From Reuters Health Information
By Frederik Joelving
NEW YORK (Reuters Health) Feb 07 - For mild persistent asthma, fluticasone propionate with salmeterol cuts the risk of exacerbations more than ciclesonide, but both regimens effectively control daily symptoms.
The findings appear in the February issue of Chest, and are doubly reassuring according to one expert, who was not involved in the study.
"It does look like the current guidelines are on course in terms of mild persistent asthma needing just an inhaled corticosteroid," said Dr. Andy Nish of the Allergy and Asthma Care Center in Gainesville, Georgia.
"But it is interesting that the combination product -- while I'm certainly not advocating treating mild persistent asthma with a combination product -- performed at least as well," he added.
For the study, funded by Nycomed, which markets the glucocorticoid ciclesonide (Alvesco), researchers randomized 657 patients aged 12 to 75 years to ciclesonide 160 mcg once daily, fluticasone propionate/salmeterol (Advair) 100/50 mcg twice daily, or placebo. (The U.S. Food and Drug Administration approved Alvesco for asthma in 2006.)
Over one year, only the combination therapy prolonged the time to asthma exacerbation compared with placebo (p=.0002). The probabilities of not experiencing exacerbations were 82% for patients on combination therapy, 70% for monotherapy and 65% for placebo.
This finding contrasts with earlier results from the OPTIMA trial, note Dr. Dirkje S. Postma, of the University Medical Center Groningen in The Netherlands, and colleagues in Chest. In that trial, adding a long-acting beta-agonist (formoterol) to a corticosteroid (budesonide) didn't reduce the likelihood of exacerbations.
In the current study, both regimens cut asthma symptom scores and the number of poorly controlled asthma days, and they increased the number of symptom-free days by about a week.
The combination therapy also increased lung function significantly, whereas ciclesonide did not. Asthma quality-of-life scores were higher in both treatment groups, and the ciclesonide group saw a greater increase than the combination group (p<.0001).
"In conclusion, as a first-line approach in mild asthma, CIC160 monotherapy offered similar clinical benefits to FP200/S100 for a large number of measures of asthma control," the researchers write. "Combination therapy may be required in some patients to attain full benefits for reducing exacerbations."
Sixty-four percent of the patients on combination therapy reported adverse events, including asthma attacks and nasopharyngitis, compared to 73% in the ciclesonide group and 74% in the placebo group.
"It appears that the combination product in this group was both safe and effective," said Dr. Nish. "That is reassuring for those people who do merit being on the combination."
Still, he added, "unless there is a clear-cut and clinically significant improvement with the combination treatment over monotherapy, then in general monotherapy should be recommended."
Chest. 2011;139:311-318. Abstract