• Taiwan Registry Study: Fluoroquinolones Carry Higher Risk in Aortic Dissection and Aneurysm Patients

    Fluoroquinolones carried higher risk of adverse outcomes in patients diagnosed with aortic dissection (AD) and aneurysm (AA) in a large Taiwanese cohort.

    The findings, from a retrospective study of 31,570 adult survivors of AD or AA in the Taiwan National Health Insurance Research Database, were published online on Monday as part of the April 20 issue of the Journal of the American College of Cardiology.

    The authors, led by Shao-Wei Chen, MD, PhD, of Chang Gung Memorial Hospital, Taoyuan City, Taiwan, noted that the current study is a response to recent population-based research revealing a link between the class of antibiotics and increased risk of AD and AA.

    No evidence has been available on whether fluoroquinolones increase adverse events in those already diagnosed with AD and AA, however, they noted.

    The researchers, therefore, set out to investigate whether fluoroquinolone use raises the risk of aortic-related adverse events and deaths in the high-risk population using data from the Taiwan National Health Insurance Research Database in patients admitted for AD (13,495, 42.7%) or AA (18,075, 57.3%) between January 1, 2001, and December 31, 2013.

    Each calendar year was divided into six units of 2 months for each patient during follow-up because medications for chronic illnesses are refilled with a maximum length of 2 to 3 months according to Taiwan National Health Insurance reimbursement policy.

    Patients’ mean age was 70.2 years, while 72.6% were male, 76.2% had hypertension, and 24.4% (a total 7,709 patients) underwent aortic surgery during the index admission. The study population excluded patients younger than 20 years old, those previously diagnosed with any aortic disease, and those who died during admission.

    Another common antibiotic, amoxicillin, was used as a negative control exposure, which had been prescribed to 5.6% of the patients before the index submission vs. the 5% of patients prescribed fluoroquinolones.

    The incidence of all-cause death were 351 events per 1,000 person-years in the exposure period and 129.5 events per 1,000 person-years in the control period.

    After adjusting for covariates including age, sex, socioeconomic status, medical utilization in the previous year, other medical conditions and comorbidities, hospital level for the index admission, and whether the patient underwent aortic surgery at the index admission, fluoroquinolones were associated with higher risk of death (adjusted hazard ratio [HR]: 1.61; 95% confidence interval [CI]: 1.50 to 1.73; p < 0.05).

    Their use was also associated with raised risk of aortic death (adjusted HR: 1.80; 95% CI: 1.50 to 2.15; p < 0.05), and later aortic surgery (open surgery adjusted HR: 1.49; 95% CI: 1.24 to 1.79, p < 0.05; aortic stent adjusted HR: 1.64; 95% CI: 1.30 to 2.06, p < 0.05). The negative effects of fluoroquinolone use on outcomes were not significantly different between the AD and AA groups.

    Amoxicillin was not significantly associated with risk for any of these outcomes.

    In a sensitivity analysis excluding patients prescribed fluoroquinolones in the preceding 2 months, “the results were identical,” the researchers said.

    It is believed that this is the first study to evaluate association between exposure to fluoroquinolones and the risk of adverse outcomes in patients diagnosed with AD or AA, they added.

    “Clinicians should carefully weigh the benefits against the potential harm of (fluoroquinolones) for treating patients with AD or AA,” the researchers stressed, adding that these antibiotics “should not be used in patients with AD or AA unless no other treatment options are available”.

    They went on to push for further animal studies clarifying the pathophysiological mechanism of these drugs in specific genetic disorders, which could support development of future prevention or treatment strategies.

    In an accompanying editorial, Scott A. LeMaire, MD, from Baylor College of Medicine, Texas, said the report represents an important contribution to the growing body of evidence driving concerns over the detrimental effects of fluoroquinolones on the aortic wall.

    He, too, called for further laboratory and clinical studies to improve understanding of the risk and to inform clinical practice.

    “In the meantime, given the life-threatening nature of the complications, it seems prudent to follow the existing (U.S. Food and Drug Administration and European Medicines Agency) warnings and avoid the use of these drugs in patients at risk for aortic complications, particularly those with existing aortic disease.”

    Sources:

    Chen SW, Chan YH, Wu VCC, et al. Effects of Fluoroquinolones on Outcomes of Patients With Aortic Dissection or Aneurysm. J Am Coll Cardiol 2021;77:1875–87.

    LeMaire SA. Fluoroquinolones in Patients With Aortic Aneurysms or Dissections: Pouring Gasoline on a Fire. J Am Coll Cardiol 2021;77:1888-90.

     

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