Int J Clin Pharmacol Ther. 2023 Jan;61(1):16-23. doi: 10.5414/CP204266.
Fractures are significantly associated with increased morbidity and mortality in older individuals; additionally, patients with diabetes mellitus are highly prone to fractures. The aim of the present study was to examine the association between dipeptidyl peptidase-4 (DPP-4) inhibitor use and the risk of fracture in older patients by analyzing data obtained from spontaneous adverse event reporting databases from the United States and Japan.
Data on older patients registered in the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) from the first quarter of 2013 to the end of 2019 and data registered in the Japanese Adverse Drug Event Report database (JADER) from April 2004 to December 2019 were used. Reporting odds ratio (ROR) and information component (IC) values were used for disproportionality analysis.
Significant inverse associations between DPP-4 inhibitor use and fracture were found for DPP-4 inhibitors as a whole (ROR = 0.80; 95% CI = 0.73 - 0.88; IC = -0.31, 95% CI = -0.46 to -0.17); linagliptin (ROR = 0.74; 95% CI = 0.59 - 0.94; IC = -0.42, 95% CI = -0.75 to -0.08); and sitagliptin (ROR = 0.77; 95% CI = 0.68 - 0.88; IC = -0.36, 95% CI = -0.55 to -0.17) in the analyses of FAERS data. Similarly, significant inverse associations were also found for DPP-4 inhibitors as whole (ROR = 0.71; 95% CI = 0.59 to 0.86; IC = -0.46, 95% CI = -0.74 to -0.18); sitagliptin (ROR = 0.70; 95% CI = 0.52 - 0.95; IC = -0.49, 95% CI = -0.93 to -0.05); and vildagliptin (ROR = 0.54; 95% CI = 0.35 - 0.83; IC = -0.85, 95% CI = -1.49 to -0.22) in the analyses of JADER data.
Our analysis of adverse event databases using different algorithms revealed that DPP-4 inhibitor use was inversely associated with fracture in older patients.
骨折与老年人发病率和死亡率的增加显著相关；此外，糖尿病患者极易发生骨折。本研究旨在通过分析来自美国和日本自发不良事件报告数据库的数据，探讨二肽基肽酶-4（DPP-4）抑制剂在老年患者中的使用与骨折风险之间的关联。
使用了美国食品和药物管理局不良事件报告系统（FAERS）自 2013 年第一季度至 2019 年底和日本药物不良事件报告数据库（JADER）自 2004 年 4 月至 2019 年 12 月期间登记的老年患者的数据。报告比值比（ROR）和信息成分（IC）值用于不匀称性分析。
DPP-4 抑制剂的整体使用与骨折之间存在显著的负相关（ROR=0.80；95%置信区间为 0.73-0.88；IC=-0.31，95%置信区间为 0.46-0.17）；在 FAERS 数据的分析中，DPP-4 抑制剂的单独使用也与骨折之间存在显著的负相关（linagliptin，ROR=0.74；95%置信区间为 0.59-0.94；IC=-0.42，95%置信区间为 0.75-0.08）；（sitagliptin，ROR=0.77；95%置信区间为 0.68-0.88；IC=-0.36，95%置信区间为 0.55-0.17）。同样，在 JADER 数据的分析中，DPP-4 抑制剂的整体使用（ROR=0.71；95%置信区间为 0.59-0.86；IC=-0.46，95%置信区间为 0.74-0.18）、sitagliptin（ROR=0.70；95%置信区间为 0.52-0.95；IC=-0.49，95%置信区间为 0.93-0.05）和 vildagliptin（ROR=0.54；95%置信区间为 0.35-0.83；IC=-0.85，95%置信区间为 1.49-0.22）也与骨折呈负相关。
本研究通过对使用不同算法的不良事件数据库进行分析，发现 DPP-4 抑制剂的使用与老年患者的骨折呈负相关。
