establishing short- and long-term safety in pregnancy, including retrospective studies, observational studies and prospective registry analyses (van De Ven et al, 2020). Sakai et al. reported safety signals for drug exposure during pregnancy using a spontaneous reporting database.
Onda et al. used multiple logistic regression analysis to adjust for patient background in the disproportionality analysis. Their logistic regression analysis showed that adding folic acid (FA) to methotrexate (MTX)-based therapy could help reduce the dose-dependent adverse events of MTX, providing clinical evidence to support the beneficial effect of FA.
Taiwan’s National Health Insurance (NHI) program covered more than 99.9% of the 14 Taiwanese population by 2014 (Lin et al, 2018). The NHI Research Database (NHIRD) records residence, sex, age, salary, prescription, medical procedures and disease diagnosis according to the International Classification of Diseases. Lin et al. hypothesize that statins inhibit MSU-induced gout flares through their anti-inflammatory properties, and a cohort study using the 2000 Longitudinal Generation Tracking Database (LGTD 2000), a randomly selected dataset of 2 million NHI recipients, found that statins have chemopreventive potential against MSU.
Yen et al. recruited participants with type 2 diabetes mellitus (T2DM) and cirrhosis from the NHIRD between 1 January 2000 and 31 December 2017 and followed them until 31 December 2018. This report found that using alpha-glucosidase inhibitors was associated with a reduced risk of mortality, hepatocellular carcinoma, compensated cirrhosis, and liver failure in patients with diabetes and compensated cirrhosis.
This type of study has not been conducted exclusively in Taiwan. The Pharmaceuticals and Medical Devices Agency (PMDA), the Japanese regulatory authority, conducts various pharmacoepidemiological studies based on actual data from its medical information database for post-marketing drug safety evaluation. Shida et al. carefully explained the details of these studies.
Since various medical information is a source of pharmacoepidemiological studies, researchers should properly characterize the sources and consider the study design.
The inverse signals detected by pharmacoepidemiological studies are known to be helpful in the search for drug candidates (Kinoshita et al, 2020), and many papers have been submitted on this Research Topic. However, unfortunately, none have been accepted for publication. We hope that research in this area will develop in the future.
Author contributions
All authors listed have made a substantial, direct and intellectual contribution to the work, and approved it for publication.
Funding
YN is supported by JSPS KAKENHI Grant Numbers JP22K12890. MY is supported by National Natural Science Foundation of China (Grant No. 81803830). SY is supported by JSPS KAKENHI Grant Number JP19K16461.
Acknowledgments
We wish to thank all the authors contributing to this Frontiers Research Topic and all the reviewers and invited editors who have helped to make it solid.
Conflict of interest
The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
Publisher’s note
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.
References
Fusaroli, M., Isgrò, V., Cutroneo, P. M., Ferrajolo, C., Cirillo, V., Del Bufalo, F., et al. (2022). Post-marketing surveillance of CAR-T-cell therapies: Analysis of the FDA adverse event reporting system (FAERS) database. Drug Saf. 45, 891–908. doi:10.1007/s40264-022-01194-z
Kinoshita, S., Hosomi, K., Yokoyama, S., and Takada, M. (2020). Inverse association between metformin and amiodarone-associated extracardiac adverse events. Int. J. Med. Sci. 17, 302–309. doi:10.7150/ijms.39342
Lin, L. Y., Warren-Gash, C., Smeeth, L., and Chen, P. C. (2018). Data resource profile: The national health insurance research database (NHIRD). Epidemiol. Health 40, e2018062. doi:10.4178/epih.e2018062
Noguchi, Y., Tachi, T., and Teramachi, H. (2021). Detection algorithms and attentive points of safety signal using spontaneous reporting systems as a clinical data source. Brief. Bioinform 22, bbab347. doi:10.1093/bib/bbab347
van De Ven, N. S., Pozniak, A. L., Levi, J. A., Clayden, P., Garratt, A., Redd, C., et al. (2020). Analysis of pharmacovigilance databases for dolutegravir safety in pregnancy. Clin. Infect. Dis. 70, 2599–2606. doi:10.1093/cid/ciz684
Keywords: pharmacovigilance, drug repositioning, pharmacoepidemiology, adverse events, drug-drug interactions (DDI), synergy pharmaceutical science
Citation: Noguchi Y, Yan M, Yokoyama S and Poluzzi E (2023) Editorial: Pharmacovigilance and drug repositioning research using pharmacoepidemiology. Front. Pharmacol. 14:1225909. doi: 10.3389/fphar.2023.1225909
Received: 20 May 2023; Accepted: 16 June 2023;
Published: 26 June 2023.
Edited and reviewed by:
Anick Bérard, Montreal University, CanadaCopyright © 2023 Noguchi, Yan, Yokoyama and Poluzzi. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
*Correspondence: Yoshihiro Noguchi, bm9ndWNoaXlAZ2lmdS1wdS5hYy5qcA==