An Observational Study to Evaluate the Potential Association Between ParsabivTM and Gastrointestinal Bleeding (20170561)

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:
  Cohort

  Other
• Non-interventional study design, other:
  Nested, matched case-control study

Study drug and medical condition

• Name of medicine:
  PARSABIV
• Study drug International non-proprietary name (INN) or common name:
  ETELCALCETIDE HYDROCHLORIDE
• Anatomical Therapeutic Chemical (ATC) code:
  (H05BX04) etelcalcetide

  etelcalcetide
• Medical condition to be studied:
  Gastrointestinal haemorrhage

Population studied

• Short description of the study population:
  Patients with secondary hyperparathyroidism (HPT) receiving maintenance hemodialysis (HD) aged 18 years or more identified from DaVita-Medicare linked database between 2018 and 2020. ; Inclusion criteria: ;  age ≥ 18 years;  at least 91 days on HD;  covered by Medicare Parts A, B, and D for at least 365 days;  received HD for at least 91 days at a DaVita dialysis facility;  parathyroid hormone > 300 pg/mL during the baseline period (365 days before the cohort entry date);  no etelcalcetide use for 365 days (baseline period);  no GI-bleeding event for 365 days (baseline period); ; Exclusion criteria:;  history of parathyroidectomy;  previous kidney transplant
• 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:
  Other

  Renal impaired
• Special population of interest, other:
  Patients with secondary hyperparathyroidism
• Estimated number of subjects:
  40000

Study design details

• Main study objective:
  To assess the potential association between ParsabivTM use and risk of gastrointestinal bleeding in secondary hyperparathyroidism (HPT) patients receiving maintenance hemodialysis
• Outcomes:
  The composite event of fatal and non-fatal GI bleeding. A fatal GI bleeding will be defined as death with GI bleeding as a cause and a non-fatal GI bleeding event will be defined as a hospitalization with GI bleeding as the primary diagnosis
• 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 the associated 95% confidence interval (CI) for the association between ParsabivTM use (reference = no ParsabivTM 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 1.30, the conclusion will be that ParsabivTM use is associated with a less than 30% increased relative risk of fatal or non fatal GI bleeding.

Documents

Study results

20170561 ORSR_Redacted