IMI PROTECT (Work Package 2): Calcium Channel Blockers and Cancer

NCT01587742 | Completed

• 2 other identifiers: 115736WEUKBRE5558
• Study Type: observational
• Target: 1
• Locations: 0 countries
• Sites: N/A

Brief Summary

The studies described in this protocol are all performed within the framework of PROTECT (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium) Workpackage 2 (WP2) and Workgroup 1. The primary aim of these studies is to develop, test and disseminate methodological standards for the design, conduct and analysis of Pharmacoepidemiological (PE) studies applicable to different safety issues and using different data sources. To achieve this, results from PE studies on 5 key adverse events (AEs) performed in different databases will be evaluated. Therefore, emphasis will be on the methodological aspects of the studies in this protocol and not on the clinical consequences of the association under investigation. The standards to develop will contribute to decreasing the discrepancies in results from different studies in the future and increase the usefulness and reliability of these studies for benefit-risk assessment in the EU. Within WP2, five possible adverse event - drug pairs have been selected for analyses; one of these includes the possible role of calcium channel blockers (CCBs) in the risk of cancer. Analyses will address the hypothesis that CCBs modify the risk of cancer (all forms of cancer combined and various groups of cancers). This hypothesis will be investigated using two sources of data: the UK General Practice Research Database (GPRD) and the Danish national databases. Investigations in the UK may also use The Health Improvement Network (THIN). The primary objective of the study is to investigate the possible association between use of CCBs and risk of all forms of cancer combined, among adult patients (18 to 79 years of age during the study period, January 1, 1996 to December 31, 2009). The study will be conducted using three databases with different study designs (descriptive, cohort, population based cohort study and nested case-control) across different databases (GPRD, THIN, Danish databases) and to compare the results between databases, across designs to evaluate the impact of design/database/population differences on the outcome of the studied association. Secondary objectives are to investigate the potential association between use of CCBs and risk of all forms of breast cancer in women; all forms of prostate cancer; and all forms of colon cancer using the same age groups and databases).

Conditions

Hypertension

Keywords

Calcium channel blockers; cancer

Outcome Measures

Primary Outcomes (1)

• Change in incidence of primary cancer (all forms) cases, defined by Read codes in GPRD/THIN and ICD-10 codes in the Danish data

  During Jan 1, 1996 to Dec 31, 2009 , cancer outcomes will be assessed as those occurring six months - 1 year, 1-4 years and more than 5 years following initiation of CCB therapy

Secondary Outcomes (3)

• Change in incidence of breast cancer cases in women only defined by Read codes in GPRD/THIN and ICD-10 codes in the Danish data

  During Jan 1, 1996 to Dec 31, 2009, cancer outcomes will be assessed as those occurring six months - 1 year, 1-4 years and more than 5 years following initiation of CCB therapy

• Change in incidence of prostate cancer cases only, defined by Read codes in GPRD/THIN and ICD-10 codes in the Danish data

  During Jan 1, 1996 to Dec 31, 2009, cancer outcomes will be assessed as those occurring six months - 1 year, 1-4 years and more than 5 years following initiation of CCB therapy

• Change in incidence of colon cancer cases only, defined by Read codes in GPRD/THIN and ICD-10 codes in the Danish data

  During Jan 1, 1996 to Dec 31, 2009, cancer outcomes will be assessed as those occurring six months - 1 year, 1-4 years and more than 5 years following initiation of CCB therapy

Study Arms (5)

Patients with a diagnosis of any cancer type

All patients of the study population with a diagnosis of any cancer type based on Read codes and ICD-10 codes

Drug: CCB use

Patients with a diagnosis of breast cancer

All patients of the study population with a diagnosis of breast cancer based on Read codes and ICD-10 codes

Drug: CCB use

Patients with a diagnosis of prostate cancer

All patients of the study population with a diagnosis of prostate cancer based on Read codes and ICD-10 codes

Drug: CCB use

Patients with a diagnosis of colon cancer

All patients of the study population with a diagnosis of colon cancer based on Read codes and ICD-10 codes

Drug: CCB use

Patients without a diagnosis of any cancer type

All patients of the study population without a diagnosis of any cancer type

Drug: CCB use

Interventions

CCB use DRUG

Prescription of CCB during the study period between January 1, 1996 to December 31, 2009. The CCBs administered to the patients include isradipine and lacidipine.

Patients with a diagnosis of any cancer type; Patients with a diagnosis of breast cancer; Patients with a diagnosis of colon cancer; Patients with a diagnosis of prostate cancer; Patients without a diagnosis of any cancer type

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of CCB first-time users and non-users from January 1, 1996 to December 31, 2009, aged 18 to 79 years enrolled in the GPRD, THIN or Danish National database

You may qualify if:

• First time users or non-users of a CCB from January 1, 1996 to December 31, 2009
• Patients aged 18 to 79 years

You may not qualify if:

• Patients with any cancer recorded in the GPRD or the Danish database prior to cohort entry
• Patients aged less than 18 years or more than 79 years

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Hypertension; Neoplasms

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2012
• First Posted: April 30, 2012
• Study Start: November 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: August 1, 2014
• Last Updated: December 23, 2014

Record last verified: 2014-12