Retrospective analysis of the safety profile of oral and intravenous ciprofloxacin in a geriatric population.
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 > or = 65 years.


OBJECTIVE
The objectives of this retrospective analysis were to compare the safety profile of ciprofloxacin in patients aged > or = 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 > or = 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 received ciprofloxacin therapy and 3284 received comparator antimicrobial agents. Of the ciprofloxacin-treated patients, 898 (25.1%) were aged > or = 65 years; 887 (27.0%) of the patients who received comparator antimicrobial agents were aged > or = 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 > or = 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 > or = 65 years (16.8%). Premature discontinuation due to any adverse event was reported in 3.9% (105 of 2681) and 3.7% (33 of 898) of ciprofloxacin-treated patients aged <65 years and > or = 65 years, respectively. Corresponding rates for the comparator antimicrobial group were 3.9% (93 of 2397) and 3.8% (34 of 887), respectively, for patients aged <65 years and > or = 65 years. The most common drug-related adverse events reported for ciprofloxacin-treated patients aged <65 years and > or = 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
This retrospective analysis suggests that there is no clinically important difference in the safety profile of ciprofloxacin in patients aged > or = 65 years versus patients aged <65 years.
Heyd
A
A
Bayer Corporation, Pharmaceutical Division, West Haven, Connecticut 06516, USA.
Haverstock
D
D
D000284:Administration, Oral; D000368:Aged; D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D002939:Ciprofloxacin / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D002986:Clinical Trials as Topic; D005260:Female; D005853:Geriatrics; D006801:Humans; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D010406:Penicillins / Q000009:adverse effects; D012189:Retrospective Studies
D000890:Anti-Infective Agents; D010406:Penicillins; D002939:Ciprofloxacin