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. (NOCDURNA PASS)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  DESMOPRESSIN
• Anatomical Therapeutic Chemical (ATC) code:
  (H01BA02) desmopressin

  desmopressin
• Medical condition to be studied:
  Nocturia

Population studied

• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  7090

Study design details

• Main study objective:
  Retrospective study to assess the post-authorisation safety of NOCDURNA using longitudinal RWD. Also, since it is desirable to put these observations into context and characterise a population with similar indications who do not receive desmopressin, a similar number of patients receiving standard care for other lower urinary tract symptoms will be evaluated in order to inform NOCDUR safety and use.
• Outcomes:
  To estimate the incidence rate of symptomatic hyponatraemia (defined as a recorded diagnosis of hyponatraemia) among patients treated with NOCDURNA, and patients with LUTS separately, overall and by subgroups of interest (including elderly patients, aged ≥ 65years). 1. Describe the demographic 2. Incidence rate of hyponatraemia requiring hospital intensive care 3. Incidence rate of hyponatraemia 4. Rate of mortality 5. Incidence rate of CV and venous thromboembolic events 6. Incidence rate of acute exacerbation of CHF 7. Patients adhering to the label 8. Adjustment for confounding 9. Treatment withdrawal of NOCDURNA
• Data analysis plan:
  This is a multi-country, cohort study using secondary data collected from research databasesand administrative national healthcare registries in selected European countries (Denmark, Germany and Sweden). Cohorts of patients using NOCDURNA or treatment of LUTS (new user) will be identified from existing data sources in each country of study. These data sources hold information on dispensed prescriptions, patient demographics and diagnoses. The LUTS contextual cohort will be comprised of patients based newly starting treatments associated with polyuria, receiving relevant standard care. For secondary comparative analyses, the comparator group for NOCDURNA patients will be LUTS patients. In addition to the final study report, there will be annual interim reports on study progress and any emerging safety data. Both country-specific and pooled results (meta-analysis) will be presented in the final report, where data are available.