Evaluating the utilisation of Urospir® (spironolactone) in paediatric and adult patients in the United Kingdom: A drug utilisation study using the Clinical Practice Research Datalink (CPRD) database

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name, other:
  Urospir
• Study drug International non-proprietary name (INN) or common name:
  SPIRONOLACTONE
• Anatomical Therapeutic Chemical (ATC) code:
  (C03DA01) spironolactone

  spironolactone

Population studied

• Short description of the study population:
  The study population will comprise all patients within CPRD Aurum and CPRD Gold who have received at least one prescription of Urospir® (25mg/5ml or 50mg/5ml strength) during the study recruitment period.
• Age groups:
  • Paediatric Population (< 18 years)

    • Neonate

      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
  • 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:
  350

Study design details

• Study design:
  A retrospective cohort DUS conducted in CPRD Aurum and CPRD Gold. Data will be collected on patients started on Urospir® (any strength) from August 2024 to data extraction (18-24 months after licensing).
• Main study objective:
  The overall aim of this drug utilisation study will be to characterise paediatric and adult patients prescribed Urospir® oral solution 25mg/5ml and 50mg/5ml.
• Setting:
  This study will be conducted using routinely collected health data from primary care practices in the UK which contribute data to the CPRD Aurum and CPRD Gold databases.; In the UK, while spironolactone treatment is likely to be initiated by a specialist in secondary care (either as an inpatient or at an outpatient clinic), many patients will have medicines management transferred to their General Practitioner (GP) in primary care. Thus, the GP may take on the primary role of monitoring treatment, providing prescriptions, and altering the dose, when necessary, with the option of referral to secondary care if and when required. It is therefore anticipated that the use of the primary care CPRD databases, with additional data from relevant linked datasets, will capture sufficient detail on the utilisation of Urospir® to answer the study aim and objectives.;
• Comparators:
  Not applicable
• Outcomes:
  The primary outcomes are: Patient demographics and clinical characteristics; Urospir® initial treatment regimen; Changes to Urospir® treatment; Off-label prescribing; Potential medication errors.
• Summary results:
  Descriptive summary statistics will be produced to provide an overall description of the patient characteristics and the medical condition for which Urospir® was prescribed. Patient ages will be categorised. Prescribing patterns of Urospir® 25mg/5ml and 50mg/5ml oral solution will be described, including off-label use. For numerical variables, frequencies and percentages will be presented, along with estimates of the mean (standard deviation) or median (interquartile range) where appropriate. Further details will be provided in the statistical analysis plan (SAP).