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Step-up tx helped tame uncontrolled asthma.

NEW ORLEANS -- Approximately 98% of children with uncontrolled asthma experienced clinically significant improvements on each of three types of step-up therapy but treatment with long-acting beta-agonists yielded significantly better responses, according to a new study "Step-up with long-acting beta-agonists was more than one and a half times more likely to produce the best response," Dr. Robert F. Lemanske Jr. said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. The results were presented at the meeting and published online in the New England Journal of Medicine.

Asthma treatment with long-acting beta-agonists (LABAs) has come under scrutiny in the wake of recent recommendations from the Food and Drug Administration to step down the use of these drugs in asthmatic children once their asthma is controlled. But few data are available to guide clinicians on the next steps in the treatment of children with asthma who are already using a low-dose inhaled corticosteroid (ICS), he said.

To determine whether there is a best next step for children whose asthma is not controlled on low-dose corticosteroids, Dr. Lemanske of the University of Wisconsin, Madison, and his colleagues developed the Best Add-on Therapy Giving Effective Responses (BADGER) trial (N. Engl. J. Med. 2010 March 2 [doi: 10.1056/NEJMoa1001278]). "This trial was not intended to look at safety," he emphasized.

In the study, the researchers randomized 182 children aged 6-17 years with uncontrolled mild to moderate asthma to one of three therapies in three 16-week study periods. Every patient received each of the three therapies for 16 weeks. The first 4 weeks of the last two 16-week periods were considered run-in and washout periods. A total of 25 treatment failures occurred, and complete data were available for 157 patients.

The three therapies were ICS step-up therapy, consisting of 250 mcg of fluticasone twice daily; LABA stepup therapy, consisting of 100 mcg of fluticasone plus 50 mcg of salmeterol twice daily; or leukotriene-receptor antagonist (LTRA) therapy, consisting of 100 mcg of fluticasone twice daily plus an age-appropriate dose (5 or 10 mg) of montelukast daily.

In pair comparisons, the proportion of children who responded best to LABA was 52% vs. LTRA (34%), and 54% vs. ICS (32%). The differences between LABA and each of the other two protocols were significant, but the differences between LTRA and ICS were not. Of several primary factors used to predict best response, only a higher baseline score (greater than 19) on the Asthma Control Test or Childhood Asthma Control Test (depending on age) was a significant predictor of best response to the LABA therapy.

The findings suggest a ceiling effect beyond which low-dose ICS therapy is not effective, the researchers wrote.

Although the proportion of children who had a best response to LABA was significantly greater than with the other two treatments, "many children demonstrated a best response to either ICS or LTRA step-up therapy, highlighting the need to regularly monitor and appropriately adjust each child's asthma therapy," Dr. Lemanske said at the meeting.

When the results of one of the three treatment plans--LABA, LTRA, or step-up ICS--are unsatisfactory, "what you should not do is go to step 4," he said. Instead, "based on the fact that our data showed a differential response to one of these three options in almost all of the kids in the trial, we would suggest that you choose one of the other options at step 3 care."

A total of seven serious adverse events were reported. One occurred during the 4-week run-in period and six during the treatment phase, with two in each stepup group. The most common serious adverse event was asthma exacerbation.

The study findings inform clinical practice, wrote Dr. Erika von Mutius of the University Children's Hospital in Munich, Germany, and Dr. Jeffrey M. Drazen, editor-in-chief of the New England Journal of Medicine, in an accompanying editorial.

"Since any of the three step-up therapies may work in an individual patient, we would base our first choice for a given patient on three things: surety of safety, price, and convenience, in that order," they wrote. Given the safety concerns regarding LABAs, the doctors wrote, their first choice would be ICS or LTRA (N. Engl. J. Med. 2010 March 2 [doi: 10.1056/NEJMe1002058]). Disclosures: Dr. Lemanske has received consulting fees and grant support from multiple pharmaceutical companies, including MAP Pharmaceuticals Inc., Gray Consulting Inc., Merck & Co., AstraZeneca, and Genentech Inc. The study was funded in part by the National Heart, Lung, and Blood Institute, and the study drugs and matching placebos were supplied by GlaxoSmithKline and Merck.
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Title Annotation:CLINICAL ROUNDS
Author:Splete, Heidi
Publication:Pediatric News
Date:Mar 1, 2010
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