Efficacy and Tolerability of Once-Daily Therapy with Telithromycin for 5 or 10 Days for the Treatment of Acute Maxillary Sinusitis

Abstract

Background: The efficacy and tolerability of oral telithromycin 800 mg once daily for 5 vs. 10 days were assessed in patients with acute maxillary sinusitis (AMS). Methods: Adults (n = 341) with confirmed AMS diagnosed on clinical signs and symptoms and sinus X-ray showing total opacity or air-fluid level were randomized to receive oral telithromycin for 5 days (followed by placebo for 5 days; n = 170) or 10 days (n = 171). Causative pathogens were isolated by pretreatment sinus puncture (day 1). Clinical and bacteriologic outcomes, and safety and tolerability endpoints were assessed. Results: Clinical cure rates post-therapy (per-protocol; days 17–21) were comparable (91.1% in the 5-day group, n = 123; 91.0% in the 10-day group, n = 133). Bacteriologic eradication rates (per-protocol) were also similar (90.7 vs. 91.3%). Both regimens were well tolerated. Conclusions: A 5-day course of telithromycin 800 mg once daily is an effective, well-tolerated treatment for adults with AMS, comparable to a 10-day regimen.

Efficacy and side effects of antibiotics in the treatment of acute rhinosinusitis: a systematic review

“…Conversely, while the efficacy of clarithromycin (79% -91%) and telithromycin (72.9% -91.9%) is high, the incidence of side effects reported in the various studies done has also been shown to be high, with an incidence of 28% -48.4% (17,28,30) and 24.1% -46.9% (11,13,(20)(21)(22) , respectively. Clarithromycin and telithromycin should be used judiciously and their efficacy needs to be balanced against the common side effects.…”

“…All studies reviewed used a dose of 800 mg OD. Most studies had a dosing regimen that lasted for 5 days (n = 5) (11)(12)(13)(20)(21)(22) while the rest had a dosing regimen that lasted for 10 days (n = 2) (21,22) . There was no signifi cant diff erence in the effi cacy of using telithromycin 800 mg OD for 10 days over 5 days (10 …”

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.…”

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

“…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.…”