Antihypertensive Medications and the Risk of Sepsis

Sponsor

Boehringer Ingelheim (Industry)

Overall Status

Completed

CT.gov ID

NCT02248896

Collaborator

(none)

1,129,062

Enrollment

Study Details

Study Description

Brief Summary

The primary objective of this study was to assess whether there is an increased risk of sepsis with the use of telmisartan compared with other ARBs and with the other major antihypertensive classes, including ACEIs, beta-blockers, CCBs and thiazide diuretics. A secondary objective was to assess whether the use of ARBs and ACEIs, compared with the other three major antihypertensive classes and with untreated hypertension, is associated with an increased risk of sepsis. A third objective was to evaluate whether the use of telmisartan compared with other ARBs, ACEIs and other major antihypertensive classes is associated with an increased risk of worse outcomes due to sepsis, in particular acute kidney injury and death

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: Telmisartan Drug: Other angiotensin-receptor blockers (ARBs) Drug: Angiotensin-converting enzyme inhibitors (ACEIs) Drug: Other major antihypertensive medication classes

Study Design

Study Type:

Observational

Actual Enrollment :

1129062 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Official Title:

Antihypertensive Medications and the Risk of Sepsis

Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

Mar 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Hypertensive patients Hypertensive patients or patients treated with antihypertensive drugs with linked GPRD and hospital episodes statistics database (HES) data	Drug: Telmisartan Drug: Other angiotensin-receptor blockers (ARBs) Drug: Angiotensin-converting enzyme inhibitors (ACEIs) Drug: Other major antihypertensive medication classes e.g. beta-blockers, calcium channel blockers (CCBs), diuretics

Arm

Intervention/Treatment

Hypertensive patients

Hypertensive patients or patients treated with antihypertensive drugs with linked GPRD and hospital episodes statistics database (HES) data

Drug: Telmisartan

Drug: Other angiotensin-receptor blockers (ARBs)

Drug: Angiotensin-converting enzyme inhibitors (ACEIs)

Drug: Other major antihypertensive medication classes

e.g. beta-blockers, calcium channel blockers (CCBs), diuretics

Outcome Measures

Primary Outcome Measures

Occurence of sepsis, including severe sepsis [Up to 9 years and 5 months]
Severe sepsis defined as cases that develop renal failure or die within 30 days

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients, 18 years or older, with at least two-year follow-up in United Kingdom's general practice research database (GPRD), who had a diagnosis of or treatment for hypertension