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首页> 外文期刊>Pharmacoepidemiology and drug safety >Risk of serious ventricular arrhythmia and sudden cardiac death in a cohort of users of domperidone: a nested case-control study.
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Risk of serious ventricular arrhythmia and sudden cardiac death in a cohort of users of domperidone: a nested case-control study.

机译:一组使用多潘立酮的人发生严重心律失常和心源性猝死的风险:一项嵌套的病例对照研究。

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PURPOSE: Limited information from spontaneous reports and results of two case-control studies raised concern about the cardiotoxicity of oral domperidone therapy. This case-control study nested in a retrospective cohort evaluated the combined risk of serious ventricular arrhythmia (SVA) and sudden cardiac death (SCD) in users of domperidone compared with users of proton pump inhibitors (PPIs), or non-users of these medications. METHODS: A cohort of users of domperidone or a PPI from 1990 to 2005 was identified from existing electronic databases of Saskatchewan Health. Possible cases of SVA/SCD were identified using hospital discharge and vital statistics codes. SVA cases were validated by cardiologist review of abstracted hospital medical charts. Up to four controls were matched to each case by index date, year of birth, sex, and diabetes status. The odds ratio (OR) of current domperidone exposure relative to non-use or to current PPI exposure was estimated and adjusted for possible confounding variables using conditional logistic regression. RESULTS: From 83 212 individuals in the exposure cohort we identified 1608 cases, 49 SVA and 1559 SCD (mean age 79.4 years, females 52.9%, diabetes 22.3%) and 6428 matched controls. The adjusted OR for SVA/SCD with current domperidone use compared with non-use was (1.59, 95%CI: 1.28-1.98), or compared with current PPI use was (1.44, 95%CI: 1.12-1.86). In stratified analyses adjusted ORs were numerically higher in males, older subjects, and non-diabetics. CONCLUSIONS: The increased risk of SVA/SCD for current domperidone users remained after adjustment for multiple covariates. The risk may vary among subgroups of exposed individuals.
机译:目的:来自自发报告和两项病例对照研究结果的信息有限,引起人们对口服多潘立酮治疗的心脏毒性的担忧。这项回顾性队列研究中的病例对照研究评估了多潘立酮使用者与质子泵抑制剂(PPI)使用者或非药物使用者的严重心律失常(SVA)和心源性猝死(SCD)的合并风险。方法:从萨斯喀彻温省卫生局的现有电子数据库中识别出1990年至2005年间使用多潘立酮或PPI的用户。使用出院和生命统计代码确定可能的SVA / SCD病例。心脏病专家对摘要的医院病历表进行了复查,从而确认了SVA病例。根据索引日期,出生年份,性别和糖尿病状况,每个病例最多匹配四个对照。估计当前多潘立酮暴露相对于未使用或当前PPI暴露的比值比(OR),并使用条件逻辑回归对可能的混淆变量进行了调整。结果:在暴露队列的83 212名患者中,我们确定了1608例,49例SVA和1559例SCD(平均年龄79.4岁,女性52.9%,糖尿病22.3%)和6428名匹配的对照组。当前使用多潘立酮的SVA / SCD与未使用相比调整后的OR为(1.59,95%CI:1.28-1.98),或者与当前PPI使用相比为(1.44,95%CI:1.12-1.86)。在分层分析中,男性,老年受试者和非糖尿病患者的校正OR数值较高。结论:调整了多个协变量后,当前多潘立酮使用者的SVA / SCD风险增加。在暴露个体的亚组之间,风险可能有所不同。

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