UNASSIGNED: To assess the consistency of information on drugs potentially interacting with PPIs as reported in their SPCs and different ICs.
UNASSIGNED: This cross-sectional study was conducted using data from SPCs for 5 PPIs (omeprazole, esomeprazole, lansoprazole, pantoprazole, and rabeprazole) and 5 ICs (ie, INTERCheck WEB, Micromedex, Lexicomp, Epocrates, and drugs.com). Information from the SPCs and the ICs were extracted between July 15 and 30, 2023.
UNASSIGNED: The main outcome was the level of agreement among SPCs and the 5 ICs in identifying drugs potentially interacting with PPIs and attributing drug-drug interaction (DDI) severity categories. The level of agreement was computed using Gwet AC1 statistic on the 5 ICs and by comparing 4-sets and 2-sets of ICs. As a sensitivity analysis, the level of agreement in listing PPI-related DDIs was evaluated using Cohen κ and Fleiss κ coefficients.
UNASSIGNED: Considering SPCs and the 5 ICs, a total of 518 potentially interacting drugs with omeprazole were reported, 455 for esomeprazole, 433 for lansoprazole, 421 for pantoprazole, and 405 for rabeprazole. As compared with the ICs, the SPCs reported a much smaller number of drugs potentially interacting with PPIs, with proportions ranging from 2.7% (11 potentially interacting drugs) for rabeprazole to 7.6% (33 potentially interacting drugs) for lansoprazole of the total identified drugs at risk of interaction with a PPI. The overall level of agreement among the 5 ICs for identifying potential interactions was poor (from 0.23 [95% CI, 0.21-0.25] for omeprazole to 0.27 [95% CI, 0.24-0.29] for pantoprazole and 0.27 [95% CI, 0.25-0.29] for rabeprazole). Similarly, the level of agreement was low in 4-set and 2-set analyses as well as when restricting the analysis to the potential DDIs identified as severe (range, 0.30-0.32).
UNASSIGNED: This cross-sectional study found significant disagreement among different ICs and SPCs, highlighting the need to focus on standardizing DDI databases. Therefore, to ensure evaluation and prevention of clinically relevant DDIs, it is recommended to revise multiple ICs and consult with specialists, such as clinical pharmacologists, particularly for patients with complex medical conditions.
■评估在其SPC和不同IC中报告的药物可能与PPI相互作用的信息的一致性。
■这项横断面研究是使用来自SPC的5个PPI的数据进行的(奥美拉唑,埃索美拉唑,兰索拉唑,泮托拉唑,和雷贝拉唑)和5个IC(即,INTERCheckWEB,Micromedex,词典,Epocrates,和drugs.com)。SPC和IC的信息是在2023年7月15日至30日之间提取的。
■主要结果是SPC和5个IC在识别潜在与PPI相互作用的药物和归因药物-药物相互作用(DDI)严重程度类别方面的一致性水平。使用对5个IC的GwetAC1统计量并通过比较4组和2组IC来计算一致性水平。作为敏感性分析,使用Cohenκ和Fleissκ系数评估列出PPI相关DDI的一致性水平。
■考虑到SPC和5个IC,共报告了518种可能与奥美拉唑相互作用的药物,455用于埃索美拉唑,433兰索拉唑,泮托拉唑为421,405和雷贝拉唑。与IC相比,SPCs报告的药物可能与PPI相互作用的数量要少得多,雷贝拉唑(11种潜在相互作用药物)和兰索拉唑(33种潜在相互作用药物)在已确定的总药物中有与PPI相互作用的风险,比例从2.7%(11种潜在相互作用药物)到7.6%(33种潜在相互作用药物)不等。5个ICs之间识别潜在相互作用的总体一致性水平较差(从奥美拉唑的0.23[95%CI,0.21-0.25]到泮托拉唑的0.27[95%CI,0.24-0.29]和雷贝拉唑的0.27[95%CI,0.25-0.29])。同样,在4集和2集分析中,以及当将分析限制在被确定为严重的潜在DDI时,一致性水平较低(范围,0.30-0.32)。
■这项横断面研究发现,不同IC和SPC之间存在重大分歧,强调需要专注于标准化DDI数据库。因此,为了确保临床相关DDI的评估和预防,建议修改多个IC并咨询专家,如临床药理学家,特别是对于有复杂医疗条件的患者。