Background: Fluoroquinolones (FQs) are one of the most widely used antibiotic classes for patients (pts) with community acquired bacterial pneumonia (CABP). Despite their frequent use, there are emerging safety concerns highlighted by the FDA. One of the more problematic adverse events are tendinopathy and tendon rupture. The objectives of this study were to 1) quantify the incidence and 2) identify the predictors of FQ-associated adverse tendon events (FQATE) among Veterans Affairs (VA) pts with CABP.
Methods: A retrospective cohort study was performed among VA pts from the Upstate New York Veterans Healthcare Administration. Inclusion criteria: 1) age ≥ 18 years, 2) diagnosis of CABP (initial ICD9 code followed by manual confirmation) from 1/2014 to 12/2015, 3) receipt of IV or oral FQ ≥ 1 day, and 4) treatment initiated while pt inpatient. Demographics, comorbidities, laboratory values, treatment history, course of hospitalization and outcomes were collected from pts medical records. Occurrence of FQATE was defined using a natural word search algorithm of pts clinical progress notes within 90 days of starting FQ therapy. Word search terms were: tendinopathy, tendon pain, tendon rupture, tendinitis, and Achilles heel pain/tear/torn/rupture. Multivariable statistics were used to determine predictors of FQATE.
Results: Among the 379 pts included, most were male (96.0%) and mean (SD) age was 73.0 (12.7) yrs. Mean (SD) APACHE-II was 10.2 ± 5.1 and 18% were admitted to an ICU. Levofloxacin (52.8%) was most commonly used, followed by moxifloxacin (41.2%) and ciprofloxacin (6.1%). Median (IQR) duration of therapy was 4 (2 7) days. Inappropriate renal dose adjustment was present in 55 (14.5%) pts. There were 9 (2.4%) pts with FQATE occurring after a median (IQR) of 21 (6 70) days since starting FQ therapy. Two pts had multiple FQATE terms. Most frequent terms were tendinitis (55.6%), tendon pain (22.2%), Achilles heel pain (22.2%), tendinopathy (11.1%), tendon rupture (11.1%) and none for Achilles heel tear/torn/rupture. None of the cases of FQATE died within the 90 day observation period. Body mass index (BMI) ≥ 30 was the only variable significantly associated with FQATE in multivariable analyses adjusting for duration of therapy and osteoarthritis.
Conclusion: Incidence of FQATE was 2.4% among VA pts and predicted by BMI ≥ 30.
Gilead Sciences, Inc.:
Merck & Co., Inc.: Grant Investigator , Research grant
Theravance Biopharma US, Inc.: Consultant and Speaker's Bureau , Speaker honorarium
J. Murray, None
J. Bowles, None
T. P. Lodise Jr., allergan: Consultant , Grant Investigator , Scientific Advisor and Speaker's Bureau , Consulting fee and Speaker honorarium
medicines company: Consultant , Grant Investigator , Scientific Advisor and Speaker's Bureau , Consulting fee , Research support and Speaker honorarium
melinta: Consultant , Consulting fee
motif: Consultant and Scientific Advisor , Consulting fee
paratek: Consultant and Scientific Advisor , Consulting fee
nabriva: Consultant , Consulting fee