Bullous Pemphigoid and Diabetes medications: A disproportionality analysis based on the FDA Adverse Event Reporting System.
Bullous Pemphigoid and Diabetes medications: A disproportionality analysis based on the FDA Adverse Event Reporting System.
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大疱性类天疱疮和糖尿病药物：基于 FDA 不良事件报告系统的不成比例分析。
DOI：
10.7150/ijms.55421
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发表时间：
2021
影响因子：
3.6
通讯作者：
Jiang Y
中科院分区：
文献类型：
--
作者：
Huang L;Liu Y;Li H;Huang W;Geng R;Tang Z;Jiang Y
背景：世界上第一种糖尿病药物(胰岛素)于1923年10月上市。一些研究表明糖尿病药物与大疱性类天疱疮(BP)，特别是二肽基肽酶4(DPP-4)抑制剂有关。这项研究旨在根据FDA不良事件报告系统(FAERS)检测糖尿病药物(主要是DPP-4抑制剂)和大疱性类天疱疮之间的关联。方法：本研究纳入FAERS收录的2004年3月至2020年8月期间所有糖尿病药物与血压抑制剂相关的自发报告。进行不成比例分析，找出糖尿病药物和血压之间的信号。计算卡方检验(χ2Yates)、比例报告比(PRR)和报告优势比95%可信区间下限(ROR025)。ROR025；1、PRR>；2、χ2Yates>；4和至少3例检测到信号。结果：FAERS共收到3770篇BP报告。糖尿病药物-BP相关性的最强信号是顺铂-4抑制剂(ROR025：13.700，PRR：15.408)，其次是美格列酮(ROR025：12.708，PRR：16.777)，非磺酰脲(ROR025：6.434，PRR：7.016)，α-葡萄糖苷酶抑制剂(ROR025：6.105，PRR：10.738)，磺脲类(ROR025：2.655，PRR3.200)。结论：本研究在FAERS中检测到BP与DDP-4抑制剂、α-葡萄糖苷酶抑制剂、麦格列酮、非磺酰脲和磺脲类药物之间存在强烈的信号。与其他DPP-4抑制剂相比，alogliptin的信号显著增强。这项研究没有表明胰岛素类似物、胰岛素、SGLT-2抑制剂、噻唑烷二酮类药物与FAERS中的BP之间存在关联。
Background: The world's first Diabetes Medications (Insulin) was marketed in October 1923. Some studies suggested the association of diabetes medications with Bullous Pemphigoid (BP), especially the Dipeptidyl Peptidase 4 (DPP-4) inhibitors. The study aims to detect an association between diabetes medications (focusing on DPP-4 inhibitors) and bullous pemphigoid based on FDA Adverse Event Reporting System (FAERS). Methods: All spontaneous reports of diabetes medications inhibitors-related BP recorded in the FAERS between March 2004 and August 2020 were included in the present study. Disproportionality analysis was performed to find the signal between diabetes medications and BP. The Chi-Squared with Yates' correction (χ2Yates), proportional reporting ratio (PRR) and the lower limit of the 95% confidence interval of the Reporting Odds Ratio (ROR025) were calculated as a measure. A signal was detected when ROR025 > 1, PRR > 2, χ2Yates > 4 and at least 3 cases. Results: There were 3770 reports for BP in FAERS. The strongest signal for diabetes medications-BP association were DDP-4 inhibitors (ROR025: 13.700, PRR: 15.408), followed by Meglitinides (ROR025: 12.708, PRR: 16.777), Non-sulfonylureas (ROR025: 6.434, PRR: 7.016), Alpha-glucosidase inhibitors (ROR025: 6.105, PRR: 10.738), Sulfonylureas (ROR025:2.655, PRR: 3.200). Conclusions: This study detected a strong signal between BP and DDP-4 inhibitors, alpha-glucosidase inhibitors, meglitinides, non-sulfonylureas, and sulfonylureas in FAERS. The signal was significantly higher with alogliptin than with the other DPP-4 inhibitors. The study doesn't suggest the association between the incretin mimetics, insulin, SGLT-2 inhibitors, thiazolidinediones and BP in FAERS.
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