Statins and the risk of adrenal insufficiency: a nested case-control study (R.USTESE)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

Non-interventional study

• Non-interventional study design:
  Case-control

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (C10AA) HMG CoA reductase inhibitors

  HMG CoA reductase inhibitors
• Medical condition to be studied:
  Adrenal insufficiency

Population studied

• 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:
  50000

Study design details

• Main study objective:
  to assess the association between statin exposure and the development of adrenal insufficiency.
• Outcomes:
  Adrenal insufficiency
• Data analysis plan:
  The association will be estimated using conditional logistic regression adjusted for confounders included in a disease risk score. Analyses will be stratified on age, sex and history of corticosteroid use.