Rapid Data Analysis – Tolperisone drug utilisation

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

• Study drug International non-proprietary name (INN) or common name:
  TOLPERISONE

Population studied

• Short description of the study population:
  Patients receiving at least one prescription with Tolperisone 50 mg or 150 mg film-coated tablets.; ; Only patients with a minimum observation time of 365 days over the period 2009-2020 were eligible to be included in the study which resulted in extending the observation period to 1 January 2008 to assess eligbility.
• Age groups:
  • 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)
  • 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)
• Estimated number of subjects:
  20000

Study design details

• Main study objective:
  To study yearly prescribing of tolperisone including indications for use.
• Data analysis plan:
  Descriptive study.