The utilization and toxicity profile of oral corticosteroids among asthma patients in the UK: an epidemiological study using Data from the Clinical Practice Research Datalink (CPRD).

Date of ISAC Approval: 
23/05/2016
Lay Summary: 
In addition to their desired effect, corticosteroids tablets (drugs suppressing the immune system and inflammation) may damage various organs of the human body.They can lead to thinning of the bones and subsequent fractures, increased eye pressure or clouding of the lens in the eye, increased blood pressure and blood lipids, or suppression of the immune system causing infections. It is presumed that especially long-term use and high daily doses of corticosteroids tablets are the driving force behind the development of such undesired effects. Corticosteroids tablets are a mainstay treatment for severe asthma (an illness that makes breathing difficult), but the risk of developing such undesired effects has not been quantified in asthma patients specifically, where patients may take corticosteroids tablets on a short term basis for acute asthma attacks continuously in severe asthma which cannot be controlled by other drugs. We aim to quantify the risk of corticosteroid-related undesired effects in asthma patients with short term or continuous use, and we will assess the role of how long and in which doses the patients used these tablets.
Technical Summary: 
We aim to perform a cohort study to quantify incidence rates of corticosteroid-related adverse effects in asthma patients with and without oral prednisone or prednisolone (the most commonly used oral corticosteroids, referred to as prednisolone in this protocol) use. In a matched (1:4) nested case-control analysis we will then quantify relative risk estimates (calculated as odds ratios) for prednisolone-related adverse effects, sub-classified into the duration of prednisolone use, continuous vs. burst use, the cumulative prednisolone dose (in continuous and burst users separately) and the average daily prednisolone dose in continuous users. We will apply multivariable conditional logistic regression analyses to calculate odds ratios with 95% confidence intervals. The proposed study is the first study to quantify corticosteroid-related adverse effects in asthma patients specifically, and which will differentiate between patients with burst use of oral prednisolone and of continuous oral maintenance therapy with prednisolone.
Health Outcomes to be Measured: 
Bone related conditions; bone fracture, osteoporosis Hypertension Peptic or esophageal ulcer Severe infections requiring hospitalization Herpes zoster Diabetes Cataract Glaucoma Chronic kidney disease Psychiatric events Cardiovascular disease
Collaborators: 

Christoph Meier - Chief Investigator - University of Basel
Julia Spoendlin - Collaborator - University of Basel
Klaus Kuhlbusch - Researcher - Roche
Liam Heaney - Researcher - Queens University Belfast
Marlene Bloechliger - Researcher - University of Basel
Shih-Chen Chang - Researcher - Pharmacyclics
Dr Susan S Jick - Researcher - BCDSP - Boston Collaborative Drug Surveillance Program

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