Abstract

BackgroundFluoroquinolones (FQs) are used commonly for patients with community acquired bacterial pneumonia (CABP). A recent FDA Drug Safety Communication strengthened labeling regarding tendinopathy/tendon rupture for FQs. The data prompting this change lacked a comparator group of patients using other antibiotics, like ceftriaxone/azithromycin (CTX-AZ) for similar indications. The objectives of this study were to compare the incidence of adverse tendon events (TE) between FQ and CTX-AZ among patients with CABP and determine if FQ treatment is independently associated with TE.MethodsA retrospective cohort study was performed among patients in the Upstate New York Veterans’ Healthcare Administration. Inclusion criteria: (1) age ≥ 18 years, (2) diagnosis of CABP (ICD9 code with manual confirmation) from January 2014 to December 2015, (3) receipt of IV/oral FQ or CTX-AZ ≥ 1 day, and (4) treatment initiated as inpatient. Data were collected from pt’s medical records. Occurrence of TE was defined using a natural word search algorithm of patients’ clinical progress notes within 90 days of starting FQ or CTX-AZ therapy. Search terms were: tendinopathy, tendon pain, tendon rupture, tendinitis, and Achilles heel pain/tear/torn/rupture. Classification and regression tree (CART) was used to identify breakpoints in continuous variables associated with TE.ResultsThere were 379 FQ and 274 CTX-AZ recipients. Mean ± standard deviation (SD) ages for FQ and CTX-AZ recipients were, 73.0 ± 12.7 vs. 72.8 ± 12.7 years, respectively. Mean (SD) APACHE-II was significantly higher for FQ than CTX-AZ recipients, 10.2 ± 5.1 vs. 8.5 ± 3.6, respectively (P < 0.001). Residence in the intensive care unit at start of therapy did not differ (FQ: 11.6% vs. CTX-AZ: 10.2%, P = 0.58). The incidence of TE did not differ between groups (FQ: 9/379 [2.4%] vs. CTX-AZ: 4/274 [1.5%], P = 0.57). In multivariate analyses (figure), treatment was not independently associated with TE (aOR: 1.78, 95% confidence interval: 0.51–6.21, P = 0.37) after adjustment for treatment duration, APACHE-II, age ≥52 years and BMI ≥27.5. ConclusionIncidence of TE did not significantly differ between FQ and CTX-AZ recipients. After adjustment, FQ treatment was not independently associated with an increased risk of TE.Disclosures T. P. Lodise, paratek: Consultant and Scientific Advisor, Consulting fee.

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