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
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