Study type

Study topic

Disease /health condition
Human medicinal product

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Case-control
Study drug and medical condition

Study drug International non-proprietary name (INN) or common name

FINASTERIDE

Medical condition to be studied

Breast cancer male
Population studied

Short description of the study population

Males residing in either Denmark, Finland, Norway, or Sweden on the index date who were aged 35 years and older.
In substudy 1: Finasteride user group included men who have redeemed at least two prescriptions of finasteride in the study period (either as one group or divided into three groups, i.e. 2-3 packs of 98 pills, 4-6 packs, and 7+ packs), and Non-finasteride user group included men who have redeemed less than two prescriptions of finasteride in the study period.
In substudy 2: Men with a diagnosis of primary breast cancer (see section 9.2.3 Primary breast cancer case definition) were included as cases, whereas men without a diagnosis of breast cancer at index date were included as controls.

Age groups

  • Adult and elderly population (≥18 years)
    • Adults (18 to < 65 years)
      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)
      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)

Special population of interest

Other

Special population of interest, other

Breast cancer male patients

Estimated number of subjects

428000
Study design details

Main study objective

1. To describe finasteride users compared to non-users with respect to potential confounding factors.2. To analyze the effect of finasteride use on male breast cancer incidence while takingaccount of confounding factors that may explain the previously reported increasedincidence.

Outcomes

Stage 1 - Person-Years of Exposure to Finasteride by Participant Age and Year Stage 1 - Initial Incidence Rates of Male Breast Cancer Stratified by Exposure to FinasterideStage 1 - All-Cause Mortality Rates in Males with Breast Cancer by Exposure to FinasterideStage 2 - Odds (or Likelihood) of Exposure to Finasteride in Male Breast Cancer Cases Relative to Controls

Data analysis plan

1. Logistic regression will be performed by comparing potential confounding factors forfinasteride users compared to non-users and between levels of cumulative finasteride use. 2. Conditional logistic regression will be performed by comparing male breast cancercases with controls in respect to either finasteride users versus non-users or cumulative finasteride use and including confounding factors in the analysis.