A pooled analysis of seven randomized crossover studies of the palatability of cefdinir oral suspension versus amoxicillin/clavulanate potassium, cefprozil, azithromycin, and amoxicillin in children aged 4 to 8 years.
OBJECTIVE
This analysis of the results of 7 trials compared the taste and smell acceptability scores of cefdinir oral suspension and 4 other pediatric antibiotic oral suspensions--amoxicillin/clavulanate potassium, cefprozil, azithromycin, or generic amoxicillin--using a visual smile-face scale.


METHODS
Data from 7 randomized, single-blind, cross-over trials were pooled and analyzed. In each study, children aged 4 to 8 years were asked to taste and smell 2 different antibiotic suspensions and assign preference using a visual smile-face scale. Ratings were converted to a numeric score ranging from 5 (really good) to 1 (really bad).


RESULTS
A total of 1011 healthy subjects were randomly assigned to 1 of 2 treatment-order groups; 965 were evaluable for the taste and smell analyses. Baseline demographics of evaluable subjects were similar among test groups. Approximately even proportions of participants were female or male (50.1 % vs 49.9%), most (84.1%) were white, and slightly more participants were aged 7 or 8 years rather than younger (age 4 years, 16.0%; age 5 years, 17.4%; age 6 years, 18.7%; age 7 years, 23.2%; age 8 years, 24.8%). Of the 965 children who tasted both antibiotic suspensions and determined their preference, 798 (82.7%) rated the taste of cefdinir as really good or good (the highest possible ratings); 712 (73.8%) assigned the same ratings to amoxicillin/clavulanate potassium, cefprozil, azithromycin, or generic amoxicillin (P < or = 0.001). With regard to smell, 671 (69.5%) rated the smell of cefdinir as really good or good; 636 (65.9%) assigned these same ratings to the comparator agents (P = NS).


CONCLUSIONS
In this pooled analysis of data from 7 randomized, single-blind, crossover trials, children between the ages of 4 and 8 years preferred the taste of cefdinir oral suspension to that of other pediatric antibiotic suspensions. Based on smile-face scores, subjects found the smell of cefdinir oral suspension to be at least as good as that of the comparators.
Holas
Cynthia
C
Abbott Laboratories, Abbott Park, IL 60064, USA. cynthia.holas@abbott.com
Chiu
Yi-Lin
YL
Notario
Gerard
G
Kapral
Dolores
D
D000284:Administration, Oral; D000658:Amoxicillin / Q000008:administration & dosage / Q000009:adverse effects; D019980:Amoxicillin-Potassium Clavulanate Combination / Q000008:administration & dosage / Q000009:adverse effects; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects; D017963:Azithromycin / Q000008:administration & dosage / Q000009:adverse effects; D000077525:Cefdinir; D002511:Cephalosporins / Q000008:administration & dosage / Q000009:adverse effects; D002648:Child; D002675:Child, Preschool; D018592:Cross-Over Studies; D005260:Female; D006801:Humans; D008297:Male; D017060:Patient Satisfaction; D016032:Randomized Controlled Trials as Topic; D016037:Single-Blind Method; D012903:Smell; D013535:Suspensions; D013649:Taste; D000097670:Cefprozil
D000658:Amoxicillin; D019980:Amoxicillin-Potassium Clavulanate Combination; D000900:Anti-Bacterial Agents; D017963:Azithromycin; D000077525:Cefdinir; D002511:Cephalosporins; D013535:Suspensions; D000097670:Cefprozil