Safety profile of vonoprazan compared with proton pump inhibitors: insight from a pharmacovigilance study
Safety profile of vonoprazan compared with proton pump inhibitors: insight from a pharmacovigilance study
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DOI：
10.1691/ph.2020.0604
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发表时间：
2020-10-01
期刊：
影响因子：
1.6
通讯作者：
Iwanaga, K.
中科院分区：
文献类型：
--
作者：
Kambara, H.;Hosohata, K.;Iwanaga, K.
质子泵抑制剂（PPI）用于治疗酸相关疾病，如消化性溃疡和胃食管反流病。最近，沃诺拉赞（一种新型钾竞争性酸阻滞剂（P-CAB））已被引入作为更有效的治疗选择。本研究的目的是使用自发报告系统数据库阐明与沃诺拉赞相比PPI相关的不良事件。我们使用日本药物不良事件报告（JADER）数据库进行了一项回顾性药物警戒性分析。分析了2004年至2017年期间提交给药品和医疗器械管理局的不良事件报告，并计算了每起不良事件的报告比值比（ROR）和95%置信区间（CI）。数据库包括11，433份PPI相关报告和636份沃诺拉赞相关报告。PPI和沃诺拉赞中常见肝脏和皮肤疾病。间质性肺病与PPI作为一个类别显著相关（ROR：1.61，95%CI：1.47-1.77），但与沃诺拉赞无关。沃诺拉赞与出血性小肠结肠炎密切相关（ROR，86.5; 95%CI，59.7125）。在PPI中，兰索拉唑组显微镜下结肠炎的信号评分值得注意（ROR，405; 95%CI，348-472）。这表明PPI和沃诺拉赞与不良事件之间的关联强度存在差异。我们的研究结果可能为酸相关疾病的治疗提供有用的信息，但需要更多数据的进一步研究才能最终澄清这一点。
Proton pump inhibitors (PPIs) are used to treat acid-related disorders such as peptic ulcer and gastroesophageal reflux disease. Recently, vonoprazan, a novel potassium-competitive acid blocker (P-CAB), has been introduced as more effective treatment option. The purpose of this study was to clarify the adverse events associated with vonoprazan compared to PPIs using a spontaneous reporting system database. We performed a retrospective pharmacovigilance disproportionality analysis using the Japanese Adverse Drug Event Report (JADER) database. Adverse event reports submitted to the Pharmaceuticals and Medical Devices Agency between 2004 and 2017 were analyzed, and the reporting odds ratio (ROR) and 95% confidence interval (CI) for each adverse event were calculated. The database comprised 11,433 reports associated with PPIs, and 636 reports with vonoprazan. Hepatic and skin disorders were commonly detected in both PPIs and vonoprazan. There was a significant association of interstitial lung disease with PPIs as a class (ROR: 1.61, 95%Cl: 1.47-1.77), but not with vonoprazan. Vonoprazan was strongly associated with haemorrhagic enterocolitis (ROR, 86.5; 95%CI, 59.7125). Among the PPIs, the signal score of microscopic colitis was noteworthy in the case of lansoprazole (ROR, 405; 95%CI, 348-472). It is suggested that there is a diversity in the strength of the association between PPIs and vonoprazan with adverse events. Our results may provide useful information for the treatment of acid-related disorders, but further research with more data is needed to finally clarify this.