Abstract: PO0355
Real-World Experience with Etelcalcetide in an Academic Dialysis Program
Session Information
- Biochemical Aspects of Mineral and Bone Disease
October 22, 2020 | Location: On-Demand
Abstract Time: 10:00 AM - 12:00 PM
Category: Bone and Mineral Metabolism
- 402 Bone and Mineral Metabolism: Clinical
Authors
- Hu, Dennis, University of Virginia Health System, Charlottesville, Virginia, United States
- Lobo, Benjamin, University of Virginia Health System, Charlottesville, Virginia, United States
- Bowman, Brendan T., University of Virginia Health System, Charlottesville, Virginia, United States
Background
High parathyroid hormone (PTH) levels may increase fracture risk, vascular calcification, and cardiovascular disease in end-stage kidney disease (ESKD) patients. Treatments include phosphorus binders, Vitamin D analogues, and cinacalcet. However, many ESKD patients persist with high PTH levels. Etelcalcetide (ETC) is an injectable calcimimetic recently approved to treat hyperparathyroidism in ESKD. To date, few studies have described the safety and efficacy of ETC on calcium (Ca) and PTH levels in real world usage.
Methods
This retrospective chart review of 195 in-center HD patients describes those who received a stable dose of ETC for at least 12 consecutive weeks. ETC dose, Ca, albumin, and PTH levels were obtained monthly x 3 months prior to ETC start and up to 9 months post. 23 patients were included for 2 or more doses of ETC. Overall and severe hypocalcemia were defined as corrected Ca <8.3 and <7.5 mg/dL, respectively.
Results
See Table 1. PTH changed from +3.37% (2.5mg) to -32.57% (10mg) to -3.19% (15mg). As expected, ETC use yielded a statistically significant lower PTH when compared to pre-treatment average of 1 and 2 months pre-drug PTH values versus 3 months post drug average (p=0.0034 via t-test for related samples). Corrected Ca decreased in a dose dependent fashion from 0.22% (2.5mg) to 11.89% (15mg). Overall, hypocalcemia occurred in 36.6% of patients. Severe hypocalcemia ranged between 0% (2.5, 5, 12.5, 15mg) and ~ 1% (7.5, 10mg).
Conclusion
Prior studies have used aggressive PTH lowering targets (<300pg/mL or >30% reduction from baseline) yielding high rates of hypocalcemia (61-68%). Our study is the first to describe results of a typical real world dosing strategy. Our results suggest that PTH levels decrease in a dose dependent fashion and severe hypocalcemia is rare. At doses > 10mg diminishing PTH reductions occur which could be due to a preponderance of patients with refractory / tertiary hyperparathyroidism. Rates of overall and severe hypocalcemia were lower here. Limitations of this study include limited adjustment for confounding variables, retrospective nature and small population at higher doses.
| ETC dose | 2.5mg | 5mg | 7.5mg | 10mg | 12.5mg | 15mg |
| Number of patients | 45 | 106 | 40 | 17 | 6 | 4 |
| Percent change in corrected Ca at 3 months | -0.22% | -5.5% | -9.47% | -7.37% | -8.21% | -11.89% |
| Rate of severe hypocalcemia (%) | 0 | 0 | 0.9 | 0.9 | 0.45 | 0 |
| Percent change in PTH at 3 months | +3.37% | -16.21% | -7.32% | -32.5% | -24.18% | -3.19% |