Optimal Management of RTI – Intriguing New Results in ABECOPD in Asia

29 March, 2018

Question 10

Do clinical trial data support the safety of the 750 mg dose?

Yes, they do. A randomized double-blind clinical trial comparing the 750 mg 5-day course of levofloxacin to the 500 mg 10-day course found no significant differences in the safety profile between the two doses (6). Safety data was available from 256 patients in both dosage groups and the incidence of treatment-emergent adverse events was similar for the two groups (95% confidence interval [CI]: -6.8 to 10.5). The most common events in the group receiving 500 mg were insomnia (10.6%), diarrhea (6.0%), headache (5.7%) and nausea (5.7%), while the most common in the 750 mg group were headache (8.6%), nausea (8.6%), insomnia (7.0%), constipation (5.1%) and vomiting (5.1%). In another study comparing adverse event profiles between the two doses in patients with RTI, it was found that overall the safety profile was similar but not identical. Drug-related adverse events occurred in 7.6% of those treated with 500 mg and 8.0% in the 750 mg group (13). I have not had a problem using the 750 mg dose although if the patient is very small, has diminished renal function or is sensitive due to preexisting disease, I tend to use the lower 500 mg dose. However, in the majority of patients who are acutely ill, the 750 mg dose is as well tolerated as the 500 mg dose.