Vol.56 No.5 September 2008
A multicenter, open label study of a sustained-release formulation of azithromycin (azithromycin SR) for the treatment of acute pharyngolaryngitis, acute tonsillitis and acute rhinosinusitis
Department of Otolaryngology-Head and Neck Surgery, Wakayama Medical University, 811-1 Kimiidera, Wakayama, Japan
Abstract
A Phase 3, multicenter, open-label study was conducted to confirm the clinical efficacy and safety of a single 2.0 g dose of a new formulation of the macrolide antibiotic azithromycin, namely, a sustained-release oral suspension formulation (azithromycin SR), in patients with acute pharyngolaryngitis, acute tonsillitis or acute rhinosinusitis.
The clinical efficacy (efficacy rate) on Day 8, which was the primary endpoint, in the "clinical per protocol set" was 88.5% (77/87 subjects) for the entire population. The efficacy rate by disease was 97.1% (34/35 subjects) for acute pharyngolaryngitis, 94.4% (17/18 subjects) for acute tonsillitis, and 76.5% (26/34 subjects) for acute rhinosinusitis. The efficacy rate increased over time in subjects with acute rhinosinusitis (91.2 and 100% on Days 15 and 29, respectively).
The bacteriological response (eradication rate) on Day 8 in the "bacteriologic per protocol set" was 78.1% (25/32 subjects) for the entire population. The eradication rate by disease was 92.3% (12/13 subjects) for acute pharyngolaryngitis, 66.7% (4/6 subjects) for acute tonsillitis, and 69.2% (9/13 subjects) for acute rhinosinusitis. The eradication rate increased over time in subjects with acute rhinosinusitis [100% (13/13 subjects) on Day 15].
As for safety, the incidence of treatment-related adverse events was 54.5% (54/99 subjects). The incidence of diarrhoea and/or abdominal pain (36.4%) was high, but all of these cases recovered. No severe or serious adverse events, deaths or discontinuations due to adverse events were noted in this study.
Based on the abovementioned results, we conclude that azithromycin SR administered as a single 2.0 g oral dose is highly effective and well tolerated for the treatment of acute pharyngolaryngitis, acute tonsillitis and acute rhinosinusitis. Azithromycin SR is considered as a very useful antibiotic from various aspects, including drug compliance, for the treatment of otorhinolaryngological infections in clinical practice.
Key word
azithromycin, single-dose, extended release, acute tonsillitis, acute rhinosinusitis
Received
March 28, 2008
Accepted
June 2, 2008
Jpn. J. Chemother. 56 (5): 525-537, 2008
