Comparative efficacy and tolerability of clarithromycin and amoxycillin in the treatment of out-patients with acute maxillary sinusitis

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Abstract
The efficacy and tolerability of clarithromycin and amoxycillin in the treatment of acute maxillary sinusitis were compared in an open, Phase III multi-centre study. Sixty-one out-patients (40 males, 21 females) received clarithromycin (two 250 mg tablets twice daily) and 59 (34 males, 25 females) out-patients received amoxycillin (two 500 mg capsules twice daily). Fifty-seven and 47 patients in the clarithromycin group were evaluable for clinical efficacy and bacteriological effectiveness, respectively. In the amoxycillin group, 57 and 40 patients were evaluated for clinical efficacy and bacteriological effectiveness, respectively. Body temperature, bacteriological culture results, blood and urine chemistries, and clinical signs and symptoms were evaluated prior to drug administration, between Days 4 to 6 and between Days 9 to 11 of treatment, and within 48 hours and, if required, 6 weeks after the end of treatment. Clinical signs and symptoms improved significantly (p less than 0.001) in both treatment groups. When evaluated within 48 hours after the end of treatment, there was no significant difference between the clinical success rate for clarithromycin (91%) and amoxycillin (84%) nor in the number of patients whose original pathogen was eradicated (89% clarithromycin, 93% amoxycillin). Six patients reported adverse events, 2 with clarithromycin (urticaria, gastro-intestinal) and 4 with amoxycillin (2 urticaria, 2 gastro-intestinal). Clarithromycin was comparable to amoxycillin with respect to clinical efficacy and tolerability and offers a useful addition to the available therapies for the treatment of acute maxillary sinusitis.