Clozapine-treated patients and myocardial infarction in adults: a pharmacovigilance study in VigiBase interpreted in the context of the literature.

IF 3.1 3区医学 Q2 PHARMACOLOGY & PHARMACY

Expert Opinion on Drug Safety Pub Date : 2025-06-13 DOI:10.1080/14740338.2025.2518234

Carlos De Las Cuevas, Emilio J Sanz, Jose de Leon

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引用次数: 0

Abstract

Background: Clozapine is the best treatment for treatment-resistant schizophrenia (TRS) but is associated with metabolic adverse drug reactions (ADRs).

Research dosing/methods: The international pharmacovigilance database (VigiBase) uses the information component (IC) as a disproportionality analysis. On 1 July 2024, we studied in VigiBase: 1) the myocardial infarction (MI) ICs for antipsychotics and 2) clozapine reports for MI since clozapine's introduction. After excluding 298 patients with incomplete data, 1490 adults were studied for fatal outcomes using logistic regression with adjusted odds ratios (aOR) and survival analysis.

Results: Clozapine was associated with the highest IC (IC = 0.903; IC₀₂₅ = 0.835). Olanzapine (IC = 0.524; IC₀₂₅ = 0.398) showed a lower but significant association. The ICs for quetiapine, risperidone and haloperidol were non-significant or negative. Mortality in 1490 adult clozapine-treated patients with MI was 68%. Using a baseline age 18-44 years, age 45-64 years had a significant (p < 0.001) aOR = 1.87 with CI 1.43-2.44, while age ≥65 years had a significant (p < 0.001) aOR = 4.07 with CI 2.77-5.97. High clozapine doses (>600 mg/day) displayed an aOR = 2.18 for fatal outcomes.

Conclusion: A MI IC around 0.9 is higher than that of other antipsychotics, but we cannot rule out that it is explained by TRS present in clozapine-treated patients.

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氯氮平治疗的患者和成人心肌梗死：在文献背景下解释的VigiBase药物警戒研究。

背景：氯氮平是治疗难治性精神分裂症（TRS）的最佳药物，但与代谢性药物不良反应（adr）相关。研究剂量/方法：国际药物警戒数据库（VigiBase）使用信息成分（IC）作为歧化分析。2024年7月1日，我们在VigiBase中研究了：1)抗精神病药物的心肌梗死（MI） ic和2)氯氮平引入以来的心肌梗死报告。在排除298例数据不完整的患者后，1490名成年人使用调整优势比（aOR）和生存分析的逻辑回归研究了致命结局。结果：氯氮平与最高IC相关(IC = 0.903；ic025 = 0.835)。奥氮平(IC = 0.524；IC025 = 0.398)相关性较低，但显著。喹硫平、利培酮和氟哌啶醇的ic无显著性或阴性。1490例氯氮平治疗的心肌梗死患者死亡率为68%。以18-44岁为基准，45-64岁的致命结果aOR = 2.18 （p < 600mg /天）。结论：MI IC在0.9左右高于其他抗精神病药物，但不能排除氯氮平治疗患者出现TRS的可能。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Expert Opinion on Drug Safety 医学-药学

CiteScore

5.90

自引率

3.20%

发文量

审稿时长

6-12 weeks

期刊介绍： Expert Opinion on Drug Safety ranks #62 of 216 in the Pharmacology & Pharmacy category in the 2008 ISI Journal Citation Reports. Expert Opinion on Drug Safety (ISSN 1474-0338 [print], 1744-764X [electronic]) is a MEDLINE-indexed, peer-reviewed, international journal publishing review articles on all aspects of drug safety and original papers on the clinical implications of drug treatment safety issues, providing expert opinion on the scope for future development.