Drug updated on 9/4/2024
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.
Latest News
Summary
- Parsabiv (etelcalcetide) is indicated for secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- Etelcalcetide significantly increased the likelihood of achieving target PTH levels compared to evocalcet (OR, 4.93; 95% CI, 1.33-18.2) and cinacalcet (OR, 2.78; 95% CI, 1.19-6.67) in dialysis patients.
- In patients receiving hemodialysis, etelcalcetide resulted in more participants achieving a ≥ 30% reduction in PTH (RR 8.64; 95% CI, 6.66 to 11.19; p < 0.00001) and a PTH level of ≤ 300 pg/mL (RR 11.80; 95% CI, 8.15 to 17.08; p < 0.00001) compared to placebo.
- Etelcalcetide was also effective in reducing serum phosphate (MD -7.28; 95% CI, -8.82 to -5.74; p < 0.00001), calcium phosphorus product (MD -14.48; 95% CI, -15.07 to -13.88), and bone-specific alkaline phosphatase (MD -24.80; 95% CI, -28.91 to -20.68) levels in this population.
- Etelcalcetide increased the incidence of hypocalcemia (RR 18.76; 95% CI, 4.55 to 77.26; p < 0.0001), nausea (RR 1.79; 95% CI, 1.19 to 2.70; p = 0.006), and vomiting (RR 1.82; 95% CI, 1.17 to 2.85; p = 0.008) compared to placebo.
- Differences in the risk of serious adverse events, all-cause mortality, cardiovascular mortality, heart failure, or fractures across calcimimetic agents could not be discerned with sufficient certainty.
- The reviewed evidence pertains primarily to adults with chronic kidney disease, particularly those on dialysis, with a focus on patients with secondary hyperparathyroidism receiving hemodialysis. The findings emphasize the effectiveness of etelcalcetide in controlling serum PTH and mineral metabolism disorders in this subgroup, though it is associated with an increased risk of hypocalcemia and other side effects. The evidence is limited to short-term assessments, and differences in side-effect profiles exist across calcimimetic agents.
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 |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
VA/DoD clinical practice guideline for the management of chronic kidney disease. | 2019 | The Management of Chronic Kidney Disease Work Group |