Incidence of phimosis and paraphimosis in patients treated with SGLT2 inhibitors

Study type

• Study topic:
  Disease /health condition

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

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (A10BK) Sodium-glucose co-transporter 2 (SGLT2) inhibitors

  Sodium-glucose co-transporter 2 (SGLT2) inhibitors
• Medical condition to be studied:
  Phimosis

  Paraphimosis

Population studied

• Short description of the study population:
  The study population included male patients with any identified phimosis/paraphimosis event initiated treatment with SGLT2 inhibitors from January 2022 to January 2023
• 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:
  10000

Study design details

• Main study objective:
  To estimate the incidence of phimosis and paraphimosis in male patients who initiated SGLT2 inhibitors (regardless of indication and restricted to a type-2 diabetes mellitus cohort) and also in type-2 diabetic male patients no exposed to SGLT2 inhibitors (background population).
• Outcomes:
  Phimosis and paraphimosis
• Data analysis plan:
  Eligible study participants were followed from study entry (i.e., initiation of an SGLT2 inhibitor in the treated cohorts or start of calendar year in the background cohort) until the first of: outcome event, death, loss to follow-up or the end of the study period. Crude incidence proportions were calculated as the ratio of: numerator: number of study participants who experienced the outcome event during follow-up denominator: number of patients at risk at the start of follow-up .To account for censoring during follow-up, incidence proportions (i.e., cumulative incidences) were also calculated using the product-limit method.