Leukotriene antagonists as first-line or add-on asthma controller therapy

Price, David, Musgrave, Stanley D., Shepstone, Lee, Hillier, Elizabeth V., Sims, Erika J., Gilbert, Richard F. T., Juniper, Elizabeth F., Ayres, Jon G., Kemp, Linda, Blyth, Annie, Wilson, Edward C. F., Wolfe, Stephanie, Freeman, Daryl, Mugford, Miranda, Murdoch, Jamie and Harvey, Ian (2011) Leukotriene antagonists as first-line or add-on asthma controller therapy. New England Journal of Medicine, 364 (18). pp. 1695-1707. ISSN 0028-4793

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Abstract

Most randomized trials of treatment for asthma study highly selected patients under idealized conditions. METHODS: We conducted two parallel, multicenter, pragmatic trials to evaluate the real-world effectiveness of a leukotriene-receptor antagonist (LTRA) as compared with either an inhaled glucocorticoid for first-line asthma-controller therapy or a long-acting beta(2)-agonist (LABA) as add-on therapy in patients already receiving inhaled glucocorticoid therapy. Eligible primary care patients 12 to 80 years of age had impaired asthma-related quality of life (Mini Asthma Quality of Life Questionnaire [MiniAQLQ] score =6) or inadequate asthma control (Asthma Control Questionnaire [ACQ] score =1). We randomly assigned patients to 2 years of open-label therapy, under the care of their usual physician, with LTRA (148 patients) or an inhaled glucocorticoid (158 patients) in the first-line controller therapy trial and LTRA (170 patients) or LABA (182 patients) added to an inhaled glucocorticoid in the add-on therapy trial. RESULTS: Mean MiniAQLQ scores increased by 0.8 to 1.0 point over a period of 2 years in both trials. At 2 months, differences in the MiniAQLQ scores between the two treatment groups met our definition of equivalence (95% confidence interval [CI] for an adjusted mean difference, -0.3 to 0.3). At 2 years, mean MiniAQLQ scores approached equivalence, with an adjusted mean difference between treatment groups of -0.11 (95% CI, -0.35 to 0.13) in the first-line controller therapy trial and of -0.11 (95% CI, -0.32 to 0.11) in the add-on therapy trial. Exacerbation rates and ACQ scores did not differ significantly between the two groups. CONCLUSIONS: Study results at 2 months suggest that LTRA was equivalent to an inhaled glucocorticoid as first-line controller therapy and to LABA as add-on therapy for diverse primary care patients. Equivalence was not proved at 2 years. The interpretation of results of pragmatic research may be limited by the crossover between treatment groups and lack of a placebo group.

Item Type: Article
Faculty \ School: Faculty of Medicine and Health Sciences > Norwich Medical School
Faculty of Medicine and Health Sciences > School of Health Sciences
Faculty of Medicine and Health Sciences > Allied Health Professions
Depositing User: Val Knights
Date Deposited: 24 Feb 2011 12:05
Last Modified: 21 Apr 2020 16:36
URI: https://ueaeprints.uea.ac.uk/id/eprint/24588
DOI: 10.1056/NEJMoa1010846

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