■长期或过度使用酸抑制剂可能会通过改变肠道微生态系统而增加艰难梭菌感染(CDI)的风险。沃诺拉赞,一种新型的钾竞争性酸阻断剂,比质子泵抑制剂(PPI)表现出更快,更持续的酸抑制作用。因此,vonoprazan可能对肠道微生物群产生更大的影响,可能导致CDI。
■本研究旨在通过日本不良药物事件报告(JADER)和FDA不良事件报告系统(FAERS)数据库探索酸抑制剂与CDI之间的潜在关系。
■通过不成比例分析对JADER和FAERS数据库进行回顾性分析。
■我们使用JADER和FAERS数据库对vonoprazan和PPI诱导的CDI进行了信号检测分析。使用报告比值比(ROR)和相应的95%置信区间(95%CI)计算酸抑制剂与CDI之间的关联。当95%CI的下限超过1时,认为该关联具有统计学意义。
■在JADER数据库中,基于可疑药物报告的沃诺拉赞和PPI的ROR(95%CI)为15.84(12.23-20.50)和2.51(1.92-3.28),分别。在FAERS数据库中,基于主要和次要可疑药物报告的沃诺拉赞和PPI的ROR(95%CI)为11.50(6.36-20.82)和1.42(1.34-1.51),分别。亚组分析显示,60岁及以上的老年患者与CDI的相关性更强。在JADER数据库中,60岁及以上患者的vonoprazan和PPI的ROR(95%CI)为15.35(11.59-20.33)和1.65(1.14-2.39),分别。同样,FAERS数据库中vonoprazan和PPI的ROR(95%CI)为12.56(6.26-25.20)和1.43(1.31-1.57),分别。排除幽门螺杆菌(H.幽门螺杆菌)感染,抑酸剂的使用仍与CDI相关.
■虽然基于JADER和FAERS数据库的信号检测分析无法确定因果关系,我们的研究表明,vonoprazan和PPI均与CDI显著相关.在两个数据库中,Vonoprazan与CDI的相关性更强。
沃诺拉赞和艰难梭菌感染风险。
■沃诺拉赞是一种新型的抑酸剂,与传统的质子泵抑制剂(PPI)相比,它对酸的抑制作用更强。沃诺拉赞可能对肠道微生物群产生更大的影响,这可能会增加艰难梭菌感染(CDI)的风险。FDA创建了FDA不良事件报告系统(FAERS)数据库以支持上市后监测计划。PMDA创建了日本药品不良反应事件报告(JADER)数据库,专门收集日本的不良反应报告。为了进一步了解抑酸剂与CDI之间的潜在关系,本研究使用JADER和FAERS数据库进行分析.
■本研究分析了在JADER和FAERS数据库中使用酸抑制剂后报告的CDI案例。
■分析显示,在两个数据库中,vonoprazan和PPI均与CDI显着相关。值得注意的是,与PPI相比,vonoprazan表现出更强的关联。亚组分析表明,这种关联在60岁及以上的老年患者中更为明显。此外,排除幽门螺杆菌的影响(H.pylori)并未减少酸抑制剂与CDI之间的关联。
■尽管基于JADER和FAERS数据库的信号检测分析无法确定因果关系,结果显示,vonoprazan和PPI均与CDI显著相关.沃诺拉赞与CDI的相关性也比PPI更强,这可能是一个潜在的安全问题,需要进一步的临床研究来证实这一发现。
UNASSIGNED: Prolonged or excessive use of acid suppressants may increase the risk of Clostridioides difficile infection (CDI) by altering the intestinal microecosystem. Vonoprazan, a novel potassium-competitive acid blocker, exhibits a faster and more sustained acid-suppressive effect than proton pump inhibitors (PPIs). Therefore, vonoprazan may have a greater impact on the gut microbiota, potentially resulting in CDI.
UNASSIGNED: This study aimed to explore the potential relationship between acid suppressants and CDI by the Japan Adverse Drug Event Report (JADER) and the FDA Adverse Event Reporting System (FAERS) databases.
UNASSIGNED: A retrospective analysis of the JADER and FAERS databases was examined by disproportionality analysis.
UNASSIGNED: We performed signal detection analyses of CDI induced by vonoprazan and PPIs using the JADER and FAERS databases. The association between acid suppressants and CDI was calculated using the reporting odds ratio (ROR) and corresponding 95% confidence interval (95% CI). When the lower limit of the 95% CI is exceeded by 1, the association is considered statistically significant.
UNASSIGNED: In the JADER database, the ROR (95% CI) for vonoprazan and PPIs based on suspect drug reports was 15.84 (12.23-20.50) and 2.51 (1.92-3.28), respectively. In the FAERS database, the ROR (95% CI) for vonoprazan and PPIs based on primary and secondary suspect drug reports was 11.50 (6.36-20.82) and 1.42 (1.34-1.51), respectively. Subgroup analysis showed that elderly patients aged 60 years and older were more strongly associated with CDI. The ROR (95% CI) for vonoprazan and PPIs in patients aged 60 years and older in the JADER database was 15.35 (11.59-20.33) and 1.65 (1.14-2.39), respectively. Similarly, the ROR (95% CI) for vonoprazan and PPIs in the FAERS database was 12.56 (6.26-25.20) and 1.43 (1.31-1.57), respectively. Excluding the effect of Helicobacter pylori (H. pylori) infection, the use of acid suppressants was still associated with CDI.
UNASSIGNED: While signal detection analysis based on the JADER and FAERS databases could not establish causality, our study demonstrated that both vonoprazan and PPIs were significantly associated with CDI. Vonoprazan showed a stronger association with CDI in both databases.
Vonoprazan and Clostridioides difficile infection risk.
UNASSIGNED: Vonoprazan is a new type of acid suppressant, which has a stronger effect on acid inhibition than traditional proton pump inhibitors (PPIs). Vonoprazan may have a greater impact on the gut microbiota, which may increase the risk of Clostridioides difficile infection (CDI). The FDA created the FDA Adverse Event Reporting System (FAERS) database to support the post-market surveillance program. The PMDA created the Japan Adverse Drug Reaction Event Report (JADER) database to specifically collect adverse reaction reports in Japan. To further understand the potential relationship between acid suppressants and CDI, this study was analyzed using the JADER and FAERS databases.
UNASSIGNED: This study analyzed cases of CDI reported after the use of acid suppressants in the JADER and FAERS databases.
UNASSIGNED: The analysis revealed that vonoprazan and PPIs are significantly associated with CDI in both databases. Notably, vonoprazan exhibited a stronger association compared to PPIs. Subgroup analysis indicated that this association was more pronounced in elderly patients aged 60 years and older. Additionally, excluding the influence of Helicobacter pylori (H. pylori) did not diminish the association between acid suppressants and CDI.
UNASSIGNED: Although signal detection analysis based on the JADER and FAERS databases could not establish causality, the results showed that both vonoprazan and PPIs were significantly associated with CDI. Vonoprazan was also more strongly associated with CDI than PPIs, which could be a potential safety concern, and further clinical studies are needed to confirm this finding.