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| |  Significant Benefits Seen From Early/Sustained Treatment of Mild Asthma LONDON, ENGLAND -- November 12, 2001 -- Earlier and more sustained treatment of mild asthma improves control of asthma symptoms and reduces the risk of a severe exacerbation, thereby preventing lung function damage according to the results of the Canadian-led OPTIMA (Oxeze and Pulmicort Turbuhaler In the Management of Asthma) study, published today in the American Journal of Respiratory and Critical Care Medicine (1). The year-long primary care study showed for the first time that in mild asthma patients, who were not previously treated with inhaled corticosteroids, a low dose of the inhaled corticosteroid, Pulmicort® (budesonide) reduced the rate of severe exacerbations and poorly controlled asthma days by half. In patients already taking low-dose inhaled corticosteroids, but still experiencing asthma symptoms, the addition of the fast-onset, long-acting beta-agonist, Oxeze® (formoterol), was more effective than doubling the dose of budesonide in improving symptom control and reducing severe exacerbations (1). The FACET (Formoterol And Corticosteroids [budesonide] Establishing Therapy) study, has already demonstrated that the combined use of formoterol and budesonide helps the moderate to severe asthma patient to control their symptoms by reducing exacerbations (2). OPTIMA however, is the first study to demonstrate the benefits of more aggressive use of treatment in patients with mild asthma. The combination of budesonide and formoterol, studied in both FACET and OPTIMA, makes up Symbicort®, the new asthma treatment launched in August 2000. "OPTIMA has important implications for patients with mild asthma, many of whom are managed in primary care and receive no or sub-optimal treatment and so suffer poor symptom control (1,3,4,7)," said Professor Paul O’Byrne, chairman of the OPTIMA scientific advisory committee and Professor of Medicine and Head of the Division of Respiratory Medicine, McMaster University in Hamilton, Ontario, Canada. "For many of these mild-asthma patients the current treatment recommendations (5,6) are not being effectively implemented." A combination of the drugs found in Oxeze Turbuhaler® (formoterol) and Pulmicort Turbuhaler (budesonide), studied in OPTIMA, are found in Symbicort™, a new single inhaler combination asthma therapy currently under review with Health Canada. Symbicort, developed by AstraZeneca, is not yet available in Canada. "The results clearly show that better asthma control can be achieved in the previously untreated patient," said Dr. O'Byrne. "On this evidence, family physicians can now adopt an earlier and more sustained approach to the treatment of mild asthma. "The significant lack of disease control among people with asthma is a growing problem. The results from OPTIMA contribute to our understanding about the effective management of the disease," said Jo-Anne Harper Sobie, Executive Director, Asthma Society of Canada. "The Asthma Society of Canada supports asthma education and management through provision of information, tools and access to certified asthma educators to help people gain control of their asthma. The 1,970 mild asthma patients from 27 sites in Canada and from 16 other countries were randomly assigned to one of two groups. Group A comprised of 698 previously untreated (steroid-naïve) patients and received twice-daily treatments with placebo, or 100 µg budesonide, or 100 µg budesonide plus 4.5 µg formoterol. Group B comprised of 1272 corticosteroid-treated patients and were given twice-daily treatment with 100 µg budesonide, or 100 µg budesonide plus 4.5 µg formoterol, or 200 µg budesonide, or 200 µg budesonide 4.5 µg formoterol. In group A, low dose budesonide alone reduced the risk for the first severe asthma exacerbation by 60 percent and the rate of poorly controlled asthma days by 48 percent compared with placebo. There was also an improvement in lung function and a reduction in the rate of exacerbations, asthma symptoms, nocturnal awakening and number of rescue inhalations of short-acting inhaled beta-agonists in the budesonide group. The addition of formoterol to the budesonide treated group resulted in a small improvement in lung function but offered no further benefit to exacerbation risk or asthma control. In Group B, doubling the dose of budesonide had little clinical effect, but adding formoterol reduced the risk for the first severe exacerbation by 43 percent and the rate of poorly controlled asthma days by 30 percent. In addition, lung function was improved and asthma symptoms, including the need for rescue inhalations of a short-acting inhaled beta-agonist, were reduced. All treatments were well tolerated with class-specific adverse effects occurring in less than two per cent of patients in any treatment arm. That there is a significant morbidity associated with mild asthma is demonstrated by the fact that one third of the patients taking placebo in Group A experienced a severe asthma exacerbation during the study period. Asthma in this group was poorly controlled on 14 per cent of the days, with frequent symptoms such as nocturnal awakening and number of rescue inhalations of a short-acting inhaled beta-agonist. These patients would normally be considered to have mild asthma and would be managed in the primary care setting, often without inhaled corticosteroids. Regular treatment with budesonide was highly effective in this group of patients. The results from OPTIMA Group B suggest that patients, with what is perceived to be very mild asthma, would benefit from early treatment with budesonide and formoterol. In patients that do not achieve ideal asthma control on inhaled corticosteroids alone, addition of formoterol improves asthma control and reduces exacerbations. The OPTIMA treatment regimen is key to the successful management approach demonstrated in the OPTIMA study. Extensive clinical experience supports the safety and efficacy of both budesonide and formoterol which, when given through Turbuhaler, combine good lung deposition with minimal systemic effects (8) and are easy to use compared with other devices (9,10,11). Formoterol provides long-lasting bronchodilation with a fast onset of action (12), giving rapid relief of symptoms, whilst also benefiting from delivery via the user friendly and highly effective Turbuhaler. References: 1. O’Byrne PM, Barnes PJ, Rodriguez-Roisin R, Runnerstrom E, Sandström T, Svensson K, Tattersfield A. Low dose inhaled budesonide and formoterol in mild persistent asthma: the OPTIMA randomized trial. Am J Respir Crit Care Med, 2001; 164, Issue 8 2. Pauwels RA, Löfdahl C-G, Postma DS, Tattersfield AE, O’Byrne P, Barnes PJ, Ullman A. Effect of inhaled formoterol and budesonide on exacerbations of asthma. N Engl J Med, 1997; 337:1405-11 3. Turner-Warwick M. Nocturnal asthma: a study in general practice. J R Coll Gen Pract, 1989; 39:239-43. 4. O'Byrne PM, Cuddy L, Taylor DW, Birch S, Morris J, Syrotiuk J. The clinical efficacy and cost benefit of inhaled corticosteroids as therapy in patients with mild asthma in primary care practice. Can.Resp.J, 1996; 3:169-75. 5. Global Initiative for Asthma (GINA). Pocket guide for asthma management and prevention. Publication No. 96-3659B. National Institutes of Health, National Heart, Lung and Blood Institute. Revised November 1998. 6. The British Thoracic Society, The National Asthma Campaign, The Royal College of Physicians of London in association with the General Practitioner in Asthma Group, the British Association of Accident and Emergency Medicine, the British Paediatric Society and the Royal College of Paediatrics and Child Health. The British guidelines on asthma management: 1995 review and position statement. Thorax, 1997; 52(suppl 1): 1-21S 7. Rabe KF, Vermiere PA, Soriano, JB, Maier WC. Clinical Management of asthma in 1999: the Asthma Insights and Reality in Europe (AIRE) study. Eur Respir J, 2000; 16: 802-807 8. Pauwels R, Newman S, Borgström L. Airway deposition and airway effects of antiasthma drugs delivered from metered-dose inhalers. Eur Respir J, 1997; 10: 2127-38 9. Pederson S, O’Byrne PA. A comparison of the efficacy and safety of inhaled corticosteroids in asthma. Allergy, 1997; 52(suppl 39):1-34 10. Van Spiegel PI, Jenner F. A patient preference study comparing Turbuhaler with Diskus, two multi-dose dry powder inhaler devices. Br J Clin Research, 1997; 8: 33-45 11. Jadad AR, Sullivan C, Luo D, Allen IE, Ross SD, Sheinhait IA. Patient preferences for turbuhaler or pressurized metered dose inhalers (pMDIs) in the treatment of obstructive airway disease: A systematic review. J Allergy Clin Immunol, 2000; 105(No 1 Pt2): S17 12. Palmqvist M, Persson G, Lazer L, Rosenborg J, Larsson P, Lötvall J. Inhaled dry-powder formoterol and salmeterol in asthmatic patients: onset of action, duration of effect and potency. Eur Respir J 1997; 10:2484-2489. SOURCE: AstraZeneca
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