Trends in prescriptions of valproate and valpromide for bipolar disorder in IMS France and IMS Germany between 2010 and June 2016 and in UK THIN between 1999 and 2015

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (N03AG01) valproic acid

  valproic acid
• Medical condition to be studied:
  Bipolar disorder

  Epilepsy

  Migraine

Population studied

• Short description of the study population:
  All patients with a consultation date between 1 January 2010 and 30 June 2016 were identified.; Population denominators used for the analysis of valproate prescribing trends in THIN are defined as follows:; a) All patients with bipolar disorder meeting cohort entry and exit criteria described above.; b) All patients in the THIN database.; c) All patients with a Read code for epilepsy recorded in each calendar year in THIN.; d) All patients with a Read code for migraine recorded in each calendar year in THIN.; Different cohort denominators were used for epilepsy and migraine to reflect active management of patients as opposed to bipolar disorder which is a more pervasive chronic illness. In this regard, it was noted that inclusion of people simply with a past history of epilepsy and migraine lead to an underestimation of the prevalence of valproate prescribing over time (due to the accrual of non-active patients).
• Age groups:
  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:
  Other
• Special population of interest, other:
  Population with Bipolar disorder, Epilepsy and Migraine
• Estimated number of subjects:
  100000

Study design details

• Main study objective:
  Measure prevalence and prescribing trends in valproate prescribing overall and in people with certain indications in the general population.
• Outcomes:
  Prevalence of valproate prescribing overall and in people with certain indications (e.g. bipolar disorder, epilepsy, migraine) in the general population.
• Data analysis plan:
  Simple descriptive analysis with counts and percentages. Annual and quarterly time trends in valproate prescribing.