The anti-inflammatory asthma drug montelukast (Singulair) plus intranasal corticosteroids was an effective initial alternative to surgery for mild obstructive sleep apnea (OSA) in children, a retrospective study showed.
That strategy was associated with normalization of sleep findings in 62%,David Gozal, MD, of Chicago's Comer Children's Hospital, and colleagues found.
Overall, taking into account nonadherence and parents refusing the strategy, 81% were able to avoid surgery, the researchers reported online in Chest.
With "the absence of significant side effects and overall favorable safety profile associated with the use of either intranasal corticosteroids, or of oral montelukast," the combination "may ultimately replace adenotonsillectomy as the first line of treatment in mild OSA," they suggested.
Pediatric sleep apnea can resolve on its own, and that might have accounted for some of the results, Gozal's group acknowledged.
However, "the combined evidence from in vitro experiments showing marked reductions in tonsillar and adenoid tissue proliferation with application of corticosteroids or montelukast, and the experience garnered from clinical trials using either intranasal corticosteroids alone or oral montelukast alone," support a real effect.
Prospective randomized controlled trial evidence is "sorely" needed, the group concluded.
Until such a trial is done, it would be premature to offer the drug combo routinely,Christopher Carroll, MD, medical director of surgical critical care at Connecticut Childrens Medical Center in Hartford, commented in an interview with MedPage Today.
Nevertheless, "I don't think there's any problem with trying this before going to surgery," he suggested, noting that its OSA resolution rate was fairly competitive with the 75% rate found for surgery in a recent review.
"We tend to think that surgery is definitive and is curative 100% of the time, but that's just not true," he said. "And it carries a significant risk."
The retrospective review included 836 otherwise healthy children ages 2 to 14 who were clinically and polysomnographically diagnosed with mild OSA at three centers.
Among them, 752 accepted open-label treatment with a combination of oral montelukast and an intranasal corticosteroid for 12 weeks, with continued montelukast for 6 to 12 months if symptoms persisted at subsequent polysomnographs or a recommendation for surgery if they worsened.
Predictors of nonresponse were older age (odds ratio 2.3 for age older than 7, 95% CI 1.43-4.13) and obesity (OR 6.3 with BMI z score over 1.65, 95% CI 4.23-11.18).
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