An Observational Study to Evaluate the Potential Association Between Cinacalcet and Gastrointestinal Bleeding (20170171)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• 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:
  Case-control

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  CINACALCET
• Medical condition to be studied:
  Hyperparathyroidism secondary

Population studied

• Short description of the study population:
  Hemodialysis patients who, between 2007 and 2010, satisfy the following criteria:; 1. Age ≥ 18 years; 2. At least 91 days on hemodialysis; 3. Covered by Medicare Parts A, B, and D for at least 365 days; 4. Received hemodialysis for at least 91 days in a DaVita dialysis facility; 5. Parathyroid hormone (PTH) >300 pg/mL during the baseline period; 6. No cinacalcet use for 365 days (baseline period); 7. No GI bleeding event for 365 days (baseline period)
• 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:
  12000

Study design details

• Main study objective:
  This nested case control study is designed to address the FDA requirement by assessing the potential association between cinacalcet use and the risk of fatal and non-fatal GI bleeding among hemodialysis patients using the linked DaVita-USRDS database.
• Outcomes:
  The primary outcomes is the composite event of fatal and non-fatal GI bleeding.
• Data analysis plan:
  Descriptive statistics will be used to compare cases and controls, with respect to demographic, comorbidity and medication use characteristics. The odds of exposure among case and controls will be calculated. Conditional logistic regression will be used to estimate the OR and associated 95% confidence interval (CI) for the association between cinacalcet use and risk of fatal and non-fatal GI bleeding adjusting for other potential confounders. If the upper limit of the 95% confidence interval of the estimated OR is less than 1.3, the conclusion will be that cinacalcet use is not associated with an elevated relative risk of fatal or non-fatal GI bleeding.

Documents

Study results

ORSR abstract 20170171