Stottlemyer Britney A, McDermott Michael C, Minogue Mackenzie R, Gray Matthew P, Boyce Richard D, Kane-Gill Sandra L
School of Pharmacy, University of Pittsburgh, Pittsburgh, PA, USA.
Department of Biomedical Informatics, University of Pittsburgh, Pittsburgh, PA, USA.
Ther Adv Drug Saf. 2023 Jun 12;14:20420986231181334. doi: 10.1177/20420986231181334. eCollection 2023.
Between 2012 and 2017, the U.S. Food and Drug Administration (FDA) approved 10 antidiabetic indicated therapies. Due to the limited literature on voluntarily reported safety outcomes for recently approved antidiabetic drugs, this study investigated adverse drug reactions (ADRs) reported in the FDA Adverse Event Reporting System (FAERS).
A disproportionality analysis of spontaneously reported ADRs was conducted. FAERS reports from January 1, 2012 to March 31, 2022 were compiled, allowing a 5-year buffer following drug approval in 2017. Reporting odds ratios were calculated for the top 10 ADRs, comparing new diabetic agents to the other approved drugs in their therapeutic class.
127,525 reports were identified for newly approved antidiabetic medications listed as the primary suspect (PS). For sodium-glucose co-transporter-2 (SGLT-2) inhibitors, the odds of blood glucose increased, nausea, and dizziness being reported was greater for empagliflozin. Dapagliflozin was associated with greater reports of weight decreased. Canagliflozin was found to have a disproportionally higher number of reports for diabetic ketoacidosis, toe amputation, acute kidney injury, fungal infections, and osteomyelitis. Assessing glucagon-like peptide-1 (GLP-1) receptor agonists, dulaglutide and semaglutide were associated with greater reports of gastrointestinal adverse drug reactions. Exenatide was disproportionally associated with injection site reactions and pancreatic carcinoma reports.
Pharmacovigilance studies utilizing a large publicly available dataset allow an essential opportunity to evaluate the safety profile of antidiabetic drugs utilized in clinical practice. Additional research is needed to evaluate these reported safety concerns for recently approved antidiabetic medications to determine causality.
2012年至2017年期间，美国食品药品监督管理局（FDA）批准了10种抗糖尿病适应症疗法。由于关于近期批准的抗糖尿病药物自愿报告的安全性结果的文献有限，本研究调查了FDA不良事件报告系统（FAERS）中报告的药物不良反应（ADR）。
对自发报告的ADR进行不成比例分析。汇编了2012年1月1日至2022年3月31日的FAERS报告，在2017年药物批准后留出5年缓冲期。计算了前10种ADR的报告比值比，将新型糖尿病药物与其治疗类别中的其他批准药物进行比较。
确定了127,525份将新批准的抗糖尿病药物列为主要怀疑对象（PS）的报告。对于钠-葡萄糖协同转运蛋白2（SGLT-2）抑制剂，恩格列净报告血糖升高、恶心和头晕的几率更高。达格列净与体重减轻的报告较多有关。卡格列净被发现糖尿病酮症酸中毒、脚趾截肢、急性肾损伤、真菌感染和骨髓炎的报告数量不成比例地更高。评估胰高血糖素样肽-1（GLP-1）受体激动剂时，度拉糖肽和司美格鲁肽与胃肠道药物不良反应的报告较多有关。艾塞那肽与注射部位反应和胰腺癌报告不成比例地相关。
利用大量公开可用数据集进行的药物警戒研究为评估临床实践中使用的抗糖尿病药物的安全性提供了重要机会。需要进一步研究来评估这些关于近期批准的抗糖尿病药物的报告的安全问题，以确定因果关系。
