1. Analysis of the trials on an intention-to-treat basis indicates that the orally-administered new fluoroquinolones offer no statistically significant additional clinical successes against other antibiotics for the empirical treatment of CAP. An evaluable subjects analysis found new fluoroquinolones to be slightly more effective in treating individuals diagnosed with CAP than comparator antibiotics.
2. The CMA indicates that new fluoroquinolones approved for use in Canada have a small cost advantage for a 10-day course of outpatient (oral) treatment, when compared to some recommended alternative regimens (clarithromycin, cefuroxime axetil + erythromycin). This cost advantage is lost, however, when other recommended alternative treatments are considered (amoxycillin/clavulanate + erythromycin). It should be noted that new generic versions of comparator antibiotics (cefuroxime axetil, amoxicillin/clavulinic acid) are expected to become available soon in Canada. This may potentially result in a cost advantage in favor of the comparators.
3. The CEA was conducted from a provincial government payer perspective and based on the results of the evaluable subject analysis. It suggested that the new fluoroquinolones used orally and IV/orally for CAP may be more effective and cost less than other antibiotics used to treat CAP. However, these results should be interpreted with caution, since the evaluable subjects analysis may exaggerate the effect of the intervention since we cannot account for study dropouts. Also, a limited number of comparator antibiotics was used in the model, with clarithromycin being the first line alternative to fluoroquinolones.
4.Decisions about the choice of empirical antibacterial treatment of CAP may involve other considerations, such as the regional pattern of bacterial resistance, adverse drug reaction profiles and patient convenience. Concerns about potential cross-resistance among fluoroquinolones resulting from overuse should also be considered.