Antihypertensive Medications and the Risk of Sepsis

NCT02248896 | Completed

• 1 other identifier: 502.590
• Study Type: observational
• Target: 1,129,062
• Locations: 0 countries
• Sites: N/A

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

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Occurence of sepsis, including severe sepsis

  Severe sepsis defined as cases that develop renal failure or die within 30 days

  Up to 9 years and 5 months

Study Arms (1)

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

Interventions

Telmisartan DRUG

Hypertensive patients

Other angiotensin-receptor blockers (ARBs) DRUG

Hypertensive patients

Angiotensin-converting enzyme inhibitors (ACEIs) DRUG

Hypertensive patients

Other major antihypertensive medication classes DRUG

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

Hypertensive patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of, or treatment for hypertension

You may qualify if:

• \- 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

You may not qualify if:

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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Hypertension

Interventions

Telmisartan; Angiotensin-Converting Enzyme Inhibitors

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2014
• First Posted: September 25, 2014
• Study Start: January 1, 2010
• Primary Completion: March 1, 2011
• Last Updated: September 25, 2014

Record last verified: 2014-09