Study type

Study topic

Human medicinal product
Disease /health condition

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine

MIMPARA

Study drug International non-proprietary name (INN) or common name

CINACALCET HYDROCHLORIDE

Anatomical Therapeutic Chemical (ATC) code

(H05BX01) cinacalcet
cinacalcet

Medical condition to be studied

Gastrointestinal haemorrhage
Population studied

Short description of the study population

Patients aged ≥18 years who had received in-center hemodialysis at a Dialysis Outcomes and Practice Patterns Study (DOPPS) facility.

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)

Special population of interest

Renal impaired

Estimated number of subjects

10000
Study design details

Main study objective

1: Estimate the association between exposure to cinacalcet and the risk of hospitalization from GI bleeding, by region and overall.2. Estimate the association between exposure to cinacalcet and the risk of death from GI bleeding, by region and overall.3: Estimate the rate of hospitalization from GI bleeding and the rate of death from GI bleeding, by region and overall.

Outcomes

GI bleeding in a hospital setting and death from GI bleeding

Data analysis plan

Descriptive statistics using mean and standard deviation (SD) or median and 25th/75th percentile estimates for continuous variables (as appropriate) and number and percentages (n, %) for categorical variables will be used to examine patient characteristics in a cohort of subjects with SHPT who are on dialysis.We will estimate the hazard ratio (HR) and 95% CI for the association of cinacalcet exposure and risk of an inpatient hospitalization for GI bleeding (or death from GI bleeding), implemented using conditional logistic regression analysis for standard matched case-control studies.We will estimate the crude incidence rates of hospitalization for GI bleeding or crude death rates from GI bleeding and associated 95% CIs using the Poisson model.
Documents
Study results
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