Montelukast Comparable to Salmeterol in Fluticasone-Treated Asthma Patients

Emma Hitt, PhD

March 10, 2003

March 10, 2003 (Denver) — For the treatment of persistent asthma, montelukast in combination with fluticasone appears to be at least as effective as salmeterol in combination with fluticasone, although more drug-related adverse events are apparent in the salmeterol group, research suggests.

According to the researchers, addition of complementary therapy with either a leukotriene receptor antagonist or a long-acting beta-2 agonist may increase symptom control in patients receiving inhaled corticosteroids. However, asthma attacks rates have not been studied with the addition of either of these two agents to fluticasone therapy.

Jorge F. Maspero, MD, from Buenos Aires Children's Hospital "Ricardo Gutierrez," University of Buenos Aires, Argentina, presented the findings of the IMPACT study at the 60th annual meeting of the American Academy of Allergy, Asthma, and Immunology here on Saturday.

The researchers randomized patients with uncontrolled asthma receiving fluticasone 100 µg twice daily to receive montelukast 10 mg daily (n = 747) or salmeterol 50 µg twice daily (n = 743) for 48 weeks. All patients had an FEV 1 of 50% to 90% predicted and a 12% or greater reversibility.

In both groups, the proportion of patients with asthma attacks was equivalent. In the montelukast group, 20.1% experienced attacks compared with 19.1% in the salmeterol group. The average duration of attacks was also similar.

Montelukast reduced blood eosinophils significantly compared with salmeterol ( P = .011). Prebronchodilator FEV 1 favored salmeterol (0.07 L), but similar improvements were seen in postbronchodilator FEV 1, quality-of-life scores, and nocturnal awakenings in the two groups.

Resource utilization, which was defined as the number of hospital visits, phone calls, and unscheduled visits to physicians and corticosteroid use were also similar.

A total of 71% of patients receiving montelukast and 72.4% of patients receiving salmeterol experienced adverse events, although the salmeterol group experienced a greater incidence of drug-related adverse events (10% vs. 6.3%), the researchers report.

Dr. Maspero told Medscape that the two combinations were equally effective, but the use of either combination should depend on the individual patient.

"For example, if the patient has asthma with concomitant allergic rhinitis, I would consider using the montelukast combination instead of the salmeterol combination," Dr. Maspero said. "In contrast, for patients with beta-2 agonist reversibility, the long-acting beta-2 agonist salmeterol combination may be preferable," he said. "We need to individualize the therapy to each patient."

According to session moderator Stanley Szefler, MD, an asthma specialist at the National Jewish and Medical Research Center, in Denver, Colorado, the information presented showed that these combinations were equivalent and that the clinician could use either one as an alternative.

But he told Medscape that he tends to prescribe the inhaled corticosteroid fluticasone and the long-acting beta-2 agonist "just because it's sold as a combination (Advair) and is more convenient for patients to take."

The IMPACT study was funded by Merck & Co.

AAAAI 60th Annual Meeting: Abstract 227. Presented March 8, 2003.

Reviewed by Gary D. Vogin, MD

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