The Use of Angiotensin Receptor Blockers and the Risk of Cancer

Completed

• Conditions: Neoplasm
• Interventions: Drug: ARB; Drug: ACEI; Drug: Beta-blockers; Drug: Diuretics; Drug: Telmisartan

• Registration Number: NCT02215733
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The primary objective of this study was to assess whether angiotensin blockers (ARBs) and telmisartan in particular, are associated with an increased overall risk of the four most common cancers, namely, lung, colorectal, breast and prostate cancers. A secondary objective was to explore these effects separately for each of the four cancers and in combination with angiotensin-converting-enzyme-inhibitors (ACEIs).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Primary Completion: 2012-02
• Status Verified: 2014-08
• Study First Submitted: 2014-08-12
• Study First Submitted QC: 2014-08-12
• Last Update Submitted: 2014-08-12
• Study First Posted: 2014-08-13
• Last Update Posted: 2014-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1165781

Inclusion Criteria

• Patients prescribed an antihypertensive agent between 01-JAN-1995 and 31-DEC-2008 with at least two years of up-to-standard medical history in United Kingdom's General Practice Research Database (GPRD)

Exclusion Criteria

• History of cancer at any time prior to cohort entry

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients prescribed antihypertensives	ACEI	-
Patients prescribed antihypertensives	Diuretics	-
Patients prescribed antihypertensives	ARB	-
Patients prescribed antihypertensives	Beta-blockers	-
Patients prescribed antihypertensives	Telmisartan	-

Primary Outcome Measures

Name	Time	Method
Ratio of occurrence of lung, colorectal, breast and prostate cancers related to use of telmisartan, relative to beta-blockers and diuretics	16 years
Ratio of occurrence of lung, colorectal, breast and prostate cancers related to use of telmisartan relative to other ARBs	16 years
Number of patients with occurrences of lung, colorectal, breast and prostate cancers related to use of ARBs	16 years
Determination of dose-response in terms of ARB duration of use and cumulative dose and the risk of lung, colorectal, breast and prostate cancers combined	16 years
Ratio of occurrence of lung, colorectal, breast and prostate cancers related to use of ARBs, relative to beta-blockers and diuretics	16 years

Secondary Outcome Measures

Name	Time	Method
Number of patients with occurrences of lung cancer related to use of ARBs with ACEI	16 years
Number of patients with occurrences of breast cancer related to use of ARBs with ACEI	16 years
Number of patients with occurrences of lung cancer related to use of ARBs alone	16 years
Number of patients with occurrences of breast cancer related to use of ARBs alone	16 years
Ratio of occurrence of colorectal cancer related to use of telmisartan relative to other ARBs	16 years
Number of patients with occurrences of prostate cancer related to use of ARBs with ACEI	16 years
Ratio of occurrence of lung cancer related to use of telmisartan relative to other ARBs	16 years
Ratio of occurrence of prostate cancer related to use of telmisartan relative to other ARBs	16 years
Number of patients with occurrences of prostate cancer related to use of ARBs alone	16 years
Number of patients with occurrences of colorectal cancer related to use of ARBs alone	16 years
Number of patients with occurrences of colorectal cancer related to use of ARBs with ACEI	16 years
Ratio of occurrence of breast cancer related to use of telmisartan relative to other ARBs	16 years