PMID- 22902134 OWN - NLM STAT- MEDLINE DCOM- 20130116 LR - 20151119 IS - 1532-3064 (Electronic) IS - 0954-6111 (Linking) VI - 106 IP - 11 DP - 2012 Nov TI - Risk of new onset diabetes mellitus in patients with asthma or COPD taking inhaled corticosteroids. PG - 1487-93 LID - S0954-6111(12)00273-9 [pii] LID - 10.1016/j.rmed.2012.07.011 [doi] AB - BACKGROUND: A recent case-controlled study reported an increased risk of diabetes mellitus in patients treated with inhaled corticosteroids for asthma or COPD, versus age-matched controls. OBJECTIVE: The purpose of the current study was to evaluate whether there was an increased risk of new onset diabetes mellitus or hyperglycaemia among patients with asthma or COPD treated with inhaled corticosteroids. METHODS: A retrospective analysis evaluated all double-blind, placebo-controlled, trials in patients >/=4 years of age involving budesonide or budesonide/formoterol in asthma (26 trials; budesonide: n = 9067; placebo: n = 5926), and in COPD (8 trials; budesonide: n = 4616; non-ICS: n = 3643). A secondary dataset evaluated all double-blind, controlled trials in asthma involving the use of inhaled corticosteroids (60 trials; budesonide: n = 33,496; fluticasone: n = 2773). RESULTS: In the primary asthma dataset, the occurrence of diabetes mellitus/hyperglycaemia adverse events (AEs) was 0.13% for budesonide and 0.13% for placebo (HR 0.98 [95% CI: 0.38-2.50], p = 0.96) and serious adverse events (SAEs) was 0% for budesonide and 0.05% for placebo. In the secondary dataset, the occurrence of diabetes/hyperglycaemia as AE and SAE was 0.19% and 0.03%, respectively. In the COPD dataset, the occurrence of diabetes mellitus/hyperglycaemia AEs was 1.3% for budesonide and 1.2% for non-ICS (HR 0.99 [95% CI: 0.67-1.46], p = 0.96) and SAEs was 0.1% for budesonide and 0.03% for non-ICS. CONCLUSION AND CLINICAL RELEVANCE: Treatment with inhaled corticosteroids in patients with asthma or COPD was not associated with increased risk of new onset diabetes mellitus or hyperglycaemia. CI - Copyright (c) 2012 Elsevier Ltd. All rights reserved. FAU - O'Byrne, P M AU - O'Byrne PM AD - Firestone Institute of Respiratory Health, Michael G DeGroote School of Medicine, McMaster University, Hamilton, Ontario, Canada. obyrnep@mcmaster.ca FAU - Rennard, S AU - Rennard S FAU - Gerstein, H AU - Gerstein H FAU - Radner, F AU - Radner F FAU - Peterson, S AU - Peterson S FAU - Lindberg, B AU - Lindberg B FAU - Carlsson, L-G AU - Carlsson LG FAU - Sin, D D AU - Sin DD LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't PT - Review DEP - 20120815 PL - England TA - Respir Med JT - Respiratory medicine JID - 8908438 RN - 0 (Adrenal Cortex Hormones) RN - 0 (Androstadienes) RN - 0 (Anti-Asthmatic Agents) RN - 0 (Ethanolamines) RN - 51333-22-3 (Budesonide) RN - CUT2W21N7U (Fluticasone) RN - W34SHF8J2K (Formoterol Fumarate) SB - IM MH - Administration, Inhalation MH - Adrenal Cortex Hormones/administration & dosage/*adverse effects MH - Adult MH - Androstadienes/administration & dosage/adverse effects MH - Anti-Asthmatic Agents/administration & dosage/*adverse effects MH - Asthma/*drug therapy MH - Budesonide/administration & dosage/adverse effects MH - Diabetes Mellitus/*chemically induced MH - Double-Blind Method MH - Ethanolamines/administration & dosage/adverse effects MH - Fluticasone MH - Formoterol Fumarate MH - Humans MH - Hyperglycemia/chemically induced MH - Pulmonary Disease, Chronic Obstructive/*drug therapy MH - Randomized Controlled Trials as Topic MH - Retrospective Studies MH - Risk Factors EDAT- 2012/08/21 06:00 MHDA- 2013/01/17 06:00 CRDT- 2012/08/21 06:00 PHST- 2012/05/11 00:00 [received] PHST- 2012/07/19 00:00 [revised] PHST- 2012/07/25 00:00 [accepted] PHST- 2012/08/21 06:00 [entrez] PHST- 2012/08/21 06:00 [pubmed] PHST- 2013/01/17 06:00 [medline] AID - S0954-6111(12)00273-9 [pii] AID - 10.1016/j.rmed.2012.07.011 [doi] PST - ppublish SO - Respir Med. 2012 Nov;106(11):1487-93. doi: 10.1016/j.rmed.2012.07.011. Epub 2012 Aug 15.