A MULTICENTER, INVESTIGATOR-BLINDED, RANDOMIZED COMPARISON OF ORAL LEVOFLOXACIN AND ORAL CLARITHROMYCIN IN THE TREATMENT OF ACUTE BACTERIALSINUSITIS

A multicenter, investigator-blinded, randomized, parallel-group study was conducted to compare oral levofloxacin 500 mg once/day for 14 days with clarithromycin 500 mg twice/day for 14 days in the treatment of acute bacterial sinusitis. Of 216 adult outpatients randomized to trea tment, 190 were evaluable for efficacy. The primary efficacy measure w as clinical response, based on resolution of signs and symptoms 2-5 da ys after therapy. A secondary efficacy measure was relapse rate 1 mont h after therapy. Among evaluable patients, clinical success rates (cur ed or improved) were 96.0% and 93.3% for levofloxacin (L) and clarithr omycin (C), respectively (95% CI -9.2%, 3.7%). The confidence interval (CI) for treatment difference (C-L) included zero and its upper limit was less than 15%, indicating that levofloxacin was as effective as c larithromycin. In all, 4.1% of patients receiving levofloxacin and 7.2 % receiving clarithromycin had a relapse of symptoms 1 month after the rapy (95% CI -12.2%, 3.2%). Long-term success (initial success, absenc e of relapse at I month, no further antibacterial therapy 2-5 days aft er therapy) was 79.2% in the levofloxacin group and 76.4% in the clari thromycin group (95% CI -14.7%, 9.0%). Based on investigator-assessed treatment-emergent adverse events, overall tolerability of the drugs w as similar, except for a higher frequency of taste perversion and diar rhea in the clarithromycin group. Levofloxacin had an advantage over c larithromycin based on two quality-of-life (QOL) parameters: number of times taking other drugs for targeted medical conditions and mean tot al cost of these drugs. No statistical significance was found in other QOL variables. These findings suggest that the efficacy and tolerabil ity of levofloxacin 500 mg once/day are comparable with those of clari thromycin 500 mg twice/day in the treatment of acute bacterial sinusit is.