Quantifying the real life risk profile of inhaled corticosteroids in COPD by record linkage analysis.

Rob W Flynn,Adrian Hapca,Isla S Mackenzie,Thomas M Macdonald,Stuart Schembri

doi:10.1186/s12931-014-0141-y

Rob W Flynn, Adrian Hapca + Show 3 more

Open Access

https://doi.org/10.1186/s12931-014-0141-y

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Journal: Respiratory research	Publication Date: Nov 19, 2014
Citations: 47	License type: CC BY 4.0

Affiliation: Ninewells Hospital, University of Dundee

Abstract

BackgroundInhaled corticosteroids (ICS), especially when prescribed in combination with long-acting β2 agonists have been shown to improve COPD outcomes. Although there is consistent evidence linking ICS with adverse effects such as pneumonia, the complete risk profile is unclear with conflicting evidence on any association between ICS and the incidence or worsening of existing diabetes, cataracts and fractures. We investigated this using record linkage in a Dundee COPD population.MethodsA record linkage study linking COPD and diabetes datasets with prescription, hospitalisation and mortality data via a unique Community Health Index (CHI) number. A Cox regression model was used to determine the association between ICS use and new diabetes or worsening of existing diabetes and hospitalisations for pneumonia, fractures or cataracts after adjusting for potential confounders. A time dependent analysis of exposure comparing time on versus off ICS was used to take into account patients changing their exposure status during follow-up and to prevent immortal time bias.Results4305 subjects (3243 exposed to ICS, total of 17,229 person-years of exposure and 1062 non exposed, with a follow-up of 4,508 patient-years) were eligible for the study. There were 239 cases of new diabetes (DM) and 265 cases of worsening DM, 550 admissions for pneumonia, 288 hospitalisations for fracture and 505 cataract related admissions. The hazard ratio for the association between cumulative ICS and outcomes were 0.70 (0.43-1.12), 0.57 (0.24-1.37), 1.38 (1.09-1.74), 1.08 (0.73-1.59) and 1.42 (1.07-1.88) after multivariate analysis respectively.ConclusionThe use of ICS in our cohort was not associated with new onset of diabetes, worsening of existing diabetes or fracture hospitalisation. There was however an association with increased cataracts and pneumonia hospitalisations.

Highlights

Inhaled corticosteroids (ICS), especially when prescribed in combination with long-acting β2 agonists have been shown to improve Chronic obstructive pulmonary disease (COPD) outcomes
This is especially the case with ICS, as for example in Scotland, the Scottish Medicines Consortium has consistently advised that ICS should not be used for patients with COPD and a Forced expiratory volume in one second (FEV1) > 50% of predicted [12,13], they are widely used in patients outside these strict spirometric parameters [14]
The Medicines Monitoring Unit (MEMO) database contains several datasets including all dispensed community prescriptions, hospital discharge data, demographic data and biochemistry results. These data can be linked to disease-specific databases such as Tayside allergy and respiratory disease information system (TARDIS) (Tayside Allergy and Respiratory Disease Information System), Diabetes audit and research in tayside (DARTS) (The Diabetes Audit and Research in Tayside Scotland; called SCIDC) and other routine clinical data, all of which are linked by a Community Health Index (CHI) number that is unique to each patient

Summary

Introduction

Inhaled corticosteroids (ICS), especially when prescribed in combination with long-acting β2 agonists have been shown to improve COPD outcomes. There is consistent evidence linking ICS with adverse effects such as pneumonia, the complete risk profile is unclear with conflicting evidence on any association between ICS and the incidence or worsening of existing diabetes, cataracts and fractures. We investigated this using record linkage in a Dundee COPD population. Inhaled corticosteroids (ICS), especially when prescribed in combination with long-acting β2 agonists (LABA) improve quality of life (QoL), decrease exacerbations and hospitalisations, and have been associated with a trend towards a reduction in all-cause mortality [5]. This is especially the case with ICS, as for example in Scotland, the Scottish Medicines Consortium has consistently advised that ICS should not be used for patients with COPD and a FEV1 > 50% of predicted [12,13], they are widely used in patients outside these strict spirometric parameters [14]

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