Post-Authorisation Safety Study (PASS) for Flupirtine – Effect of Risk Minimisation Measures in Germany

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:
  Other
• Non-interventional study design, other:
  Cohort analysis

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (N02BG07) flupirtine

  flupirtine
• Medical condition to be studied:
  Pain

Population studied

• Short description of the study population:
  All outpatients in Germany who have received flupirtine before and after implementation of risk minimisation measures identified from IMS® Disease Analyzer and IMS® LRx databases.
• 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:
  150000

Study design details

• Main study objective:
  The main objective of the study is to evaluate the impact of the implementation of risk minimisation measures (RMMs) (DHPC and updated SmPC) on the prescription behaviour of physicians in Germany.
• Outcomes:
  • indication for flupirtineDescription of proportion of patients with• pre-existing liver disease/alcohol abuse • pre-treatment with/ contraindications for NSAIDs and weak opioids• duration of treatment• single and repeated flupirtine prescriptions • concomittant use of hepatotoxic drugs• liver function test monitoring, The secondary objective of this study is to:• Compare the length of treatment or proportions observed for each of the objectives listed above in the patients initiating flupirtine since implementation of RMMs to treatment length or proportions observed in the patients treated with flupirtine before the implementation of RMMs.
• Data analysis plan:
  The data will be analysed separately by data source (IMS® Disease Analyzer and IMS® LRx).The statistical analysis will be done descriptively and performed separately by database, per physician panel and per observational period. All analyses will be stratified by incident and prevalent users. Missing values will be reported as missing and no imputation will be conducted. Descriptive tables will be made for all variables. Confidence intervals (95%) around estimates before and after the implementation minimization measures will be calculated. For comparison of patients initiating on flupirtine since the implementation of RMMs with patients treated with flupirtine before the implementation appropriate statistical tests will be used.