Post-authorisation safety study of nocdurna for the symptomatic treatment of nocturia due to idiopathic nocturnal polyuria: A multi-country cohort study using secondary data
Description
- Nocdurna (desmopressin) has been approved in Germany since January 2017 for the treatment of nocturia in adult patients with idiopathic nocturnal polyuria. Desmopressin is an analog of the antidiuretic hormone vasopressin, thus causing water retention in the kidneys and reducing the amount of urine. Findings on the effect of vasopressin, results of the approval studies, clinical observations and experience from the higher-dose use of desmopressin for other indications suggest that its effect on fluid balance can in rare cases lead to hyponatremia or exacerbation of pre-existing heart failure. In addition, there are safety concerns regarding an increased risk of thromboembolic or ischemic events due to possible interactions of desmopressin with the coagulation system.
It is not yet clear whether and how frequently these adverse effects occur in the low and sex-adapted dosage (daily 25μg for women, 50μg for men) for long term treatment of idiopathic nocturnal polyuria outside of controlled study conditions, and whether specific patient groups have an increased risk of certain side effects. The prevalence of idiopathic nocturnal polyuria increases with age. A meta-analysis of clinical studies showed that older age and polymorbidity can favor the occurrence of complications of Nocdurna therapy.
Against this background, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) requested a multinational safety study to be carried out to assess the long-term follow-up of Nocdurna users, quantification of potential adverse drug reactions and identification of risk groups in order to enable a targeted adjustment of the marketing authorization if necessary. The final report is planned for Q1 2024.
Funding period
- Begin: November 2020
End: December 2023
Sponsor
- Pharmaceutical industry
Contact
Project management (international)
- Christian Froesig, Ferring Pharmaceuticals A/S, Kopenhagen, Dänemark