Cinacalcet Use and the Risk of Gastrointestinal (GI) Bleeding Among Hemodialysis Patients with Secondary Hyperparathyroidism (SHPT) in DOPPS

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

20170665_Observational Research Study Report - Cinacalcet Use and the Risk of Gastrointestinal Bleeding abstract