Characterizing the management of hypocalcemia among European hemodialysis patients receiving cinacalcet (20150330)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Retrospective cohort study

Study drug and medical condition

• Name of medicine:
  MIMPARA
• Study drug International non-proprietary name (INN) or common name:
  CINACALCET
• Anatomical Therapeutic Chemical (ATC) code:
  (H05BX01) cinacalcet

  cinacalcet
• Medical condition to be studied:
  Hyperparathyroidism secondary

Population studied

• Short description of the study population:
  Adult subjects presenting at one of 304 participating facilities in 14 European countries (Czech Republic, France, Hungary, Ireland, Italy, Poland, Portugal, Romania, Russia, Serbia, Slovak Republic, Slovenia, Spain, and United Kingdom) and Turkey enrolled between 01 January 2007 and 31 December 2009.
• 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:
  1200

Study design details

• Main study objective:
  Describe prescribing patterns of cinacalcet at time of cinacalcet initiation, at time of hypocalcemia event and after hypocalcemiaDescribe prescribing patterns of any treatment intervention (e.g. vitamin D, phosphate binders, and cardiovascular medications) at time of cinacalcet initiation, at time of hypocalcemia and after hypocalcemiaIdentify factors associated with changes to any treatment
• Outcomes:
  No change, dose reduction, discontinuation or dose increase of cinacalcet or any treatment intervention (e.g. vitamin D, phosphate binders and CVD medications) after hypocalcemia event, To describe characteristics of cinacalcet patients who do and do not develop hypocalcemiaAmong patients who discontinued cinacalcet following hypocalcemia, to describe factors associated with cinacalcet re-initiation
• Data analysis plan:
  Point estimates and 95% confidence intervals will be derived to determine the rate of cinacalcet discontinuation and changes to disease related prescribing patterns following a hypocalcemic event Time to first hypocalcemia event, time to any treatment intervention following hypocalcemia event, and time to cinacalcet re-initiation will be estimated using Kaplan Meier methods according to baseline calcium levels. Cox regression models will be used to identify baseline covariates associated with time to first occurrence of hypocalcemia during the first 12 months of the study, time to any treatment intervention during the 12 months following hypocalcemia event and time to cinacalcet re-iniation during the 12 months following cinacalcet discontinuation. Hazard ratios and 95% confidence intervals will be calculated.

Documents

Study results

ORSR abstract 20150330