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

• Sponsor: University of Leeds (Other)
• Overall Status: Completed
• CT.gov ID: NCT03760562
• Collaborator: (none)
• Enrollment: 111,804
• Actual Duration (Months): 212.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: Glucocorticoids

Detailed 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 111804 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: The Risk of Hypertension Associated With Oral Glucocorticoids in Chronic Inflammatory Diseases in England.
• Actual Study Start Date: Jan 1, 1998
• Actual Primary Completion Date: Jan 30, 2015
• Actual Study Completion Date: Sep 30, 2015

Outcome Measures

Primary Outcome Measures

1. Glucocorticoid-related hypertension [18 years]

   Number of patients with incident hypertension

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Leeds

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mar Pujades Rodriguez, Principal Investigator, University of Leeds
• ClinicalTrials.gov Identifier: NCT03760562
• Other Study ID Numbers: 16_146H
• First Posted: Nov 30, 2018
• Last Update Posted: Nov 30, 2018
• Last Verified: Nov 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypertension; Glucocorticoids

Study Results

No Results Posted as of Nov 30, 2018