Clinical Question:
Is cefpodoxime-proxetil clinically effective as amoxicillin-clavulanic acid
in adults with acute maxillary sinusitis?
Bottom Line:
In this study, a 5-day course of cefpodoxime-proxetil at 200 mg bid was as
clinically effective as amoxicillin-clavulanic acid 1 g/125 mg bid for 8
days with a significantly better safety profile and compliance.
Reference:
Treatment of acute maxillary sinusitis in adults. Comparison of
cefpodoxime-proxetil and amoxicillin-clavulanic acid,Polonovski JM, El
Mellah M. Presse Med. 2006 Jan;35(1 Pt 1):33-8.
Study Design:
Prospective, multicenter, centrally-randomized, open-label study
Synopsis:
The aim was to demonstrate the equivalence of the clinical efficacy and
safety of cefpodoxime-proxetil (200 mg bid for 5 days) to that of
amoxicillin-clavulanic acid (1 g/125 mg bid for 8 days) in adults with acute
maxillary sinusitis. In this prospective, multicenter, centrally-randomized,
open-label study, 73 general practitioners and 11 ear, nose, and throat
specialists included 512 patients with unilateral acute maxillary sinusitis.
The clinical success rates at day 12-19 in the per-protocol population
(primary analysis) were 92.3% (215/233) in the cefpodoxime-proxetil group
and 93.6% (204/218) in the amoxicillin-clavulanic acid group. The 95%
confidence interval of [6.5%; 3.9%] demonstrated that cefpodoxime-proxetil
was not inferior to amoxicillin-clavulanic acid. Cure rates at follow-up
(day 25-30) were 90.6% and 92.7%, respectively. Results were similar in the
intent-to-treat population. Compliance was significantly better in the
cefpodoxime-proxetil group (99.2% versus 95.5%; p=0.011). Tolerance was also
significantly better: 1.2% (3/247) of cefpodoxime-proxetil patients reported
a treatment-related adverse event, compared with 10.7% (26/244) in the
amoxicillin-clavulanic acid group (p<0.001). Most events were
gastrointestinal and of mild to moderate intensity. |