Abstract: PO0546
US Hemodialysis Facilities Switching from Cinacalcet to Etelcalcetide: Impact on Parathyroid Hormone (PTH) Levels
Session Information
- Bone and Mineral Metabolism: Clinical
November 04, 2021 | Location: On-Demand, Virtual Only
Abstract Time: 10:00 AM - 12:00 PM
Category: Bone and Mineral Metabolism
- 402 Bone and Mineral Metabolism: Clinical
Authors
- Karaboyas, Angelo, Arbor Research Collaborative for Health, Ann Arbor, Michigan, United States
- Muenz, Daniel G., Arbor Research Collaborative for Health, Ann Arbor, Michigan, United States
- Hwang, Yunji, Amgen Inc, Thousand Oaks, California, United States
- Goodman, William, Amgen Inc, Thousand Oaks, California, United States
- Cheng, Sunfa, Amgen Inc, Thousand Oaks, California, United States
- Desai, Pooja, Amgen Inc, Thousand Oaks, California, United States
- Fox, Kathleen M., Amgen Inc, Thousand Oaks, California, United States
- Robinson, Bruce M., Arbor Research Collaborative for Health, Ann Arbor, Michigan, United States
- Pisoni, Ronald L., Arbor Research Collaborative for Health, Ann Arbor, Michigan, United States
Background
Some US hemodialysis (HD) facilities switched from oral cinacalcet (Cina) to intravenous (IV) etelcalcetide (Etel) as the primary calcimimetic therapy to control parathyroid hormone (PTH) levels after the introduction of Etel in 2017. While clinical trial data have indicated superior efficacy of Etel vs. Cina, real-world evidence is lacking.
Methods
We evaluated facility calcimimetic use during 6-month intervals before (Period 1: May-October 2016) and after (Period 2: March-August 2019) introduction of Etel using US-DOPPS data. We compared the pre-post difference in outcomes – PTH, Ca, P – over the 6 months after each exposure period among calcimimetic users in HD facilities that “switched” from treating >75% of calcimimetic users with cinacalcet (“Cina-first”) in Period 1 to treating >75% of calcimimetic users with etelcalcetide (“Etel-first”) vs. facilities that remained Cina-first in Period 2.
Results
Among 32 US HD facilities that switched to Etel-first in Period 2, mean PTH decreased from 671 to 484 pg/mL and % PTH >600 pg/mL decreased from 39% to 21%. Among 34 facilities that remained Cina-first in Period 2, mean PTH increased from 632 to 698 pg/mL and % PTH >600 pg/mL increased from 37% to 43%. The adjusted difference-in-difference between switch to Etel-first and remain Cina-first was -169 (95% CI: -249, -90) pg/mL for mean PTH and -14.5% (95% CI: -22.4%, -6.7%) for PTH >600 pg/mL. Serum Ca levels were slightly lower in facilities that switched to Etel-first, while serum P was not associated with facility calcimimetic type [Table 1].
Conclusion
In this natural experiment, we observed better PTH control in facilities that switched to etelcalcetide (vs. remained cinacalcet) as the primary calcimimetic therapy. Further research is needed to evaluate whether this clear difference in real-world effectiveness translates to a reduction in hospitalizations and mortality.
Funding
- Other NIH Support –