Inhaled budesonide reduced symptoms of mild asthma in primary care
ACP J Club. 1997 Jan-Feb;126:25. doi:10.7326/ACPJC-1997-126-1-025
O'Byrne P, Cuddy L, Taylor DW, et al. Efficacy and cost benefit of inhaled corticosteroids in patients considered to have mild asthma in primary care practice. Can Respir J. 1996 May/Jun;3:169-75.
To determine the efficacy and cost-effectiveness, including willingness-to-pay, of inhaled budesonide in primary care patients with mild asthma.
16-week, randomized, double-blind, placebo-controlled trial.
7 clinical centers in Canada.
57 patients who were ≥ 18 years of age (mean age 35 y, 56% women) and had mild asthma that required the use of inhaled bronchodilators. The inclusion criterion was variable peak expiratory flow rates (PEFR) before and after use of the bronchodilator defined as a > 10% difference between highest and lowest daily values for ≥ 3 days or the 7-day screening period. Exclusion criteria were indications for use of inhaled corticosteroids (ICSs) or oral steroids currently or within the past 3 months. 68% of patients finished the protocol.
20 patients were allocated to placebo; 17 to budesonide, 400 µg/d; and 20 to budesonide, 800 µg/d. Bronchodilators were supplied, and the theophylline dose was kept constant. Treatment for asthma flare-ups was standardized.
Main outcome and cost measures
Asthma symptoms; restriction of activities; PEFR; and use of bronchodilators, ICSs, and oral prednisone. Costs included those for study drugs, bronchodilators, hospitalization, and provincial fees for physician services. Patient willingness-to-pay was also assessed.
Analysis was by intention to treat. At 16 weeks, no difference in any outcome was found among patients who were taking 400 or 800 µg/d of budesonide. Patients in the budesonide groups had greater changes in evening PEFR than did patients in the placebo group (P < 0.05). Patients taking budesonide reported symptoms less frequently than did those taking placebo (31% for 400 µg/d and 31% for 800 µg/d vs 86% for placebo, P = 0.004), awoke less often with symptoms at night (0% and 8% vs 43%, P = 0.007) and early in the morning (8% and 15% vs 50%, P = 0.003), had fewer problems with sputum production (15% and 21% vs 59%, P = 0.02), and were less likely to use bronchodilators > 4 times/d (0% and 8% vs 35%, P = 0.01). The groups did not differ for adverse events or rate of exacerbations requiring an increase in treatment. Total cost per patient for drugs and medical care was Canadian $92.77for placebo; $78.88 for budesonide, 400 µg/d; and $140.02 for budesonide, 800 µg/d. The difference in what patients were willing to pay per week to prevent symptoms was not significant ($6 for placebo; $23 for budesonide, 400 µg/d; and $20 for budesonide, 800 µg/d).
Budesonide reduced asthma symptoms in patients with mild asthma whose primary care providers did not believe them to require inhaled corticosteroids.
Source of funding: Astra Draco Incorporated.
For article reprint: Dr. P. O'Byrne, Department of Medicine, Room 3U1 Health Sciences Centre, McMaster University, 1200 Main Street West, Hamilton, Ontario L8N 3Z5, Canada. FAX 905-521-5053.
Almost all patients who have asthma with mild-to-moderate bronchospastic disease are treated by primary care providers. Although the study by O'Byrne and colleagues has limitations (discussed below), its message is clear: Most adults with mild asthma who need to use a bronchodilator are not optimally managed. Previous studies indicate that patients with relatively mild asthma benefit from use of regularly administered ICSs. Current guidelines recommend that ICSs be considered in patients with disease that is not well controlled with relatively low doses of as-needed inhaled β-agonists (1, 2). Because evidence suggests that prolonged, regular use of inhaled β-agonists may be associated with decreased control of asthma (3), the National Heart, Blood, and Lung Institute indicates that it may be preferable to manage these patients by adding an ICS rather than by regularly scheduled treatment with β-agonists.
The authors of this study have investigated the clinical and cost benefits of giving additional relatively low doses of inhaled budesonide to patients who did not require an ICS according to their primary care physicians. A major problem of the study is that it is difficult to determine the severity of asthma at baseline: Data on baseline β-agonist requirements, number of nocturnal awakenings, early morning symptoms, and other indices of asthma severity were not fully provided. Therefore, it is difficult for physicians to discern whether the results can be extrapolated to their patients with mild asthma. The greater implication of this study, however, remains intact. Primary care practitioners have seen the benefits that may be derived from early and regular use of such agents as ICSs that target the underlying pathophysiology of asthma.
Peter K. Honig, MD, MPH
U.S. Food and Drug AdministrationRockville, Maryland, USA
2. National Heart, Lung, and Blood Institute. National Institutes of Health Guidelines for the Diagnosis and Management of Asthma. U.S. Department of Health and Human Services Publication No. 91-3042. Bethesda, MD: National Institutes of Health; 1991.