Antihypertensive Medications and the Risk of Sepsis

Completed

• Conditions: Hypertension
• Interventions: Drug: Telmisartan; Drug: Other angiotensin-receptor blockers (ARBs); Drug: Angiotensin-converting enzyme inhibitors (ACEIs); Drug: Other major antihypertensive medication classes

• Registration Number: NCT02248896
• Lead Sponsor: Boehringer Ingelheim

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2011-03
• Status Verified: 2014-09
• Study First Submitted: 2014-09-24
• Study First Submitted QC: 2014-09-24
• Last Update Submitted: 2014-09-24
• Study First Posted: 2014-09-25
• Last Update Posted: 2014-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1129062

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

Exclusion Criteria

• Sepsis, chronic renal failure or on dialysis in the two-year period prior to cohort entry

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hypertensive patients	Other major antihypertensive medication classes	Hypertensive patients or patients treated with antihypertensive drugs with linked GPRD and hospital episodes statistics database (HES) data
Hypertensive patients	Other angiotensin-receptor blockers (ARBs)	Hypertensive patients or patients treated with antihypertensive drugs with linked GPRD and hospital episodes statistics database (HES) data
Hypertensive patients	Angiotensin-converting enzyme inhibitors (ACEIs)	Hypertensive patients or patients treated with antihypertensive drugs with linked GPRD and hospital episodes statistics database (HES) data
Hypertensive patients	Telmisartan	Hypertensive patients or patients treated with antihypertensive drugs with linked GPRD and hospital episodes statistics database (HES) data

Primary Outcome Measures

Name	Time	Method
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