Efficacy and safety of Amoxycillin/Clavulanate (Augmentin (R)) twice dailyversus three times daily in the treatment of acute otitis media in children

This multicenter, randomized, single-blind study compared the efficacy and safety of a new, twice-daily formulation of amoxycillin/clavulanate (Augmen tin(R)) with the standard three-times-daily formulation, Children with a cl inical diagnosis of acute otitis media, aged between 2 months and 12 years, received either amoxycillin/clavulanate 45/6.4 mg/kg/day twice-daily (b.d. ) (range 38.3/5.5-76.2/10.9 mg/kg/day) or amoxycillin/clavulanate 40/10 mg/ kg/day three-times-daily (t.d.s.) (range 25/6.25-56/14 mg/kg/day) for 7 or 10 days, Patients were evaluated during therapy (Days 3-5), at the end of t herapy (Days 7-12) and at follow-up (Days 38-42), At the end of therapy, fo r the intent-to-treat and per-protocol populations, respectively, clinical success (cure) was achieved by approximately 94% of patients in both treatm ent groups. A successful bacteriological response at the end of therapy (Vi sit 3) was documented in 7/9 patients (77.8%) in the twice-daily group and in 11/13 patients (84.6%) in the three-times-daily group. At follow-up (Vis it 4), 93.3% of patients in the twice-daily group and 87.9% in the three-ti mes-daily group continued to have a clinically successful response. Both tr eatment regimens were well tolerated, with most adverse events being of a m ild-moderate and transient nature. The most common treatment-related advers e event was diarrhea, occurring in 7.2% of patients in the twice-daily grou p and in 10.7% of the three-times-daily group, In total, 173 patients (82.8 %) in the twice-daily group and 151 patients (73.3%) in the three-times-dai ly group were compliant with medication. In conclusion, this study confirms that b.d. amoxycillin/clavulanate is an effective treatment for pediatric acute otitis media and demonstrates that the b.d. and t.d.s. formulations of amoxycillin/clavulanate produce equival ent efficacy, Furthermore, there was a trend towards a higher level of comp liance and a lower incidence of drug-related adverse events in the twice-da ily compared with the three-times-daily treatment group.