The Use of Angiotensin Receptor Blockers and the Risk of Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT02215733
First received: August 12, 2014
Last updated: NA
Last verified: August 2014
History: No changes posted
  Purpose

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 Intervention
Neoplasm
Drug: ARB
Drug: ACEI
Drug: Beta-blockers
Drug: Diuretics
Drug: Telmisartan

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Use of Angiotensin Receptor Blockers and the Risk of Cancer

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Number of patients with occurrences of lung, colorectal, breast and prostate cancers related to use of ARBs [ Time Frame: 16 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Ratio of occurrence of lung, colorectal, breast and prostate cancers related to use of telmisartan relative to other ARBs [ Time Frame: 16 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of patients with occurrences of lung cancer related to use of ARBs alone [ Time Frame: 16 years ] [ Designated as safety issue: No ]
  • Number of patients with occurrences of colorectal cancer related to use of ARBs alone [ Time Frame: 16 years ] [ Designated as safety issue: No ]
  • Number of patients with occurrences of breast cancer related to use of ARBs alone [ Time Frame: 16 years ] [ Designated as safety issue: No ]
  • Number of patients with occurrences of prostate cancer related to use of ARBs alone [ Time Frame: 16 years ] [ Designated as safety issue: No ]
  • Number of patients with occurrences of lung cancer related to use of ARBs with ACEI [ Time Frame: 16 years ] [ Designated as safety issue: No ]
  • Number of patients with occurrences of colorectal cancer related to use of ARBs with ACEI [ Time Frame: 16 years ] [ Designated as safety issue: No ]
  • Number of patients with occurrences of breast cancer related to use of ARBs with ACEI [ Time Frame: 16 years ] [ Designated as safety issue: No ]
  • Number of patients with occurrences of prostate cancer related to use of ARBs with ACEI [ Time Frame: 16 years ] [ Designated as safety issue: No ]
  • Ratio of occurrence of lung cancer related to use of telmisartan relative to other ARBs [ Time Frame: 16 years ] [ Designated as safety issue: No ]
  • Ratio of occurrence of colorectal cancer related to use of telmisartan relative to other ARBs [ Time Frame: 16 years ] [ Designated as safety issue: No ]
  • Ratio of occurrence of breast cancer related to use of telmisartan relative to other ARBs [ Time Frame: 16 years ] [ Designated as safety issue: No ]
  • Ratio of occurrence of prostate cancer related to use of telmisartan relative to other ARBs [ Time Frame: 16 years ] [ Designated as safety issue: No ]

Enrollment: 1165781
Study Start Date: February 2011
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients prescribed antihypertensives Drug: ARB
other than telmisartan
Drug: ACEI Drug: Beta-blockers Drug: Diuretics Drug: Telmisartan

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02215733     History of Changes
Other Study ID Numbers: 502.599
Study First Received: August 12, 2014
Last Updated: August 12, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Adrenergic beta-Antagonists
Telmisartan
Angiotensin Receptor Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Angiotensin II Type 1 Receptor Blockers

ClinicalTrials.gov processed this record on October 19, 2014