Agomelatine Drug Utilisation Study in Selected European Countries: A Multinational, Observational Study to Assess Effectiveness of Risk-Minimisation Measures

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Other

  Safety study (incl. comparative)
• If ‘other’, further details on the scope of the study:
  Patient survey
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Cross-sectional

  Other
• Non-interventional study design, other:
  Post-authorization safety study

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (N06AX22) agomelatine

  agomelatine
• Medical condition to be studied:
  Major depression

Population studied

• Short description of the study population:
  Physician prescribers (i.e., psychiatrists and general practitioners [GPs]) practising in outpatient settings (hospital outpatient clinics, other outpatient clinics, or private practices) where outpatients treated with agomelatine are managed in Denmark, France, Germany, and Spain.
• 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:
  1600

Study design details

• Main study objective:
  To evaluate the effectiveness of additional risk minimisation measures for agomelatine before and after implementation of these measures. For the medical record abstraction: to evaluate the adherence to the liver test monitoring regimen and the compliance with relevant contraindications. For the patient survey: to evaluate patients’ reasons for non-compliance with the liver test monitoring regimen
• Outcomes:
  For the medical record abstraction: proportion of patients with a liver test performed before treatment or at initiation and at least one test performed during treatmentFor the survey: Proportion of patients acknowledging receipt of the patient booklet and reason for non-compliance to the liver test monitoring regimen, For the medical record abstraction : proportion of patients with a liver test performed before treatment or at initiation and a test performed at 3, 6, 12, and 24 weeks after treatment initiation—accounting for “duration of treatment” and dose escalation
• Data analysis plan:
  Descriptive analyses overall and by country, and, if numbers allow, by specialty. Medical record abstraction: A single estimate of the prevalence of adherence to liver test will be provided separately for each study period with 95% CIs around the point estimate. The difference between the prevalence of adherence before and after RMMs will be calculated as an estimate of the change with the 95% CI. A chi-square test or a t-test will be used to test the differences between the two study periods (before and after RMM).Patient survey: The proportion of patients acknowledging receipt of the patient booklet and the reasons for non-compliance to the liver test monitoring will be providedThe number of subjects with missing data will be reported for each variable. Descriptive analysis comparing patients with and without missing data will be conducted. To assess the potential impact of a non-random missing data pattern for adherence/compliance, a sensitivity analysis will be conducted.

Documents

Study publications

E. Jacquot, E. Collin, A. Ladner, A. Tormos, L. Hamm, S. Perez-Gutthann, L. Gut…