Health care delivery and qualityCost-effectiveness analysis of early intervention with budesonide in mild persistent asthma☆
Section snippets
Methods
START was a pragmatic study conducted in 32 countries in which 7241 patients were randomized to budesonide once daily (200 μg for children <11 years at baseline and 400 μg for other patients) or usual asthma therapy. If judged appropriate by the investigators, all patients were allowed to receive other asthma treatments, including other inhaled or oral corticosteroids, according to local practice.
We have previously reported the design and analysis plan of the cost-effectiveness evaluation for
Background data
Seven thousand two hundred forty-one patients entered the study. Data from 4 centers (56 patients) were discarded for administrative reasons. Twenty patients did not receive the study drug, leaving 7165 patients (budesonide, 3597; usual asthma therapy, 3568) for analysis. Drop-out rates and reasons for discontinuation were equally distributed between the 2 groups.11 A total of 5155 patients completed the 3-year follow-up.
Cost data were available for all 7165 patients of the analysis set, but
Discussion
The START study investigators have reported that once-daily treatment with low-dose budesonide reduced the risk of a severe asthma-related event by nearly 50%, improved symptom-free time, reduced the need for additional courses of systemic glucocorticoids, and improved FEV1.11 These data support earlier studies that have shown that regular treatment with ICSs initiated in the year after recognition and diagnosis of asthma can reduce the risk of asthma exacerbations and hospitalizations for
Acknowledgements
Yu Zhi Chen and Romain A. Pauwels contributed on behalf of the START Steering Committee, which included the following: B. Andersson, W. W. Busse, L. G. Carlsson, Y. Z. Chen, C. J. Lamm, P. M. O'Byrne, S. Pedersen, S. V. Ohlsson, R. A. Pauwels, W. C. Tan, and A. Ullman. We thank Ann-Sofi Hörstedt for statistical programming, Eva Runnerström and Ulf Farmängen for monitoring the clinical trial, and Catrena Sullivan for assistance with data collection.
References (29)
- et al.
Trends in the cost of illness for asthma in the United States, 1985-1994
J Allergy Clin Immunol
(2000) - et al.
Asthma pharmacotherapy and utilization by children in 3 managed care organizations
J Allergy Clin Immunol
(2000) - et al.
Early intervention with budesonide in mild persistent asthma
Lancet
(2003) - et al.
Design and analytic considerations in determining the cost-effectiveness of early intervention in asthma from a multinational clinical trial
Control Clin Trials
(2001) - et al.
Effects of long-term treatment with an inhaled corticosteroid on growth and pulmonary function in asthmatic children
Respir Med
(1994) - et al.
Effect of early vs late intervention with inhaled corticosteroid in asthma
Chest
(1995) - et al.
Advantages of high dose inhaled budesonide
Lancet
(1988) - et al.
Cost-effectiveness analysis of inhaled cortico-steroids in asthma
A review of the analytical standards. Respir Med
(2003) - Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention. Bethesda: National Heart,...
- et al.
The inhaled steroid treatment as regular therapy in early asthma (START) rationale and design
Control Clin Trials
(2001)
Direct and indirect costs of asthma in Canada, 1990
CMAJ
Use of inhaled anti-inflammatory medication in children with asthma in managed care settings
Arch Pediatr Adolesc Med
Low dose inhaled budesonide and formoterol in mild persistent asthma: the OPTIMA randomized trial
Am J Respir Crit Care Med
Efficacy and cost benefit of inhaled corticosteroids in patients considered to have mild asthma in primary care practice
Can Respir J
Cited by (66)
Executive summary: Japanese guidelines for adult asthma (JGL) 2021
2023, Allergology InternationalAsthma and Allergy
2022, Clinical ImmunologyRelationship between obesity and school absenteeism in Australian children: Implications for carer productivity
2021, Obesity Research and Clinical PracticeJapanese guidelines for adult asthma 2020
2020, Allergology International
- ☆
Supported by AstraZeneca Research and Development, Lund, Sweden.
- 1
On behalf of the Inhaled Steroid as Regular Therapy in Early Asthma Steering Committee.