[Treatment of acute maxillary sinusitis in adults. Comparison of cefpodoxime-proxetil and amoxicillin-clavulanic acid].
OBJECTIVE
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.


METHODS
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.


RESULTS
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.


CONCLUSIONS
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.
Polonovski
Jean-Michel
JM
Centre hospitalier A. Mignot, Le Chesnay. jmpolonovski@ch-versailles.fr
El Mellah
Mohcen
M
D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D019980:Amoxicillin-Potassium Clavulanate Combination / Q000008:administration & dosage / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D015296:Ceftizoxime / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016001:Confidence Intervals; D004791:Enzyme Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D015523:Maxillary Sinusitis / Q000188:drug therapy*; D010349:Patient Compliance; D018579:Patient Selection; D011446:Prospective Studies; D013997:Time Factors; D016896:Treatment Outcome; D000097627:Cefpodoxime Proxetil
D019980:Amoxicillin-Potassium Clavulanate Combination; D000900:Anti-Bacterial Agents; D015296:Ceftizoxime; D004791:Enzyme Inhibitors; D000097627:Cefpodoxime Proxetil