Efficacy and Tolerability of Telithromycin for 5 or 10 Days vs Amoxicillin/Clavulanic Acid for 10 days in Acute Maxillary Sinusitis

Abstract

Telithroniycin (HMR 3647) is a new ketolide antimicrobial that was developed for the treatment ofcommunityacquired respiratory tract infections. We conducted a randomized, double-blind, multicenter study to compare the clinical efficacy and safety of oral telithromycin; at 800 mg once dail yfor 5 or 10 days, with that ofamoxicillin/ clavulanic acid, at 500/125 mg three times daily for 10 days, in adults with acute maxillary sinusitis (AMS). A total of 754 patients with AMS of less than 28 days' duration were randomized to receive either telithromycin for 5 days follow ed by pla cebo for 5 days, telithromycin fo r 10 days, or amoxicillin/clavulanic acidfor 10 days. Clinical out com e was assessed at a test-of-cure (TOC) visit between days 17 and 24 and at a late post-therapy visit between days 31 and 45. Analysis ofclinical outcome on a per-protocol basis (n =434) demonstrated therapeutic equivalence among the three regimens at the TOC visit; in each treatment group , the clini cal cure rate was approximately 75%. Only a few patients (3 to 5 in each group) had relapsed by the late post-therapy follow-up visit. Telith romycin was generally saf e and well tolerated. The most common adverse events were mild or moderate gastrointestinal effects, which occurred with similarfrequency in all three group s. We conclude that 5 or 10 days of telithromycin at 800 mg once daily is as effective clinically and as well tolerated as 10 days of

Telithromycin new product overview

“…[60][61][62][63][64][65][66][67][68][69] AECB More than 6% of US adults have AECB. 70 Approximately 50% of exacerbations are caused by typical bacteria (ie, S pneumoniae, H influenzae, and M catarrhalis).…”

Bacteriological efficacy of 5-day therapy with telithromycin in acute maxillary sinusitis

“…The bacteriological results were supported by the clinical efficacy data, which demonstrated that the 5-day regimen of telithromycin is as effective as 10-day regimens of telithromycin and two currently available comparators, amoxicillin-clavulanic acid and cefuroxime axetil. In addition, the individual studies from which data for the current pooled analysis were taken showed that telithromycin was as effective as either comparator alone; the clinical efficacy rates observed in these studies were: telithromycin (5 days) 74.1% versus amoxicillin-clavulanate (10 days) 74.5% [29] and telithromycin (5 days) 85.2% versus cefuroxime-axetil (10 days) 82.0% [27]. Previous studies have demonstrated that telithromycin has high activity in vitro against S. pneumoniae [16,[18][19][20][21][22][23] and also exhibits concentration-dependent bactericidal activity against this pathogen [21].…”

“…In these trials, a 5-day course of oral telithromycin 800 mg administered once daily was compared with a 10-day course of oral telithromycin (Study 3002) [28], a 10-day course of oral telithromycin or a 10-day course of oral amoxicillin-clavulanic acid 500/125 mg three-times daily (Study 3005) [29], and a 10-day course of oral cefuroxime axetil 250 mg twice daily (Study 3011) [27]. In a pooled analysis, the bacteriological and clinical efficacy of 5 days' therapy with telithromycin was evaluated.…”

“…Three randomised, controlled trials have been performed in patients with AMS [27][28][29]. In two of these studies [28,29], equivalence between a 5-and a 10-day course of treatment with telithromycin has been demonstrated.…”

“…Three randomised, controlled trials have been performed in patients with AMS [27][28][29]. In two of these studies [28,29], equivalence between a 5-and a 10-day course of treatment with telithromycin has been demonstrated. Here we present the results of a pooled analysis comparing the efficacy and tolerability of a 5-day regimen of telithromycin with that of a 10-day regimen of other antibacterial agents (amoxicillin-clavulanic acid and cefuroxime axetil) in the treatment of patients with AMS, with emphasis on bacteriological efficacy against key pathogens.…”