Serious ventricular arrhythmias among users of cisapride and other QT-prolonging agents in the United States
Serious ventricular arrhythmias among users of cisapride and other QT-prolonging agents in the United States
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DOI：
10.1002/pds.725
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发表时间：
2002-09-01
影响因子：
2.6
通讯作者：
Walker, AM
中科院分区：
文献类型：
--
作者：
Enger, C;Cali, C;Walker, AM
目的评价美国使用西沙必利发生严重室性心律失常（SVA）的危险性。方法研究人群包括28078例年龄在65岁以下的患者，他们在1993年至1998年期间接受西沙必利治疗，无抗心律失常治疗史。根据西沙必利的使用和其他因素对每个随访日进行分类。使用医疗索赔记录和国家死亡指数检索确定SVA的结局，并通过医疗记录审查确认。计算西沙必利治疗和停药时间的事件发生率。Poisson回归分析用于计算校正率ratio.Results有23例SVA，10在西沙必利使用期间和13在非使用期间。西沙必利使用时间与非使用时间的SVA事件的校正率比为1.60（95%CI：0.67-3.82），其他QT延长药物的95%CI为1.60（95%置信区间：结论：考虑到西沙必利治疗和停药的观察时间，西沙必利相关的SVA风险增加的证据是不明确的，并调整风险因素，尽管我们不能排除风险增加3.8倍的可能性。总体而言，西沙必利的合理风险与其他QT延长药物相似。版权所有（C）2002约翰威利父子有限公司
Purpose To evaluate the risk of serious ventricular arrhythmia (SVA) with cisapride use in the United States.Methods The study population included 28 078 patients under the age of 65 years who received cisapride between 1993 and 1998 with no history of antiarrhythmia treatment. Each follow-up day was classified according to use of cisapride and other factors. Outcomes of SVAs were identified using medical claims records and National Death Index search, and confirmed by medical record review. Rates of events were calculated for time on and off cisapride. Poisson regression analysis was used to calculate adjusted rate ratios.Results There were 23 cases of SVAs; 10 during periods of cisapride use and 13 during periods of non-use. The adjusted rate ratio comparing SVA events in cisapride use time to non-use time was 1.60 (95% CI: 0.67-3.82), and that identified for the other QT-prolonging drugs was 1.60 (95% CI: 0.65-3.98).Conclusions The evidence for an increased risk of SVAs associated with cisapride was equivocal after taking observation time on and off cisapride into account, and adjusting for risk factors, though we cannot exclude the possibility of a 3.8-fold increased risk. Overall, the plausible risks of cisapride were similar to those of other QT-prolonging drugs. Copyright (C) 2002 John Wiley Sons, Ltd.