New asthma combo, Advair Diskus, approved for maintenance treatment of asthma.
Recognizing that both inflammation and bronchoconstriction play crucial roles in causing asthma symptoms, GlaxoSmithKline (GSK) will soon offer what it claims is the first medication that targets both of these components. Advair Diskus combines the long-acting beta2 agonist salmeterol (Serevent, GSK) with the anti-inflammatory, corticosteroid fluticasone propionate (Flovent, GSK).
"The beauty of this drug is that you control the inflammation and you also have the smooth-muscle effects in a single, easy-to-use product. Therefore, you can think of it as a two-hit system," said Christine Sorkness, Pharm.D., an investigator and professor of pharmacy and medicine at the University of Wisconsin.
According to Asthma in America, a landmark survey of patient and professional attitudes toward asthma in the United States, nearly three out of five persons with moderate persistent asthma overestimate how well controlled their asthma is, while almost one in three with severe persistent asthma mistakenly consider it to be well controlled. Sorkness has been surprised by the willingness of people to accept less than ideal control. "We must raise the bar of their expectations, and then we have to give them effective easy-to-use drugs to meet those expectations," she said. By having a product that will simultaneously treat both aspects of asthma with the convenience of one inhalation twice daily and the simplicity of the Diskus device, Sorkness believes it may make it easier for patients to adhere to therapy. This, in turn, should result in better asthma control and a better quality of life.
The Food & Drug Administration has approved Advair Diskus for the long-term, twice-daily maintenance treatment of asthma in patients 12 years and older. Advair Diskus is not indicated for the relief of acute bronchospasm, and bold-face labeling warns that it "should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of asthma."
With the FDA granting Advair Diskus such a broad indication, who will benefit most? According to Sorkness, Advair Diskus is for the patient with persistent asthma who is clearly a candidate for an inhaled steroid or is not ideally controlled on a low dose of an inhaled steroid. "There have been several studies that have suggested increasing the dose of inhaled steroids would get you better control. But, alternatively, if you can keep the same dose of the inhaled steroid and add salmeterol, you will get better control of asthma," she added. She also noted that consistent clinical observations have shown that using an inhaled, long-acting beta2 agonist with an inhaled corticosteroid provides better asthma control and causes fewer asthma exacerbations than does using a higher dose of inhaled corticosteroid alone.
The FDA approved Advair Diskus based on the results of several different clinical trials in more than 1,200 patients. In clinical trials comparing Advair Diskus with the individual components, improvements in most efficacy pointsincluding greater improvement in lung function, more symptom-free days, and less use of rescue medicationwere seen more often with the use of the Advair Diskus than with the use of either salmeterol or fluticasone alone.
The safety profile of Advair Diskus is similar to that of its individual components, with the most frequent side effects being upper respiratory infection, pharyngitis, and headaches. The Advair Diskus will be available in three strengths of fluticasone propionate (100, 250, and 500 mcg) and a fixed dose of salmeterol (50 mcg). For patients 12 years of age and older, the dosage is one inhalation twice daily (morning and evening, approximately 12 hours apart). The recommended starting dose is based upon the patients' current asthma therapy with a maximum dose of 500/50 twice daily. The labeling provides dosing guidelines for patients already taking inhaled corticosteroids and warns that Advair Diskus should not be used for transferring patients from systemic corticosteroid therapy. Although significant improvement may occur within the first 30 minutes of taking the first dose, the full benefit may not be achieved until treatment has been administered for one week or longer.
Tammy Chernin. New asthma combo offers dual approach. Drug Topics 2001;7:24.