Linaclotide Utilisation Study in Selected European Populations

Study type

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

Population studied

• Short description of the study population:
  New users of linaclotide with at least 12 months of previous enrolment in the database (baseline period) before the date of first prescription or dispensation of linaclotide (index date) from three different countries: the UK, Spain, and Sweden.
• Age groups:
  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

  Pregnant women

  Renal impaired
• Estimated number of subjects:
  9650

Study design details

• Main study objective:
  To describe linaclotide utilisation among patients from three selected European countries: UK, Spain, and Sweden.
• Outcomes:
  Linaclotide treatment discontinuation and linaclotide treatment switching.
• Data analysis plan:
  Baseline analyses will be conducted to characterise linaclotide users, and socio-demographic and clinical variables will be described for all users and for those subgroups of patients who were not sufficiently documented in the clinical development programme. Linaclotide treatment patterns will be described from index date to end of study period for linaclotide utilisation. Kaplan-Meier estimates will be used to describe time to discontinuation in the prescription or dispensation of linaclotide, and to describe switching from linaclotide to another drug used in IBS-C. To better assess differences in time to event by the alleged reason for linaclotide prescription (IBS-C or other condition), Cox regression analysis will be employed if the proportional hazards assumption holds, if not, more complex models will be proposed, including predictor variable interactions with time.