[an error occurred while processing this directive]

Meta-analysis of the efficacy of a new generation of intravenous calcimimetic agent in the treatment of secondary hyperparathyroidism

  • ZHANG Ju-Hong ,
  • LI Ying
Expand
  • Department of Nephrology, First Affiliated Hospital of Chongqing Medical University, Chongqing 400016, China

Received date: 2024-05-11

  Revised date: 2024-08-26

  Online published: 2024-12-12

Abstract

Objective  To evaluate the efficacy and adverse reactions of etelcalcetide in the treatment of secondary hyperparathyroidism in hemodialysis patients.  Methods  Randomized controlled trials  or cohort studies on Etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in dialysis patients published before May 2024 were searched in CNKI, Wanfang Database, PubMed, Embase and Cochrane library. Meta-analysis was performed by the software RevMan 5.0.  Results  A total of 14 articles were included, including 15 experiments, with a total sample size of 9628 cases. Meta-analysis showed that Etelcalcetide was more effective in reducing PTH level by 30% than the control group (Blank control group: RR=8.440, 95% CI: 6.515~10.935, P<0.001; Cinacalcet group: RR=1.131, 95% CI:1.040~1.229, P= 0.004; Vitamin D receptor agonist group: RR=4.272, 95% CI: 2.259~8.081, P< 0.001), improving serum phosphate compliance rate (RR=1.122, 95% CI: 1.049~1.205, P=0.001) and decreasing the level of serum fibroblast growth factor (FGF-23) (treatment time < 1 year: MD=-0.563, 95% CI: -0.713~-0.413, P<0.001 ; treatment duration ≥1 year: MD=-2.108, 95% CI: -2.405~-1.812, P < 0.001), while no statistical differences in the rate of serum calcium compliance (RR=0.910, 95% CI: 0.778~1.064, P=0.240) and drug persistence (RR=1.439, 95% CI: 0.903~2.292, P=0.120). In terms of adverse events, the incidence of symptomatic hypocalcemia was higher in Etelcalcetide group than in control group (RR=2.890,95% CI:1.915~4.361, P<0.001), and the incidence of nausea in Etelcalcetide group was higher than that in blank control group (RR=1.747, 95% CI: 1.150~2.652, P=0.009), which was lower than that in oral medication group (RR=0.769, 95% CI: 0.611~0.969, P=0.030), while no significant difference in the incidence of vomiting. Conclusion  Etelcalcetide, a new generation of intravenous calcimimetic agent, has more advantages in reducing PTH level, improving hyperphosphatemia and reducing FGF-23 level, but it increased the incidence of hypocalcemia. 

Cite this article

ZHANG Ju-Hong , LI Ying . Meta-analysis of the efficacy of a new generation of intravenous calcimimetic agent in the treatment of secondary hyperparathyroidism[J]. Chinese Journal of Blood Purification, 2024 , 23(12) : 896 -900 . DOI: 10.3969/j.issn.1671-4091.2024.12.003

References

参考文献
[1] Bikbov B, Purcell A C, Levey S A, et al. Global, regional, and national burden of chronic kidney disease, 1990–2017: a systematic analysis for the Global Burden of Disease Study 2017[J]. The Lancet, 2020, 395(10225):709-733.
[2] Herzog CA, Asinger RW, Berger AK, et al. Cardiovascular disease in chronic kidney disease. A clinical update from Kidney Disease: Improving Global Outcomes (KDIGO)[J]. Kidney Int, 2011, 80(6):572-86.
[3] Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Update Work Group KDIGO 2017 clinical practice guideline update for the diagnosis, evaluation, prevention, and treatment of Chronic Kidney Disease–Mineral and Bone Disorder (CKD-MBD) [J]. Kidney Int Suppl (2011), 2017, 7(1):1-59.
[4] 拟钙剂在慢性肾脏病患者中应用共识专家组.拟钙剂在慢性肾脏病患者中应用的专家共识[J]. 中华肾脏病杂志,2018,34(9):703-708.
[5] Ure?a-Torres P, Bridges I, Christiano C, et al. Efficacy of cinacalcet with low-dose vitamin D in incident haemodialysis subjects with secondary hyperparathyroidism[J]. Nephrol Dial Transplant, 2013, 28(5):1241-54.
[6] 郑飞,张彦丽,张谦等.伊特卡塞肽:治疗慢性肾病继发性甲状旁腺机能亢进新药[J].药物评价研究,2017,40(03):428-432.
[7] Fukagawa M,Yokoyama K, Shigematsu T,et al. A phase 3, multicentre, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of etelcalcetide (ONO-5163/AMG 416), a novel intravenous calcimimetic, for secondary hyperparathyroidism in Japanese haemodialysis patients[J]. Nephrol Dial Transplant, 2017, 32(10):1723-1730.
[8] Block GA, Bushinsky DA, Cunningham J, et al. Effect of Etelcalcetide vs Placebo on Serum Parathyroid Hormone in Patients Receiving Hemodialysis With Secondary Hyperparathyroidism: Two Randomized Clinical Trials[J]. JAMA, 2017, 317(2):146-155.
[9] Bell G, Huang S, Martin KJ, et al. A randomized, double-blind, phase 2 study evaluating the safety and efficacy of AMG 416 for the treatment of secondary hyperparathyroidism in hemodialysis patients[J]. Curr Med Res Opin, 2015, 31(5):943-52.
[10] Itano Y, Kato S, Tsuboi M, et al. A prospective, randomized clinical trial of etelcalcetide in patients receiving hemodialysis with secondary hyperthyroidism (The DUET trial) [J]. Kidney Int Rep, 2020, 5(12):2168-2177.
[11] D?rr K, Kammer M, Reindl-Schwaighofer R, et al. Randomized Trial of Etelcalcetide for Cardiac Hypertrophy in Hemodialysis[J]. Circ Res, 2021, 128(11):1616-1625.
[12] Shoji T, Nakatani S, Kabata D, et al. Comparative Effects of Etelcalcetide and Maxacalcitol on Serum Calcification Propensity in Secondary Hyperparathyroidism: A Randomized Clinical Trial[J]. Clin J Am Soc Nephrol, 2021, 16(4):599-612.
[13] Dudar I, Shifris I, Dudar S, et al. Current therapeutic options for the treatment of secondary hyperparathyroidism in end-stage renal disease patients treated with hemodialysis: a 12-month comparative study[J]. Pol Merkur Lekarski, 2022, 50(299):294-298.
[14] Block GA, Bushinsky DA, Cheng S, et al. Effect of Etelcalcetide vs Cinacalcet on Serum Parathyroid Hormone in Patients Receiving Hemodialysis With Secondary Hyperparathyroidism: A Randomized Clinical Trial[J]. JAMA, 2017, 317(2):156-164.
[15] Amgen. Head-to-Head Study of Etelcalcetide and Cinacalcet in Asian Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT). https://clinicaltrials.gov/show/NCT03299244. 2017
[16] Perrone V, Dovizio M, Veronesi C, et al. Real-World Evaluation of Calcimimetics for the Treatment of Secondary Hyperparathyroidism in Chronic Kidney Disease, in an Italian Clinical Setting[J]. Healthcare (Basel), 2022, 10(4):709-709.
[17] Danese MD, Lubeck D, Belozeroff V, et al. Real World Use and Effects of Calcimimetics in Treating Mineral and Bone Disorder in Hemodialysis Patients[J]. Am J Nephrol, 2020, 51(10):815-822.
[18] Pereira LAL, Meng C, Amoedo MAG, et al. Etelcalcetide controls secondary hyperparathyroidism and raises sclerostin levels in hemodialysis patients previously uncontrolled with cinacalcet[J]. Nefrologia(Engl Ed), 2023, 43(2):197-203.
[19] Xipell M, Montagud-Marrahi E, Rubio MV, et al. Improved Control of Secondary Hyperparathyroidism in Hemodialysis Patients Switching from Oral Cinacalcet to Intravenous Etelcalcetide, Especially in Nonadherent Patients[J]. Blood Purif, 2019, 48(2):106-114.
[20] Stephens JM, Fox KM, Desai P, et al. Calcimimetic use in US hemodialysis facilities in first 2 years after the launch of etelcalcetide: A descriptive analysis of real-world clinical practice and outcomes[J]. Hemodial Int, 2021, 26(2):243-254.
[21] Goltzman D, Mannstadt M, Marcocci C. Physiology of the Calcium-Parathyroid Hormone-Vitamin D Axis[J]. Front Horm Res, 2018, 501-13.
[22] Cunningham J, Locatelli F, Rodriguez M. Secondary hyperparathyroidism: pathogenesis, disease progression, and therapeutic options[J]. Clin J Am Soc Nephrol, 2011, 6(4):913-21.
[23] Gogusev J, Duchambon P, Hory B, et al. Depressed expression of calcium receptor in parathyroid gland tissue of patients with hyperparathyroidism[J]. Kidney Int, 1997, 51(1):328-336.
[24] Rodriguez M, Nemeth E, Martin D. The calcium-sensing receptor: a key factor in the pathogenesis of secondary hyperparathyroidism[J]. Kidney Int Suppl, 2005, 288(2):F253-64.
[25] Hyder R, Sprague SM. Secondary Hyperparathyroidism in a Patient with CKD[J]. Clin J Am Soc Nephrol, 2020, 15(7): 1041-1043.
Outlines

/

[an error occurred while processing this directive]