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| |  ERS: Adding Formoterol to Budesonide May Not Provide Benefit for Mild Asthmatics By Cameron Johnston Special to DG News BERLIN, GERMANY -- September 28, 2001-- Adding formoterol to budesonide for treatment of mild, persistent asthma is not likely to lead to a statistically significant improvement in exacerbations or other measures of asthma control. These findings were reported this week at the European Respiratory Society meeting, held in Berlin, Germany. In the 17-country study, 698 patients were randomized, and 562 completed a one-year regimen where they received either budesonide (Pulmicort 100 µg b.i.d via Turbuhaler), or budesonide 100 µg b.i.d. plus formoterol (Oxis 4.5 µg b.i.d. via Turbuhaler) or placebo. Lead investigators on the study were Dr. Paul O'Byrne, a member of the respiratory and internal medicine staff at McMaster University Medical Centre, in Hamilton, Ontario, Canada, and Dr. Peter Barnes, of the Imperial College, London, England. Forced expiratory volume in one second (FEV1) was measured at all nine clinical visits throughout the study. Study results showed that patients in the placebo group had a severe asthmatic exacerbation rate of 0,77 per year, compared with 0.29 in the group receiving budesonide alone, and 0.34 in the group receiving budesonide and formoterol. The difference in rate of exacerbations was statistically significant between the budesonide monotherapy group and the placebo group, but not between the two groups receiving budesonide. Similarly, those in the placebo group had 29.4 days with symptoms compared with 23.1 days with symptoms in the budesonide monotherapy group and 21.5 in the budesonide/formoterol group. Again, the difference was not statistically significant between the two groups receiving budesonide. The improvement in FEV1 was, however, significantly improved in the group receiving both formoterol and budesonide (p=0.0001), but not in the budesonide monotherapy group (p=0.12) In conclusion, low-dose inhaled budesonide via a dry-powder inhaler reduced severe asthmatic exacerbations by 60 percent and improved asthma control by 48 percent, but while adding formoterol resulted in a small improvement in lung function, this was not accompanied by improvements in any other measures of asthma control. At the same time, a second study analyzed the cost-benefit of using budesonide compared with placebo and reported that budesonide alone, for mild asthma, is a cost-effective management strategy. The number of days with symptoms was 75.9 (28.2 percent) in the budesonide monotherapy group, compared with 68.3 (31.4 percent) in the placebo group (p=0.007). Significant reductions in total resource costs were observed with budesonide compared with placebo (p=0.02), and the decrease in indirect costs due to fewer days lost form work and fewer out of pocket expenses approached significance (p=0.07), the investigators said. The mean total cost of treatment with budesonide per year was 4011 SEK (Swedish Krowns) compared with 2704 SEK for placebo - a not statistically significant difference. From a straight cost-effectiveness point of view, budesonide resulted in lower total costs and avoided severe exacerbations and additional symptom-free days, indicating that there were cost savings when comparing this drug with placebo, the authors concluded. Both studies were funded as part of AstraZeneca’s Oxis and Pulmicort Turbuhaler in the Management of Asthma (OPTIMA) International Study Group.
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