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Abstract：
UNASSIGNED: 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).
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
Adverse drug reactions reported for antidiabetic medications Introduction: This study investigated the trends in voluntary reporting of adverse drug reactions for recently approved antidiabetic medications. Methods: Data from the FDA Adverse Events Reporting System were evaluated. The top 10 adverse drug reactions were compared between antidiabetic medications in the same therapeutic class. Results: We identified 127,525 adverse drug reaction reports for the newer approved antidiabetic medications. For SGLT-2 inhibitors, empagliflozin was associated with greater reports of blood glucose increase, nausea, and dizziness; weight decreased was reported more often for dapagliflozin; and diabetic ketoacidosis, toe amputation, acute kidney injury, fungal infections, and osteomyelitis were reported more commonly for canagliflozin. Assessing GLP-1 receptor agonists, the odds of gastrointestinal adverse drug reactions being reported was greater for dulaglutide and semaglutide. Exenatide was disproportionally associated with injection site reactions and pancreatic carcinoma reports. Conclusion: Medication safety studies using a large publicly available dataset allows an essential opportunity to evaluate the safety profile of antidiabetic drugs in the real-world setting. Additional research is needed to determine if the reported safety concerns for recently approved antidiabetic medications to determine causality.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
Adverse drug reactions reported for antidiabetic medications Introduction: This study investigated the trends in voluntary reporting of adverse drug reactions for recently approved antidiabetic medications. Methods: Data from the FDA Adverse Events Reporting System were evaluated. The top 10 adverse drug reactions were compared between antidiabetic medications in the same therapeutic class. Results: We identified 127,525 adverse drug reaction reports for the newer approved antidiabetic medications. For SGLT-2 inhibitors, empagliflozin was associated with greater reports of blood glucose increase, nausea, and dizziness; weight decreased was reported more often for dapagliflozin; and diabetic ketoacidosis, toe amputation, acute kidney injury, fungal infections, and osteomyelitis were reported more commonly for canagliflozin. Assessing GLP-1 receptor agonists, the odds of gastrointestinal adverse drug reactions being reported was greater for dulaglutide and semaglutide. Exenatide was disproportionally associated with injection site reactions and pancreatic carcinoma reports. Conclusion: Medication safety studies using a large publicly available dataset allows an essential opportunity to evaluate the safety profile of antidiabetic drugs in the real-world setting. Additional research is needed to determine if the reported safety concerns for recently approved antidiabetic medications to determine causality.
摘要：
■在2012年至2017年之间，美国食品和药物管理局（FDA）批准了10种抗糖尿病适应症疗法。由于关于最近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).
■对自发报告的不良反应进行了不相称性分析。FAERS从2012年1月1日至2022年3月31日的报告已编制，在2017年药物批准后允许5年缓冲。计算前10名ADR的报告优势比，将新的糖尿病药物与其他批准的治疗药物进行比较。
■127,525份报告被确定为新批准的抗糖尿病药物被列为主要嫌疑人（PS）。对于钠-葡萄糖共转运蛋白-2（SGLT-2）抑制剂，血糖增加的几率,恶心,据报道，依帕列净的头晕更大。达格列净与更多的体重减轻报告相关。发现Canagliflozin的糖尿病酮症酸中毒报告数量高得多，脚趾截肢,急性肾损伤，真菌感染,骨髓炎。评估胰高血糖素样肽-1（GLP-1）受体激动剂，杜拉鲁肽和司马鲁肽与更多的胃肠道药物不良反应报告相关。艾塞那肽与注射部位反应和胰腺癌报告不成比例地相关。
■利用大量公开数据集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一个重要的机会。需要进一步的研究来评估最近批准的抗糖尿病药物的这些报告的安全性问题，以确定因果关系。
抗糖尿病药物不良反应报告简介：本研究调查了最近批准的抗糖尿病药物不良反应自愿报告的趋势。方法：评估来自FDA不良事件报告系统的数据。比较了同一治疗类别中抗糖尿病药物之间的前10个不良反应。结果：我们为新批准的抗糖尿病药物确定了127,525例不良反应报告。对于SGLT-2抑制剂，empagliflozin与更多的血糖升高报告相关，恶心,和头晕;达帕格列净更常报告体重下降;和糖尿病酮症酸中毒,脚趾截肢,急性肾损伤，真菌感染,和骨髓炎更常见于canagliflozin。评估GLP-1受体激动剂，杜拉鲁肽和司马鲁肽报告的胃肠道药物不良反应的几率更大.艾塞那肽与注射部位反应和胰腺癌报告不成比例地相关。结论：使用大型公开数据集进行的药物安全性研究提供了在现实世界中评估抗糖尿病药物安全性的重要机会。需要进一步的研究来确定是否报告了最近批准的抗糖尿病药物的安全性问题，以确定因果关系。
■对自发报告的不良反应进行了不相称性分析。FAERS从2012年1月1日至2022年3月31日的报告已编制，在2017年药物批准后允许5年缓冲。计算前10名ADR的报告优势比，将新的糖尿病药物与其他批准的治疗药物进行比较。
■127,525份报告被确定为新批准的抗糖尿病药物被列为主要嫌疑人（PS）。对于钠-葡萄糖共转运蛋白-2（SGLT-2）抑制剂，血糖增加的几率,恶心,据报道，依帕列净的头晕更大。达格列净与更多的体重减轻报告相关。发现Canagliflozin的糖尿病酮症酸中毒报告数量高得多，脚趾截肢,急性肾损伤，真菌感染,骨髓炎。评估胰高血糖素样肽-1（GLP-1）受体激动剂，杜拉鲁肽和司马鲁肽与更多的胃肠道药物不良反应报告相关。艾塞那肽与注射部位反应和胰腺癌报告不成比例地相关。
■利用大量公开数据集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一个重要的机会。需要进一步的研究来评估最近批准的抗糖尿病药物的这些报告的安全性问题，以确定因果关系。
抗糖尿病药物不良反应报告简介：本研究调查了最近批准的抗糖尿病药物不良反应自愿报告的趋势。方法：评估来自FDA不良事件报告系统的数据。比较了同一治疗类别中抗糖尿病药物之间的前10个不良反应。结果：我们为新批准的抗糖尿病药物确定了127,525例不良反应报告。对于SGLT-2抑制剂，empagliflozin与更多的血糖升高报告相关，恶心,和头晕;达帕格列净更常报告体重下降;和糖尿病酮症酸中毒,脚趾截肢,急性肾损伤，真菌感染,和骨髓炎更常见于canagliflozin。评估GLP-1受体激动剂，杜拉鲁肽和司马鲁肽报告的胃肠道药物不良反应的几率更大.艾塞那肽与注射部位反应和胰腺癌报告不成比例地相关。结论：使用大型公开数据集进行的药物安全性研究提供了在现实世界中评估抗糖尿病药物安全性的重要机会。需要进一步的研究来确定是否报告了最近批准的抗糖尿病药物的安全性问题，以确定因果关系。
