A study presented yesterday at the International Society of Quality of
Life Research (ISOQOL) in Boston showed that children who were taking
Omnicef(REG) (cefdinir oral suspension) were more likely to take all of
their medication (68 percent) than were children taking Augmentin
(REG) (amoxicillin/clavulanate potassium oral suspension) (53 percent).
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.
"This study showed that patients in the Omnicef group were 28 percent 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, M.D., professor of clinical pediatrics at the Clinic of Kentucky and president of Kentucky Pediatric Research, Inc. "Omnicef clearly has a major role in the pediatrician's armamentarium to treat acute otitis media."
Results of the study, to which evaluated parent- reported outcomes for children taking either Omnicef or Augmentin oral suspensions, were presented yesterday at ISOQOL. More than 360 parents completed a questionnaire regarding their overall response to administering medication to their child. The survey asked parents to rate their experience with the medicine on several criteria including, how their children tolerated the medicine, satisfaction, overall compliance, and work or daycare missed as a result of the infection.
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.
The primary study results were previously presented at the Pediatric 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 percent effectiveness for Omnicef vs. 85 percent effectiveness for Augmentin).
This Phase IV study was a single-blind, active-controlled, randomized, parallel-group, multi-center study of 425 pediatric 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, Ph.D., 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."
About Acute Otitis Media
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. When the tube becomes infected with a virus or bacteria, fluid in the ear thickens and the tube swells, resulting in fluid not draining out of the middle ear properly, which may lead to AOM. AOM is common in young children because a child's Eustachian tube is shorter and less slanted than an adult's, so fluid does not drain as easily from the ear. During respiratory season (September through March) young children may experience several colds and viral infections, sometimes resulting in AOM. Only bacterial ear infections should be treated with antibiotics and only your child's health care professional can properly diagnose AOM and determine if antibiotic therapy is an appropriate treatment option.
About Omnicef
Omnicef oral suspension is indicated for pediatric patients (ages six months to 12 years) for the treatment of mild to moderate infections, including acute bacterial otitis media due to Haemophilus influenzae (including beta-lactamase-producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only) and Moraxella catarrhalis (including beta-lactamase-producing strains); and pharyngitis/tonsillitis due to Streptococcus pyogenes. Omnicef is effective in the eradication of Streptococcus pyogenes from the orapharynx. Omnicef has not, however, been studied for the prevention of rheumatic fever following Streptococcus pyogenes pharyngitis/tonsillitis.
Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever. Omnicef oral suspension is also indicated for the treatment of uncomplicated skin and skin structure infections due to Streptococcus aureus (including beta-lactamase-producing strains) and Streptococcus pyogenes.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Omnicef and other antibacterial drugs, Omnicef should be used only to treat or prevent infections that are strongly suspected to be caused by susceptible bacteria.
Omnicef is contraindicated in patients with known allergy to the cephalosporin class of antibiotics. Patients with previous hypersensitivity to penicillins should be closely monitored when taking Omnicef. If allergic reaction to Omnicef occurs, the drug should be discontinued. The safety and efficacy of Omnicef in neonates and infants less than six months of age have not been established. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Omnicef and other antibacterial drugs, Omnicef should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
In clinical studies, Omnicef was well tolerated. In pediatric trials, the most common adverse events were: diarrhea (8 percent), rash (3 percent) and vomiting (1 percent).
For complete details, please see full prescribing information, which is available at www.omnicef.com.
About Abbott
Abbott supports appropriate antibiotic use and strongly recommends that all parents discuss antibiotic therapy carefully with their child's health care professional and comply fully with all dosing requirements if antibiotics are prescribed for their children.
Abbott Laboratories is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 55,000 people and markets its products in more than 130 countries.
"This study showed that patients in the Omnicef group were 28 percent 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, M.D., professor of clinical pediatrics at the Clinic of Kentucky and president of Kentucky Pediatric Research, Inc. "Omnicef clearly has a major role in the pediatrician's armamentarium to treat acute otitis media."
Results of the study, to which evaluated parent- reported outcomes for children taking either Omnicef or Augmentin oral suspensions, were presented yesterday at ISOQOL. More than 360 parents completed a questionnaire regarding their overall response to administering medication to their child. The survey asked parents to rate their experience with the medicine on several criteria including, how their children tolerated the medicine, satisfaction, overall compliance, and work or daycare missed as a result of the infection.
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.
The primary study results were previously presented at the Pediatric 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 percent effectiveness for Omnicef vs. 85 percent effectiveness for Augmentin).
This Phase IV study was a single-blind, active-controlled, randomized, parallel-group, multi-center study of 425 pediatric 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, Ph.D., 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."
About Acute Otitis Media
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. When the tube becomes infected with a virus or bacteria, fluid in the ear thickens and the tube swells, resulting in fluid not draining out of the middle ear properly, which may lead to AOM. AOM is common in young children because a child's Eustachian tube is shorter and less slanted than an adult's, so fluid does not drain as easily from the ear. During respiratory season (September through March) young children may experience several colds and viral infections, sometimes resulting in AOM. Only bacterial ear infections should be treated with antibiotics and only your child's health care professional can properly diagnose AOM and determine if antibiotic therapy is an appropriate treatment option.
About Omnicef
Omnicef oral suspension is indicated for pediatric patients (ages six months to 12 years) for the treatment of mild to moderate infections, including acute bacterial otitis media due to Haemophilus influenzae (including beta-lactamase-producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only) and Moraxella catarrhalis (including beta-lactamase-producing strains); and pharyngitis/tonsillitis due to Streptococcus pyogenes. Omnicef is effective in the eradication of Streptococcus pyogenes from the orapharynx. Omnicef has not, however, been studied for the prevention of rheumatic fever following Streptococcus pyogenes pharyngitis/tonsillitis.
Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever. Omnicef oral suspension is also indicated for the treatment of uncomplicated skin and skin structure infections due to Streptococcus aureus (including beta-lactamase-producing strains) and Streptococcus pyogenes.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Omnicef and other antibacterial drugs, Omnicef should be used only to treat or prevent infections that are strongly suspected to be caused by susceptible bacteria.
Omnicef is contraindicated in patients with known allergy to the cephalosporin class of antibiotics. Patients with previous hypersensitivity to penicillins should be closely monitored when taking Omnicef. If allergic reaction to Omnicef occurs, the drug should be discontinued. The safety and efficacy of Omnicef in neonates and infants less than six months of age have not been established. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Omnicef and other antibacterial drugs, Omnicef should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
In clinical studies, Omnicef was well tolerated. In pediatric trials, the most common adverse events were: diarrhea (8 percent), rash (3 percent) and vomiting (1 percent).
For complete details, please see full prescribing information, which is available at www.omnicef.com.
About Abbott
Abbott supports appropriate antibiotic use and strongly recommends that all parents discuss antibiotic therapy carefully with their child's health care professional and comply fully with all dosing requirements if antibiotics are prescribed for their children.
Abbott Laboratories is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 55,000 people and markets its products in more than 130 countries.
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