5ARI and Prostate Cancer Mortality Study (116059)

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:
  Cohort

Study drug and medical condition

• Medicinal product name, other:
  dutasteride and finasteride

Population studied

• Short description of the study population:
  All men age 50 years and older treated with a BPH medication (5ARI and/or alphablocker) will be eligible for inclusion. Men using alpha-blocker medications were; selected as the comparison group for this study as alpha-blockers are the most common treatment for BPH and men with BPH or lower urinary tract symptoms that are untreated for their condition are likely to be very different from those with severe enough symptoms to seek medical care and take medication.; ; INCLUSION CRITERIA:; 1. Male; 2. A new prescription for BPH medication (5ARI and/or alpha-blocker) in 1992 or later that is identified as appropriate treatment for BPH/LUTS from the National Pharmacy guidelines; 3. Treatment with BPH medication initiated prior to Jan1, 2008.; 4. Age 50 years or older at time of treatment with 5ARI or alpha-blocker; 5. At least 1-year of coverage in the healthcare system before the first prescription for BPH medication (5ARI and/or alpha-blocker).; 6. At least 3 consecutive prescriptions (90 days of supply) for a BPH medication (5ARI and/or alpha-blocker); ; EXCLUSION CRITERIA:; 1. Diagnosis of prostate cancer any time before the first prescription for BPH; medication (5ARI and/or alpha-blocker).; Diagnosis of prostate cancer within 3 months after first BPH medication (5ARI; and/or alpha-blocker); Patients treated with finasteride 1mg prior to BPH medication. Finasteride 1mg is; the dose approved for androgenic alopecia and as the target population for this; study is men with treated BPH, we will exclude all men treated with the 1mg; dose. Patients treated with 1mg Finasteride will be characterized in terms of; which study exposure group they would have transitioned into (5ARI or alphablocker) had they been included in the study population, and basic baseline; demographic factors.
• Age groups:
  • Adults (46 to < 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:
  Prostate cancer patients
• Estimated number of subjects:
  219000

Study design details

• Main study objective:
  To assess the risk of prostate cancer mortality associated with use of 5ARIs, with or without alpha-blockers, compared to alpha-blockers in men treated with BPH medications.
• Outcomes:
  To acess prostate cancer mortality. To access combined endpoint of prostate cancer mortality or metastatic cancer, and all cause mortality.
• Data analysis plan:
  Cox proportional hazard regression models will be fit in the overall data set to compare prostate cancer mortality between groups while adjusting for the pre-treatment characteristics.