Mahyar Etminan1, Mohit Sodhi2, Saeed Ganjizadeh-Zavareh3, Bruce Carleton4, Abbas Kezouh5, James M Brophy6. 1. Department of Ophthalmology and Visual Sciences, University of British Columbia, Vancouver, British Columbia, Canada; Therapeutic Evaluation Unit, British Columbia Provincial Health Services Authority, Vancouver, British Columbia, Canada. Electronic address: etminanm@mail.ubc.ca. 2. Department of Ophthalmology and Visual Sciences, University of British Columbia, Vancouver, British Columbia, Canada. 3. Department of Medicine, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada. 4. Department of Ophthalmology and Visual Sciences, University of British Columbia, Vancouver, British Columbia, Canada; Division 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. 5. Department of Epidemiology and Biostatistics, McGill University, Montreal, Quebec, Canada. 6. Departments of Medicine, Epidemiology, and Biostatistics, McGill University, Montreal, Quebec, Canada.
Abstract
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.
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.
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