Cargando…
Safety and efficacy of etelcalcetide, an intravenous calcimimetic, for up to 52 weeks in hemodialysis patients with secondary hyperparathyroidism: results of a post-marketing surveillance in Japan
BACKGROUND: Etelcalcetide is a second-generation calcimimetic for the management of secondary hyperparathyroidism (SHPT) in patients on dialysis. We performed a post-marketing surveillance (PMS) to obtain information on the safety and efficacy of etelcalcetide in clinical practice in Japan. METHODS:...
Autores principales: | , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer Singapore
2020
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7794109/ https://www.ncbi.nlm.nih.gov/pubmed/32816132 http://dx.doi.org/10.1007/s10157-020-01936-2 |
_version_ | 1783634139067449344 |
---|---|
author | Yokoyama, Keitaro Fukagawa, Masafumi Shigematsu, Takashi Akiba, Takashi Yoshikawa, Ken Tsuchiya, Akira Kuwabara, Misato Akizawa, Tadao |
author_facet | Yokoyama, Keitaro Fukagawa, Masafumi Shigematsu, Takashi Akiba, Takashi Yoshikawa, Ken Tsuchiya, Akira Kuwabara, Misato Akizawa, Tadao |
author_sort | Yokoyama, Keitaro |
collection | PubMed |
description | BACKGROUND: Etelcalcetide is a second-generation calcimimetic for the management of secondary hyperparathyroidism (SHPT) in patients on dialysis. We performed a post-marketing surveillance (PMS) to obtain information on the safety and efficacy of etelcalcetide in clinical practice in Japan. METHODS: This PMS enrolled SHPT patients who started initial treatment with etelcalcetide between April 1, 2017 and February 28, 2018 in Japan. Safety [adverse drug reactions (ADRs)] and efficacy [serum intact parathyroid hormone (iPTH), corrected calcium (cCa), phosphorous (P), and alkaline phosphatase (ALP)] were recorded for up to 52 weeks or until treatment discontinuation. Treatment decisions were at the physician’s discretion. RESULTS: Of 1226 patients enrolled across 282 centers, safety and efficacy data were available for 1195 and 1192, respectively, while 933 continued treatment to Week 52. The starting dose was 5 mg in 82.0% of patients. There were 218 ADRs in 169 patients (14.1%). Metabolism and nutrition disorders (8.8%), adverse laboratory test results (1.8%), and gastrointestinal disorders (1.6%) were the most frequent classes of ADRs. Hypocalcemia-related ADRs occurred in 104 patients (8.7%). The percentage of patients with iPTH levels within the target range (60–240 pg/mL) steadily increased from 19.5% at Week 0 to 64.1% at Week 52 or last dose. cCa, P, and ALP levels remained well controlled. CONCLUSION: This was the first real-world, large-scale, long-term observational PMS of etelcalcetide in Japan. We did not observe any new safety concerns. Etelcalcetide was associated with clinically relevant improvements in serum iPTH and maintenance of serum cCa, P, and ALP levels. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s10157-020-01936-2) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-7794109 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Springer Singapore |
record_format | MEDLINE/PubMed |
spelling | pubmed-77941092021-01-19 Safety and efficacy of etelcalcetide, an intravenous calcimimetic, for up to 52 weeks in hemodialysis patients with secondary hyperparathyroidism: results of a post-marketing surveillance in Japan Yokoyama, Keitaro Fukagawa, Masafumi Shigematsu, Takashi Akiba, Takashi Yoshikawa, Ken Tsuchiya, Akira Kuwabara, Misato Akizawa, Tadao Clin Exp Nephrol Original Article BACKGROUND: Etelcalcetide is a second-generation calcimimetic for the management of secondary hyperparathyroidism (SHPT) in patients on dialysis. We performed a post-marketing surveillance (PMS) to obtain information on the safety and efficacy of etelcalcetide in clinical practice in Japan. METHODS: This PMS enrolled SHPT patients who started initial treatment with etelcalcetide between April 1, 2017 and February 28, 2018 in Japan. Safety [adverse drug reactions (ADRs)] and efficacy [serum intact parathyroid hormone (iPTH), corrected calcium (cCa), phosphorous (P), and alkaline phosphatase (ALP)] were recorded for up to 52 weeks or until treatment discontinuation. Treatment decisions were at the physician’s discretion. RESULTS: Of 1226 patients enrolled across 282 centers, safety and efficacy data were available for 1195 and 1192, respectively, while 933 continued treatment to Week 52. The starting dose was 5 mg in 82.0% of patients. There were 218 ADRs in 169 patients (14.1%). Metabolism and nutrition disorders (8.8%), adverse laboratory test results (1.8%), and gastrointestinal disorders (1.6%) were the most frequent classes of ADRs. Hypocalcemia-related ADRs occurred in 104 patients (8.7%). The percentage of patients with iPTH levels within the target range (60–240 pg/mL) steadily increased from 19.5% at Week 0 to 64.1% at Week 52 or last dose. cCa, P, and ALP levels remained well controlled. CONCLUSION: This was the first real-world, large-scale, long-term observational PMS of etelcalcetide in Japan. We did not observe any new safety concerns. Etelcalcetide was associated with clinically relevant improvements in serum iPTH and maintenance of serum cCa, P, and ALP levels. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s10157-020-01936-2) contains supplementary material, which is available to authorized users. Springer Singapore 2020-08-20 2021 /pmc/articles/PMC7794109/ /pubmed/32816132 http://dx.doi.org/10.1007/s10157-020-01936-2 Text en © The Author(s) 2020 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. |
spellingShingle | Original Article Yokoyama, Keitaro Fukagawa, Masafumi Shigematsu, Takashi Akiba, Takashi Yoshikawa, Ken Tsuchiya, Akira Kuwabara, Misato Akizawa, Tadao Safety and efficacy of etelcalcetide, an intravenous calcimimetic, for up to 52 weeks in hemodialysis patients with secondary hyperparathyroidism: results of a post-marketing surveillance in Japan |
title | Safety and efficacy of etelcalcetide, an intravenous calcimimetic, for up to 52 weeks in hemodialysis patients with secondary hyperparathyroidism: results of a post-marketing surveillance in Japan |
title_full | Safety and efficacy of etelcalcetide, an intravenous calcimimetic, for up to 52 weeks in hemodialysis patients with secondary hyperparathyroidism: results of a post-marketing surveillance in Japan |
title_fullStr | Safety and efficacy of etelcalcetide, an intravenous calcimimetic, for up to 52 weeks in hemodialysis patients with secondary hyperparathyroidism: results of a post-marketing surveillance in Japan |
title_full_unstemmed | Safety and efficacy of etelcalcetide, an intravenous calcimimetic, for up to 52 weeks in hemodialysis patients with secondary hyperparathyroidism: results of a post-marketing surveillance in Japan |
title_short | Safety and efficacy of etelcalcetide, an intravenous calcimimetic, for up to 52 weeks in hemodialysis patients with secondary hyperparathyroidism: results of a post-marketing surveillance in Japan |
title_sort | safety and efficacy of etelcalcetide, an intravenous calcimimetic, for up to 52 weeks in hemodialysis patients with secondary hyperparathyroidism: results of a post-marketing surveillance in japan |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7794109/ https://www.ncbi.nlm.nih.gov/pubmed/32816132 http://dx.doi.org/10.1007/s10157-020-01936-2 |
work_keys_str_mv | AT yokoyamakeitaro safetyandefficacyofetelcalcetideanintravenouscalcimimeticforupto52weeksinhemodialysispatientswithsecondaryhyperparathyroidismresultsofapostmarketingsurveillanceinjapan AT fukagawamasafumi safetyandefficacyofetelcalcetideanintravenouscalcimimeticforupto52weeksinhemodialysispatientswithsecondaryhyperparathyroidismresultsofapostmarketingsurveillanceinjapan AT shigematsutakashi safetyandefficacyofetelcalcetideanintravenouscalcimimeticforupto52weeksinhemodialysispatientswithsecondaryhyperparathyroidismresultsofapostmarketingsurveillanceinjapan AT akibatakashi safetyandefficacyofetelcalcetideanintravenouscalcimimeticforupto52weeksinhemodialysispatientswithsecondaryhyperparathyroidismresultsofapostmarketingsurveillanceinjapan AT yoshikawaken safetyandefficacyofetelcalcetideanintravenouscalcimimeticforupto52weeksinhemodialysispatientswithsecondaryhyperparathyroidismresultsofapostmarketingsurveillanceinjapan AT tsuchiyaakira safetyandefficacyofetelcalcetideanintravenouscalcimimeticforupto52weeksinhemodialysispatientswithsecondaryhyperparathyroidismresultsofapostmarketingsurveillanceinjapan AT kuwabaramisato safetyandefficacyofetelcalcetideanintravenouscalcimimeticforupto52weeksinhemodialysispatientswithsecondaryhyperparathyroidismresultsofapostmarketingsurveillanceinjapan AT akizawatadao safetyandefficacyofetelcalcetideanintravenouscalcimimeticforupto52weeksinhemodialysispatientswithsecondaryhyperparathyroidismresultsofapostmarketingsurveillanceinjapan |