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A pharmacovigilance study to quantify the strength of association between the combination of antimalarial drugs and azithromycin and cardiac arrhythmias: implications for the treatment of COVID-19.
Expert Review of Pharmacoeconomics & Outcomes Research ( IF 2.3 ) Pub Date : 2020-12-08 , DOI: 10.1080/14737167.2021.1851600
Vakaramoko Diaby 1 , Reem D. Almutairi 2 , Ziyan Chen 1 , Richard K. Moussa 3 , Abdrahmane Berthe 4
Affiliation  

ABSTRACT

Background: Hydroxychloroquine, an antimalarial drug, combined with azithromycin has been considered a potential treatment for COVID-19. However, these drugs may cause electrocardiogram QT prolongation (QTp) and torsade de Pointes (TdP). We examined potential safety signals for these cardiac arrhythmias.

Methods: Using the OpenVigil 2.1 MedDRA platform, we mined data from the U.S. Food and Drug Administration’s Adverse Event Reporting System (FAERS) from December 2019 to June 2020. We extracted individual case safety reports based on exposures of seven antimalarial drugs, azithromycin, and combinations. All other drugs in FAERS served as controls. Events of interest included QTp and TdP, with associations between drug exposures and events expressed as adjusted Reporting-Odds-Ratios (aRORs) and confidence intervals. The lower end of aROR 95% confidence interval >1 was used as the statistically significant signal detection threshold.

Results: QTp safety signals were found for hydroxychloroquine[aROR:11.70 (10.40–13.16)], chloroquine[aROR:18.97 (11.30–31.87)], quinine[aROR:16.66 (10.18–27.25)], atovaquone[aROR:6.91 (4.14–11.56)], azithromycin alone [aROR:28.02 (22.87–34.32)] and hydroxychloroquine + azithromycin [aROR:75.23 (51.15–110.66)]. TdP safety signals were found for hydroxychloroquine [aROR: 5.62 (4.94–6.38)], chloroquine[aROR:49.37 (30.63–79.58)], and hydroxychloroquine + azithromycin[aROR:33.09 (21.22–51.61)].

Conclusion: Hydroxychloroquine/chloroquine and/or azithromycin was associated with QTp/TdP safety signals and their use should be monitored carefully.



中文翻译:

一项药物警戒性研究,以量化抗疟疾药物和阿奇霉素与心律不齐的组合之间的关联强度:对COVID-19的治疗意义。

摘要

背景:抗疟疾药物羟氯喹与阿奇霉素联合被认为是治疗COVID-19的潜在方法。但是,这些药物可能会导致心电图QT延长(QTp)和Torsade de Pointes(TdP)。我们检查了这些心律不齐的潜在安全信号。

方法:我们使用OpenVigil 2.1 MedDRA平台,从美国食品和药物管理局的不良事件报告系统(FAERS)收集了2019年12月至2020年6月的数据。我们根据7种抗疟药,阿奇霉素和组合。FAERS中的所有其他药物均用作对照。感兴趣的事件包括QTp和TdP,药物暴露与事件之间的关联以调整后的报告几率(aROR)和置信区间表示。95%置信区间> 1的aROR的下限用作统计上显着的信号检测阈值。

结果:发现了羟氯喹[aROR:11.70(10.40–13.16)],氯喹[aROR:18.97(11.30–31.87)],奎宁[aROR:16.66(10.18–27.25)],阿托伐醌[aROR:6.91(QTp安全信号) 4.14–11.56)],单独使用阿奇霉素[aROR:28.02(22.87–34.32)]和羟氯喹+阿奇霉素[aROR:75.23(51.15–110.66)]。羟氯喹[aROR:5.62(4.94–6.38)],氯喹[aROR:49.37(30.63–79.58)]和羟氯喹+阿奇霉素[aROR:33.09(21.22–51.61)]的TdP安全信号被发现。

结论:羟氯喹/氯喹和/或阿奇霉素与QTp / TdP安全信号有关,应仔细监测其使用。

更新日期:2021-01-29
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