Prescription Pattern of Monoamine Oxidase B Inhibitors Combined with Levodopa: A Retrospective Observational Analysis of Italian Healthcare Administrative Databases

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

  Cross-sectional

Study drug and medical condition

• Name of medicine:
  RASAGILINE
• Study drug International non-proprietary name (INN) or common name:
  LEVODOPA

  RASAGILINE MESILATE

  RASAGILINE TARTRATE

  SAFINAMIDE METHANESULFONATE

  SELEGILINE
• Anatomical Therapeutic Chemical (ATC) code:
  (N04BA02) levodopa and decarboxylase inhibitor

  levodopa and decarboxylase inhibitor

  (N04BA03) levodopa, decarboxylase inhibitor and COMT inhibitor

  levodopa, decarboxylase inhibitor and COMT inhibitor

  (N04BA05) melevodopa and decarboxylase inhibitor

  melevodopa and decarboxylase inhibitor

  (N04BD01) selegiline

  selegiline

  (N04BD02) rasagiline

  rasagiline

  (N04BD03) safinamide

  safinamide
• Medical condition to be studied:
  Parkinson's disease

Population studied

• Short description of the study population:
  Starting with the ReS database, we selected adults analyzable from 2013 to 2019 and with at least one supply, in 2017, of one MAO-BI, among selegiline (ATC code: N04BD01), rasagiline (N04BD02) and safinamide (N04BD03).
• 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)

Study design details

• Study design:
  Retrospective longitudinal cohort study
• Main study objective:
  To describe the prescription pattern of monoamine oxidase B inhibitors (MAO-BIs) marketed in Italy (selegiline, rasagiline, safinamide) as an add-on to levodopa among new users of MAO-BIs reimbursed by the Italian National Health Service (SSN).
• Setting:
  In-hospital and local outpatient settings in public and affiliated with SSN facilities
• Summary results:
  In 2017, 1059 new users received an MAO-BI (incidence 22.6 × 100,000 adults) combined with levodopa: 502 subjects (10.7 × 100,000) were treated with selegiline, 161 (3.4 × 100,000) were treated with rasagiline, and 396 (8.4 × 100,000) were treated with safinamide. The cohorts mainly consisted of males with a median age of ≥ 74 years. Treatment incidences increased with age. Switches occurred in 18.0%, 11.0%, and 4.3% of the selegiline, rasagiline, and safinamide cohorts, respectively. Most of the patients switching from selegiline/safinamide changed to rasagiline, while most of the patients switching from rasagiline changed to safinamide. From the first to second years, patient numbers reduced by ≤ 50%, and the daily milligrams/monthly tablets slightly increased. Six-month discontinuation occurred in > 50% of all cohorts, and ≥ 65% of discontinuing patients changed to another anti-Parkinson drug.