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

Adrenal; Insufficiency Gluccorticoid-Induced Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03575247
• Other study ID #: 16_146
• Status: Completed
• Start date: January 1, 1998
• Est. completion date: September 30, 2015

Study information

• Verified date: June 2018
• Source: University of Leeds
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Adrenal insufficiency is a clinical condition that is associated with a deficiency of adrenal hormones, mainly: glucocorticoids and mineralocorticoids. Cushing syndrome is also a condition that stems from the existence of persistent high cortisol level in the body. The majority of Cushing syndrome cases are exogenous (iatrogenic or due to use of medication).

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. This is a retrospective cohort study of people diagnosed with at least one of six chronic inflammatory diseases (polymialgia rheumatica, giant cell arteritis, systemic lupus erythematosus, rheumatoid arthritis, vasculitis and inflammatory bowel disease).

This study will be based on the analysis of existing primary care health records routinely collected, linked to hospital and mortality data.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111804
• Est. completion date: September 30, 2015
• Est. primary completion date: January 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patients aged under 18 years during the study period

• Registered in general practices that did not consent to data linkage

Related Conditions & MeSH terms

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

Intervention

Drug:
• Glucocorticoids
Long-term use of glucocorticoids

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Leeds

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucocorticoid-related adrenal insufficiency	First recorded diagnosis of adrenal insufficiency	18 years
Primary	Glucocorticoid-related Cushing syndrome	First recorded diagnosis of Cushing syndrome	18 years
Secondary	All cause mortality	Recorded death of any cause	18 years