Abstract
Objectives:
To examine the real-life effectiveness of inhaled corticosteroids (ICS) versus leukotriene receptor antagonists (LTRA) monotherapy in children with mild or moderate asthma.
Methods:
Using medical and drug records, we accrued a cohort of 227 children aged 2–17 years, prescribed daily LTRA or ICS monotherapy. LTRA-treated children were matched on age, gender, and previous acute-care visits in a 1:3 ratio to ICS-treated children. Outcomes included rescue oral corticosteroids, prescription duration and dispensing, acute-care visits, hospital admissions, and β2-agonist use.
Results:
More ICS- than montelukast-treated children had persistent asthma (73 vs. 50%) and fewer had good asthma control (35 vs. 61%) at baseline, suggesting residual confounding by indication. Physician prescriptions covered 62% of the follow-up period for ICS compared to 97% for montelukast (mean group difference [MGD]: −17%, 95% CI: −28%, −7%). In pharmacies, patients claimed 51 vs. 74% of prescribed ICS and montelukast, respectively (MGD = −12% [−20%, −4%]). Consequently, dispensed ICS and montelukast covered 24% and 38% of follow-up period, respectively (MGD = −14% [−22%, −6%]). No group differences in oral corticosteroids (RR = 1.10 [0.66, 1.84]) and acute-care visits (RR = 1.79 [0.96, 3.34]) were observed. ICS-treated children experienced more hospital admissions (RR = 3.63 [1.20, 11.03]) and needed more frequently rescue β2-agonist use of ≥4 doses per week (RR = 2.54 [1.23, 5.23]).
Conclusions:
When compared to LTRA, the prescription of ICS monotherapy did not significantly reduce rescue oral corticosteroids or acute care visits and was associated with a higher rate of hospital admission for asthma and rescue β2-agonist use. The findings may be due to paradoxical shorter ICS prescription duration and lower patient adherence, despite more persistent asthma and poorer control than in LTRA-treated children.
Transparency
Declaration of funding
Funding for this study was provided by a research grant from Merck & Co., Inc.
Declaration of financial/other relationships
F.D. reports receiving research grants from GlaxoSmithKline Canada and Merck & Co, USA and unrestricted donations from Merck, Novartis, and Nycomed to support an electronic database of children with asthma. F.N. reports unrestricted grants for educational purposes from GlaxoSmithKline, AstraZeneca, Merck, Novartis, and Nycomed. F.A-R. and E.M. are employees and shareholders of Merck. J.G. declares no conflict of interest. L.B. reports receiving research grants from AstraZeneca, Pfizer, Sanofi-Aventis, and Genentech.
Acknowledgments
The authors acknowledge the Fonds de la Recherche en Santé du Québec (FRSQ) for the infrastructure support provided to the Research Center of the CHU Sainte-Justine and of the McGill University Health Center. We are indebted to the research assistants, namely Cheryl Savdie and Stéphanie Ducharme-Bénard for diligent data entry of all Asthma Center visits and Asthma Education Center, respectively. We are indebted to Lyudmyla Khomenko for merging all hospital databases and to Marilyse Julien for assisting in the analysis; Carole Forget for manuscript preparation. The paper was revised by our medical editor, Danielle Buch.
CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.
This work was presented in part at the European Academy of Allergy and Clinical Immunology’s Pediatric Allergy & Asthma Meeting in Venice, Italy, November 2009, the American Thoracic Society Meeting in New Orleans, USA, May 2010, and the European Respiratory Society in Barcelona, Spain, September 2010.