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

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)

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).