Outcome of pregnancy in a randomized controlled study of patients with asthma exposed to budesonide
| Autor: | Michael Silverman, Søren Pedersen, Albert L. Sheffer, Maria Broddene, Maria Gerhardsson de Verdier, Bertil Lindmark, Romain Pauwels, Patricia V. Diaz, Finn Radner |
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| Rok vydání: | 2005 |
| Předmět: |
Adult
Pulmonary and Respiratory Medicine Budesonide medicine.medical_specialty Pediatrics Randomization Adolescent medicine.drug_class Immunology Placebo Congenital Abnormalities law.invention Randomized controlled trial Pregnancy law medicine Humans Immunology and Allergy Child Asthma business.industry Pregnancy Outcome Middle Aged medicine.disease Dry-powder inhaler Bronchodilator Agents Surgery Abortion Spontaneous Child Preschool Corticosteroid Female business medicine.drug |
| Zdroj: | Annals of Allergy, Asthma & Immunology. 95:566-570 |
| ISSN: | 1081-1206 |
| DOI: | 10.1016/s1081-1206(10)61020-4 |
| Popis: | Background Budesonide is the only inhaled corticosteroid to be given a category B pregnancy rating by the US Food and Drug Administration, based on observational data from the Swedish Medical Birth Registry. However, data from large randomized controlled trials are lacking. Objective To compare pregnancy outcomes among patients with recent-onset mild-to-moderate persistent asthma receiving low-dose budesonide vs placebo. Methods In a randomized, double-blind, placebo-controlled trial, 7,241 patients aged 5 to 66 years with mild-to-moderate persistent asthma for less than 2 years and no previous regular corticosteroid therapy received once-daily budesonide or placebo via dry powder inhaler in addition to their usual asthma medication for 3 years. This trial was followed by a 2-year open-label treatment period. The daily dose of budesonide was 400 μg for adults. The study included 2,473 females aged 15 to 50 years at randomization. Pregnancy was not an exclusion criterion (except for US patients). Results Of 319 pregnancies reported, 313 were analyzed. Healthy children were delivered in 81% and 77% of all pregnancies in the budesonide and placebo groups, respectively. Of the 196 pregnancies reported by participants taking budesonide, 38 (19%) had adverse outcomes: 23 (12%) had miscarriages, 3 (2%) had congenital malformations, and 12 (6%) had other outcomes. Of the 117 pregnancies reported in the placebo group, 27 (23%) had adverse outcomes: 11 (9%) had miscarriages, 4 (3%) had congenital malformations, and 12 (10%) had other outcomes. Conclusions Treatment with low-dose inhaled budesonide in females with mild-to-moderate persistent asthma does not seem to affect the outcome of pregnancy. |
| Databáze: | OpenAIRE |
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