Clinical trial NCT02215733: The Use of Angiotensin Receptor Blockers and the Risk of Cancer
Official title: The Use of Angiotensin Receptor Blockers and the Risk of Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplasm
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-08-13
Enrollment: 1165781
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients prescribed an antihypertensive agent between January 1, 1995 and December 31, 2008, with follow-up until December 31, 2010 Information extracted from United Kingdom General Practice Research Database (GPRD)

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).


Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with occurrences of lung, colorectal, breast and prostate cancers related to use of ARBs
timeFrame: 16 years
measure: 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
timeFrame: 16 years
measure: Ratio of occurrence of lung, colorectal, breast and prostate cancers related to use of ARBs, relative to beta-blockers and diuretics
timeFrame: 16 years
measure: Ratio of occurrence of lung, colorectal, breast and prostate cancers related to use of telmisartan, relative to beta-blockers and diuretics
timeFrame: 16 years
measure: Ratio of occurrence of lung, colorectal, breast and prostate cancers related to use of telmisartan relative to other ARBs
timeFrame: 16 years
Secondary outcomes:
measure: Number of patients with occurrences of lung cancer related to use of ARBs alone
timeFrame: 16 years
measure: Number of patients with occurrences of colorectal cancer related to use of ARBs alone
timeFrame: 16 years
measure: Number of patients with occurrences of breast cancer related to use of ARBs alone
timeFrame: 16 years
measure: Number of patients with occurrences of prostate cancer related to use of ARBs alone
timeFrame: 16 years
measure: Number of patients with occurrences of lung cancer related to use of ARBs with ACEI
timeFrame: 16 years
measure: Number of patients with occurrences of colorectal cancer related to use of ARBs with ACEI
timeFrame: 16 years
measure: Number of patients with occurrences of breast cancer related to use of ARBs with ACEI
timeFrame: 16 years
measure: Number of patients with occurrences of prostate cancer related to use of ARBs with ACEI
timeFrame: 16 years
measure: Ratio of occurrence of lung cancer related to use of telmisartan relative to other ARBs
timeFrame: 16 years
measure: Ratio of occurrence of colorectal cancer related to use of telmisartan relative to other ARBs
timeFrame: 16 years
measure: Ratio of occurrence of breast cancer related to use of telmisartan relative to other ARBs
timeFrame: 16 years
measure: Ratio of occurrence of prostate cancer related to use of telmisartan relative to other ARBs
timeFrame: 16 years
Other outcomes:
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