Retrospective analysis of the safety profile of oral and intravenous ciprofloxacin in a geriatric population

Abstract

Background: Ciprofloxacin is a broad-spectrum fluoroquinolone antibiotic used in the treatment of a wide range of mild to moderate gram-positive and gram-negative infections. Although extensive information is available on the safety profile of ciprofloxacin in adults, few published data exist regarding the tolerability and toxicity of this drug in patients aged ≥65 years. Objectives: The objectives of this retrospective analysis were to compare the safety profile of ciprofloxacin in patients aged ≥65 years versus patients aged <65 years and to compare the adverse-event profile of ciprofloxacin with that of other comparator antimicrobial agents used in clinical trials. Methods: We retrospectively reviewed 23 prospective, controlled anti-infective clinical trials in the US Bayer ciprofloxacin database that included patients aged ≥65 years. These trials comprised the submission file of the original and supplemental New Drug Application for ciprofloxacin. The incidence of treatment-emergent and drug-related adverse events was assessed. Results: Of the 6863 patients in these 23 clinical trials, 3579 recieved ciprofloxacin therapy and 3284 received comparator antimicrobial agents. Of the ciprofloxacin-treated patients, 898 (25.1%) were aged ≥65 years; 887 (27.0%) of the patients who received comparator antimicrobial agents were aged ≥65 years. Among ciprofloxacin-treated patients, drug-related adverse events were reported more often in those aged <65 years (24.0%) compared with those aged ≥65 years (17.9%). The incidence of drug-related adverse events in the comparator group was also higher in those aged <65 years (25.1%) than in those aged >-65 years (16.8%). Premature discontinuation due to any adverse events was reported in 3.9% (105 or 2681) and 3.7% (33 of 898) of ciprofloxacin-treated patients aged <65 years and ≥65 years, respectively. Corresponding rates for the comparator antimicrobial group were 3.9% (93 to 2397) and 3.8% (34 of 887), respectively, for patients aged <-65 years and ≥65 years. The most common drug-related adverse events reported for ciprofloxacin-treated patients aged <65 years and >-65 years were digestive system-related (18.1% and 11.4%, respectively) and central nervous system-related events (6.6% and 4.9%, respectively). Conclusions: The retrospective analysis suggests that there is no clinically important difference in the safety profile of ciprofloxacin in patients aged >-65 years versus patients aged <65 years.