Efficacy, tolerability, and parent reported outcomes for cefdinir vs. high-dose amoxicillin/clavulanate oral suspension for acute otitis media in young children

• Published in: Current medical research and opinion Vol. 22; no. 9; pp. 1839 - 1847
• Main Authors: Block, Stan L., Schmier, Jordana K., Notario, Gerard F., Akinlade, Bolanle K., Busman, Todd A., MacKinnon, George E., Halpern, Michael T., Nilius, Angela M.
• Format: Journal Article
• Language: English
• Published: England Informa UK Ltd 01.09.2006; Taylor & Francis; Informa Healthcare
• Subjects: Acute Disease; Acute otitis media; Amoxicillin-Potassium Clavulanate Combination - administration & dosage; Amoxicillin-Potassium Clavulanate Combination - adverse effects; Amoxicillin/clavulanate; Cefdinir; Cephalosporins - administration & dosage; Cephalosporins - adverse effects; Child; Child, Preschool; Dose-Response Relationship, Drug; Female; Humans; Infant; Male; Otitis Media - drug therapy; Parents; Prospective Studies; Treatment Outcome
• ISSN: 0300-7995; 1473-4877
• DOI: 10.1185/030079906X132406

ABSTRACT Objectives: To compare efficacy, tolerability, and parental satisfaction of cefdinir and high-dose amoxicillin/clavulanate oral suspensions given to young children with non-refractory acute otitis media (AOM) based on clinical endpoints and outcomes measures. Research design and methods: This was an investigator-blinded, multicenter study in which 318 children 6 months through 6 years of age with a clinical diagnosis of AOM were randomized to receive 10 days of either cefdinir (14 mg/kg divided BID) or high-dose amoxicillin/clavulanate (90/6.4 mg/kg divided BID). Main outcome measures: Investigators evaluated clinical response at an end-of-therapy (EOT) office visit conducted on day 12–15. Outcomes of satisfaction, tolerability, and adherence were also assessed at that visit using an Otitis Parent Questionnaire. Results: The treatment groups were similar at baseline with respect to patient demographics. At the EOT visit, for cefdinir and amoxicillin/clavulanate, respectively, intent-to-treat (ITT) clinical cure rates were 82% (129/158) and 85% (134/158) ( p = 0.547; 95% confidence interval [CI] –11.7 to 5.4) and per-protocol cure rates were 82% (123/150) and 90% (129/143) ( p = 0.045; 95% CI –16.4 to 0.0). This difference was driven primarily by reduced cefdinir response in patients with recurrent AOM (p = 0.010) and those younger than 24 months (p = 0.039). Comparing cefdinir with amoxicillin/clavulanate, parents more often reported significantly better ease of use (89% vs. 57%; p < 0.0001), better taste (85% vs. 39%; p < 0.0001), and better adherence (at least 95% of doses) (82% vs. 61%; p < 0.0001). Diarrhea/loose stools were more common in the amoxicillin/clavulanate group than in the cefdinir group (28% vs. 18%, respectively; p = 0.0341). One patient in the cefdinir group and eight patients in the amoxicillin/clavulanate group withdrew from the study prematurely due to at least one adverse event ( p = 0.0364). Study limitations included assessment of clinical recurrence by telephone call rather than office visit, exclusion of children with refractory AOM, and no assessment of middle ear microbiology. Conclusions: Among young children with non-refractory AOM, cefdinir was as efficacious as high-dose amoxicillin/clavulanate in the ITT group, but somewhat less effective in per-protocol analysis. From the parental perspective, cefdinir was easier to administer, had a better taste, caused less diarrhea, and resulted in higher treatment adherence than high-dose amoxicillin clavulanate.