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Current therapeutic options for the treatment of secondary hyperparathyroidism in end-stage renal disease patients treated with hemodialysis: a 12-month comparative study.
Pol Merkur Lekarski. 2022 Oct 21; 50(299):294-298.PM

Abstract

AIM

The aim of the study was to investigate the effect of a new calcimimetic, Etelcalcetide, on secondary hyperparathyroidism and its effects in end-stage renal disease (ESRD) patients treated with hemodialysis (HD) compared with hemodialysis (HD) patients not treated with calcimimetics.

MATERIALS AND METHODS

The cohort study included 203 ESRD patients with secondary hyperparathyroidism (SHPT) who received HD treatment. Total number patients were randomly to two groups. The main group (n=71) included HD patients treated by new calcimimetic Etelcalcetide. The historical group (n=132) was evaluated retrospectively and included patients who had SHPT but did not receive calcimimetic treatment. Serum levels of phosphorus, calcium and parathyroid hormone were compared for 12 months. The primary endpoint of the study was death from any cause, surrogates - cases of fractures, parathyroidectomy, death from cardiovascular (CV) events.

RESULTS

The dose of Etelcalcetide changed monthly and averaged 8.58±1.79 mg. The dynamics of parathormone (PTH) indicators showed that the decrease in PTH levels by 30% from basal occurred after 3 months of treatment in 39 (54.9%) and 12 (9.1%) patients of the main group and historical group, respectively (p<0.0001). At the end of the study, the target PTH level reached in 52 (73.2%) patients in the main group and only 14 (10.6%) in the comparison group (p<0.0001). In addition to the decrease in serum PTH content, in the main group of patients, there was also a decrease in serum calcium and phosphorus levels. During the time to be analyzed, 36 deaths were reported, 61.1% of which were fatal CV events. The proportion of CV events in the mortality structure is more than 70% higher in the historical group than in the group of patients treated with Etelcalcetide, and is 69,2% vs 40,0%, respectively. The frequency of fractures is almost three times higher in the historical than in the main group of patients. The proportion of patients who required parathyroidectomy was significantly more than three times higher in the historical group than in the main group (p<0,05).

CONCLUSIONS

In a prospective study, we demonstrated the high efficacy of Etelcalcetide in the treatment of SHPT in hemodialysis patients. Treatment of SHPT with the inclusion of Etelcalcetide is accompanied by improved clinical outcomes such as the incidence of bone fractures, cardiovascular morbidity and mortality.

Authors+Show Affiliations

SI Institute of Nephrology of the National Academy of Medical Sciences of Ukraine, Kyiv, Ukraine.SI Institute of Nephrology of the National Academy of Medical Sciences of Ukraine, Kyiv, Ukraine.Shupyk National Healthcare University of Ukraine, Department Orthopedics and Traumatology No2, Kyiv, Ukraine.CNPE Kyiv City Center of Nephrology and Dialysis, Ukraine.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

36283011

Citation

Dudar, Iryna, 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." Polski Merkuriusz Lekarski : Organ Polskiego Towarzystwa Lekarskiego, vol. 50, no. 299, 2022, pp. 294-298.
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. Pol Merkur Lekarski. 2022;50(299):294-298.
Dudar, I., Shifris, I., Dudar, S., & Kulish, V. (2022). Current therapeutic options for the treatment of secondary hyperparathyroidism in end-stage renal disease patients treated with hemodialysis: a 12-month comparative study. Polski Merkuriusz Lekarski : Organ Polskiego Towarzystwa Lekarskiego, 50(299), 294-298.
Dudar I, 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. Pol Merkur Lekarski. 2022 Oct 21;50(299):294-298. PubMed PMID: 36283011.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Current therapeutic options for the treatment of secondary hyperparathyroidism in end-stage renal disease patients treated with hemodialysis: a 12-month comparative study. AU - Dudar,Iryna, AU - Shifris,Iryna, AU - Dudar,Sergey, AU - Kulish,Viktor, PY - 2022/10/25/entrez PY - 2022/10/26/pubmed PY - 2022/10/28/medline KW - Etelcalcetide, treatment KW - chronic kidney disease KW - mineral and bone disorders (CKD-MBD) SP - 294 EP - 298 JF - Polski merkuriusz lekarski : organ Polskiego Towarzystwa Lekarskiego JO - Pol Merkur Lekarski VL - 50 IS - 299 N2 - AIM: The aim of the study was to investigate the effect of a new calcimimetic, Etelcalcetide, on secondary hyperparathyroidism and its effects in end-stage renal disease (ESRD) patients treated with hemodialysis (HD) compared with hemodialysis (HD) patients not treated with calcimimetics. MATERIALS AND METHODS: The cohort study included 203 ESRD patients with secondary hyperparathyroidism (SHPT) who received HD treatment. Total number patients were randomly to two groups. The main group (n=71) included HD patients treated by new calcimimetic Etelcalcetide. The historical group (n=132) was evaluated retrospectively and included patients who had SHPT but did not receive calcimimetic treatment. Serum levels of phosphorus, calcium and parathyroid hormone were compared for 12 months. The primary endpoint of the study was death from any cause, surrogates - cases of fractures, parathyroidectomy, death from cardiovascular (CV) events. RESULTS: The dose of Etelcalcetide changed monthly and averaged 8.58±1.79 mg. The dynamics of parathormone (PTH) indicators showed that the decrease in PTH levels by 30% from basal occurred after 3 months of treatment in 39 (54.9%) and 12 (9.1%) patients of the main group and historical group, respectively (p<0.0001). At the end of the study, the target PTH level reached in 52 (73.2%) patients in the main group and only 14 (10.6%) in the comparison group (p<0.0001). In addition to the decrease in serum PTH content, in the main group of patients, there was also a decrease in serum calcium and phosphorus levels. During the time to be analyzed, 36 deaths were reported, 61.1% of which were fatal CV events. The proportion of CV events in the mortality structure is more than 70% higher in the historical group than in the group of patients treated with Etelcalcetide, and is 69,2% vs 40,0%, respectively. The frequency of fractures is almost three times higher in the historical than in the main group of patients. The proportion of patients who required parathyroidectomy was significantly more than three times higher in the historical group than in the main group (p<0,05). CONCLUSIONS: In a prospective study, we demonstrated the high efficacy of Etelcalcetide in the treatment of SHPT in hemodialysis patients. Treatment of SHPT with the inclusion of Etelcalcetide is accompanied by improved clinical outcomes such as the incidence of bone fractures, cardiovascular morbidity and mortality. SN - 1426-9686 UR - https://wwww.unboundmedicine.com/medline/citation/36283011/Current_therapeutic_options_for_the_treatment_of_secondary_hyperparathyroidism_in_end_stage_renal_disease_patients_treated_with_hemodialysis:_a_12_month_comparative_study_ DB - PRIME DP - Unbound Medicine ER -