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

Contact details

Julien Bezin

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Date of final study report

Planned:
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