AZITHROMYCIN IN PATIENTS WITH RESPIRATORY -TRACT INFECTIONS

Three post-marketing surveillances were performed in Austria between m ay 1994 and april 1997 to confirm the positive benefit-risk-ratio of A zithromycin, a macrolide antibiotic, in routine therapy of patients wi th upper and lower respiratory tract infections (inclusive otitis medi a). The participating physicians had to record clinical symptoms and t he course of treatment in patients given Azithromycin for three days f or their airway infections. Approximately 7 to 10 days after the entry examination efficacy and safety of Azithromycin were documented. A to tal of 5504 subjects were analyzed. Mean age was 29.9 years, with 22.4 % of these patients being 6 years old or younger. In a total of 96.1% of patients the efficacy of Azithromycin was rated as ''very good'' or ''good'', in only 3.9% as ''insufficient''. In 248 patients (4.5%) ad verse events were documented, in 223 cases (4.1%) the relation to Azit hromycin was rated as ''possible'' or ''probable''. Most frequently re corded events were gastrointestinal disorders (179 patients, 3.3%) mos tly with ''mild'' or ''moderate'' intensity. In a total of 99.0% of su bjects the safety of Azithromycin was rated as ''very good'' or ''good '', in only 1.0% as ''insufficient''. There were no differences betwee n children and adults concerning safety. In conclusion, the results of these three post-marketing surveillances confirm the positive benefit -risk-ratio of Azithromycin in treatment of patients with respiratory tract infections.