Risk of congenital malformations for asthmatic pregnant women using a long-acting ?2-agonist and inhaled corticosteroid combination versus higher-dose inhaled corticosteroid monotherapy - 06/01/15
Abstract |
Background |
Current recommendations for managing persistent asthma during pregnancy when low-dose inhaled corticosteroids (ICSs) are insufficient include adding a long-acting β2-agonist (LABA) or increasing the ICS dose. However, there are no data to help clinicians evaluate the safest regimen during pregnancy.
Objective |
We sought to compare the risk of major congenital malformations in asthmatic women exposed to a LABA plus ICS combination and those exposed to ICS monotherapy at higher doses during the first trimester.
Methods |
A cohort of asthmatic pregnant women exposed to ICSs during the first trimester who delivered between January 1990 and March 2009 was established. The primary outcome was major malformation recorded at birth or during the first year of life. Two subcohorts were established as follows: (1) users of a LABA plus low-dose ICS combination or users of a medium-dose ICS and (2) users of a LABA plus medium-dose ICS combination or users of a high-dose ICS. Generalized estimating equations were used to compare the risk of major malformations between the groups.
Results |
In one subcohort there were 643 women who used a LABA plus low-dose ICS and 305 who used a medium-dose ICS; the other subcohort included 198 users of a LABA plus medium-dose ICS and 156 users of a high-dose ICS. The prevalence of major malformations was 6.9% and 7.2%, respectively. The adjusted odds ratio for major malformations was 1.1 (95% CI, 0.6-1.9) when a LABA plus low-dose ICS was used compared with a medium-dose ICS and 1.2 (95% CI, 0.5-2.7) when a LABA plus medium-dose ICS was used compared with a high-dose ICS.
Conclusion |
The risk of major malformations was similar with a LABA plus ICS combination and ICS monotherapy at higher doses, suggesting that both therapeutic options can be considered during pregnancy.
Le texte complet de cet article est disponible en PDF.Key words : Asthma, pregnancy, congenital malformations, inhaled corticosteroid, long-acting β2-agonist, combination therapy, high-dose inhaled corticosteroid, cohort study, comparative safety study, administrative health databases
Abbreviations used : ICD-9, ICD-10, ICS, LABA, MED-ECHO, OR, RAMQ, SABA
Plan
| Supported by a research grant received from the Canadian Institutes of Health Research (grant MOP97731). |
|
| Disclosure of potential conflict of interest: S. Eltonsy has received research support from the Canadian Institutes of Health Research and Le Fonds de recherche du Quebec–Sante (FRQS). M.-F. Beauchesne has received research support, payment for lectures, and payment for development of educational presentations from Novartis. L. Blais has received research support from the Canadian Institutes of Health Research, Novartis, Merck, Pfizer, GlaxoSmithKline, and AstraZeneca. A. Forget declares no relevant conflicts of interest. |
Vol 135 - N° 1
P. 123 - janvier 2015 Retour au numéro
Article précédent
- Indoor fungal diversity and asthma: A meta-analysis and systematic review of risk factors
- Richard A. Sharpe, Nick Bearman, Christopher R. Thornton, Kerryn Husk, Nicholas J. Osborne
- Perception versus reality: The saga of inhaled asthma controller medication and fetal risk
- Joshua A. Steinberg
Bienvenue sur EM-consulte, la référence des professionnels de santé.
L’accès au texte intégral de cet article nécessite un abonnement.
Déjà abonné à cette revue ?