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Researchers Find Formoterol Safe in Overall Use for Asthmatic Patients: Presented at ACAAI By Micheal Casasnovas MIAMI BEACH, Fla -- November 13, 2009 -- Researchers said they found no evidence of increased risk of asthma-related hospitalisation with formoterol-containing versus non-long-acting beta2-adrenergic agonist treatment or with formoterol with inhaled corticosteroids versus inhaled corticosteroids alone. “There was no evidence of an increased risk of all-cause death or asthma-related death, intubation, or hospitalisation with formoterol-containing treatment versus non-long-acting beta2-adrenergic agonist therapy in this analysis,” said Harold Nelson, MD, National Jewish Health/University of Colorado, Denver, Colorado, here on November 8 at the American College of Allergy, Asthma & Immunology (ACAAI) annual scientific meeting. “Results from this analysis support asthma management guideline recommendations for use of inhaled corticosteroids/long-acting beta2-adrenergic agonist in patients whose asthma is not well controlled with inhaled corticosteroids alone.” Researchers included data from 13,542 formoterol-randomised and 9,968 non-long-acting beta2-adrenergic agonist patients from 42 trials. Included in these trials were all blinded, parallel-arm, active- and placebo-controlled, randomised asthma studies that met the specific US Food and Drug Administration criteria using a formoterol-containing treatment and a non-long-acting beta2-adrenergic agonist comparator. Researchers used data from only the blinded phase of the randomised studies. Studies were excluded if they were uncontrolled, designed primarily to obtain clinical pharmacology data, or performed for an indication other than asthma. Researchers found a low incidence of all-cause death in the 13,542 formoterol-randomised patients. There were 3 fatalities among those patients. There were 4 fatalities among the 9,968 patients taking non-long-acting beta2-adrenergic agonists. Dr. Nelson said the researchers found no occurrences of asthma-related deaths; 1 patient in the formoterol-containing treatment group required asthma-related intubation. He reported fewer asthma-related hospitalisations/1,000 patient treatment-years -- 12.05 versus 16.40 in the formoterol patients. There were fewer discontinuations -- 12.7% versus 15.4% among the formoterol patients. Numerically fewer asthma-related hospitalisations/1,000 patient treatment-years also were seen for formoterol plus inhaled corticosteroids versus inhaled corticosteroids alone -- 11.14 versus 15.65. Relative to non-long-acting beta2-adrenergic agonist, increasing the daily formoterol dose did not result in an increased rate or incidence of asthma-related hospitalisation, Dr. Nelson said. “Analysis by individual trial, formoterol dose threshold, and concomitant inhaled corticosteroids administration also showed no evidence of an increased risk of asthma-related hospitalisation, consistent with the overall findings,” Dr. Nelson said. [Presentation title: Combined Analysis of Formoterol Safety Data From Double-Blind, Randomized, Controlled Trials of Patients With Asthma. Abstract P77] E-mail this page to a friend or colleague! To print, use this version