A comparison of the safety and efficacy of moxifloxacin (BAY 12-8039) and cefuroxime axetil in the treatment of acute bacterial sinusitis in adults

Abstract

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.

Updated guideline for the management of upper respiratory tract infections in South Africa: 2008

“…44 However, evidence for moxifloxacin and telithromycin suggests that a shorter course of 5-7 days is clinically and/or bacteriologically equivalent to a 10-day course. 45,46 Recent studies have also shown that bacteriological eradication occurs within 72 hours with moxifloxacin (400 mg once daily) or with high-dose, short-course levofloxacin (750 mg once daily for five days). 47,48 This higher dose of levofloxacin improves the PK/PD profile of the agent and in a comparative trial of this dose versus levofloxacin 500mg once daily for 10 days, clinical and microbiological efficacy was found to be similar.…”

Fluoroquinolones compared with -lactam antibiotics for the treatment of acute bacterial sinusitis: a meta-analysis of randomized controlled trials

“…Two additional trials eligible for inclusion were detected after a secondary search on the Scopus database, but no additional trials were identified in the Cochrane Central Register of Controlled Trials. A total of 11 trials [21][22][23][24][25][26][27][28][29][30][31] were included in the meta-analysis ( Figure 1). The 2 reviewers independently reached the same conclusions regarding studies to be included.…”

“…In addition to the treatments being compared in these studies, adjunctive medications for symptomatic relief, mostly decongestants, antihistamines and analgesics, were permitted in 8 of the trials. 22,[24][25][26][27][28][29][30] Two of these trials reported the percentage of patients using such medications: 76% in one study 28 and 83.5% in the other.…”

Moxifloxacina: profilo farmacologico, terapeutico e farmacoeconomico

“…L'efficacia clinica e la tollerabilità della moxifloxacina nella CAP, nelle AECB e nelle ABS sono state studiate su un numero elevato di pazienti, nel corso di diversi trial multicentrici controllati, nazionali e internazionali, strutturati nella maggior parte come studi in doppio cieco [101][102][103][104][105][106][107][108][109][110][111][112][113][114][115][116][117][118].…”