Thamir M Alshammari1, E Paul Larrat, Haley J Morrill, Aisling R Caffrey, Brian J Quilliam, Kerry L LaPlante. 1. Thamir M. Alshammari, Ph.D., is Assistant Professor, College of Pharmacy, Hail University, Saudi Arabia. E. Paul Larrat, Ph.D., is Dean, College of Pharmacy, University of Rhode Island (URI), Kingston; at the time of this study, he was Professor of Pharmacy, College of Pharmacy, URI. Haley J. Morrill, Pharm.D., is Clinical Research Outcomes Fellow in Antimicrobial Stewardship, Infectious Diseases Research Program, Providence Veterans Affairs Medical Center (VAMC), Providence, RI, and College of Pharmacy, URI. Aisling R. Caffrey, Ph.D., M.S., is Director of Outcomes Research, Infectious Diseases Research Program, Providence VAMC, and Assistant Professor of Pharmacoepidemiology, College of Pharmacy, URI. Brian J. Quilliam, Ph.D., is Associate Professor of Pharmacy, College of Pharmacy, URI. Kerry L. LaPlante, Pharm.D., is Associate Professor of Pharmacy, College of Pharmacy, URI; Director, Infectious Diseases Research Program, and Infectious Diseases Pharmacotherapy Specialist, Providence VAMC; and Adjunct Clinical Associate Professor of Medicine, Brown University, Providence.
Abstract
PURPOSE: Results of a pharmacoepidemiologic evaluation of fluoroquinolone-associated hepatotoxicity using national hospital admissions data on Veterans Affairs (VA) patients are reported. METHODS: In a retrospective case-control study, all adults with a primary diagnosis of hepatotoxicity on admission to a VA facility during a 6.5-year period (January 2002-June 2008) were identified. After the exclusion of patients whose records indicated known causes of hepatotoxicity or a history of liver disease, a subgroup of 7,862 patients with exposure to fluoroquinolone antibiotics in the six months prior to hospital admission were matched with nonexposed controls (n = 45,512). Conditional logistic regression was used to assess the overall and drug-specific risks of hepatotoxicity in the case group, controlling for comorbidities, concomitant use of known hepatotoxic medications, and other variables. RESULTS: After adjusting for confounders, logistic regression analysis indicated a significantly higher overall risk of hepatotoxicity development among fluoroquinolone users relative to controls (odds ratio [OR], 1.20; 95% confidence interval [CI], 1.04-1.38). Drug-specific risk analyses focused on three fluoroquinolone agents (ciprofloxacin, levofloxacin, and moxifloxacin) indicated a significant association between ciprofloxacin use and an increased risk of hepatotoxicity (OR, 1.29; 95% CI, 1.05-1.58); when considered as independent variables, levofloxacin use and moxifloxacin use were not significantly associated with hepatotoxicity risk. CONCLUSION: The findings of a national VA safety study suggested an increased hepatotoxicity risk asssociated with fluoroquinolone exposure in the study population.
PURPOSE: Results of a pharmacoepidemiologic evaluation of fluoroquinolone-associated hepatotoxicity using national hospital admissions data on Veterans Affairs (VA) patients are reported. METHODS: In a retrospective case-control study, all adults with a primary diagnosis of hepatotoxicity on admission to a VA facility during a 6.5-year period (January 2002-June 2008) were identified. After the exclusion of patients whose records indicated known causes of hepatotoxicity or a history of liver disease, a subgroup of 7,862 patients with exposure to fluoroquinolone antibiotics in the six months prior to hospital admission were matched with nonexposed controls (n = 45,512). Conditional logistic regression was used to assess the overall and drug-specific risks of hepatotoxicity in the case group, controlling for comorbidities, concomitant use of known hepatotoxic medications, and other variables. RESULTS: After adjusting for confounders, logistic regression analysis indicated a significantly higher overall risk of hepatotoxicity development among fluoroquinolone users relative to controls (odds ratio [OR], 1.20; 95% confidence interval [CI], 1.04-1.38). Drug-specific risk analyses focused on three fluoroquinolone agents (ciprofloxacin, levofloxacin, and moxifloxacin) indicated a significant association between ciprofloxacin use and an increased risk of hepatotoxicity (OR, 1.29; 95% CI, 1.05-1.58); when considered as independent variables, levofloxacin use and moxifloxacin use were not significantly associated with hepatotoxicity risk. CONCLUSION: The findings of a national VA safety study suggested an increased hepatotoxicity risk asssociated with fluoroquinolone exposure in the study population.
Authors: Khalidah A Alenzi; Najah S Alanazi; Mohammed Almalki; Homoud Alomrani; Fahad O Alatawi Journal: Saudi Pharm J Date: 2022-03-31 Impact factor: 4.562
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