Efficacy of twice-daily dosing of Augmentin (R) (1 g/125 mg) in acute maxillary sinusitis

Objective - The authors had for aim to determine the therapeutic equivalenc e of Augmentin(R) sachets, containing 1 g/125 mg, administered twice daily and the reference Augmentin(R) formulation (tablets containing 0.5 g/125 mg ) administered thrice daily, in acute maxillary sinusitis. Material and methods - We carried our a multicenter; randomized, double-bli nd trial through 62 centers. Three hundred seventy two patients were enroll ed. The end point for efficacy was the clinical cure rate 3-5 days after th e end of treatment defined as the disappearance of purulent rhinitis, pain, and fever. Results-Bacteriological culture was positive in 44% of cases, yielding main ly Haemophilus influenzae and Streptococcus pneumoniae, and to a lesser ext ent enterobacteriaceae, streptococci and Moraxella catarrhalis. At the end of treatment, the clinical success rates were very close: respectively 94.4 % and 92.3% for the 1 g/125 mg and 0.5 g/125 mg formulations, with a confid ence interval of [-2.2; + 6.5]. Furthermore, the cure rates were equivalent in both groups: respectively 86.6% and 85.1% with a confidence interval of [-4,5; +7,6]. The results were not influenced by the presence, at enrollme nt, of penicillin-resistant pneumococci or betalactamase-producing Haemophi lus influenzae or Moraxella catarrhalis. Gastrointestinal tolerability was improved with the new formulation and dosage. Comments - This study confirms that the new Augmentin(R) formulation (I g/1 25 mg), administered twice daily, is at least as efficient as the reference formulation in the treatment of acute maxillary sinusitis, and that it is adapted to the bacterial species encountered in this clinical setting, incl uding those which are increasingly resistant. (C) 2000 Editions scientifiqu es ef medicales Elsevier SAS.