Author + information
- Received May 17, 2019
- Revision received June 20, 2019
- Accepted July 2, 2019
- Published online September 9, 2019.
- Mahyar Etminan, PharmD, MSca,b,∗ (, )
- Mohit Sodhi, BSc, MSca,
- Saeed Ganjizadeh-Zavareh, MD, MScc,
- Bruce Carleton, BPharm, PharmDa,d,
- Abbas Kezouh, PhDe and
- James M. Brophy, MD, PhDf
- aDepartment of Ophthalmology and Visual Sciences, University of British Columbia, Vancouver, British Columbia, Canada
- bTherapeutic Evaluation Unit, British Columbia Provincial Health Services Authority, Vancouver, British Columbia, Canada
- cDepartment of Medicine, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada
- dDivision of Translational Therapeutics, Department of Pediatrics, and Pharmaceutical Outcomes Programme, British Columbia Children’s Hospital Research Institute, University of British Columbia, Vancouver, British Columbia, Canada
- eDepartment of Epidemiology and Biostatistics, McGill University, Montreal, Quebec, Canada
- fDepartments of Medicine, Epidemiology, and Biostatistics, McGill University, Montreal, Quebec, Canada
- ↵∗Address for correspondence:
Dr. Mahyar Etminan, The University of British Columbia, The Eye Care Center, Room 323-2550 Willow Street, Vancouver, British Columbia V5Z 3N9, Canada.
Background Recent studies have linked fluoroquinolones (FQs) to cardiac adverse events, including aortic dissection and aneurysm. To date, whether FQs can increase the risk of aortic or mitral regurgitation has not been studied.
Objectives This disproportionality analysis and case-control study examined whether FQs increase the risk of aortic and mitral regurgitation.
Methods Data from the U.S. Food and Drug Administration’s adverse reporting system database was used to undertake a disproportionality analysis, and a random sample of 9,053,240 patients from the U.S. PharMetrics Plus database (IQVIA) was used for the matched nested case-control study. Current FQ exposure implied an active prescription at the index date or 30 days prior to the event date. Recent FQ exposure was defined as FQ use within days 31 to 60 and past within days 61 to 365 prior to the event date. Rate ratios (RRs) were compared to users of amoxicillin and azithromycin. Conditional logistic regression was used to compute RRs adjusting for confounders.
Results The reported odds ratio for the disproportionality analysis was 1.45 (95% confidence interval [CI]: 1.20 to 1.77). A total of 12,505 cases and 125,020 control subjects were identified in the case-control study. The adjusted RRs for current users of FQ compared with amoxicillin and azithromycin users were 2.40 (95% CI: 1.82 to 3.16) and 1.75 (95% CI: 1.34 to 2.29), respectively. The adjusted RRs for recent and past FQ users when compared with amoxicillin were 1.47 (95% CI: 1.03 to 2.09) and 1.06 (95% CI: 0.91 to 1.21), respectively.
Conclusions These results show that the risk of aortic and mitral regurgitation is highest with current use followed by recent use. No risk was observed with past use of FQs. Future studies are necessary to confirm or refute these associations.
This study was funded by the Therapeutic Evaluation Unit of the British Columbia Provincial Health Services Authority. The funding source had no role in the design and conduct of the study. The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Listen to this manuscript's audio summary by Editor-in-Chief Dr. Valentin Fuster on JACC.org.
- Received May 17, 2019.
- Revision received June 20, 2019.
- Accepted July 2, 2019.
- 2019 American College of Cardiology Foundation
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