Clinical nephrology · 2020
Etelcalcetide versus placebo for secondary hyperparathyroidism in patients receiving hemodialysis: A meta-analysis of randomized controlled trials.
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Zhu Yan, Ou Jihong, Liu Xinkuo, Xie Zhijuan
Аннотация
AIMS: The aim of the study was to evaluate the efficacy and safety of etelcalcetide for the treatment of secondary hyperparathyroidism (SHPT) in patients receiving hemodialysis, and a meta-analysis was performed using randomized controlled trials (RCTs).
MATERIALS AND METHODS: We searched studies published on PubMed, Cochrane Central Register of Controlled Trials, and Embase to collect RCTs comparing etelcalcetide with placebo for the treatment of SHPT. Unpublished studies and information were also searched in ClinicalTrials.
RESULTS: Five RCTs involving 1,268 participants were eligible for inclusion in this meta-analysis. Compared with placebo, etelcalcetide contributed to more participants who achieved ≥ 30% reduction in parathyroid hormone (PTH) (relative risk (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) as well as an increase in 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), or vomiting (RR 1.82; 95% CI, 1.17 to 2.85; p = 0.008). Etelcalcetide reduced serum phosphate (mean difference (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; p < 0.00001), and bone-specific alkaline phosphatase (MD -24.80; 95% CI, -28.91 to -20.68) levels compared with the placebo.
CONCLUSION: Etelcalcetide can effectively control serum PTH and disorder of mineral metabolism but with more side effects than placebo. Further studies comparing etelcalcetide with other medication treatments for SHPT will be needed to evaluate if etelcalcetide might be a valuable choice with less pill burden for patients with SHPT receiving hemodialysis.
MATERIALS AND METHODS: We searched studies published on PubMed, Cochrane Central Register of Controlled Trials, and Embase to collect RCTs comparing etelcalcetide with placebo for the treatment of SHPT. Unpublished studies and information were also searched in ClinicalTrials.
RESULTS: Five RCTs involving 1,268 participants were eligible for inclusion in this meta-analysis. Compared with placebo, etelcalcetide contributed to more participants who achieved ≥ 30% reduction in parathyroid hormone (PTH) (relative risk (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) as well as an increase in 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), or vomiting (RR 1.82; 95% CI, 1.17 to 2.85; p = 0.008). Etelcalcetide reduced serum phosphate (mean difference (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; p < 0.00001), and bone-specific alkaline phosphatase (MD -24.80; 95% CI, -28.91 to -20.68) levels compared with the placebo.
CONCLUSION: Etelcalcetide can effectively control serum PTH and disorder of mineral metabolism but with more side effects than placebo. Further studies comparing etelcalcetide with other medication treatments for SHPT will be needed to evaluate if etelcalcetide might be a valuable choice with less pill burden for patients with SHPT receiving hemodialysis.