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| |  AAAAI: Rapid Dose Escalation of Inhaled Steroid Therapy Using Salmeterol-Fluticasone or Fluticasone Provides Safe Control in Asthma By Paula Moyer SAN FRANCISCO, CA -- March 24, 2004 -- Patients who require rigorous asthma control may undergo rapid "step-up" dosing of an inhaled corticosteroid -- either salmeterol-fluticasone (Advair) or fluticasone (Flovent) -- with no undue risk for adverse events, according to findings presented here March 21st at the American Academy of Allergy, Asthma, and Immunology 60th Annual Meeting. Principal investigator Timothy Clark, MD, Professor of Pulmonary Medicine, National Heart and Lung Institute, Imperial College, London, United Kingdom, presented safety data from the Gaining Optimal Asthma Control (GOAL) study, and said that the findings should reassure physicians and patients that dose escalations of inhaled corticosteroids do not entail undue risk. "For some physicians the question has been, if you push the inhaled corticosteroid dose to the highest level, will you be controlling the asthma at the cost of adverse events?" Dr. Clark said. "We looked at whether rapid dose escalation entailed such risks, and the answer is no. Total control -- the elimination of asthma symptoms -- is well tolerated and safe." The GOAL study involved 3,416 patients with asthma that was poorly controlled at baseline. The investigators stratified patients into 3 groups by their prior use of inhaled corticosteroids -- 1,098 were treatment-naïve; 1,163 were previously treated with low-dose therapy, and 1,155 were previously treated with a moderate-dose therapy. Patients were randomised to either inhaled salmeterol/fluticasone or fluticasone. The combination consisted of 50 mcg of salmeterol and 100 to 500 mcg of fluticasone twice daily. Monotherapy consisted of 100 to 500 mcg of fluticasone twice daily. These patients were followed for up to 1 year, and the investigators recorded adverse events at each clinic visit. In addition, 24-hour urinary free cortisol excretion was monitored in a subgroup of patients. In evaluating side effect incidence, investigators found that in the corticosteroid-naïve group, 55% of the patients on fluticasone monotherapy and 56% of the patients on the salmeterol/fluticasone combination experienced adverse events. In the low-dose group, those rates were 60% and 57%, respectively. In the moderate-dose group, the rates were 69% and 67%, respectively. The most common adverse events, with a rate of 5% in each group were similar for the 2 treatment arms, were nasopharyngitis, upper respiratory tract infection, headache, sinusitis and influenza. The 24-hour free urinary cortisol excretion at week 52 versus baseline did not differ between treatments. The incidence of serious adverse events was low and reported in 2% of corticosteroid-naïve patients on the combination and 4% of corticosteroid-naïve patients on monotherapy; in 3% and 2% of low-dose patients in each treatment group, respectively; in 6% of moderate-dose patients receiving combination therapy and 4% of moderate-dose patients on monotherapy. The overall incidence of adverse events was 10% for both treatment arms, suggesting that the total control strategy in asthma using inhaled corticosteroids is safe and well tolerated, Dr. Clark said. The study was funded by GlaxoSmithKline, which manufactures Advair.
[Study title: Salmeterol/Fluticasone and Fluticasone Alone Are Well Tolerated Over 1 Year of Treatment Stepped-up to Achieve Total Control: Safety Results of the GOAL Study. Abstract 359]
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