The Use of Angiotensin Receptor Blockers and the Risk of Cancer

Neoplasm Clinical Trial

Official title:

The Use of Angiotensin Receptor Blockers and the Risk of Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02215733
• Other study ID #: 502.599
• Status: Completed
• Phase: N/A
• First received: August 12, 2014
• Last updated: August 12, 2014
• Start date: February 2011

Study information

• Verified date: August 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1165781
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Neoplasm

Intervention

Drug:
• ARB
other than telmisartan
• ACEI

• Beta-blockers

• Diuretics

• Telmisartan

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with occurrences of lung, colorectal, breast and prostate cancers related to use of ARBs		16 years	No
Primary	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	No
Primary	Ratio of occurrence of lung, colorectal, breast and prostate cancers related to use of ARBs, relative to beta-blockers and diuretics		16 years	No
Primary	Ratio of occurrence of lung, colorectal, breast and prostate cancers related to use of telmisartan, relative to beta-blockers and diuretics		16 years	No
Primary	Ratio of occurrence of lung, colorectal, breast and prostate cancers related to use of telmisartan relative to other ARBs		16 years	No
Secondary	Number of patients with occurrences of lung cancer related to use of ARBs alone		16 years	No
Secondary	Number of patients with occurrences of colorectal cancer related to use of ARBs alone		16 years	No
Secondary	Number of patients with occurrences of breast cancer related to use of ARBs alone		16 years	No
Secondary	Number of patients with occurrences of prostate cancer related to use of ARBs alone		16 years	No
Secondary	Number of patients with occurrences of lung cancer related to use of ARBs with ACEI		16 years	No
Secondary	Number of patients with occurrences of colorectal cancer related to use of ARBs with ACEI		16 years	No
Secondary	Number of patients with occurrences of breast cancer related to use of ARBs with ACEI		16 years	No
Secondary	Number of patients with occurrences of prostate cancer related to use of ARBs with ACEI		16 years	No
Secondary	Ratio of occurrence of lung cancer related to use of telmisartan relative to other ARBs		16 years	No
Secondary	Ratio of occurrence of colorectal cancer related to use of telmisartan relative to other ARBs		16 years	No
Secondary	Ratio of occurrence of breast cancer related to use of telmisartan relative to other ARBs		16 years	No
Secondary	Ratio of occurrence of prostate cancer related to use of telmisartan relative to other ARBs		16 years	No

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