A European Post-Authorisation Observational Study (Registry) of Patients With Chronic Adrenal Insufficiency (AI)

Conditions

Chronic Adrenal Insufficiency

Keywords

Adrenal insufficiency, DuoCort, Congenital adrenal hyperplasia (CAH), Modified release, Hydrocortisone

Brief summary

As a post-approval requirement of the European Medicines Agency, this European patient post authorization safety study is an observational study being conducted to monitor the safety of long-term treatment with Plenadren and other glucocorticoid replacement therapies in routine clinical practice in patients with chronic adrenal insufficiency (primary or secondary).

Bertil Ekman, Marcus Quinkler, Pinggao Zhang, Andrea M. Isidori, Robert Murray et al. (7 authors)

Journal of Endocrinological Investigation2025-09-06

10.1007/s40618-025-02657-7

Characterization of patients with adrenal insufficiency and frequent adrenal crises

Marcus Quinkler, Robert Murray, Pinggao Zhang, Claudio Marelli, Robert Petermann et al. (8 authors)

European Journal of Endocrinology2021-03-2619 citations

10.1530/eje-20-1324

Mortality data from the European Adrenal Insufficiency Registry-Patient characterization and associations.

Quinkler M, Ekman B, Zhang P, Isidori AM, Murray RD, EU-AIR Investigators.

2018-04-2246 citations

10.1111/cen.13609

Management of glucocorticoid replacement in adrenal insufficiency shows notable heterogeneity - data from the EU-AIR.

Murray RD, Ekman B, Uddin S, Marelli C, Quinkler M, Zelissen PM, the EU-AIR Investigators.

2016-12-0540 citations

10.1111/cen.13267

European Adrenal Insufficiency Registry (EU-AIR): a comparative observational study of glucocorticoid replacement therapy.

Ekman B, Fitts D, Marelli C, Murray RD, Quinkler M, Zelissen PM.

2014-05-0922 citations

10.1186/1472-6823-14-40

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

No

Inclusion criteria

* Diagnosis of chronic adrenal insufficiency * Written informed consent/assent in compliance with applicable country-specific and local regulations

Exclusion criteria

* Participation in an interventional clinical trial

Design outcomes

Primary

Measure	Time frame	Description
Incidence of intercurrent illness	approximately 10 years	Monitor the safety of long-term treatment with PLENADREN and other glucocorticoid replacement therapies in patients with chronic AI
Incidence of adrenal crisis	approximately 10 years	Monitor the safety of long-term treatment with PLENADREN and other glucocorticoid replacement therapies in patients with chronic AI
Incidence of serious adverse events	approximately 10 years	Monitor the safety of long-term treatment with PLENADREN and other glucocorticoid replacement therapies in patients with chronic AI

Countries

Germany, Italy, Netherlands, Sweden, United Kingdom

Outcome results