A study presented at the International Society of Quality of Life Research (ISOQOL) in Boston showed that children who were taking Omnicef (cefdinir oral suspension) were more likely to take all of their medication (68 per cent) than were children taking Augmentin (amoxicillin/clavulanate potassium oral suspension) (53 per cent).
In the study, researchers compared the safety and efficacy of Omnicef to Augmentin for the treatment of acute otitis media and analyzed parent- reported outcomes regarding various attributes of the medicines. Parents rated Omnicef a significantly better tasting, easier-to-use medicine.
Results of the study, to which evaluated parent- reported outcomes for children taking either Omnicef or Augmentin oral suspensions, were presented at ISOQOL. More than 360 parents completed a questionnaire regarding their overall response to administering medication to their child. Children treated in this study were between six months and six years of age. The children did not have systemic treatment with any antibiotic agent seven days prior to this study. Parents reported that Omnicef had a more favorable tolerability profile, with parents reporting that children taking Omnicef were half as likely to vomit after administration than children taking Augmentin.
"This study showed that patients in the Omnicef group were 28 per cent more likely to finish all their medication than those in the Augmentin group. And, Omnicef was shown to be as effective as Augmentin in half the number of days," said Stan Block, professor of clinical paediatrics at the Clinic of Kentucky and president of Kentucky Paediatric Research, Inc. "Omnicef clearly has a major role in the paediatrician's armamentarium to treat acute otitis media," Stan added.
The primary study results were previously presented at the Paediatric Infectious Disease Society Conference in October 2003. The study was the first head-to-head comparison of Omnicef twice-a-day for five days to Augmentin twice-a-day for 10 days. The primary objective of this study was to compare the clinical effectiveness of the two treatment regimens for acute otitis media, a bacterial infection of the ear. Omnicef administered twice daily for five days was shown to be as effective as Augmentin administered twice daily for 10 days (88 per cent effectiveness for Omnicef vs. 85 per cent effectiveness for Augmentin).
This phase IV study was a single-blind, active-controlled, randomized, parallel-group, multi-centre study of 425 paediatric patients with a diagnosis of acute otitis media. The distribution of patients was similar in respect to demographics, pretreatment conditions and severity of pretreatment signs and symptoms. Both of the regimens were well tolerated and the incidence of adverse events was similar.
"Compliance with therapy is crucial to effectively treating the infection and preventing the spread of antibiotic resistance," said Mary Cifaldi, assistant director of Global Health Economics and Outcomes Research, Abbott Laboratories. "This study affirms that Omnicef's five-day dosing and patient-preferred strawberry taste make it easier for children to take their medicine as prescribed," she added.
Acute Otitis Media (AOM) is a bacterial infection of the middle ear. The Eustachian tube connects the middle ear to the back of the nose, and acts as the route through which fluid drains out of the middle ear.
Omnicef oral suspension is indicated for paediatric patients (ages six months to 12 years) for the treatment of mild to moderate infections, including acute bacterial otitis media, pharyngitis/tonsillitis due to Streptococcus pyogenes.