The oral medications, known as leukotriene-receptor antagonists, “have shown similar efficacy and cost and better compliance, and should be considered for any patient, not as a last option but as an option for any patient,” said study co-author Dr. Stanley Musgrove, a senior research associate at the University of East Anglia in Norwich.
“Every different patient will have their own issues that are important to their care: their compliance to different medications, how well they feel that different medications work for them, their concerns about different medications, any possible minor side effects, etcetera, and all of those should be considered when the clinician and the patient are making a decision about the best medication,” he noted.
Results of the study are published in the May 5 issue of the New England Journal of Medicine.
The study was designed to be what the researchers call a “pragmatic” trial, which more closely mimics the way people use medications in real life as opposed to the strict rules of a clinical trial, according to Musgrove.
The researchers recruited 650 people with mild to moderate asthma. The study volunteers were between the ages of 12 and 80, and had inadequate asthma control or an impaired quality of life due to asthma symptoms.
Volunteers were randomly assigned to a group. One arm of the study compared leukotriene-receptor antagonists (Accolate and Singulair) to inhaled corticosteroids as a first-line treatment for asthma. The other arm of the study compared people who were already taking inhaled steroids who then added on either a long-acting rescue medication (known as a LABA) or leukotriene-receptor antagonists (LTRAs).
Patients were allowed to comply as they wanted to and change medications as they needed to, Musgrove said.
The results at two months suggested that LTRAs were similarly effective to inhaled corticosteroids when used as a first-line treatment and to LABAs when used as an additional treatment. After two years, the effectiveness of both treatments was similar but researchers noted that “equivalence was not proved.”
The main measure of the medications’ effectiveness was the Mini Asthma Quality of Life Questionnaire. This 15-item quiz has total scores ranging from 15 to 105, with the higher scores indicating less asthma impairment. Scores increased by an average of 0.8 to 1 point in both arms of the trial. Asthma control and the frequency of asthma exacerbations was similar among the groups.
Musgrove said there were no significant side effects reported for any of the medications. However, in 2009, the U.S. Food and Drug Administration requested that the makers of LTRA medications add a warning to their drug labels because of serious behavioral side effects, including suicidal thoughts and depression in some people taking the medications.
The risks of inhaled steroids for asthma include hoarseness, thrush, sore throat, and possibly reduced bone density.
In terms of costs, a 2010 United Kingdom study that compared the costs of the two therapies
for initial asthma control found that the price of LTRAs was “significantly higher” than that of inhaled steroids.
One expert said the most recent study comparing the effectiveness of LTRAs and inhaled steroids underscored the need for individualized therapy.
“These study findings don’t make me change my mind. It confirms that there are various options, and there’s not one answer for everyone,” said Dr. Jennifer Appleyard, chief of allergy and immunology at St. John Hospital and Medical Center in Detroit.
“The National Institutes of Health has issued guidelines on managing asthma, and a lot of literature review went into setting up those guidelines that recommend trying inhaled corticosteroids first. And, it’s been my experience that I get good control with more patients using inhaled corticosteroids,” she said.
“But if someone is having trouble using an inhaler regularly or they’re having side effects, then I would think about changing their medication,” she added. “But, there’s no one medication that will help everyone, and no medication is without risk.”