Drug-induced torsades de pointes:: a review of the Swedish pharmacovigilance database
Drug-induced torsades de pointes:: a review of the Swedish pharmacovigilance database
复制标题
DOI：
10.1002/pds.1607
复制
发表时间：
2008-06-01
影响因子：
2.6
通讯作者：
Hagg, Staffan
中科院分区：
文献类型：
--
作者：
Astrom-Lilja, Cecilia;Odeberg, Johanna Mercke;Hagg, Staffan
目的 描述瑞典自发报告的尖端扭转型室速 (TdP) 病例，并调查该药物不良反应 (ADR) 是否在相关药物的产品特性摘要 (SPC) 中标注。 方法 对 1991-2006 年报告的 TdP 病例进行识别，并根据药物使用和其他可能的危险因素进行评估。 结果 在总共 61788 例 ADR 中，确定了 88 例 TdP 病例。在这些案件中，涉及 27 种不同的可疑药物。大多数报告涉及心脏药物（74%；65/88），其中索他洛尔是最常见的可疑药物（57%，58/88）。除药物治疗外，85% 的病例 (75/88) 还存在两种或多种已确定的危险因素。心脏病（90%；79/88）是最常见的危险因素，其次是年龄超过 65 岁（72%；63/88）和女性（70%；62/88）。 88 例病例中，33% (9/27) 的药物被标记为 TdP 或 QT 延长。然而，在其他地方发现了报告中涉及的不同药物之间存在关联的支持证据，比例为 56% (15/27)。尽管西酞普兰是报告中第三常见的可疑药物（10%；9/88），但 TdP 并未列入 SPC。结论 TdP 是一种罕见报告的 ADR。经常存在多种风险因素。在报告中涉及的三分之二的药物中，SPC 中均未标记 TdP 或 QT 延长。需要对西酞普兰和电视之间的关联进行进一步调查 版权所有 (C) 2008 John Wiley & Sons, Ltd.
Aim To describe spontaneously reported cases of torsades de pointes (TdP) in Sweden and to investigate if this adverse drug reaction (ADR) was labelled in the summary of product characteristics (SPC) for the drugs implicated.Methods Reported cases of TdP 1991-2006 were identified and evaluated with regard to drug use and other possible risk factor.Results Among a total of 61788 ADRs, 88 cases of TdP were identified. In these cases, 27 different suspected drugs were implicated. Cardiac drugs were involved in most reports (74%; 65/88), with sotalol being the most frequently suspected drug (57%, 58/88). In addition to drug treatment two or more established risk factors were present in 85% of the cases (75/88). Heart disease (90%; 79/88) was the most common risk factor followed by age over 65 years (72%; 63/88) and female gender (70%; 62/88). TdP or QT prolongation were labelled in the SPC for 33% (9/27) of the drugs implicated in the 88 cases. However, supporting evidence for an association was found elsewhere in 56% (15/27) for the different drugs implicated in the reports. Although citalopram was the third most common suspected drug in the reports (10%; 9/88), TdP was not listed in the SPC.Conclusion TdP is a rarely reported ADR. Several risk factors are often present. In two thirds of the drugs implicated in the reports neither TdP nor QT prolongation was labelled in the SPC. Further investigations are needed regarding the association between citalopram and TV Copyright (C) 2008 John Wiley & Sons, Ltd.