The Risk of Adrenal Insufficiency and Cushing Syndrome Associated With Glucocorticoid Therapy in People With Chronic Inflammatory Diseases

NCT03575247 | Completed

• 1 other identifier: 16_146
• Study Type: observational
• Target: 111,804
• Locations: 0 countries
• Sites: N/A

Brief Summary

Glucocorticoids are widely used for the treatment of chronic inflammatory diseases. Although glucocorticoids are effective in controlling disease symptoms, continuous use of the drugs can lead to suppression of adrenal hormones or excessive cortisol level in the blood stream. That is, excess blood cortisol level due to glucocorticoid exogenous supply can either inhibit the 'hypothalamus-pituitary-adrenal axis' for adrenal hormones production or result in Cushing symptoms. In the period between 1989 and 2008 in the UK, it was estimated that 0.6%-0.8% of the general adult population were long-term users of oral glucocorticoids. However, there is no data on the risk of adrenal suppression and Cushing syndrome due to chronic use of glucocorticoids in the UK to date. The aim of the study is to investigate the risk of adrenal insufficiency and Cushing syndrome due to long-term use of glucocorticoids in England.

Conditions

Adrenal; Insufficiency Gluccorticoid-Induced; Cushing; Syndrome or Disease, Glucocorticoid-Induced

Outcome Measures

Primary Outcomes (2)

• Glucocorticoid-related adrenal insufficiency

  First recorded diagnosis of adrenal insufficiency

  18 years

• Glucocorticoid-related Cushing syndrome

  First recorded diagnosis of Cushing syndrome

  18 years

Secondary Outcomes (1)

• All cause mortality

  18 years

Interventions

Glucocorticoids DRUG

Long-term use of glucocorticoids

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients registered in CPRD who were eligible for data linkage and had been diagnosed with at least one of six chronic inflammatory diseases (inflammatory bowel diseases, systemic lupus erythematosus, polymyalgia rheumatica, giant cell arteritis, rheumatoid arthritis, and vasculitis) in the period between 1st Jan 1998 and 30th September 2015.

You may qualify if:

• Patients aged 18 years old or over
• Registered in a participating general practice for more than 1 year during the study period
• Minimum of 1 year prior to study entry meeting CPRD data quality
• Diagnosed with at least one of the 6 chronic inflammatory diseases

You may not qualify if:

• Patients aged under 18 years during the study period
• Registered in general practices that did not consent to data linkage

Sponsors & Collaborators

• University of Leeds: lead

MeSH Terms

Conditions

Syndrome; Disease

Interventions

Glucocorticoids

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Mar Pujades-Rodriguez, PhD

  University of Leeds

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University Academic Fellow

Study Record Dates

• First Submitted: June 20, 2018
• First Posted: July 2, 2018
• Study Start: January 1, 1998
• Primary Completion: January 30, 2015
• Study Completion: September 30, 2015
• Last Updated: July 2, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share