QT Prolongation and Torsade De Pointes Related to Antimalarial Drugs and Azithromycin: A Pharmacovigilance Study in the Context of the COVID-19 Crisis
Author(s)
Diaby V1, Almutairi R2, Chen Z3, Moussa RK4, Berthe A5
1Princess Nourah University, Riyadh, 01, Saudi Arabia, 2MCPHS, Boston, MA, USA, 3University of Florida, College of Pharmacy, Gainesville, FL, USA, 4Ecole Nationale Superieure de Statistique et d'Economie Appliquee, Abidjan, Côte d'Ivoire, 5Consortium In Management, Evaluation and Decision Aid (CEMAID), Longueil, QC, Canada
OBJECTIVES: Hydroxychloroquine, an antimalarial drug, combined with azithromycin have recently been considered a miracle cure in the treatment of COVID-19. However, these drugs have the potential to cause electrocardiogram QT prolongation (QTp) and torsade de pointes (TdP). Here, we quantified the association between seven antimalarial drugs and/or azithromycin and two adverse events, QTp and TdP.
METHODS: We conducted a case/non‐case analysis of the FDA Adverse Event Reporting System (FAERS) to identify antimalarial drugs and azithromycin-induced QTp (n: 13,713) and TdP (n: 3,748) and related to other drugs (n: 7,687,270) through 12/2019. We measured the associations between antimalarial drugs and/or azithromycin and QTp and TdP using adjusted Reporting-Odds-Ratio (aROR). RESULTS : Disproportionality in the reporting of QTp was lower for hydroxychloroquine [aROR: 1·99 (1·72 - 2·30)] than atovaquone [aROR: 2·12 (1·27 - 3·54)], mefloquine [aROR of 2·69 (1·41 - 5·30)], quinine [aROR of 4·17 (2·95 - 5·90)], chloroquine [aROR: 6·44 (4·25 - 9·78)], and primaquine [aROR:19·35 (8·84 - 42·32)]. Atovaquone combined with azithromycin increased the reporting odds of QTp by 25 times [aROR: 24·61 (12·90 - 46·92)]. Disproportionality for TdP was lower for hydroxychloroquine [aROR: 3·00 (2·42 - 3·71)] than quinine [aROR: 5·37 (3·27 - 8·80)] and chloroquine [aROR: 16·63 (10·80 - 25·59)]. CONCLUSIONS: Using hydroxychloroquine alone increases the odds for QTp and TdP two and three times the odds than for all other drugs in the FAERS, respectively. Funding Statement: The study was not funded. Declaration of Interests: The authors declare no competing interests.
Conference/Value in Health Info
2020-11, ISPOR Europe 2020, Milan, Italy
Value in Health, Volume 23, Issue S2 (December 2020)
Code
PDG29
Topic
Clinical Outcomes, Epidemiology & Public Health, Methodological & Statistical Research, Organizational Practices
Topic Subcategory
Academic & Educational, Comparative Effectiveness or Efficacy, PRO & Related Methods, Safety & Pharmacoepidemiology
Disease
Drugs, Infectious Disease (non-vaccine)