Drug utilization of temozolomide with or without antiepileptic drugs in patients with malignant gliomas in the Tuscany region

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• 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

  Other
• Non-interventional study design, other:
  Descriptive, retrospective observational study

Study drug and medical condition

• Name of medicine:
  TEMODAL
• Medical condition to be studied:
  Glioblastoma

Population studied

• Short description of the study population:
  The study population included patients with malignant gliomas treated with temozolomide with or without antiepileptic drugs identified through Agenzia Regionale della Sanità Toscana (ARS) database between 2010 and 2021.
• Age groups:
  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with malignant gliomas
• Estimated number of subjects:
  1000

Study design details

• Main study objective:
  Primary objective: To describe the real-world utilization of TMZ with or without antiepileptic drugs for the treatment of patients with malignant gliomas in Tuscany between 2010 and 2021. Secondary objective: To describe the survival of patients using TMZ with or without antiepileptic drugs for the treatment of patients with malignant gliomas in Tuscany between 2010 and 2021.
• Outcomes:
  Drug utilization, Survival
• Data analysis plan:
  Descriptive analyses will be conducted to assess demographic and clinical characteristics of temozolomide users (concomitant/adjuvant) in relation to use of antiepileptic drugs. Continuous variables will be described by means and standard deviation or by median and range. Categorical variables will be described by patient counts and percentages. Characteristics of patients according to concomitant use of antiepileptic drugs will be compared using parametric or non- parametric tests according to distribution of data. A Kaplan Meier curve will be plotted for describing persistence and overall survival during follow- up. Also median overall survival will be calculated.