To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: First Multi-Center Study On Hard-To-Treat Acute Otitis Media URL: http://www.pslgroup.com/dg/2050E.htm Doctor's Guide December 5, 1996
PRINCETON, N.J., Dec. 5, 1996 -- Bristol-Myers Squibb Company (NYSE: BMY) announced today the results of a major study that demonstrates the effectiveness and safety of its oral antibiotic Cefzil(R) (cefprozil) in the treatment of children with acute otitis media (AOM), or middle ear infection, including cases of recurrent infection and previous treatment failure. AOM is the most commonly treated illness in children under the age of five and results in 30 million doctor visits per year in the United States. The study, entitled "Use of Cefprozil in Children with Recurrent Acute Otitis Media," is the first large multi-center clinical trial involving 262 children to confirm that the most prevalent organism responsible for causing recurrent otitis media in these children was Streptococcus pneumoniae, followed by Haemophilus influenzae and Moraxella catarrhalis. The results of the study show that Cefzil, a broad-spectrum cephalosporin, achieves high clinical response rates against these organisms. Of the S. pneumoniae organisms isolated in the children, 45 percent demonstrated resistance to penicillin, and of the H. influenzae organisms isolated, 56 percent produced beta-lactamase strains, also rendering them resistant to penicillin. "Cefzil produced greater than or equal to 96 percent resolution or improvement of key presenting symptoms such as ear pain, fever and irritability in patients who had those symptoms upon enrollment," said Samuel E. McLinn, M.D., F.A.A.P., a private practice pediatrician at the Scottsdale Pediatric Center and chairman of Infectious Disease, Scottsdale Memorial Hospital, Scottsdale, Arizona. "Typically, those children who have been seen by a pediatrician for recurrent episodes of middle ear infection are treated with many prescribed antibiotic therapies that don't eradicate the infection. This study shows that Cefzil provides us with a very effective weapon for those hard-to-treat middle ear infections in children." Study Design The study was presented today by Dr. McLinn during the First World Congress of Pediatric Infectious Diseases in Acapulco, Mexico. Conducted from December 1994 to October 1995, the study was designed to assess the clinical and bacteriologic efficacy of Cefzil therapy (30 mg/kg/day, a powder for oral suspension) in two equally divided doses for 10 days in the treatment of AOM in pediatric patients. The study design is unusual because it includes many children with a history of recurrent AOM or recent treatment failure. Children with these characteristics often are excluded from clinical trials. Amoxicillin, which is chemically related to penicillin, traditionally has been the standard therapy for treatment of AOM. However, the respiratory organisms associated with AOM are becoming increasingly resistant to penicillin-based antibiotics. In addition, all children (males and females aged six months to 12 years) underwent tympanocentesis -- a rarely conducted procedure to assess and confirm bacteria found in middle ear fluids. As with previous clinical experience, Cefzil therapy was well-tolerated by children in the study, and side effects related to therapy were infrequent. The most commonly reported adverse events were diarrhea (3%) and rash (2%). Acute Otitis Media AOM is an inflammation of the middle ear caused by accumulation of fluids containing mucus and pus. The onset of AOM is sudden, characterized by irritability, pain, fever and pulling on the ears. According to the American Academy of Otolaryngology-Head and Neck Surgery, about one third of all children have more than three ear infections by age three. Cefzil, a broad-spectrum cephalosporin introduced in 1992, was cleared for marketing by the U.S. Food and Drug Administration (FDA) for the treatment of patients with mild-to-moderate infections caused by susceptible strains of designated microorganisms in upper and lower respiratory tract infections and skin and skin structure infections. Cefzil recently was given clearance by the U.S. FDA for the treatment of acute bacterial sinusitis in adult and pediatric patients. Cefzil is the only cephalosporin approved for both sinusitis and otitis media in pediatric patients. Bristol-Myers Squibb is a diversified worldwide health and personal care company whose principal businesses are pharmaceuticals, consumer products, nutritionals and medical devices. It is a leading maker of innovative therapies for cardiovascular, metabolic and infectious diseases, central nervous system and dermatological disorders, and cancer. The company is also a leader in consumer medicines, orthopaedic devices, ostomy care, wound management, nutritional supplements, infant formulas, and hair and skin care products. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. 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