Depression following exposure to anastrozole

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

  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  ANASTROZOLE
• Medical condition to be studied:
  Depression

Population studied

• Short description of the study population:
  The population eligible for the study consisted of all female patients registered with an IMRD-UK for a duration of one-year or more. Patients were followed from the latest of date of registration, Acceptable Mortality Reporting (AMR) date or date of practice computerisation, and followed until the earliest of transfer out date, date of death or date of last data collection (the most recent data being available for January 2020). The study subjects were followed from the first use of anastrozole (or tamoxifen or bendroflumethiazide) to the end of follow-up on the database or until first use of the other drug (tamoxifen or anastrozole). To ensure that cases of depression were of new onset and were not associated with the comparator drug, the following were excluded:; • patients with less than 1-year lookback prior to first prescribing of anastrozole or tamoxifen or bendroflumethiazide (e.g. negative controls); • negative control patient prescribed bendroflumethiazide prior to diagnosis of breast cancer; • patients with a history of treatment for depression or diagnosis of depression in the year prior to first use of the drug; • patients exposed to tamoxifen prior to their first use of anastrozole (i.e. prevalent users of tamoxifen to be excluded); • patients exposed to anastrozole prior to their first use of tamoxifen (i.e. prevalent users of anastrozole to be excluded); • negative control patients exposed to either anastrozole or tamoxifen prior to their first use of bendroflumethiazide (i.e. prevalent users of anastrozole or tamoxifen to be excluded)
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  9644

Study design details

• Main study objective:
  Is there an association between exposure to anastrozole and subsequent risk of depressive illness?
• Outcomes:
  Depression defined as either diagnosed depression or initiation of treatment of depression
• Data analysis plan:
  The event rate of new onset depression was calculated every 30-days as the cumulative number of cases of new onset depression divided by the total duration of follow-up time in years. Patient were censored from the analysis if they left the population (moved practice, died or reached the end of follow-up for their practice) or if they received the other drug (tamoxifen or anastrozole). Analyses were conducted using SAS v9.4.

Documents

Study results

Depression following anastrozole - final report