The association between GLP-1 receptor agonist and diabetic ketoacidosis in the FDA adverse event reporting system
| Autor: | Linyu Xiang, Rong Li, Mei Mei, Zheng Yang, Chongxin Chen, Yuhuan Lv, Meng Yu |
|---|---|
| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
endocrine system diseases Diabetic ketoacidosis Databases Factual Endocrinology Diabetes and Metabolism Medicine (miscellaneous) Glucagon-Like Peptide-1 Receptor Diabetic Ketoacidosis Food and drug administration Adverse Event Reporting System medicine Diabetes Mellitus Humans Insulin Adverse effect Glucagon-like peptide 1 receptor Nutrition and Dietetics business.industry United States Food and Drug Administration nutritional and metabolic diseases medicine.disease United States Emergency medicine Regulatory agency Cardiology and Cardiovascular Medicine business Fourth quarter |
| Zdroj: | Nutrition, metabolism, and cardiovascular diseases : NMCD. 32(2) |
| ISSN: | 1590-3729 |
| Popis: | In 2019, the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom (UK) and food and drug administration (FDA) of the United States of America (US) suggested that the relationship between glucagon-like peptide-1 receptor agonists (GLP-1RA) and diabetic ketoacidosis (DKA) deserved attention. This study is aiming to assess the association between GLP-1RA and DKA/ketosis in the FDA Adverse Event Reporting System (FAERS) database.Using FAERS database, we firstly extract the number of DKA reports from the first quarter (Q1) of 2004 to the fourth quarter (Q4) of 2019 and calculate proportional reporting ratios (PRRs). We then mined each FAERS file from 2004 Q1 to 2020 Q4 and obtained detailed information on DKA reports. From the first quarter (Q1) of 2004 to the fourth quarter (Q4) of 2019, there are 1382 DKA cases (1491 ketosis cases) associated with GLP-1RA in the FAERS database. There was a slight disproportionate reporting of DKA associated with overall GLP-1RA (PRR 1.49, 95%CI 1.24-1.79, p 0.001) after excluding the impact of SGLT2i, T1D and insulin. Any disproportionality disappeared after selecting the GLP-1RA combined with insulin for comparison.When GLP-1RA not combined with insulin, the disproportionality of DKA reports associated with GLP-1RA was observed. Our analysis mined the FAERS database to provide evidence and highlight the potential association between DKA adverse events and GLP-1RA therapy that clinicians tend to overlook. |
| Databáze: | OpenAIRE |
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