Background: Children with Asthma who do not respond to first-line therapy may need inhaled corticosteroid-long-acting beta agonist combination (ICS-LABA) therapy. Adrenal insufficiency (AI) due to adrenal suppression is a recognized but relatively uncommon side effect of ICS. An increase in suspected cases of AI associated with one particular ICS-LABA, mometasone-formoterol (Zenhale) was observed at a tertiary care Asthma clinic over a 6-month period.
Objective: To identify the prevalence of AI in children treated with Zenhale.
Methods: After confirmation of AI in the index patients by low-dose synthetic ACTH stimulation (LDST) all children on Zenhale are being screened for AI symptoms along with an 0800 h plasma cortisol. Children with symptoms suggestive of AI and/or low morning cortisol (<200 nmol/l) undergo a LDST by endocrinology.
Results: 170 children in the Asthma clinic were prescribed Zenhale. Screening has been completed in 101 children to date; 30 had LDST of which 15 (14.8%) had AI (see Table). In the <6y sub-group, nine of 18 children screened (50%) had AI.
|Median (range) *P<0.01 vs no suppression (n=86)||n||0800 h Plasma Cortisol (nmol/l)||Peak cortisol on LDST (nmol/l)||Age (years)||Zenhale dose (μg/day)|
|Low 0800 h Cortisol and/or AI symptoms||Adrenal suppression||15||13 (2255)||204 (11385)||5.2 (3.212.6)*||800 (400800)*|
|No adrenal suppression||15||88.5 (3233)||631 (482890)||9.1 (3.213.2)||400 (400800)|
|Normal 0800 h Cortisol and no AI symptoms||71||372 (203747)||NA||10.8 (2.518)||400 (200800)|
|No screening performed yet||69||NA||NA||10.2 (2.317.6)||400 (200800)|
Conclusion: Zenhale therapy in children can cause adrenal suppression. Those with AI were younger and on higher doses. We will present the age and dose with highest odds of AI after ROC and give likelihood ratios. Meanwhile, we suggest caution in the use of Zenhale in children <6y and doses >400 μg/day. Children/adolescents using Zenhale under 12y or on high daily doses (>500 μg) should be advised about the signs and symptoms of AI and to avoid abruptly stopping Zenhale therapy and to discuss any dose changes with their Asthma team.
20 - 22 Sep 2014
European Society for Paediatric Endocrinology