ru-66647 and cefuroxime-axetil

To compare the efficacy and tolerability of a 5-day course of telithromycin (800 mg once daily) with a 10-day course of telithromycin or standard comparators (amoxicillin-clavulanate 500/125 mg three times daily or cefuroxime axetil 250 mg twice daily) in patients with acute maxillary sinusitis (AMS).. Data from three randomised double blind studies were pooled. The studies included patients with clinical symptoms of AMS and sinus X-ray findings of total opacity, air-fluid levels or mucosal thickening.. Pooled analysis of results for 5-day telithromycin revealed overall clinical cure rates of 83.6% (383/458 patients) at post-therapy (days 17-24) and 78.9% (330/418 patients) at late post-therapy (days 31-45) in the per-protocol population. Clinical cure rates at post-therapy were equivalent to those observed with 10-day telithromycin (82.5% vs 81.7%) or comparator treatment (80.9% vs 77.4%). Moreover, clinical cure rates exceeded 80% in subgroups of patients of interest, including those with severe infection and those fulfilling more stringent criteria for bacterial AMS. A satisfactory bacteriological outcome was achieved in 87.6% of patients. The 5-day telithromycin regimen was well tolerated.. Telithromycin once daily for 5 days offers effective treatment for AMS and is comparable to 10-day courses of standard treatments.

Topics: Acute Disease; Adolescent; Adult; Aged; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Cefuroxime; Drug Administration Schedule; Drug Resistance, Bacterial; Female; Humans; Ketolides; Male; Maxillary Sinusitis; Middle Aged

Telithromycin, the first approved ketolide antibiotic, was developed to treat community-acquired respiratory tract infections, including acute bacterial maxillary sinusitis (ABMS). A previously published study showed that a 5-day course of 800 mg telithromycin once daily is as effective as a 10-day course in the treatment of ABMS.. Data were pooled from two controlled, multinational, prospective, randomized, double-blinded ABMS trials comparing 5-day telithromycin (800 mg once daily) with 10-day amoxicillin-clavulanate (500/125 mg 3 times daily) and cefuroxime axetil (250 mg twice daily). Clinical cure and bacteriologic eradication rates were compared by means of descriptive statistics.. The clinical cure rate for telithromycin was 80.9% versus 77.4% for comparators; bacteriologic eradication rate for telithromycin was 84.9% versus 81.7% for comparators. Most adverse events were mild to moderate in intensity and, most commonly, gastrointestinal in nature.. These results support the conclusion that 5 days of treatment with telithromycin is as safe and effective in patients with ABMS as a 10-day course of treatment with amoxicillin-clavulanate or cefuroxime axetil.

Topics: Acute Disease; Adolescent; Adult; Aged; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Cefuroxime; Double-Blind Method; Drug Administration Schedule; Female; Haemophilus influenzae; Humans; Ketolides; Male; Maxillary Sinusitis; Middle Aged; Moraxella catarrhalis; Prospective Studies; Randomized Controlled Trials as Topic; Staphylococcus aureus; Streptococcus pneumoniae

A pharmacoeconomic analysis was done to compare the efficiency of two treatments in the acute exacerbation of chronic bronchitis: telithromycin and cefuroxime-axetil.. Restrospective analysis, modeled through a decision tree. The effectiveness of the treatments was estimated through a randomized and double-blind clinical trial in which 800 mg/day (5 days) of telithromycin were compared with 1,000 mg/day (10 days) of cefuroxime-axetil in patients with acute exacerbation of chronic bronchitis (140 and 142 patients, respectively). Resources use was estimated from clinical trial and from Spanish data, and the unit costs through a health costs dabatase. The model was validated by a panel of Spanish clinical experts.. Since the clinical trial was designed to demonstrate equivalence, there were no significant differences of effectiveness among both treatments (with a rate of clinical cure of 86.4% and 83.1%, respectively) which means that an analysis of costs minimization was done. In the average case, the average cost of the disease by patient was 174.83 Euros with telithromycin and 194.68 Euros with cefuroxime-axetil (a difference of 19.85 Euros). The results were maintained in the analysis of sensitivity, with favorable differences for telithromycin that ranged between 18.04 Euros and 22.25 Euros.. With telithromycin up to 22 Euros by patient with acute exacerbation of chronic bronchitis could be saved, in comparison with cefuroxime-axetil.

Topics: Acute Disease; Algorithms; Anti-Bacterial Agents; Bronchitis, Chronic; Cefuroxime; Cost-Benefit Analysis; Drug Administration Schedule; Humans; Ketolides