Drug updated on 3/28/2024
| Dosage Form | Injection (intravenous: 2.5 mg/0.5 ml, 5 mg/ml, 10 mg/2 ml) |
| Drug Class | Calcium-sensing receptor agonists |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.
Summary
- Etelcalcetide (Parsabiv) is indicated for the treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease on hemodialysis.
- Two systematic reviews/meta-analyses were reviewed, providing comparative data on the effectiveness and safety of etelcalcetide against other calcimimetic agents.
- The first review included 36 trials involving 11,247 participants, primarily dialysis patients; it found that etelcalcetide had higher odds of achieving target parathyroid hormone (PTH) levels compared to evocalcet and cinacalcet but also appeared to cause more hypocalcemia than these two drugs.
- In terms of side effects, both etelcalcetide and cinacalcet seemed to induce more nausea than placebo according to this study; however, no discernible differences in risk for mortality or cardiovascular endpoints could be identified among different calcimimetic agents due to insufficient certainty.
- The second meta-analysis involved five randomized controlled trials with a total participant count of 1,268; it concluded that while effective at controlling serum PTH levels and mineral metabolism disorder compared with placebo, etelcalcetide was associated with an increased incidence rate for hypocalcemia as well as nausea and vomiting side effects.
- Despite its efficacy in managing secondary hyperparathyroidism symptoms among hemodialysis patients per these studies' findings - including significant reductions in serum phosphate levels - further research comparing Parsabiv's performance against other SHPT treatments is recommended given its noted adverse effect profile relative to placebos used during testing phases.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Parsabiv (Etelcalcetide) Prescribing Information. | 2021 | KAI Pharmaceuticals, Inc., Thousand Oaks, CA |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Comparative effectiveness of calcimimetic agents for secondary hyperparathyroidism in adults: a systematic review and network meta-analysis. | 2020 | American Journal of Kidney Diseases |
| Etelcalcetide versus placebo for secondary hyperparathyroidism in patients receiving hemodialysis: a meta-analysis of randomized controlled trials. | 2020 | Clinical Nephrology |