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The Use of Angiotensin Receptor Blockers and the Risk of Cancer

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ClinicalTrials.gov Identifier: NCT02215733
Recruitment Status : Completed
First Posted : August 13, 2014
Last Update Posted : August 13, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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).

Condition or disease Intervention/treatment
Neoplasm Drug: ARB Drug: ACEI Drug: Beta-blockers Drug: Diuretics Drug: Telmisartan

Study Design

Study Type : Observational
Actual Enrollment : 1165781 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Use of Angiotensin Receptor Blockers and the Risk of Cancer
Study Start Date : February 2011
Primary Completion Date : February 2012
Groups and Cohorts

Group/Cohort Intervention/treatment
Patients prescribed antihypertensives Drug: ARB
other than telmisartan
Drug: ACEI Drug: Beta-blockers Drug: Diuretics Drug: Telmisartan


Outcome Measures

Primary Outcome Measures :
  1. Number of patients with occurrences of lung, colorectal, breast and prostate cancers related to use of ARBs [ Time Frame: 16 years ]
  2. 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 [ Time Frame: 16 years ]
  3. Ratio of occurrence of lung, colorectal, breast and prostate cancers related to use of ARBs, relative to beta-blockers and diuretics [ Time Frame: 16 years ]
  4. Ratio of occurrence of lung, colorectal, breast and prostate cancers related to use of telmisartan, relative to beta-blockers and diuretics [ Time Frame: 16 years ]
  5. Ratio of occurrence of lung, colorectal, breast and prostate cancers related to use of telmisartan relative to other ARBs [ Time Frame: 16 years ]

Secondary Outcome Measures :
  1. Number of patients with occurrences of lung cancer related to use of ARBs alone [ Time Frame: 16 years ]
  2. Number of patients with occurrences of colorectal cancer related to use of ARBs alone [ Time Frame: 16 years ]
  3. Number of patients with occurrences of breast cancer related to use of ARBs alone [ Time Frame: 16 years ]
  4. Number of patients with occurrences of prostate cancer related to use of ARBs alone [ Time Frame: 16 years ]
  5. Number of patients with occurrences of lung cancer related to use of ARBs with ACEI [ Time Frame: 16 years ]
  6. Number of patients with occurrences of colorectal cancer related to use of ARBs with ACEI [ Time Frame: 16 years ]
  7. Number of patients with occurrences of breast cancer related to use of ARBs with ACEI [ Time Frame: 16 years ]
  8. Number of patients with occurrences of prostate cancer related to use of ARBs with ACEI [ Time Frame: 16 years ]
  9. Ratio of occurrence of lung cancer related to use of telmisartan relative to other ARBs [ Time Frame: 16 years ]
  10. Ratio of occurrence of colorectal cancer related to use of telmisartan relative to other ARBs [ Time Frame: 16 years ]
  11. Ratio of occurrence of breast cancer related to use of telmisartan relative to other ARBs [ Time Frame: 16 years ]
  12. Ratio of occurrence of prostate cancer related to use of telmisartan relative to other ARBs [ Time Frame: 16 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
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
More Information

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02215733     History of Changes
Other Study ID Numbers: 502.599
First Posted: August 13, 2014    Key Record Dates
Last Update Posted: August 13, 2014
Last Verified: August 2014

Additional relevant MeSH terms:
Telmisartan
Angiotensin Receptor Antagonists
Diuretics
Adrenergic beta-Antagonists
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents