Comparison of the adverse event profiles of levofloxacin 500 mg and 750 mg in clinical trials for the treatment of respiratory infections.
OBJECTIVE
To compare safety data with levofloxacin 500 mg and 750 mg from clinical trials for the treatment of respiratory infections.


METHODS
We compared adverse event data for levofloxacin 500 mg and 750 mg from clinical trials in acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, and community-acquired pneumonia. Adverse events occurring after the initiation of therapy were classified as treatment-emergent adverse events (TEAE); drug-related adverse events (DRAE) were TEAE assessed by the clinical investigator as definitely/very likely or probably related to levofloxacin therapy.


RESULTS
Overall, the safety profile of the two doses was similar but not identical. TEAE occurred in 49.0% (1601/3268) of those treated with 500 mg and in 45.5% (519/1141) of those treated with 750 mg (p = 0.042); the corresponding rates of DRAE were 7.6% (248/3268) and 8.0% (91/1141) (p = 0.699). There was no statistically significant difference in terms of overall TEAE and DRAE rates within each of the three infectious conditions, but there were in specific events, all of which are expected with levofloxacin therapy. The limitations of this analysis include that it utilized a subset of available safety data, that it includes data only from clinical trials, and that we report primarily on events occurring in > or = 2% of patients.


CONCLUSIONS
Given similar adverse event profiles and the advantages of higher dose therapy, including shorter courses of therapy and potential impact on preventing resistance, clinicians should consider utilizing the 750 mg dose of levofloxacin when choosing between dosage strengths for treatment of indicated infections.
Khashab
Mohammed M
MM
Medical Affairs, PriCara, Unit of Ortho-McNeil Pharmaceutical, Raritan, NJ 08869, USA.
Xiang
Jim
J
Kahn
James B
JB
D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects*; D002986:Clinical Trials as Topic; D006801:Humans; D064704:Levofloxacin; D015242:Ofloxacin / Q000008:administration & dosage* / Q000009:adverse effects*; D012141:Respiratory Tract Infections / Q000188:drug therapy*
D000900:Anti-Bacterial Agents; D064704:Levofloxacin; D015242:Ofloxacin