VAIL, COLO. — The new asthma drug Symbicort can be used by patients as both their controller medication and their relief medication, Dr. Carolyn M. Kercsmar said at a meeting sponsored by the American Academy of Pediatrics.
This is because one of the two components of the drug—formoterol—is a long-acting β2-agonist with a rapid onset, said Dr. Kercsmar, director of the children's asthma center at Rainbow Babies & Children's Hospital, Cleveland.
The new product—a combination of the corticosteroid budesonide and formoterol (in formulations of 80/4.5 mcg and 160/4.5 mcg per inhalation)—was approved for use in the United States in July.
A growing number of trials have shown that when asthma patients have used the combination, exacerbations dropped greatly—and by as much as 79% versus fixed-dose regimens in a recent pediatric study.
That study randomized 341 children (aged 4–11 years) with asthma into three treatment groups: maintenance treatment with Symbicort, plus as-needed use; treatment with a fixed formulation of budesonide/formoterol at the same dose, plus terbutaline as rescue medicine; or treatment with a fourfold higher maintenance dose of budesonide, plus terbutaline as rescue medicine (Chest 2006;130:1733–43).
The reduction in exacerbations is thought to result from the fact that, when patients feel an asthma attack coming on and use Symbicort as a β2-agonist reliever medication, they also get some additional corticosteroid.
Formoterol has an onset of action of fewer than 15 minutes. The other combination product available in the United States—Advair—contains the long-acting β2-agonist salmeterol, which does not act so rapidly, she said.
Formoterol “starts working just as fast as albuterol,” said Dr. Kercsmar, who has no financial links to Symbicort or its maker, AstraZeneca Pharmaceuticals LP.
“You're not going to reach for your albuterol; you're going to reach for this and take a puff instead,” she added.
The Symbicort studies have shown that even with this type of use, patients do not get exposed to excessive doses of corticosteroid. Probably, they are achieving greater asthma control over the long term, and not using reliever medication as much.
In the pediatric study, only 6 of 118 (5%) patients using Symbicort for control and rescue ever used it seven or more times a day at one time, compared with 23% on the fixed-dose regimen and 15% on the fixed-dose budesonide; the average rescue use with Symbicort was 0.58 times per day, compared with 0.76 and 0.74 in the other two groups, respectively. The study reported that the yearly growth of the patients on the Symbicort was better than that of patients assigned to only budesonide.
“This decreases exacerbations in a very, very safe fashion,” she said.
Dr. Kercsmar said she intends to advise patients to use Symbicort as a reliever the same way she would advise them to use albuterol. They should use it when they begin to feel an asthma attack, and wait 4 hours before using it again, and should contact a health care provider if they need to use it three times within 12 hours, she said. However, the initial Food and Drug Administration-approved labeling will reflect daily scheduled use as a controlled medication only.