Post-Authorisation Safety Study (PASS) on Flupirtine-containing Medicinal Products - A retrospective, multicentre, non-interventional study to evaluate the effectiveness of the risk minimisation activities for flupirtine-containing medicinal products

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
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  This Post-Authorisation Safety Study (PASS) is a retrospective, multicentre, non-interventional study in patients treated with flupirtine-containing medicinal products.

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:
  Patients treated with flupirtine-containing medicinal products.
• Age groups:
  • 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:
  2000

Study design details

• Main study objective:
  The study is required as part of the RMP in order to evaluate the effectiveness of the risk minimisation measures (RMM) as laid down in the revised Summary of Product Characteristics (SmPC) in the therapy practice.
• Outcomes:
  Overall percentage of patients treated with flupirtine before and after implementation of the RMM for flupirtine-containing medicinal products determined as composite endpoint, Percentage of patients with abnormal liver function tests,Percentage of patients in whom flupirtine treatment was discontinued due to abnormal liver function tests,Percentage of patients experiencing hepatic adverse events classified according to SMQ hepatic disorders,Frequency, nature and intensity of Adverse Events (AEs)
• Data analysis plan:
  Data analysis in the study was descriptive. Descriptive statistics were presented including number of patients, mean, standard deviation, median, minimum, and maximum for continuous variables, and number and percentage of patients per category for categorical variables. Whenever meaningful, point estimates and 95 % confidence intervals were calculated. Furthermore, parameters from pre- and post-intervention periods were compared and a sensitivity analysis in regard to duration of treatment and its effect on liver parameters was realised.