The aim of this multicentre, randomized study was to compare the efficacy and safety of moxifloxacin (BAY 12-8039), a new 8-methoxy fluoroquinolone, with that of cefuroxime axetil for the treatment of acute bacterial sinusitis in adults. Diagnosis was made on a range of clinical signs and symptoms combined with radiology and microbiology. A 400 mg dose of moxifloxacin was administered once daily for 7 days to 242 patients and 250 mg twice daily of cefuroxime axetil was administered to 251 patients for 10 days. The clinical success rate at the end of treatment in the evaluable population was significantly higher (96.7%) in the moxifloxacin group (204/211) than in the cefuroxime axetil group (204/225, 90.7%; 95% confidence intervals 1.5%; 10.6%). At follow-up the success rate in the moxifloxacin group was 90.7% and that for the cefuroxime axetil group was 89.2% (95% confidence intervals -4.3%; 5.4%). The predominant pathogens isolated were Streptococcus pneumoniae and Haemophilus influenzae, followed by Moraxella catarrhalis and Staphylococcus aureus. The bacteriological eradication rates were higher for moxifloxacin (94.5%, 103/109) than for cefuroxime axetil (83.5%, 96/115; 95% CI 3.6%; 19.7%). Only one S. pneumoniae infection persisted following moxifloxacin therapy in contrast with three in individuals on cefuroxime axetil. There were slightly more adverse events in the moxifloxacin group than in the cefuroxime axetil group, but there were fewer serious adverse events following moxifloxacin treatment (three vs. eight). The drug was discontinued because of adverse events in 14 moxifloxacin patients and in 11 cefuroxime axetil patients. Overall, in all assessments, moxifloxacin was at least as effective clinically and bacteriologically, and as well tolerated, as cefuroxime axetil in the treatment of acute sinusitis.

A pharmacokinetic study was carried out to determine moxifloxacin concentrations in sinus tissue, after oral moxifloxacin 400 mg once daily for 5 days to patients with chronic sinusitis, undergoing elective sinus surgery. Patients were randomly allocated to one of seven treatment groups, in which tissues were sampled 2, 3, 4, 6, 12, 24 or 36 h post-dose. A control group with non-infected nasal polyps was also included. Forty-eight patients (13 female, 35 male, mean age 47.1 years) were allocated to one of each active treatment group (n = 42) or to the control group (n = 6). Tissue and plasma samples were taken simultaneously and stored frozen until assayed by HPLC. Thirty-nine patients were fully valid for pharmacokinetic analysis. The geometric mean moxifloxacin plasma concentration increased from 2.32 mg/L at 2 h to a maximum of 3.37 mg/L at 4 h post-dose, decreasing to 0.37 mg/L at 36 h post-dose. The moxifloxacin concentration in sinus mucosa was consistently greater than that in plasma being 4.56-5.73 mg/kg from 2 to 6 h and 2.81-1.25 mg/kg from 12 to 36 h post-dose. The elimination rates in plasma and sinus tissues were similar. The tissue/plasma ratio was c. 200% between 2 and 6 h, and up to 328.9% at 36 h. Results were similar whatever the site of tissue sampling (maxillary sinus, anterior ethmoid sinus or nasal polyps). Tissue levels exceeded the MIC(90) of all pathogens commonly causing acute sinusitis (e.g. 5-30 x MIC for Streptococcus pneumoniae: 0.25 mg/L). These results sup-port the use of moxifloxacin 400 mg once daily as a regimen for the treatment of sinus infections.

Diclofenac potassium administered as single doses of 12.5 and 25mg significantly reduced fever and throat pain in patients with acute febrile sore throat. The overall efficacy of these doses was rated significantly higher than that of paracetamol 1000mg or placebo. A dose-response relationship was seen between placebo and the three diclofenac doses. On most outcomes, paracetamol 1000mg was similar to or only slightly better than the diclofenac potassium 6.25mg dose. Diclofenac potassium 12.5mg is the lowest unit dose that could be recommended to provide reliable reduction of oral temperature and relief of throat pain.

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