抗精神病药和抗抑郁药相关的心律失常：对德国批准的原研产品说明书的分析。

Arrhythmias related to antipsychotics and antidepressants: an analysis of the summaries of product characteristics of original products approved in Germany.

机构信息

Department of Psychiatry and Psychotherapy III, University of Ulm, Leimgrubenweg 12-14, 89075, Ulm, Germany.

Institute of Pharmacology of Natural Products and Clinical Pharmacology, University of Ulm, Ulm, Germany.

出版信息

Eur J Clin Pharmacol. 2021 May;77(5):767-775. doi: 10.1007/s00228-020-03049-x. Epub 2020 Nov 23.

DOI:10.1007/s00228-020-03049-x

PMID:33230596

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8032566/

Abstract

PURPOSE

Most psychiatric drugs, such as antidepressants (AD) and antipsychotics (AP), may cause cardiac adverse events (CAE). We used summaries of product characteristics (SmPC) for assessing the likelihood of AD and AP to cause CAE.

METHODS

We identified all original medicinal products (OMP) of AD and AP approved in Germany. We searched for their SmPCs using the online services of PharmaNet.Bund, Gelbe liste®, Rote Liste®, Fachinfo-Service®, and via manufacturer contact. We extracted frequencies of reported CAE (QT prolongation, Torsade de Pointes tachycardia, and ventricular arrhythmia) and performed a risk assessment.

RESULTS

We obtained the SmPCs of 24 AD and 26 AP identified as OMP. Comparably high reported frequencies regarding QT prolongation were found for Invega® (paliperidone), Serdolect® (sertindole) (≥ 1/100 and < 1/10), and Zoloft® (sertraline) (≥ 1/10.000 and < 1/1000); regarding Torsade de Pointes tachycardia were found for Serdolect® (≥ 1/1000 to < 1/100), Zoloft®, and Trevilor® (venlafaxine) (≥ 1/10.000 and < 1/1000); regarding ventricular tachycardia for Solian® (amisulpride), Xomolix® (droperidol), Zyprexa® (olanzapine), and Trevilor® (≥ 1/10.000 and < 1/1000).

CONCLUSION

The risk and frequency of CAE, as reported in the SmPCs, varied significantly among substances and between groups. There are more reports for AP than AD. The AP with the most frequently reported CAE (QT prolongation and Torsade de Pointes tachycardia) was Serdolect®; for AD, Zoloft® (QT prolongation, Torsade de Pointes tachycardia) and Trevilor® (Torsade de Pointes tachycardia and ventricular tachycardia) carried a higher cardiac risk.

摘要

目的

大多数精神科药物，如抗抑郁药（AD）和抗精神病药（AP），可能会引起心脏不良事件（CAE）。我们使用产品特性摘要（SmPC）来评估 AD 和 AP 引起 CAE 的可能性。

方法

我们确定了在德国批准的所有 AD 和 AP 的原始药物（OMP）。我们使用 PharmaNet.Bund、Gelbe liste®、Rote Liste®、Fachinfo-Service®的在线服务以及制造商联系来搜索他们的 SmPC。我们提取了报告的 CAE（QT 延长、尖端扭转型室性心动过速和室性心律失常）的频率，并进行了风险评估。

结果

我们获得了 24 种 AD 和 26 种 AP 的 SmPC，这些药物被确定为 OMP。在 Invega®（帕利哌酮）、Serdolect®（塞曲吲哚）（≥1/100 且 <1/10）和 Zoloft®（舍曲林）（≥1/10000 且 <1/1000）中发现 QT 延长的报告频率较高；在 Serdolect®（≥1/1000 至 <1/100）、Zoloft®和 Trevilor®（文拉法辛）（≥1/10000 且 <1/1000）中发现尖端扭转型室性心动过速的报告频率较高；在 Solian®（氨磺必利）、Xomolix®（氟哌啶醇）、Zyprexa®（奥氮平）和 Trevilor®（≥1/10000 且 <1/1000）中发现室性心律失常的报告频率较高。

结论

SmPC 中报告的 CAE 的风险和频率在物质之间和组之间差异很大。AP 的报告比 AD 多。报告 CAE（QT 延长和尖端扭转型室性心动过速）最频繁的 AP 是 Serdolect®；对于 AD，Zoloft®（QT 延长、尖端扭转型室性心动过速）和 Trevilor®（尖端扭转型室性心动过速和室性心律失常）的心脏风险更高。