Association of Long-term Use of Calcium Channel Blockers (CCB) and Risk of Breast Cancer: A Retrospective Longitudinal Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 68,500
- 试验地点
- 1
- 主要终点
- Incident rate of invasive breast cancer
研究概览
简要总结
The goal of this retrospective observational study is to examine whether long-term calcium channel blocker (CCB) use is associated with the development of breast cancer amongst women enrolled in three longitudinal cohort studies in Australia and the Netherlands . The main questions it aims to answer are:
- Is long-term CCB use associated with the development of breast cancer amongst women enrolled in three longitudinal cohort studies in Australia and the Netherlands and what is the dose-response nature of this association.
- Does differences in the association between calcium channel blocker use and the development of breast cancer exist between Australian and Dutch women.
The investigators will utilise data from the Australian Longitudinal Study on Women's Health (ALSWH) , 45 and Up Study and Rotterdam study.
详细描述
Aims: To examine the association between long-term calcium channel blocker (CCB) use and the development of breast cancer.
Data sources: the Australian Longitudinal Study on Women's Health , 45 and Up Study, Rotterdam study and linked administrative data.
Study cohort: Women with self-reported hypertension (HTN) without prior breast cancer.
Harmonisation: Relevant variables will be checked for harmonisation in which variables available in all three cohort will be used in the harmonised analysis. The variables will be checked on the definition, measurement and harmonisation rules. Variables that cannot be harmonised across the cohorts will be used in the cohort specific analyses.
Exposure measurement: The primary exposure is the use of CCB, which will be identified by the anatomical therapeutic chemical code (C08) in the medicine data. Exposure to CCB as well as other antihypertensive (AHT) medicines will be captured separately as the cumulative dose-duration of exposure during follow up. Participants will be stratified in four groups: women with HTN with no AHT use, women with HTN exposed to CCB only, women with HTN exposed to non-CCB and women with HTN exposed to both CCB and non-CCB.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
No AHT
Women with HTN with no AHT use
干预措施: None AHT (Drug)
AHT but non-CCB
Women with HTN exposed to other antihypertensive medicines but not exposed to calcium channel blockers
干预措施: Beta blocker (Drug)
AHT but non-CCB
Women with HTN exposed to other antihypertensive medicines but not exposed to calcium channel blockers
干预措施: Diuretic (Drug)
AHT but non-CCB
Women with HTN exposed to other antihypertensive medicines but not exposed to calcium channel blockers
干预措施: RAS (Drug)
AHT but non-CCB
Women with HTN exposed to other antihypertensive medicines but not exposed to calcium channel blockers
干预措施: Other AHT (Drug)
CCB only
Women with HTN exposed to calcium channel blockers but not exposed to other antihypertensive medicines
干预措施: Calcium channel blocker (Drug)
Both CCB and non-CCB
Women with HTN exposed to both calcium channel blockers and other antihypertensive medicines.
干预措施: Calcium channel blocker (Drug)
Both CCB and non-CCB
Women with HTN exposed to both calcium channel blockers and other antihypertensive medicines.
干预措施: RAS (Drug)
Both CCB and non-CCB
Women with HTN exposed to both calcium channel blockers and other antihypertensive medicines.
干预措施: Beta blocker (Drug)
Both CCB and non-CCB
Women with HTN exposed to both calcium channel blockers and other antihypertensive medicines.
干预措施: Diuretic (Drug)
Both CCB and non-CCB
Women with HTN exposed to both calcium channel blockers and other antihypertensive medicines.
干预措施: Other AHT (Drug)
结局指标
主要结局
Incident rate of invasive breast cancer
时间窗: From cohort entry until the earliest date of one of the following: a diagnosis of invasive breast cancer, bilateral mastectomy (without breast cancer) or death, assessed up to 14 years.
The outcome will be defined based on the ICD-10 code of C50.x (malignant neoplasm of breast).
次要结局
未报告次要终点
研究者
Rachael Moorin
Professor
Curtin University