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Effects of alfacalcidol on cardiovascular outcomes according to alkaline phosphatase levels in the J-DAVID trial

In the Japan Dialysis Active Vitamin D (J-DAVID) trial, oral alfacalcidol numerically, but not significantly, increased the risk of cardiovascular events among patients undergoing hemodialysis. Because the cardiovascular effect of alfacalcidol could be modulated by bone turnover status, this post-ho...

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Autores principales: Oka, Tatsufumi, Sakaguchi, Yusuke, Isaka, Yoshitaka, Ishii, Haruka, Kabata, Daijiro, Shintani, Ayumi, Nakatani, Shinya, Morioka, Tomoaki, Mori, Katsuhito, Inaba, Masaaki, Emoto, Masanori, Shoji, Tetsuo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nature Publishing Group UK 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9475027/
https://www.ncbi.nlm.nih.gov/pubmed/36104443
http://dx.doi.org/10.1038/s41598-022-19820-2
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author Oka, Tatsufumi
Sakaguchi, Yusuke
Isaka, Yoshitaka
Ishii, Haruka
Kabata, Daijiro
Shintani, Ayumi
Nakatani, Shinya
Morioka, Tomoaki
Mori, Katsuhito
Inaba, Masaaki
Emoto, Masanori
Shoji, Tetsuo
author_facet Oka, Tatsufumi
Sakaguchi, Yusuke
Isaka, Yoshitaka
Ishii, Haruka
Kabata, Daijiro
Shintani, Ayumi
Nakatani, Shinya
Morioka, Tomoaki
Mori, Katsuhito
Inaba, Masaaki
Emoto, Masanori
Shoji, Tetsuo
author_sort Oka, Tatsufumi
collection PubMed
description In the Japan Dialysis Active Vitamin D (J-DAVID) trial, oral alfacalcidol numerically, but not significantly, increased the risk of cardiovascular events among patients undergoing hemodialysis. Because the cardiovascular effect of alfacalcidol could be modulated by bone turnover status, this post-hoc analysis of the J-DAVID examined how alkaline phosphatase (ALP), a more precise marker of bone turnover than parathyroid hormone (PTH), modifies the impact of alfacalcidol. The J-DAVID was a 48-month, open-label, randomized controlled trial comparing oral alfacalcidol with no vitamin D receptor activators use in terms of cardiovascular events among 976 hemodialysis patients without secondary hyperparathyroidism. This post-hoc analysis included 959 patients with available data on baseline ALP. The median [25–75th percentile] baseline ALP level was 234 [183–296] U/L. In a Cox proportional hazards model, ALP did not significantly modify the effect of alfacalcidol on the rate of cardiovascular events or all-cause death (P for effect modification = 0.54 and 0.74, respectively). The effect of alfacalcidol on time-series changes in calcium, phosphate, and intact PTH were similar across ALP subgroups. In conclusion, oral alfacalcidol did not significantly affect cardiovascular outcomes irrespective of bone turnover status.
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spelling pubmed-94750272022-09-16 Effects of alfacalcidol on cardiovascular outcomes according to alkaline phosphatase levels in the J-DAVID trial Oka, Tatsufumi Sakaguchi, Yusuke Isaka, Yoshitaka Ishii, Haruka Kabata, Daijiro Shintani, Ayumi Nakatani, Shinya Morioka, Tomoaki Mori, Katsuhito Inaba, Masaaki Emoto, Masanori Shoji, Tetsuo Sci Rep Article In the Japan Dialysis Active Vitamin D (J-DAVID) trial, oral alfacalcidol numerically, but not significantly, increased the risk of cardiovascular events among patients undergoing hemodialysis. Because the cardiovascular effect of alfacalcidol could be modulated by bone turnover status, this post-hoc analysis of the J-DAVID examined how alkaline phosphatase (ALP), a more precise marker of bone turnover than parathyroid hormone (PTH), modifies the impact of alfacalcidol. The J-DAVID was a 48-month, open-label, randomized controlled trial comparing oral alfacalcidol with no vitamin D receptor activators use in terms of cardiovascular events among 976 hemodialysis patients without secondary hyperparathyroidism. This post-hoc analysis included 959 patients with available data on baseline ALP. The median [25–75th percentile] baseline ALP level was 234 [183–296] U/L. In a Cox proportional hazards model, ALP did not significantly modify the effect of alfacalcidol on the rate of cardiovascular events or all-cause death (P for effect modification = 0.54 and 0.74, respectively). The effect of alfacalcidol on time-series changes in calcium, phosphate, and intact PTH were similar across ALP subgroups. In conclusion, oral alfacalcidol did not significantly affect cardiovascular outcomes irrespective of bone turnover status. Nature Publishing Group UK 2022-09-14 /pmc/articles/PMC9475027/ /pubmed/36104443 http://dx.doi.org/10.1038/s41598-022-19820-2 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open Access This 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/ (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Article
Oka, Tatsufumi
Sakaguchi, Yusuke
Isaka, Yoshitaka
Ishii, Haruka
Kabata, Daijiro
Shintani, Ayumi
Nakatani, Shinya
Morioka, Tomoaki
Mori, Katsuhito
Inaba, Masaaki
Emoto, Masanori
Shoji, Tetsuo
Effects of alfacalcidol on cardiovascular outcomes according to alkaline phosphatase levels in the J-DAVID trial
title Effects of alfacalcidol on cardiovascular outcomes according to alkaline phosphatase levels in the J-DAVID trial
title_full Effects of alfacalcidol on cardiovascular outcomes according to alkaline phosphatase levels in the J-DAVID trial
title_fullStr Effects of alfacalcidol on cardiovascular outcomes according to alkaline phosphatase levels in the J-DAVID trial
title_full_unstemmed Effects of alfacalcidol on cardiovascular outcomes according to alkaline phosphatase levels in the J-DAVID trial
title_short Effects of alfacalcidol on cardiovascular outcomes according to alkaline phosphatase levels in the J-DAVID trial
title_sort effects of alfacalcidol on cardiovascular outcomes according to alkaline phosphatase levels in the j-david trial
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9475027/
https://www.ncbi.nlm.nih.gov/pubmed/36104443
http://dx.doi.org/10.1038/s41598-022-19820-2
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