IMPORTANCE Although fluoroquinolones are commonly prescribed antibiotics in the US, recent international studies have shown an increased risk of aortic aneurysm and dissection after fluoroquinolone use, leading to US Food and Drug Administration warnings limiting use for high-risk patients. It is unclear whether these data are true for the US population and who is truly high risk. OBJECTIVE To assess aortic aneurysm and dissection risks in a heterogeneous US population after fluoroquinolone use. DESIGN, SETTING, AND PARTICIPANTS Prescription fills for fluoroquinolones or a comparator antibiotic from 2005 to 2017 among commercially insured individuals aged 18 to 64 years were identified in this retrospective analysis of MarketScan health insurance claims. This cohort study included 27 827 254 US adults (47 596 545 antibiotic episodes), aged 18 to 64 years, with no known previous aortic aneurysm or dissection, no recent antibiotic exposure, and no recent hospitalization. EXPOSURES Outpatient fill of an oral fluoroquinolone or comparator antibiotic (amoxicillin-clavulanate, azithromycin, cephalexin, clindamycin, and sulfamethoxazoletrimethoprim). MAIN OUTCOMES AND MEASURESThe 90-day incidence of aortic aneurysm and dissection. Inverse probability of treatment weighting in Cox regression was used to estimate the association between fluoroquinolone fill and 90-day aneurysm incidence. Interaction terms were used to assess the association of known risk factors (ie, sex, age, and comorbidities) with aneurysm after fluoroquinolone use. Data analysis was performed March 2019 to May 2020. RESULTSOf 47 596 545 prescription fills, 9 053 961 (19%) were fluoroquinolones and 38 542 584 (81%) were comparator antibiotics. The median (interquartile range) age of adults with fluoroquinolone fills was 47 (36-57) years vs 43 (31-54) years with comparator antibiotic fills. Women comprised 61.3% of fluoroquinolone fills and 59.5% of comparator antibiotic fills. Before weighting, the 90-day incidence of newly diagnosed aneurysm was 7.5 cases per 10 000 fills (6752 of 9 053 961) after fluoroquinolones compared with 4.6 cases per 10 000 fills (17 627 of 38 542 584) after comparator antibiotics. After weighting for demographic characteristics and comorbidities, fluoroquinolone fills were associated with increased incidence of aneurysm formation (hazard ratio [HR], 1.20; 95% CI, 1.17-1.24). More specifically, compared with comparator antibiotics, fluoroquinolone fills were associated with increased 90-day incidence of abdominal aortic aneurysm (
Severe acute kidney injury has a high mortality and is a risk factor for progressive chronic kidney disease. None of the potential therapies that have been identified in preclinical studies have successfully improved clinical outcomes. This failure is partly because animal models rarely reflect the complexity of human disease: most preclinical studies are short term and are commonly performed in healthy, young, male mice. Therapies that are effective in preclinical models that share common clinical features seen in patients with acute kidney injury, including genetic diversity, different sexes, and comorbidities, and evaluate long-term outcomes are more likely to predict success in the clinic. Here, we evaluated susceptibility to chronic kidney disease after ischemia-reperfusion injury with delayed nephrectomy by monitoring long-term functional and histological responses to injury. We defined conditions required to induce long-term postinjury renal dysfunction and fibrosis without increased mortality in a reproducible way and evaluate effect of mouse strains, sexes, and preexisting diabetes on these responses.
Lack of long-term patency has hindered the clinical use of small-diameter prosthetic vascular grafts with the majority of these failures due to the development of neointimal hyperplasia. Previous studies by...
Background: Federal initiatives have recently addressed the sex bias that exists in biomedical and clinical research. However, improvement to the inclusion of sex as a biological variable remains unknown. Methods: We performed a 5-year follow-up study of all clinical and biomedical research articles published in 5 surgical journals from January 1, 2017, through December 31, 2018. Human, animal, and cell subjects were analyzed for study/subject type, sex of participants, sex matching, and sex-based data reporting, analysis, and discussion. Results: Comparing 2017 to 2018 with 2011 to 2012, slightly more articles reported the sex of the human studied (87% vs 83%; P ¼ .001). Inclusion of both sexes remained high (94% vs 95%; P ¼ .22), but sex-based data reporting (36% vs 38%; P ¼ .17), analysis (35% vs 33%; P ¼ .39), and discussion of results (10% vs 23%; P < .0001) remained unchanged or worsened. Regarding animal research, the number of articles that stated the sex studied remained unchanged (79% vs 78%; P ¼ .67); if stated, slightly more included both sexes (7% vs 3%; P ¼ .002). Regarding cell research, fewer articles reported the sex of the cells studied (5% vs 24%; P ¼ .0001); if stated, more articles included both sexes, but the difference did not reach statistical significance (25% vs 7%; P ¼ .34). Sex matching remained poor with only 50% of human, 4% of animal, and 9% of cell studies matching the inclusion of both sexes by at least 50%. Conclusion: Sex bias persists in surgical research. The majority of articles failed to report, analyze, or discuss results based on sex, which will negatively affect clinical translatability and outcomes of evidence-based medicine.
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