Cefpodoxime proxetil compared with amoxicillin-clavulanate for the treatment of otitis media.
In a multicenter, randomized, investigator-blinded trial, patients were randomly selected to receive either cefpodoxime proxetil or amoxicillin-clavulanate potassium orally for the treatment of acute suppurative otitis media. Patients were seen before, during, and at the end of therapy, and 2 to 3 weeks after completion of therapy. A total of 229 patients, 153 receiving cefpodoxime and 76 receiving amoxicillin-clavulanate were entered into the study; all patients were examined to determine drug safety. A total of 146 patients, 98 in the cefpodoxime group and 48 in the amoxicillin-clavulanate group, completed the study and were examined to determine drug efficacy. End-of-therapy microbiologic eradication rates in assessable patients were 92% for cefpodoxime and 86% for amoxicillin-clavulanate (p = 0.14; 95% confidence interval (CI) on difference: -4.4%, 19.2%). End-of-therapy clinical response rates for assessable patients were as follows: cured, 68% for cefpodoxime and 65% for amoxicillin-clavulanate; improved, 24% for cefpodoxime and 23% for amoxicillin-clavulanate; and failed, 8% for cefpodoxime and 13% for amoxicillin-clavulanate (p = 0.57; 95% CI: -8.4%, 16.5%). Recurrence rates at long-term follow-up were 24% for cefpodoxime-treated patients and 25% for those given amoxicillin-clavulanate. Both drugs were well tolerated; 20.9% of those given cefpodoxime and 31.6% of amoxicillin-clavulanate-treated patients had drug-related adverse medical events (p = 0.102; 95% CI: -23.9%, 2.6%). Gastrointestinal complaints were the most frequently reported drug-related side effect in both groups: 11.8% of cefpodoxime-treated patients and 21.1% of those given amoxicillin-clavulanate (p = 0.076; 95% CI: -20.8%, 2.2%). Drug-related dermatologic side effects (e.g., diaper rash, pruritus, urticaria) were reported in 7.8% of cefpodoxime-treated patients and 14.5% of those who received amoxicillin-clavulanate (p = 0.160; 95% CI: -16.6%, 3.3%). Our findings suggest that clinical efficacy for cefpodoxime administered twice daily is equivalent to that of amoxicillin-clavulanate administered three times a day.
Mendelman
P M
PM
Children's Hospital and Medical Center, Seattle, WA 98105.
Del Beccaro
M A
MA
McLinn
S E
SE
Todd
W M
WM
D000208:Acute Disease; D000293:Adolescent; D000658:Amoxicillin / Q000627:therapeutic use*; D001419:Bacteria / Q000302:isolation & purification; D015296:Ceftizoxime / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D004423:Ear / Q000382:microbiology; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D010035:Otitis Media, Suppurative / Q000188:drug therapy* / Q000382:microbiology; D011355:Prodrugs / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D000097627:Cefpodoxime Proxetil
D000658:Amoxicillin; D015296:Ceftizoxime; D011355:Prodrugs; D000097627:Cefpodoxime Proxetil