The Risk of Hypertension Associated With Oral Glucocorticoids in Chronic Inflammatory Diseases

Hypertension Clinical Trial

Official title:

The Risk of Hypertension Associated With Oral Glucocorticoids in Chronic Inflammatory Diseases in England.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03760562
• Other study ID #: 16_146H
• Status: Completed
• Start date: January 1, 1998
• Est. completion date: September 30, 2015

Study information

• Verified date: November 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. In 2008, it was estimated that 0.8% of the United Kingdom adult population had used long-term (≥ 3 months) glucocorticoids, rising to 3% in women aged over 80 years.

The aim of the project is to investigate the dose-response estimates of risk of high blood pressure associated with oral glucocorticoids.

Description:

Hypertension is a chronic condition which affects 1 in 5 of the world adult population. The cause of hypertension is unknown in about 95% of patients, whilst 5% are secondary to underlying adrenal disorders or other identifiable causes.

Glucocorticoids are widely used for the treatment of chronic inflammatory diseases. In 2008, it was estimated that 0.8% of the UK adult population had used long-term (≥ 3 months) glucocorticoids, rising to 3% in women aged over 80 years. Glucocorticoids are effective in controlling underlying chronic inflammatory disease in majority of cases. However, their continuous use can result in a variety of complications, including hypertension.Although it is acknowledged that excess cortisol is a leading cause of hypertension, the role of exogenous glucocorticoids is less known.

The aim of the project is to investigate the dose-response estimates of risk of high blood pressure associated with oral glucocorticoids.

This is a retrospective cohort study of people diagnosed with at least one of six chronic inflammatory diseases (polymyalgia 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
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients aged 18 years old or over

• Registered in a participating general practice 1 year or more 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

• Hypertension

Intervention

Drug:
• Glucocorticoids
Oral 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 hypertension	Number of patients with incident hypertension	18 years