Use of revised national asthma guidelines urged

January 2008

DALLAS — Speakers at the Annual Scientific Meeting of the American College of Allergy, Asthma and Immunology urged physicians to put the revised National Heart, Lung and Blood Institute’s asthma guidelines into practice.

“These guidelines took a long time to come to fruition. We looked at more than 15,000 published studies and ended up with more than 1,600 articles which constituted the data for making the changes,” said H. William Kelly, PharmD, professor emeritus of the department of pediatrics at the University of New Mexico Health Sciences and one of the researchers who designed the new guidelines.

Changes to the guidelines

Although there were many revisions to the asthma guidelines, Kelly’s discussion focused on the changes that split the guidelines into three age groups: birth to 4 years, 5 to 11 years and 12 years and older.

“The primary reason for this separation is that most drugs have been evaluated in adults and adolescents aged 12 years and older and is therefore the group in which most of the data reside,” Kelly told Infectious Diseases in Children. “We are unable to determine good pulmonary function in children younger than 5 years, and it is very difficult to administer aerosols in these children. In addition, infants and young children with viral-induced wheezing may represent a different phenotype, which is discussed in the guidelines.”

The 5 to 11 years age group was specifically singled out because disease control for many children in this age group can be maintained with a low dose, daily inhaled corticosteroid instead of the combination of inhaled corticosteroids and long-acting beta 2-agonists.

“Many of the drugs that pediatricians prescribe for young patients have yet to be adequately studied in children younger than 5 years, but the best efficacy and safety profile is in low-dose inhaled corticosteroids. With appropriate prescribing of inhaled corticosteroids, fewer children should require emergency department visits and hospitalizations for severe asthma exacerbations,” he said.

Kelly noted several challenges with controlling asthma in younger children. They specifically noted issues in pharmacotherapy in the birth to 4-year-old group:

• Limited comparisons between long-term controllers.
• Few safety and efficacy data.
• Few medications approved by the FDA based upon efficacy besides budesonide and cromolyn nebulizer preparations.
• No adjunctive therapy studies in this age group at all.

Issues that Kelly noted in administering medication to the 5 to 11 years group included:

• Limited adjunctive therapy studies.
• No comparative studies of adjunctive therapies.
• FDA approval of most new drugs gained with limited efficacy data.

The guidelines also discuss omalizumab (Xolair, Genentech) use in patients who are allergic who also have severe, uncontrolled asthma, and are on high-dose inhaled corticosteroids and long-acting beta-agonists.

“While omalizumab is FDA-approved for allergic patients uncontrolled on monotherapy with inhaled corticosteroids, it has not been compared to other adjunctive therapies that are used in these patients such as LABAs, leukotriene modifiers or theophylline. In addition, omalizumab is very expensive and carries the risk of anaphylaxis at a prevalence of 0.1% of patients,” Kelly said.

The 2007 revised asthma guidelines were also discussed at the AAP National Conference and Exhibition, held in San Francisco.

“These guidelines are revolutionary in managing asthma, with an entirely new focus on control as well as initial severity assessment. Many of the changes to the guidelines relate to pediatrics, as befits the new evidence among children on asthma and control,” Paul V. Williams, MD, clinical professor of pediatrics at the University of Washington School of Medicine and allergist of the Northwest Asthma and Allergy Center, told Infectious Diseases in Children.

Other revisions made to the guidelines include the incorporation of risk into the decision process, the concept of control and the addition of two new therapy steps.

“Most important to the new guidelines is the concept of control, as well as the specific guideline changes in therapy based upon the assessment of control. Every visit for asthma should be focused on impairment and risk for future exacerbations and loss of pulmonary function,” Williams said. “The more we study asthma, the more we will learn that we have to evaluate each patient individually and treat them individually because they may respond differently.”

For a summary of these new guidelines, visit nhlbi.nih.gov.

For more information:

• Kelly H. Rationale for NAEOO EPR3 pharmacotherapy recommendations. Presented at: the Annual Scientific Meeting of the American College of Allergy, Asthma and Immunology; Nov. 9-14, 2007; Dallas.
• Williams P. NHLBI 2007 EPR3 highlights. #H146. Presented at: the American Academy of Pediatrics National Conference; Oct. 27-30, 2007; San Francisco.