Linaclotide Safety Study for the Assessment of Diarrhoea—Complications and Associated Risk Factors in Selected European Populations with IBS-C

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

Non-interventional study

• Non-interventional study design:
  Case-control

  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  LINACLOTIDE
• Medical condition to be studied:
  Irritable bowel syndrome

  Diarrhoea

Population studied

• Age groups:
  • Paediatric Population (< 18 years)

    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  200

Study design details

• Main study objective:
  -To estimate the risk (case-control OR) of SCD (case) among patients with IBS-C (source population) who received linaclotide prescription vs those who did not, controlling for other potential SCD risk factors (socio-demographics, comorbidities, co-medications and other potential variables of interest) -To describe the crude incidence of diarrhoea among patients with IBS-C (source population)
• Outcomes:
  SCD cases are suffering diarrhoea and subsequently any of following: -Dehydration that requires intravenous or oral rehydration with solutions of electrolytes -Electrolyte imbalance -Oliguria -Anuria -New-onset thromboembolism episodes, orthostatic hypotension, syncope, dizziness or vertigo -Acute renal failure -Hypovolaemic shock -Hospitalisation due to diarrhoea -Stupor -Coma -Death
• Data analysis plan:
  Patient characteristics at the IBS-C cohort entry date will be described for the full cohort of patients with IBS-C by reviewing data for a minimum of 12 months prior. Characteristics at index date will be described for the cases and controls by reviewing data for a minimum of 12 months prior to index date. The crude incidence of diarrhoea and the crude incidence of SCD will be described in: the full cohort of patients with IBS-C, the sub-cohorts of patients with prescriptions of linaclotide and for those groups of patients with increased risk of SCD (patients ≥65 yrs and patients with hypertension, diabetes, or cardiovascular disease diagnostic codes). If the validation results of cases and controls are satisfactory then information from the whole cohort would be used to estimate relative risks of SCD and the exposures of interest (linaclotide) using the Cox proportional hazard model. Otherwise only the nested case-control analysis will be conducted (conditional logistic regression).