Safety and effectiveness of daily teriparatide for osteoporosis in patients with severe stages of chronic kidney disease: post hoc analysis of a postmarketing observational study

Atsushi Nishikawa,1 Fumito Yoshiki,2 Masanori Taketsuna,2 Kenta Kajimoto,2 Hiroyuki Enomoto2 1Global Patient Safety Japan, Quality and Patient Safety, Eli Lilly Japan K.K., 2Medicines Development Unit Japan, Eli Lilly Japan K.K., Kobe, Japan Abstract: Teriparatide (recombinant 1–34 N-ter...

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Autores principales:	Nishikawa A, Yoshiki F, Taketsuna M, Kajimoto K, Enomoto H
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2016
Materias:	Bone Mineral Density Chronic Kidney Disease Fragility Fracture Parathyroid Hormone Teriparatide Safety. Geriatrics RC952-954.6
Acceso en línea:	https://doaj.org/article/9c3c3bdea66943a997a5600980434bb8
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spelling	oai:doaj.org-article:9c3c3bdea66943a997a5600980434bb82021-12-02T03:45:32ZSafety and effectiveness of daily teriparatide for osteoporosis in patients with severe stages of chronic kidney disease: post hoc analysis of a postmarketing observational study1178-1998https://doaj.org/article/9c3c3bdea66943a997a5600980434bb82016-11-01T00:00:00Zhttps://www.dovepress.com/safety-and-effectiveness-of-daily-teriparatide-for-osteoporosis-in-pat-peer-reviewed-article-CIAhttps://doaj.org/toc/1178-1998Atsushi Nishikawa,1 Fumito Yoshiki,2 Masanori Taketsuna,2 Kenta Kajimoto,2 Hiroyuki Enomoto2 1Global Patient Safety Japan, Quality and Patient Safety, Eli Lilly Japan K.K., 2Medicines Development Unit Japan, Eli Lilly Japan K.K., Kobe, Japan Abstract: Teriparatide (recombinant 1–34 N-terminal sequence of human parathyroid hormone) for the treatment of osteoporosis should be prescribed with caution in patients with severe stages of chronic kidney disease (CKD). However, in clinical settings, physicians and surgeons who treat such patients have few available options. We sought to further explore the safety and effectiveness of teriparatide for the treatment of osteoporosis in Japanese patients with severe stages of CKD. This was a post hoc analysis of a postmarketing surveillance study that included patients with osteoporosis at high risk of fracture and stage 4 or 5 CKD. Patients received subcutaneous teriparatide 20 µg daily for up to 24 months. Safety profiles were assessed by physician-reported adverse drug reactions (ADRs). Effectiveness was assessed by measuring bone formation (via procollagen type 1 N-terminal propeptide [P1NP]), bone mineral density (BMD), and the incidence of clinical vertebral or nonvertebral fragility fractures. A total of 33 patients with severe stages of CKD (stage 4, n=30; stage 5, n=3) were included. All patients were female, and 81.8% had a history of previous fracture. No serious ADRs were recorded; a total of 4 ADRs were recorded for 4 of 33 patients. Increases in BMD and P1NP levels were observed both overall and in most individual patients. New fractures occurred in 1 patient with stage 5 CKD, but not in patients with stage 4 CKD. In this post hoc analysis conducted in Japan, teriparatide appeared to be effective for the treatment of osteoporosis in elderly female patients with severe stages of CKD, and no new safety concerns were observed. Keywords: bone mineral density, chronic kidney disease, fragility fracture, parathyroid hormone, teriparatide, safety Nishikawa AYoshiki FTaketsuna MKajimoto KEnomoto HDove Medical PressarticleBone Mineral DensityChronic Kidney DiseaseFragility FractureParathyroid HormoneTeriparatideSafety.GeriatricsRC952-954.6ENClinical Interventions in Aging, Vol Volume 11, Pp 1653-1659 (2016)
institution	DOAJ
collection	DOAJ
language	EN
topic	Bone Mineral Density Chronic Kidney Disease Fragility Fracture Parathyroid Hormone Teriparatide Safety. Geriatrics RC952-954.6
spellingShingle	Bone Mineral Density Chronic Kidney Disease Fragility Fracture Parathyroid Hormone Teriparatide Safety. Geriatrics RC952-954.6 Nishikawa A Yoshiki F Taketsuna M Kajimoto K Enomoto H Safety and effectiveness of daily teriparatide for osteoporosis in patients with severe stages of chronic kidney disease: post hoc analysis of a postmarketing observational study
description	Atsushi Nishikawa,1 Fumito Yoshiki,2 Masanori Taketsuna,2 Kenta Kajimoto,2 Hiroyuki Enomoto2 1Global Patient Safety Japan, Quality and Patient Safety, Eli Lilly Japan K.K., 2Medicines Development Unit Japan, Eli Lilly Japan K.K., Kobe, Japan Abstract: Teriparatide (recombinant 1–34 N-terminal sequence of human parathyroid hormone) for the treatment of osteoporosis should be prescribed with caution in patients with severe stages of chronic kidney disease (CKD). However, in clinical settings, physicians and surgeons who treat such patients have few available options. We sought to further explore the safety and effectiveness of teriparatide for the treatment of osteoporosis in Japanese patients with severe stages of CKD. This was a post hoc analysis of a postmarketing surveillance study that included patients with osteoporosis at high risk of fracture and stage 4 or 5 CKD. Patients received subcutaneous teriparatide 20 µg daily for up to 24 months. Safety profiles were assessed by physician-reported adverse drug reactions (ADRs). Effectiveness was assessed by measuring bone formation (via procollagen type 1 N-terminal propeptide [P1NP]), bone mineral density (BMD), and the incidence of clinical vertebral or nonvertebral fragility fractures. A total of 33 patients with severe stages of CKD (stage 4, n=30; stage 5, n=3) were included. All patients were female, and 81.8% had a history of previous fracture. No serious ADRs were recorded; a total of 4 ADRs were recorded for 4 of 33 patients. Increases in BMD and P1NP levels were observed both overall and in most individual patients. New fractures occurred in 1 patient with stage 5 CKD, but not in patients with stage 4 CKD. In this post hoc analysis conducted in Japan, teriparatide appeared to be effective for the treatment of osteoporosis in elderly female patients with severe stages of CKD, and no new safety concerns were observed. Keywords: bone mineral density, chronic kidney disease, fragility fracture, parathyroid hormone, teriparatide, safety
format	article
author	Nishikawa A Yoshiki F Taketsuna M Kajimoto K Enomoto H
author_facet	Nishikawa A Yoshiki F Taketsuna M Kajimoto K Enomoto H
author_sort	Nishikawa A
title	Safety and effectiveness of daily teriparatide for osteoporosis in patients with severe stages of chronic kidney disease: post hoc analysis of a postmarketing observational study
title_short	Safety and effectiveness of daily teriparatide for osteoporosis in patients with severe stages of chronic kidney disease: post hoc analysis of a postmarketing observational study
title_full	Safety and effectiveness of daily teriparatide for osteoporosis in patients with severe stages of chronic kidney disease: post hoc analysis of a postmarketing observational study
title_fullStr	Safety and effectiveness of daily teriparatide for osteoporosis in patients with severe stages of chronic kidney disease: post hoc analysis of a postmarketing observational study
title_full_unstemmed	Safety and effectiveness of daily teriparatide for osteoporosis in patients with severe stages of chronic kidney disease: post hoc analysis of a postmarketing observational study
title_sort	safety and effectiveness of daily teriparatide for osteoporosis in patients with severe stages of chronic kidney disease: post hoc analysis of a postmarketing observational study
publisher	Dove Medical Press
publishDate	2016
url	https://doaj.org/article/9c3c3bdea66943a997a5600980434bb8
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Safety and effectiveness of daily teriparatide for osteoporosis in patients with severe stages of chronic kidney disease: post hoc analysis of a postmarketing observational study

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