Abstract: PO1062
Cinacalcet Use and the Risk of Gastrointestinal (GI) Bleeding Among Hemodialysis Subjects with Secondary Hyperparathyroidism (SHPT) in the Dialysis Outcome and Practice Patterns Study (DOPPS)
Session Information
- Hemodialysis and Frequent Dialysis - 1
October 22, 2020 | Location: On-Demand
Abstract Time: 10:00 AM - 12:00 PM
Category: Dialysis
- 701 Dialysis: Hemodialysis and Frequent Dialysis
Authors
- Karminder, Gill, Amgen, Inc., Thousand Oaks, California, United States
- Lin, Tzu-Chieh, Amgen, Inc., Thousand Oaks, California, United States
- Hernandez, Rohini, Amgen, Inc., Thousand Oaks, California, United States
Background
Cinacalcet is an oral calcimimetic for the treatment of SHPT in US adult hemodialysis (HD) patients. We conducted an observational study to evaluate the potential association between cinacalcet and fatal and non-fatal GI bleeding using data from DOPPS, an observational longitudinal data system of a random sample of patients from dialysis facilities in more than 20 countries.
Methods
The eligibility criteria for study cohort inclusion was individuals ≥18 years of age with ESRD receiving in-center hemodialysis at a DOPPS facility for a minimum of four months during calendar years 2009-2015, in the following countries: Australia, New Zealand, Canada, France, Germany, Italy, Spain, Sweden, Japan, the UK, and the US. Nested within the cohort, we conducted a matched case-control study (1:4 matching ratio) to estimate the association between cinacalcet use and GI bleeding events. We used risk-set sampling and matched on the following: (1) duration of follow-up (a same number of days), (2) time on dialysis (≤1 year, >1 year), (3) age (+/- 1 year), and (4) sex. Multivariable conditional logistic regression models were used to generate adjusted odds ratios (ORs) and 95% confidence intervals (CIs), accounting for baseline comorbidities.
Results
A total of 9,349 HD patients with SHPT met the eligibility criteria for the cohort study, 4,399 subjects from the United States and 4,950 subjects from countries outside the United States. We estimated the incidence rate of hospitalization or death due to GI bleeding (per 1,000 person-years [PYs]) in the US as 10.2 (95% CI: 7.9, 13.3); and 26.4 (95% CI: 23.5, 29.7) in countries outside the US. There was no association between cinacalcet exposure and GI bleeding (fatal or nonfatal events) in HD subjects with SHPT in US (adjusted OR: 0.68 [95% CI: 0.47, 1.00]) and ex-US (adjusted OR: 0.75 [95% CI: 0.50, 1.12]) populations.
Conclusion
Cinacalcet use was not associated with an increased risk of GI bleeding events among US and ex-US adult hemodialysis subjects with SHPT. The study results are broadly generalizable to adult subjects with ESRD receiving center-based hemodialysis in the US and selected countries outside the US.
Funding
- Commercial Support –