Safety profile of sparfloxacin, a new fluoroquinolone antibiotic

The safety profile of sparfloxacin, a newer fluoroquinolone antibiotic, was examined through an integrated analysis of safety data from 6 multicenter phase III trials. These consisted of 5 double-masked, randomized, comparati ve trials of sparfloxacin (a 400-mg oral loading dose followed by 200 mg/d for 10 days) versus standard therapies (erythromycin, cefaclor, ofloxacin, clarithromycin, and ciprofloxacin) and 1 open-label trial (noncomparative) in patients with: community-acquired pneumonia (2 trials); acute bacterial exacerbations of chronic bronchitis (1 trial); acute maxillary sinusitis (2 trials, one of which was the noncomparative trial); and complicated skin a nd skin-structure infections (1 trial). Overall, 401 (25.3%) of 1585 patien ts treated with sparfloxacin and 374 (28.1%) of 1331 receiving a comparator regimen experienced at least 1 adverse event considered to be related to t he study medication. Photosensitivity reactions, usually of mild-to-moderat e severity, were seen more frequently with sparfloxacin (7.4%) than with co mparator agents (0.5%), whereas gastrointestinal reactions (diarrhea, nause a, dyspepsia, abdominal gain, vomiting, and flatulence), insomnia, and tast e perversion were more common in patients taking comparator drugs (22.3% vs 12.1%, 4.3% vs 1.5%, and 2.9% vs 1.2%, respectively). Analysis of electroc ardiographic findings showed that the mean change from baseline in QT inter val corrected for heart rate (QT,) was significantly greater in sparfloxaci n-treated patients (10 msec) than in patients given comparator drugs (3 mse c), but no associated ventricular arrhythmias were detected. Adverse events led to discontinuation of study medication in 104 (6.6%) patients receivin g sparfloxacin and Ils (8.9%) given comparator drugs. Sparfloxacin may be c onsidered an appropriate choice for the treatment of certain community-acqu ired infections for patients who are not at risk for photosensitivity react ions or adverse events associated with prolongation of the QT(c) interval.