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      Comparative Effectiveness Of Fluoroquinolone Antibiotic Use In Uncomplicated Acute Exacerbations Of COPD: A Multi-Cohort Study

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          Abstract

          Purpose

          Fluoroquinolone antibiotics are associated with rare, but severe adverse events. They are frequently used for the treatment of acute exacerbations of COPD (AECOPD). While their effectiveness in severe exacerbations requiring hospitalisation has been well documented, the potential benefit in the ambulatory setting is less clear, especially in uncomplicated patients with COPD.

          Patients and characteristics

          We carried out a retrospective cohort study using health care databases from six Canadian provinces in subjects visiting their physician for uncomplicated COPD. Subjects dispensed either a quinolone or other antibiotics were compared using inverse probability of treatment weights with high dimensional propensity scores on 30-day outcomes, including repeat visits, hospitalisation for AECOPD and subsequent antibiotic prescription. Results from each province were combined by random effects meta-analysis.

          Results

          We identified 286,866 AECOPD events among 203,642 unique individuals. The frequency of fluoroquinolone use, mostly levofloxacin and moxifloxacin, varied by province and ranged from 8% to 32% of AECOPD antibiotic prescriptions. The risk of a repeat ambulatory care visit was increased among patients who were dispensed a fluoroquinolone compared with other antibiotics (OR 1.32, 95% CI 1.27–1.36). The risk of a hospitalisation for AECOPD was also higher with fluoroquinolones (OR 1.52, 95% CI 1.33–1.74). There was no difference in subsequent antibiotic prescriptions (OR 1.00, 95% CI 0.94–1.07).

          Conclusion

          There is no apparent benefit in short-term outcomes with fluoroquinolones as compared to other antibiotics for the ambulatory treatment of AECOPD in uncomplicated patients. These findings support current recommendations that fluoroquinolones be reserved for AECOPD in patients with recurrent exacerbations, significant co-morbidity or requiring hospitalisation.

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          Most cited references 17

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          High-dimensional propensity score adjustment in studies of treatment effects using health care claims data.

          Adjusting for large numbers of covariates ascertained from patients' health care claims data may improve control of confounding, as these variables may collectively be proxies for unobserved factors. Here, we develop and test an algorithm that empirically identifies candidate covariates, prioritizes covariates, and integrates them into a propensity-score-based confounder adjustment model. We developed a multistep algorithm to implement high-dimensional proxy adjustment in claims data. Steps include (1) identifying data dimensions, eg, diagnoses, procedures, and medications; (2) empirically identifying candidate covariates; (3) assessing recurrence of codes; (4) prioritizing covariates; (5) selecting covariates for adjustment; (6) estimating the exposure propensity score; and (7) estimating an outcome model. This algorithm was tested in Medicare claims data, including a study on the effect of Cox-2 inhibitors on reduced gastric toxicity compared with nonselective nonsteroidal anti-inflammatory drugs (NSAIDs). In a population of 49,653 new users of Cox-2 inhibitors or nonselective NSAIDs, a crude relative risk (RR) for upper GI toxicity (RR = 1.09 [95% confidence interval = 0.91-1.30]) was initially observed. Adjusting for 15 predefined covariates resulted in a possible gastroprotective effect (0.94 [0.78-1.12]). A gastroprotective effect became stronger when adjusting for an additional 500 algorithm-derived covariates (0.88 [0.73-1.06]). Results of a study on the effect of statin on reduced mortality were similar. Using the algorithm adjustment confirmed a null finding between influenza vaccination and hip fracture (1.02 [0.85-1.21]). In typical pharmacoepidemiologic studies, the proposed high-dimensional propensity score resulted in improved effect estimates compared with adjustment limited to predefined covariates, when benchmarked against results expected from randomized trials.
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            Using inverse probability-weighted estimators in comparative effectiveness analyses with observational databases.

            Inverse probability-weighted estimation is a powerful tool for use with observational data. In this article, we describe how this propensity score-based method can be used to compare the effectiveness of 2 or more treatments. First, we discuss the inherent problems in using observational data to assess comparative effectiveness. Next, we provide a conceptual explanation of inverse probability-weighted estimation and point readers to sources that address the method in more formal, technical terms. Finally, we offer detailed guidance about how to implement the estimators in comparative effectiveness analyses.
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              Fluoroquinolones and collagen associated severe adverse events: a longitudinal cohort study

              Objectives Fluoroquinolone-associated tendon ruptures are a recognised complication, but other severe collagen-associated adverse events may also be possible. Our objectives were to confirm the association of fluoroquinolones and tendon rupture, to clarify the potential association of fluoroquinolones and retinal detachment, and to test for a potentially lethal association between fluoroquinolones and aortic aneurysms. Setting Population-based longitudinal cohort study in Ontario, Canada. Participants Older adults turning 65 years between April 1 1997 and March 31 2012 were followed until primary outcome, death, or end of follow-up (March 31 2014). Fluoroquinolone prescriptions were measured as a time-varying covariate, with patients considered at risk during and for 30 days following a treatment course. Primary outcome measures Severe collagen-associated adverse events defined as tendon ruptures, retinal detachments and aortic aneurysms diagnosed in hospital and emergency departments. Results Among the 1 744 360 eligible patients, 657 950 (38%) received at least one fluoroquinolone during follow-up, amounting to 22 380 515 days of treatment. The patients experienced 37 338 (2.1%) tendon ruptures, 3246 (0.2%) retinal detachments, and 18 391 (1.1%) aortic aneurysms. Severe collagen-associated adverse events were more common during fluoroquinolone treatment than control periods, including tendon ruptures (0.82 vs 0.26/100-person years, p<0.001), retinal detachments (0.03 vs 0.02/100-person-years, p=0.003) and aortic aneurysms (0.35 vs 0.13/100-person-years, p<0.001). Current fluoroquinolones were associated with an increased hazard of tendon rupture (HR 3.13, 95% CI 2.98 to 3.28; adjusted HR 2.40, 95% CI 2.24 to 2.57) and an increased hazard of aortic aneurysms (HR 2.72, 95% CI 2.53 to 2.93; adjusted HR2.24, 95% CI 2.02 to 2.49) that were substantially greater in magnitude than the association of these outcomes with amoxicillin. The hazard of retinal detachment was marginal (HR 1.28, 95% CI 0.99 to 1.65; adjusted HR 1.47, 95% CI 1.08 to 2.00) and not greater in magnitude than that observed with amoxicillin. Conclusions Fluoroquinolones are associated with subsequent tendon ruptures and may also contribute to aortic aneurysms.
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                Author and article information

                Journal
                Int J Chron Obstruct Pulmon Dis
                Int J Chron Obstruct Pulmon Dis
                COPD
                copd
                International Journal of Chronic Obstructive Pulmonary Disease
                Dove
                1176-9106
                1178-2005
                18 December 2019
                2019
                : 14
                : 2939-2946
                Affiliations
                [1 ]Centre for Clinical Epidemiology, Lady Davis Research Institute, Jewish General Hospital , Montreal, Quebec, Canada
                [2 ]Manitoba Centre for Health Policy, Department of Community Health Sciences, Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba , Winnipeg, Manitoba, Canada
                [3 ]Institute for Clinical Evaluative Sciences , Toronto, Ontario, Canada
                [4 ]Sunnybrook Research Institute , Toronto, Ontario, Canada
                [5 ]Division of Infectious Diseases, Sunnybrook Health Sciences Centre , Toronto, Ontario, Canada
                [6 ]Faculty of Medicine, University of Toronto , Toronto, Ontario, Canada
                [7 ]Health Quality Council , Saskatoon, Saskatchewan, Canada
                [8 ]Department of Community Health & Epidemiology, College of Medicine, University of Saskatchewan , Saskatoon, Saskatchewan, Canada
                [9 ]College of Pharmacy, Dalhousie University , Halifax, Nova Scotia, Canada
                [10 ]Department of Anesthesiology, Pharmacology and Therapeutics, University of British Columbia , Vancouver, British Columbia, Canada
                [11 ]Department of Medicine, Cumming School of Medicine, University of Calgary , Calgary, Alberta, Canada
                [12 ]School of Pharmacy, Memorial University of Newfoundland , St John’s, Newfoundland and Labrador, Canada
                [13 ]College of Pharmacy, Rady Faculty of Health Sciences, University of Manitoba , Winnipeg, Manitoba, Canada
                Author notes
                Correspondence: Shawn Bugden School of Pharmacy, Memorial University of Newfoundland , 300 Prince Philip Drive, St John’s, Newfoundland and LabradorA1B 3V6, CanadaTel +1-709-864-4400Fax +1-709-864-4819 Email shawn.bugden@mun.ca
                Article
                226324
                10.2147/COPD.S226324
                6927224
                © 2019 Ernst et al.

                This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms ( https://www.dovepress.com/terms.php).

                Page count
                Figures: 4, Tables: 2, References: 24, Pages: 8
                Categories
                Original Research

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