Combination Superior to Monotherapy for Asthma Control

From the American College of Allergy, Asthma & Immunology

PHILADELPHIA?Recent studies have indicated that there may be an increased risk of serious asthma-related adverse events in patients receiving salmeterol (Serevent Diskus). However, an observational study of >64,000 patients with asthma showed that patients who take fluticasone propionate plus salmeterol (Advair Diskus) appear to be less likely to require emergency department treatment than patients who take fluticasone propionate (Flovent Diskus) alone.

A second analysis of clinical trials of patients treated with salmeterol plus fluticasone propionate showed that they had fewer exacerbations when compared with patients treated with fluticasone propionate monotherapy. These data, which were presented at the American College of Allergy, Asthma & Immunology (ACAAI) annual meeting, suggest that, in appropriate patients, combination treatment with a long-acting beta-agonist and an inhaled corticosteroid may be an effective option for maintaining asthma control.

The first study, which looked at 64,689 real-world users, compared the rate of hospitalizations and emergency department visits in patients receiving fluticasone propionate and salmeterol inhalation powder (69%) with patients receiving fluticasone propionate alone (31%). The monotherapy group had a 26% increase in asthma-related emergency department visits, a 20% increase in all-cause emergency department visits, and an 11% increase in all-cause admissions when compared with patients in the combination therapy group. The risk of asthma-related admissions and all-cause intubations was also higher for patients treated with fluticasone propionate alone, but it did not reach statistical significance.

The second study, a retrospective review, evaluated exacerbation and hospitalization rates in participants of trials that compared inhaled corticosteroid monotherapy with salmeterol plus an inhaled corticosteroid (administered via Diskus or as concomitant inhaled corticosteroid therapy). Included were 9954 patients, aged ≥4 years, representing 2859 patient-years of exposure.

The pooled analysis showed that the use of salmeterol plus an inhaled corticosteroid resulted in fewer asthma exacerbations and asthma-related hospitalizations compared with the use of an inhaled corticosteroid alone. This held true for all patients, regardless of age or ethnicity.

"These new findings help confirm that there is safety with this combination," said Todd Mahr, MD, of Gundersen Lutheran Medical Center and the University of Wisconsin School of Medicine and Public Health, Madison, Wis. "This review looked at almost 10,000 patients, which is a very large number. The problem until now has been that all the studies were too small by themselves. So, it is reassuring to see these results in such a large number of patients."

Dr Mahr, chairman of the 2006 ACAAI Abstract Review Committee, said that these data were some of the most important findings reported at the meeting. "I think these findings are something that most physicians always suspected," Dr Mahr told IMWR. "However, there has been a fear that combination therapy with a long-acting beta-agonist may result in a higher risk for serious asthma-related events. These new findings show that in appropriately managed asthma patients with these agents, there is no increase in exacerbations or hospitalizations, and your side-effect profiles are not affected."