Cargando…

Recurrent cardiovascular events in patients with type 2 diabetes and haemodialysis: analysis from the 4D Study

BACKGROUND: In the ‘Die Deutsche Diabetes Dialyse Studie’ (4D Study), treatment of patients with type 2 diabetes mellitus (T2DM) on haemodialysis (HD) with atorvastatin compared with placebo had no significant effect on the first composite primary major adverse cardiovascular event (MACE) endpoint o...

Descripción completa

Detalles Bibliográficos
Autores principales: Marx, Nikolaus, Wanner, Christoph, Jankowski, Joachim, März, Winfried, Krane, Vera, Genser, Bernd
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10539202/
https://www.ncbi.nlm.nih.gov/pubmed/37779851
http://dx.doi.org/10.1093/ckj/sfad029
_version_ 1785113446793084928
author Marx, Nikolaus
Wanner, Christoph
Jankowski, Joachim
März, Winfried
Krane, Vera
Genser, Bernd
author_facet Marx, Nikolaus
Wanner, Christoph
Jankowski, Joachim
März, Winfried
Krane, Vera
Genser, Bernd
author_sort Marx, Nikolaus
collection PubMed
description BACKGROUND: In the ‘Die Deutsche Diabetes Dialyse Studie’ (4D Study), treatment of patients with type 2 diabetes mellitus (T2DM) on haemodialysis (HD) with atorvastatin compared with placebo had no significant effect on the first composite primary major adverse cardiovascular event (MACE) endpoint of death from cardiac causes, fatal stroke, non-fatal myocardial infarction or non-fatal stroke. In this study we analysed first and recurrent events in 1255 patients from the 4D Study. METHODS: We conducted an event history analysis to investigate the effects of previous clinical events on the risk of different endpoints in the total patient group and after stratification by randomization group. RESULTS: During a median follow-up of 4 years, a total of 548 MACEs occurred, with 469 first and 79 recurrent events. The most frequent event was sudden cardiac death, followed by death due to infection/sepsis. Of the 548 total MACEs, 260 occurred in the atorvastatin group and 288 in the placebo group [hazard ratio 0.91 (95% confidence interval 0.76–1.07), P = .266]. Interestingly, analyses of the baseline hazard functions for first and recurrent events as a function of time after randomization demonstrated that the risks of the composite primary endpoint continually increased in the placebo group with increasing time in the study, whereas the risk in the atorvastatin group remained constant after ≈1.5 years. CONCLUSION: This recurrent and total event analysis from the 4D Study underscores the high risk of sudden cardiac death and death due to infection/sepsis in patients with T2DM receiving HD and raises the hypothesis that atorvastatin may stabilize cardiovascular risk only after 1–2 years in this high-risk population.
format Online
Article
Text
id pubmed-10539202
institution National Center for Biotechnology Information
language English
publishDate 2023
publisher Oxford University Press
record_format MEDLINE/PubMed
spelling pubmed-105392022023-09-30 Recurrent cardiovascular events in patients with type 2 diabetes and haemodialysis: analysis from the 4D Study Marx, Nikolaus Wanner, Christoph Jankowski, Joachim März, Winfried Krane, Vera Genser, Bernd Clin Kidney J Original Article BACKGROUND: In the ‘Die Deutsche Diabetes Dialyse Studie’ (4D Study), treatment of patients with type 2 diabetes mellitus (T2DM) on haemodialysis (HD) with atorvastatin compared with placebo had no significant effect on the first composite primary major adverse cardiovascular event (MACE) endpoint of death from cardiac causes, fatal stroke, non-fatal myocardial infarction or non-fatal stroke. In this study we analysed first and recurrent events in 1255 patients from the 4D Study. METHODS: We conducted an event history analysis to investigate the effects of previous clinical events on the risk of different endpoints in the total patient group and after stratification by randomization group. RESULTS: During a median follow-up of 4 years, a total of 548 MACEs occurred, with 469 first and 79 recurrent events. The most frequent event was sudden cardiac death, followed by death due to infection/sepsis. Of the 548 total MACEs, 260 occurred in the atorvastatin group and 288 in the placebo group [hazard ratio 0.91 (95% confidence interval 0.76–1.07), P = .266]. Interestingly, analyses of the baseline hazard functions for first and recurrent events as a function of time after randomization demonstrated that the risks of the composite primary endpoint continually increased in the placebo group with increasing time in the study, whereas the risk in the atorvastatin group remained constant after ≈1.5 years. CONCLUSION: This recurrent and total event analysis from the 4D Study underscores the high risk of sudden cardiac death and death due to infection/sepsis in patients with T2DM receiving HD and raises the hypothesis that atorvastatin may stabilize cardiovascular risk only after 1–2 years in this high-risk population. Oxford University Press 2023-03-02 /pmc/articles/PMC10539202/ /pubmed/37779851 http://dx.doi.org/10.1093/ckj/sfad029 Text en © The Author(s) 2023. Published by Oxford University Press on behalf of the ERA. https://creativecommons.org/licenses/by-nc/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial License (https://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
spellingShingle Original Article
Marx, Nikolaus
Wanner, Christoph
Jankowski, Joachim
März, Winfried
Krane, Vera
Genser, Bernd
Recurrent cardiovascular events in patients with type 2 diabetes and haemodialysis: analysis from the 4D Study
title Recurrent cardiovascular events in patients with type 2 diabetes and haemodialysis: analysis from the 4D Study
title_full Recurrent cardiovascular events in patients with type 2 diabetes and haemodialysis: analysis from the 4D Study
title_fullStr Recurrent cardiovascular events in patients with type 2 diabetes and haemodialysis: analysis from the 4D Study
title_full_unstemmed Recurrent cardiovascular events in patients with type 2 diabetes and haemodialysis: analysis from the 4D Study
title_short Recurrent cardiovascular events in patients with type 2 diabetes and haemodialysis: analysis from the 4D Study
title_sort recurrent cardiovascular events in patients with type 2 diabetes and haemodialysis: analysis from the 4d study
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10539202/
https://www.ncbi.nlm.nih.gov/pubmed/37779851
http://dx.doi.org/10.1093/ckj/sfad029
work_keys_str_mv AT marxnikolaus recurrentcardiovasculareventsinpatientswithtype2diabetesandhaemodialysisanalysisfromthe4dstudy
AT wannerchristoph recurrentcardiovasculareventsinpatientswithtype2diabetesandhaemodialysisanalysisfromthe4dstudy
AT jankowskijoachim recurrentcardiovasculareventsinpatientswithtype2diabetesandhaemodialysisanalysisfromthe4dstudy
AT marzwinfried recurrentcardiovasculareventsinpatientswithtype2diabetesandhaemodialysisanalysisfromthe4dstudy
AT kranevera recurrentcardiovasculareventsinpatientswithtype2diabetesandhaemodialysisanalysisfromthe4dstudy
AT genserbernd recurrentcardiovasculareventsinpatientswithtype2diabetesandhaemodialysisanalysisfromthe4dstudy