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Original Investigation
October 20, 2021

Analysis of Respiratory Fluoroquinolones and the Risk of Sudden Cardiac Death Among Patients Receiving Hemodialysis

Author Affiliations
  • 1University of North Carolina Kidney Center, Division of Nephrology and Hypertension, Department of Medicine, UNC School of Medicine, Chapel Hill
  • 2Division of Nephrology, Department of Medicine, Duke University School of Medicine, Durham, North Carolina
  • 3Duke Clinical Research Institute, Durham, North Carolina
  • 4Cecil G. Sheps Center for Health Services Research, University of North Carolina, Chapel Hill
  • 5Division of Cardiology, Duke University Medical Center, Durham, North Carolina
  • 6Department of Population Health Sciences, Duke University School of Medicine, Durham, North Carolina
  • 7Division of Division of Infectious Diseases, Department of Medicine, UNC School of Medicine, Chapel Hill, North Carolina
  • 8Selzman Institute for Kidney Health, Section of Nephrology, Baylor College of Medicine, Houston, Texas
JAMA Cardiol. 2022;7(1):75-83. doi:10.1001/jamacardio.2021.4234
Key Points

Question  Compared with amoxicillin-based antibiotics, are respiratory fluoroquinolones associated with a higher risk of sudden cardiac death among patients receiving hemodialysis?

Findings  In this cohort study, among 264 968 patients receiving in-center hemodialysis, respiratory fluoroquinolone vs amoxicillin-based antibiotic treatment was associated with higher relative and absolute 5-day sudden cardiac death risks.

Meaning  The findings of this study suggest that, among patients receiving hemodialysis, treatment with a respiratory fluoroquinolone may be associated with an increased risk of sudden cardiac death more than treatment with an amoxicillin-based antibiotic.


Importance  Respiratory fluoroquinolone antibiotics are some of the most common medications with QT interval–prolonging potential prescribed to patients with hemodialysis-dependent kidney failure—individuals who have a very high risk of sudden cardiac death (SCD). To date, there have been no large-scale, population-specific studies evaluating the cardiac safety of respiratory fluoroquinolones in the hemodialysis population.

Objective  To investigate the cardiac safety of respiratory fluoroquinolones among individuals with hemodialysis-dependent kidney failure.

Design, Setting, and Participants  A retrospective cohort study examining safety using an active comparator new-user design was conducted using administrative claims data from a US-wide kidney failure registry from January 1, 2007, to December 31, 2016, including 264 968 Medicare beneficiaries receiving in-center maintenance hemodialysis. Data analysis was performed from January 4 to August 16, 2021.

Exposures  Respiratory fluoroquinolone (levofloxacin or moxifloxacin) vs amoxicillin-based (amoxicillin or amoxicillin with clavulanic acid) antibiotic treatment.

Main Outcomes and Measures  Sudden cardiac death within 5 days of outpatient initiation of a study antibiotic. Inverse probability of treatment-weighted survival models to estimate hazard ratios (HRs), risk differences (RDs), and corresponding 95% CIs. Death due to a cause other than SCD was treated as a competing event. Fracture was considered as a negative control outcome.

Results  The study cohort included 264 968 unique in-center hemodialysis patients and 626 322 study antibiotic treatment episodes: 251 726 respiratory fluoroquinolone treatment episodes (40.2%) and 374 596 amoxicillin-based treatment episodes (59.8%). Of the 264 968 patients, 135 236 (51.0%) were men, and the mean (SD) age was 61 (15) years. Respiratory fluoroquinolone vs amoxicillin-based antibiotic treatment was associated with a higher relative and absolute 5-day risk of SCD (weighted HR, 1.95; 95% CI, 1.57-2.41; and weighted RD per 100 000 treatment episodes, 44.0; 95% CI, 31.0-59.2). Respiratory fluoroquinolone vs amoxicillin-based antibiotic treatment was not associated with the 5-day risk of fracture.

Conclusions and Relevance  In this study, compared with amoxicillin-based antibiotic treatment, respiratory fluoroquinolone treatment was associated with a higher short-term risk of SCD among patients with hemodialysis-dependent kidney failure. This finding suggests that decisions between the use of respiratory fluoroquinolones and amoxicillin-based antibiotics should be individualized, with prescribers considering both the clinical benefits and potential cardiac risks.

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