Drug utilisation study (DUS) on flupirtine-containing products Retrospective drug utilisation study using patient-level databases to characterise prescribing practices of flupirtine-containing drugs during routine clinical use and assess the main reasons for prescription by representative groups of prescribers

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation

  Effectiveness study (incl. comparative)
• 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:
  FLUPIRTINE

  FLUPIRTINE MALEATE

  FLUPIRTINE GLUCONATE
• Medical condition to be studied:
  Pain

Population studied

• Short description of the study population:
  All patients who have received at least one prescription for flupirtine –containing products in the reference period or in the assessment periods I or II and fulfilled the inclusion criteria from IMS® Disease Analyzer and from IMS® LRx were included.
• 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)
• Special population of interest:
  Hepatic impaired

  Immunocompromised

  Pregnant women

  Renal impaired
• Estimated number of subjects:
  13700

Study design details

• Main study objective:
  The primary objectives of the study are to describe before and after the implementation of risk minimisation measures for flupirtine-containing medicinal products.
• Data analysis plan:
  Data from both databases will not be combined. The data will be analysed separately by data source (IMS® Disease Analyzer and IMS® LRx) and by physician panel.The statistical unit will be the patient (for information such as demographical and clinical characteristics, medical history, contraindications) and the flupirtine prescription (for information such as indication, number of packages, pack size, strength, number of prescriptions, recommended treatment duration, concomitant drug prescriptions, liver function tests).The analyses will be performed separately for the reference period, assessment period I and assessment period II. The analyses will be provided for the total population and will be stratified by incident and prevalent users.The statistical analysis will be done descriptively. Missing values will be reported as missing and no imputation will be conducted. Descriptive tables will be compiled for all variables.

Documents

Study results

Abstract- Flupirtine DUS.