Real-life safety assessment of orally disintegrating desmopressin tablet: Incidence of diagnosed hyponatraemia and other events across three European countries.

Objective: This real-life analysis quantifies the incidence rate of diagnosed hyponatraemia in patients treated with a desmopressin Orally Disintegrating Tablet 25-50 μg (ODT) versus patients treated for lower urinary tract symptoms (LUTS) across Sweden, Denmark, and Germany. Material and methods: Claims data and register data from drug registries, hospital records, laboratories, and intensive care units were accessed from the three countries in this imposed Post-Authorisation Safety Study (PASS). The incidence rates of diagnosed hyponatraemia, mortality, major cardiovascular events (MACE), venous thromboembolism (VTE), and acute exacerbation of congestive heart failure (CHF) were calculated using Poisson regression. A sensitivity analysis and subgroup analyses of older adult patients and patients with contraindications were conducted. The clinicaltrial.gov number is NCT04740645. Results: In total, 1,099,545 patients were included in Sweden, Denmark, and Germany. Of these 6745 (0.61 %) were ODT-treated patients, and 1,092,800 (99.39 %) were LUTS-treated patients. The incidence rate of diagnosed hyponatraemia, based on ICD-10 codes, was in the range of 9.04-24.15/1000 patient-years in the ODT cohort and 1.39-4.45/1000 patient-years in the LUTS cohort. Laboratory measured clinically significant hyponatraemia had incidence rates of 139.9 and 33.0/1000 patient-years in the ODT and LUTS cohorts, respectively. The incidence rates of mortality, MACE, and VTE were comparable between groups, with variations in subgroups of patients. Due to different baseline characteristics between the countries, a planned meta-analysis could not be performed. Conclusion: Results from this real-life study does not indicate any added safety concerns related to use of ODT, since increased rate of hyponatraemia is already in the SmPC.