Feasibility study to assess the viability of a future observational study of the effects of corticosteroids on the incidence and progression of type 2 diabetes

Study type
Feasibility Study
Date of Approval
Study reference ID
FS000045
Lay Summary

Corticosteroids are a group of drugs that reduce inflammation and suppress the body’s immune response. They are commonly prescribed to treat a wide variety of conditions, including asthma, eczema, painful joints and muscles, and Crohn’s disease. However, corticosteroids are associated with a number of side-effects, including increased infections and fractures. We are interested in the extent to which corticosteroids of different types, dosages and forms (such as tablet, injection, or inhaler) might be associated with an increased risk of developing type 2 diabetes or of worsened type 2 diabetes where this is already present. This is a feasibility study to obtain counts and proportions of patients prescribed corticosteroids of different types and forms in our study year, 2015, and the proportions of these who have diabetes at their first corticosteroid prescription or who develop diabetes in the 12 months or 24 months following that first prescription. These data will inform us about the viability of a proposed study, also using CPRD data, that would look into associations between corticosteroids and diabetes in more detail and identify whether there are unmet needs that might be addressed by new, alternative treatments.

Technical Summary

Limited data exist on the risks of incident diabetes and diabetes progression in patients prescribed corticosteroids. Published data, predominantly from the turn of the century, suggest a doubling of incident diabetes risk in elderly people prescribed corticosteroids. In patients taking corticosteroids who already have diabetes, anecdotal evidence suggests that worsening glucose control and subsequent treatment escalation (including insulin initiation) have a substantial impact on morbidity and mortality, driving hypertension, dyslipidaemia and weight gain. The aim of this descriptive feasibility study is to tabulate counts of patients issued prescriptions for corticosteroids in 2015, overall and by corticosteroid type and route of administration, presenting these also as proportions of the total eligible CPRD population in that year, and – of these patients – to obtain counts of those who had a record of type 2 diabetes at baseline or who had a first record of type 2 diabetes in the 12 or 24 months from baseline, presenting these, respectively, as proportions of all corticosteroid patients and of diabetes-naïve patients at baseline. It is intended that these data should inform the feasibility of a more detailed, observational study using CPRD data, which would examine type 2 diabetes incidence and progression (in terms of treatment change, HbA1c and other metabolic measurements) over time by corticosteroid drug, route, prescribing pattern and dose.

Health Outcomes to be Measured

Prescriptions for corticosteroid products issued in 2015 by drug and route; patients to whom corticosteroids were prescribed in 2015 by drug and route; type 2 diabetes

Collaborators

Craig Currie - Chief Investigator - Cardiff University
Sara Jenkins-Jones - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Ellen Hubbuck - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Philip Ambery - Collaborator - AstraZeneca Ltd - UK Headquarters