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Clinical Summary

Fluoroquinolones tied to risk for aortic and mitral regurgitation

Takeaway

  • Use of oral fluoroquinolones is linked to an increased risk for mitral and aortic regurgitation.
  • Risk appears to be highest with current use; no associations observed among past users (>60 days postexposure).
  • Additional research is needed. See related editorial.

Why this matters

  • Consider non-fluoroquinolone antibiotics for patients with prior valvular regurgitation.

Key results

  • Cohort study of 8,272,981 patients including 12,502 valvulopathy cases and 125,020 controls (mean age, 58.1+12.7 years).
  • Disproportionality study: 102 reports of valvular regurgitation with fluoroquinolones, 6099 reports with other drugs (reporting OR, 1.45; 95% CI, 1.20-1.77).
  • Case control: adjusted rate ratio (aRR) for combined mitral/aortic regurgitation with current fluoroquinolone use:
    • 2.40 vs amoxicillin (95% CI, 1.82-3.16).
    • 1.75 vs azithromycin (95% CI, 1.34-2.29).
  • aRR for recent use (31-60 days) was significant vs amoxicillin (1.47; 95% CI, 1.03-2.09) but not azithromycin (1.37; 95% CI, 0.95-1.98).
  • The risk for past use (>60 days) of fluoroquinolones vs amoxicillin and
    azithromycin was very close to 1.00.

Study design

  • Drug adverse event disproportionality analysis comparing valvular regurgitation cases with fluoroquinolones vs other antibiotics during 2004-2018.
  • Case-control analysis to determine if fluoroquinolones increase aortic/mitral regurgitation risk.
  • Database: US FDA Adverse Event Reporting System (FAERS).
  • Funding:  British Columbia Provincial Health Services Authority.

Limitations

  • Reporting bias.
  • No data on unmeasured confounders.
  • Bias toward the null.
  • Limited generalizability.

References


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