Does Etelcalcetide work?
Yes, in large controlled trials of 1,023 and 683 people. They measured a blood test, not fractures or deaths.
Approval rests on two placebo-controlled phase 3 trials (1,023 patients combined) and a head-to-head trial against cinacalcet in 683 patients, all randomized and double-blind, all showing larger reductions in parathyroid hormone. The endpoint is a laboratory marker; no trial has shown that lowering PTH with etelcalcetide reduces fractures or deaths. 12
The label pools two identical placebo-controlled trials. In them, 1,023 hemodialysis patients with secondary hyperparathyroidism were randomized to etelcalcetide or placebo for 26 weeks. In each trial, 77 to 79% of etelcalcetide patients had a PTH drop of more than 30%. On placebo, 11% did. Corrected calcium also fell. Phosphate fell a little (significantly in one of the two trials). 2
The head-to-head trial randomized 683 patients for 26 weeks. One group got intravenous etelcalcetide plus oral placebo. The other got oral cinacalcet plus intravenous placebo. A PTH drop of more than 30% occurred in 68.2% of etelcalcetide patients and 57.7% of cinacalcet patients. That met the noninferiority goal and then the superiority goal. A drop of more than 50% occurred in 52.4% versus 40.2%. Both drugs caused nausea and vomiting at similar rates. 1
Evidence checklist
- Randomised controlled trial Placebo-controlled and head-to-head trials
- Human study over 100 people 1,023 patients in the pooled placebo trials
- More than one research group Amgen-sponsored phase 3 program
- Clinical outcomes, not surrogate markers PTH is a lab marker
- Human safety data beyond case reports Hypocalcemia rates from large trials
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Citations
- Block 2017, JAMA: effect of etelcalcetide vs cinacalcet on serum parathyroid hormone in patients receiving hemodialysis with secondary hyperparathyroidism doi.org
- Amgen: Parsabiv (etelcalcetide) prescribing information pi.amgen.com
Reference information only, not medical advice. Drawn from the Etelcalcetide article, fact-checked against the cited sources. No dosing anywhere on this site.