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
English (86.58 KB - PDF)View document