CLEVELAND, Dec. 17 /PRNewswire/ -- During a season of flu scares and special caution for children with chronic illnesses, there is good news for parents of asthmatic children. A study conducted in the emergency department (ED) and inpatient asthma care unit at Rainbow Babies and Children's Hospital in Cleveland, compared the standard drug racemic albuterol inhalation solution to a new drug XOPENEX (Zoe'-pen-ex) or levalbuterol.
"When treating asthma in the emergency room, the goal is to relieve the child's symptoms and send them home," said Carolyn M. Kercsmar, M.D., study co-author, Professor of Pediatrics, Case Western Reserve University, Rainbow Babies and Children's Hospital, Cleveland. "The results of this study demonstrate that XOPENEX can be more effective at managing severe attacks and could be a more effective first-line therapy than racemic albuterol."
The study evaluated 482 children between the ages of 1 and 18 with physician-diagnosed asthma, who presented to the pediatric emergency department of Rainbow Babies and Children's Hospital between April 2000 and December 2000. In this study, patients were randomized to receive either levalbuterol 1.25 mg (n=278) or racemic albuterol 2.5 mg (n=269) inhalation solution when presenting to the ED. The primary goal for the study was a reduction in number of hospital admissions. Secondary goals included reduction of inpatient length of stay, emergency department length of stay, rate of intensification of treatment, number of aerosols, requirement for supplemental oxygen and adverse effects.
"There is a significant clinical difference between these two drugs," explained Dr. Kercsmar. "The standard drug, racemic albuterol, is made up of two compounds that are mirror images, called isomers. However, only one of the isomers is actively helpful in reducing inflammation in the airways. The other isomer is inactive and may actually cause the asthma to worsen. The new drug, levalbuterol, is made up of only the single, active isomer, and we actually give less of it than the standard drug to relieve asthma. Levalbuterol also appears to have fewer negative side effects."
In this study, significantly fewer patients in the levalbuterol group (36%) required hospital admission versus the racemic albuterol treatment group (45%) (p = 0.02). Levalbuterol and racemic albuterol were both well tolerated in the study and no significant adverse events occurred in either group.
"Although racemic albuterol has been the standard of care for thirty years and somewhat less expensive than Xopenex," adds John Carl, M.D., a pulmonary specialist and study investigator. "It makes sense that if you can avoid a trip to the emergency room and a hospitalization you are much better off."
Rainbow Babies and Children's Hospital reported that a nine percent reduction in their institution's annual average of one thousand asthma admissions would translate to an approximated annual cost savings of $180,000 when substituting levalbuterol 1.25 mg for racemic albuterol 2.5 mg.
"The prevalence of asthma in the United States continues to increase, with more than 20 million Americans suffering from this debilitating condition. Many patients suffering from an asthma exacerbation use the ED as their primary resource for treatment, and it is the number one cause for hospitalization among children under the age of 15," said Bobby Lanier, M.D., President of the American College of Allergy, Asthma and Immunology. "This study provides health care professionals with new data about a treatment option that has the potential to reduce the high cost of care in the ED through effective treatment of their patient's bronchoconstriction."
Rainbow Babies & Children's Hospital University Hospitals of Cleveland University Hospitals Health System
Rainbow Babies & Children's Hospital is one of America's great children's hospitals. Rainbow is the only hospital in Cleveland dedicated solely to the care of children. As the primary teaching hospital of Case Western Reserve University, Rainbow ranks among the top academic pediatric programs in the country receiving over $34 million yearly in research funding to support cutting edge investigation into the causes and treatments of pediatric diseases. Rainbow is ranked the top children's hospital in the Midwest in the "America's Best Hospital's" issue of US News and World Report. Rainbow's Neonatal Intensive Care Unit for treating newborns is ranked the best in America by Child Magazine. Rainbow is also one of thirty-six top medical centers chosen by the elite Best Doctors Network as having the highest concentration of top doctors and services for international patients. Every new drug approved for children has been tested at Rainbow. Rainbow is a world leader in the treatment of children with cancer, heart disease, cystic fibrosis, sickle cell disease, kidney disease and pulmonary and endocrine disorders. More than 850 pediatric specialists -- the most in Ohio -- are on staff at Rainbow and its 40 special care centers. In addition Rainbow's nationally acclaimed residency training and fellowship programs trains more than 100 pediatricians yearly. Rainbow's Neonatal Intensive Care and Pediatric Intensive Care Units along with the area's only Regional Pediatric Trauma Center carry the highest-designation levels available. Rainbow's pediatric cancer center, part of the Ireland Cancer Center, is the only National Institutes of Cancer designated center in northeast Ohio. Rainbow Babies & Children's Hospital with 244 beds is the children's hospital of University Hospitals of Cleveland.
Contact: Janice Guhl at 216-844-1524
Rainbow Babies and Children's HospitalCONTACT: Janice Guhl, +1-216-844-1524, for the Rainbow Babies andChildren's Hospital
