Effect of Cinacalcet Discontinuation on Biochemical Control for Medicare Beneficiaries with Part D Coverage Treated within a Large US Dialysis Provider (20130335)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine, other:
  Sensipar
• Medical condition to be studied:
  Hyperparathyroidism secondary

Population studied

• Short description of the study population:
  Adult patients (18 years and older) with end-stage renal disease (ESRD) who received center based hemodialysis at a DaVita facility in the United States and had Medicare as their primary insurer between 2006 and 2010.
• 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:
  44000

Study design details

• Main study objective:
  To describe risk factors for first discontinuation of cinacalcet among center-based hemodialysis patients,To describe factors with reinitiation of cinacalcet among center-based hemiodialysis patients,To describe the trajectory of parathyroid hormone, calcium, and phosphorus laboratory values following the discontinuation of cinacalcet by center-based hemodialysis patients.
• Outcomes:
  Probability of first cinacalcet discontinuation.Probability of cinacalcet reinitiation follwoing the first discontinuation of period.Mean values of parathyroid hormone, calcium and phosphorus.
• Data analysis plan:
  Logistic regression will be used to estimate the probability of reinitiating or not reinitiating cinacalcet given the various convariates determined at the end of the previous 30-day interval and identify predicators of discontinuation and reinitiation. Laboratory values following of discontinuation as a function of time will be modeled using smoothing splines.

Documents

Study results

Cinacalcet_Discontinuation_20130335_ORSR_20Mar2015