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 Approval
Application Number
16_060
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 zoste,r 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 - Collaborator - Roche
Liam Heaney - Collaborator - Queen's University Belfast
Marlene Rauch - Collaborator - University of Basel
Shih-Chen Chang - Collaborator - Pharmacyclics
Susan Jick - Collaborator - BCDSP - Boston Collaborative Drug Surveillance Program

Linkages

HES Admitted Patient Care