PT  - JOURNAL ARTICLE
AU  - Paul O'Byrne
AU  - Stephen Rennard
AU  - Radner Finn
AU  - Stefan Peterson
AU  - Lars-Goran Carlsson
AU  - Don Sin
TI  - Risks of diabetes mellitus and hyperglycaemic adverse events in patients with asthma taking inhaled corticosteroids
DP  - 2011 Sep 01
TA  - European Respiratory Journal
PG  - p3968
VI  - 38
IP  - Suppl 55
4099  - http://erj.ersjournals.com/content/38/Suppl_55/p3968.short
4100  - http://erj.ersjournals.com/content/38/Suppl_55/p3968.full
SO  - Eur Respir J2011 Sep 01; 38
AB  - Background: A recent study of patients with lung disease and with prescriptions for inhaled corticosteroids (ICS) detected a 34% increased risk of diabetes mellitus.Methods: A retrospective analysis evaluated the double-blind, placebo-controlled, clinical trials in asthma (duration >3 months) in patients ≥4 years of age, involving budesonide (BUD) or BUD/formoterol (26 trials, n=9067 for BUD; n=5926 for placebo). A supplementary dataset evaluated all double-blind, non-placebo controlled trials in asthma (duration >3 months), involving the use of ICS (60 trials, n=33496 for BUD, n=2773 for fluticasone propionate [FP]). Cox proportional hazards regression modelling, both adjusted and not adjusted by study, was used to estimate the relative effect of ICS on diabetes mellitus/hyperglycaemia adverse events (AEs) or serious adverse events (SAEs) in both the primary and supplementary datasets.Results: In the primary dataset, the occurrence of diabetes mellitus/hyperglycaemia AEs was 0.13% for BUD and 0.13% for placebo (HR 0.98 [95% CI: 0.38–2.50], p=0.96); the occurrence of diabetes mellitus/hyperglycaemia SAEs was 0% for BUD and 0.05% for placebo. In the supplementary dataset, the occurrence of diabetes/hyperglycaemia as AE and SAE was 0.19% and 0.03%, respectively. There was no increased risk with higher doses of BUD, nor any difference between BUD and FP. The risk for diabetes mellitus/hyperglycaemia increased with age, BMI and disease severity.Conclusion: This retrospective analysis of all double-blind trials with BUD in asthmatic patients did not demonstrate any increased risk of diabetes mellitus/hyperglycaemia with BUD treatment.Funded by AstraZeneca.