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

Study identification

• EU PAS number:
  EUPAS48277
• Study ID:
  48278
• Official title and acronym:
  Statins and the risk of adrenal insufficiency: a nested case-control study (R.USTESE)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  By inhibiting cholesterol synthesis, statins could reduce the synthesis of steroid hormones, thus causing adrenal insufficiency. We conducted a nested case-control study using the Système National des Données de Santé. The source population was patients ≥18 years of age, affiliated to the General Health Insurance Scheme in 2010 with no history of adrenal insufficiency. Cases were patients presenting with a first adrenal insufficiency event between 01/01/2015 and 31/12/2017. Adrenal insufficiency was defined as the presence of both a hospital stay with a diagnosis of adrenal insufficiency (ICD-10 codes E271 to E274), and a first delivery of hydrocortisone ±30 days before/after hospital admission. Each case was matched to up to 10 controls on age (±2 years), sex and corticosteroid exposure in the 3 years prior to the index date. Statin exposure was measured in the 5 years prior to the index date using different definitions: history of use, cumulative use and intensity of last statin used. A 6-month censoring period for exposure was applied before the index date to avoid potential detection bias. The association was estimated using conditional logistic regression adjusted for confounders included in a disease risk score. Analyses were stratified on age, sex and history of corticosteroid use.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Academic Center for Pharmacoepidemiology (DRUGS-SAFEr)

Study timelines

Date when funding contract was signed

Actual:07/11/2019

Study start date

Actual:20/12/2019

Date of final study report

Planned:30/06/2022

Sources of funding

Other

More details on funding

ANSM

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable