BACKGROUND Cardiovascular diseases are still the leading cause of global mortality. Some antipsychotic agents can show severe cardiovascular side effects and are also associated with metabolic syndrome. METHODS This observational study was based on data of AMSP (Arzneimittelsicherheit in der Psychiatrie), a multicenter drug surveillance program in Austria, Germany and Switzerland, that recorded severe drug reactions in psychiatric inpatients. RESULTS A total of 404 009 inpatients were monitored between 1993 and 2013, whereas 291 510 were treated with antipsychotics either in combination or alone. There were 376 cases of severe cardiovascular adverse reactions reported in the given timespan, yielding a relative frequency of 0.13%. The study revealed that incidence rates of cardiovascular adverse reactions were highest during treatment with ziprasidone (0.35%), prothipendyl (0.32%), and clozapine (0.23%). The lowest rate of cardiovascular symptoms occurred during treatment with promethazine (0.03%) as well as with aripiprazole (0.06%). The most common clinical symptoms were orthostatic collapse and severe hypotonia, sinustachycardia, QTc prolongation, myocarditis, and different forms of arrhythmia. The dosage at the timepoint when severe cardiovascular events occurred was not higher in any of the given antipsychotics than in everyday clinical practice and was in average therapeutic ranges. In terms of subclasses of antipsychotics, no significant statistical difference was seen in the overall frequencies of adverse reactions cases, when first-generation high potency, first-generation low potency, and second-generation antipsychotics were compared. Thirty percent of adverse events among second-generation antipsychotics were induced by clozapine. CONCLUSIONS Our findings on cardiovascular adverse reactions contribute to a better understanding of cardiovascular risk profiles of antipsychotic agents in inpatients.

中文翻译：

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抗精神病药物治疗期间的心血管不良反应：1993 年至 2013 年间药物监测计划 AMSP 的结果。


背景技术心血管疾病仍然是全球死亡的主要原因。一些抗精神病药物可能表现出严重的心血管副作用，并且还与代谢综合征有关。方法 这项观察性研究基于 AMSP（Arzneimittelsicherheit in der Psychiatrie）的数据，AMSP 是奥地利、德国和瑞士的一个多中心药物监测项目，记录了精神病住院患者的严重药物反应。结果 1993 年至 2013 年间，共监测了 404 009 名住院患者，其中 291 510 名患者接受了联合或单独的抗精神病药物治疗。给定时间范围内报告严重心血管不良反应病例376例，相对频率为0.13%。研究显示，齐拉西酮（0.35%）、丙哌啶（0.32%）和氯氮平（0.23%）治疗期间心血管不良反应发生率最高。异丙嗪（0.03%）和阿立哌唑（0.06%）治疗期间心血管症状发生率最低。最常见的临床症状是直立性虚脱和严重肌张力减退、窦性心动过速、QTc 延长、心肌炎和不同形式的心律失常。任何给定抗精神病药物发生严重心血管事件时的剂量均不高于日常临床实践中的剂量，并且处于平均治疗范围内。就抗精神病药亚类而言，第一代高效、第一代低效、第二代抗精神病药的不良反应发生率总体无显着统计学差异。第二代抗精神病药中 30% 的不良事件是由氯氮平引起的。 结论 我们对心血管不良反应的研究结果有助于更好地了解住院患者抗精神病药物的心血管风险状况。