Efficacy of twice-daily dosing of amoxycillin/clavulanate in acute otitis media in children.

Children with acute otitis media (AOM), aged 2-12 years, were randomised to 10 days treatment with amoxycillin/clavulanate (A/C) 70/10 mg/kg/day given b.i.d. (231 patients) or to A/C 60/15 mg/kg/day given t.i.d. (232 patients). Clinical success rates at end of therapy (10-17 days) were 91.8% for the b.i.d. group and 90.5% for the t.i.d. group and at follow-up (28-42 days) were 80.1% for the b.i.d. group and 77.6% for the t.i.d. group, indicating that the b.i.d. regimen was as effective as the t.i.d. regimen. There was no statistically significant difference in incidence of adverse experiences between the two groups. The overall incidence of protocol defined diarrhoea assessed from diary booklets was low, with a lower incidence in the b.i.d. group (6.7%) than in the t.i.d. group (10.3%). Significantly more patients in the b.i.d. group (83.1%) than in the t.i.d. group (72.8%) had at least 80% compliance over a 7-10 day treatment period. A/C given twice or three-times daily was highly effective in the treatment of AOM in children. The two regimens showed equivalent clinical efficacy, both were well tolerated, and there was evidence of improved compliance with the b.i.d. regimen.

Efficacy of twice-daily amoxycillin/clavulanate ('Augmentin-Duo' 400/57) in mild to moderate lower respiratory tract infection in children.

A new amoxycillin/clavulanate regimen ('Augmentin-Duo' 400/57), to be given orally in two divided doses, has been proposed to overcome the inconvenience of tid dosing. This observer-blind, multicentre study randomised children aged two to 12 years with lower respiratory tract infection to seven days' treatment with either amoxycillin/clavulanate bid at a dose of 25/3.6mg/kg/day (221 patients) or the currently prescribed amoxycillin/clavulanate regimen of 20/5mg/kg/day tid (216 patients). Clinical success (cure) rates at follow up were 81.0% for the bid group and 77.8% for the tid group [difference 3.2%; 95% CI (-4.36, 10.80)], indicating that the regimens were of equivalent efficacy. Both regimens were well tolerated, and there was no statistically significant difference in the incidence of adverse experiences between the two groups. Compliance with study medication was high and similar for both groups (80% compliance: bid 90.0%; tid 87.0%).

Nabumetone compared with naproxen in the treatment of rheumatoid arthritis: a multicenter, double blind, randomized, parallel group trial in hospital outpatients.

In this double blind, randomized, parallel group study, 298 patients with rheumatoid arthritis received nabumetone (2000 mg/day) or naproxen (1000 mg/day) for 3 months. At the end point, nabumetone treated patients exhibited significant improvement in pain, Ritchie articular index, and duration of morning stiffness when compared to baseline. In contrast, naproxen treated patients showed significant improvement only in Ritchie articular index. Nabumetone was significantly more effective than naproxen for pain relief. More nabumetone treated patients withdrew due to lack of efficacy than naproxen treated patients. However, nabumetone was better tolerated than naproxen because fewer patients withdrew for adverse events or experienced severe adverse events, and significantly fewer patients required treatment for adverse events.