Cargando…
A randomized, open-label, multicentre study to evaluate plasma atherosclerotic biomarkers in patients with type 2 diabetes mellitus and arteriosclerosis obliterans when treated with Probucol and Cilostazol
OBJECTIVES: To evaluate the plasma atherosclerotic biomarkers in patients with type 2 diabetes mellitus (T2DM) and arteriosclerosis obliteran (ASO) when treated with Probucol plus Cilostazol in combination and individually. METHODS: In this open-label study, patients aged 40–75 years were randomized...
Autores principales: | , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Science Press
2012
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3470020/ https://www.ncbi.nlm.nih.gov/pubmed/23097651 http://dx.doi.org/10.3724/SP.J.1263.2012.02143 |
_version_ | 1782246183914176512 |
---|---|
author | Ma, Xiao-Wei Guo, Xiao-Hui Xiao, Xin-Hua Guo, Li-Xin Lv, Xiao-Feng Li, Quan-Min Gao, Yan |
author_facet | Ma, Xiao-Wei Guo, Xiao-Hui Xiao, Xin-Hua Guo, Li-Xin Lv, Xiao-Feng Li, Quan-Min Gao, Yan |
author_sort | Ma, Xiao-Wei |
collection | PubMed |
description | OBJECTIVES: To evaluate the plasma atherosclerotic biomarkers in patients with type 2 diabetes mellitus (T2DM) and arteriosclerosis obliteran (ASO) when treated with Probucol plus Cilostazol in combination and individually. METHODS: In this open-label study, patients aged 40–75 years were randomized to receive conventional therapy alone, or with Cilostazol 100 mg bid, or with Probucol 250 mg bid, or with both in combination. Endpoints included changes in plasma biomarker and safety at 12 weeks. RESULTS: Of the 200 randomized patients, 165 for per-protocol and 160 for the safety (QTc intervals) were set, respectively. Probucol significantly reduced total cholesterol (P < 0.001), low-density lipoprotein cholesterol (LDL-C), (P = 0.01), and high-density lipoprotein cholesterol (HDL-C) (P < 0.001) compared with conventional therapy. Cilostazol was effective in increasing HDL-C (P = 0.002) and reducing triglycerides levels (P < 0.01) compared with conventional therapy. A trend towards significance was observed for the difference between conventional therapy alone and Probucol plus Cilostazol group for the change in oxidized low-density lipoprotein (Ox-LDL, P = 0.065). No significant effects on the majority of the remaining biomarkers were found across the treatment groups. CONCLUSIONS: We have confirmed that Ox-LDL could be a possible plasma atherosclerotic biomarker among the evaluated biomarkers, which reflected the synergetic effect of Cilostazol plus Probucol in patients with T2DM and ASO shown previously in preclinical studies. |
format | Online Article Text |
id | pubmed-3470020 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2012 |
publisher | Science Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-34700202012-10-24 A randomized, open-label, multicentre study to evaluate plasma atherosclerotic biomarkers in patients with type 2 diabetes mellitus and arteriosclerosis obliterans when treated with Probucol and Cilostazol Ma, Xiao-Wei Guo, Xiao-Hui Xiao, Xin-Hua Guo, Li-Xin Lv, Xiao-Feng Li, Quan-Min Gao, Yan J Geriatr Cardiol Research Articles OBJECTIVES: To evaluate the plasma atherosclerotic biomarkers in patients with type 2 diabetes mellitus (T2DM) and arteriosclerosis obliteran (ASO) when treated with Probucol plus Cilostazol in combination and individually. METHODS: In this open-label study, patients aged 40–75 years were randomized to receive conventional therapy alone, or with Cilostazol 100 mg bid, or with Probucol 250 mg bid, or with both in combination. Endpoints included changes in plasma biomarker and safety at 12 weeks. RESULTS: Of the 200 randomized patients, 165 for per-protocol and 160 for the safety (QTc intervals) were set, respectively. Probucol significantly reduced total cholesterol (P < 0.001), low-density lipoprotein cholesterol (LDL-C), (P = 0.01), and high-density lipoprotein cholesterol (HDL-C) (P < 0.001) compared with conventional therapy. Cilostazol was effective in increasing HDL-C (P = 0.002) and reducing triglycerides levels (P < 0.01) compared with conventional therapy. A trend towards significance was observed for the difference between conventional therapy alone and Probucol plus Cilostazol group for the change in oxidized low-density lipoprotein (Ox-LDL, P = 0.065). No significant effects on the majority of the remaining biomarkers were found across the treatment groups. CONCLUSIONS: We have confirmed that Ox-LDL could be a possible plasma atherosclerotic biomarker among the evaluated biomarkers, which reflected the synergetic effect of Cilostazol plus Probucol in patients with T2DM and ASO shown previously in preclinical studies. Science Press 2012-09 /pmc/articles/PMC3470020/ /pubmed/23097651 http://dx.doi.org/10.3724/SP.J.1263.2012.02143 Text en Institute of Geriatric Cardiology http://creativecommons.org/licenses/by-nc-sa/3.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 Unported License, which allows readers to alter, transform, or build upon the article and then distribute the resulting work under the same or similar license to this one. The work must be attributed back to the original author and commercial use is not permitted without specific permission. |
spellingShingle | Research Articles Ma, Xiao-Wei Guo, Xiao-Hui Xiao, Xin-Hua Guo, Li-Xin Lv, Xiao-Feng Li, Quan-Min Gao, Yan A randomized, open-label, multicentre study to evaluate plasma atherosclerotic biomarkers in patients with type 2 diabetes mellitus and arteriosclerosis obliterans when treated with Probucol and Cilostazol |
title | A randomized, open-label, multicentre study to evaluate plasma atherosclerotic biomarkers in patients with type 2 diabetes mellitus and arteriosclerosis obliterans when treated with Probucol and Cilostazol |
title_full | A randomized, open-label, multicentre study to evaluate plasma atherosclerotic biomarkers in patients with type 2 diabetes mellitus and arteriosclerosis obliterans when treated with Probucol and Cilostazol |
title_fullStr | A randomized, open-label, multicentre study to evaluate plasma atherosclerotic biomarkers in patients with type 2 diabetes mellitus and arteriosclerosis obliterans when treated with Probucol and Cilostazol |
title_full_unstemmed | A randomized, open-label, multicentre study to evaluate plasma atherosclerotic biomarkers in patients with type 2 diabetes mellitus and arteriosclerosis obliterans when treated with Probucol and Cilostazol |
title_short | A randomized, open-label, multicentre study to evaluate plasma atherosclerotic biomarkers in patients with type 2 diabetes mellitus and arteriosclerosis obliterans when treated with Probucol and Cilostazol |
title_sort | randomized, open-label, multicentre study to evaluate plasma atherosclerotic biomarkers in patients with type 2 diabetes mellitus and arteriosclerosis obliterans when treated with probucol and cilostazol |
topic | Research Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3470020/ https://www.ncbi.nlm.nih.gov/pubmed/23097651 http://dx.doi.org/10.3724/SP.J.1263.2012.02143 |
work_keys_str_mv | AT maxiaowei arandomizedopenlabelmulticentrestudytoevaluateplasmaatheroscleroticbiomarkersinpatientswithtype2diabetesmellitusandarteriosclerosisobliteranswhentreatedwithprobucolandcilostazol AT guoxiaohui arandomizedopenlabelmulticentrestudytoevaluateplasmaatheroscleroticbiomarkersinpatientswithtype2diabetesmellitusandarteriosclerosisobliteranswhentreatedwithprobucolandcilostazol AT xiaoxinhua arandomizedopenlabelmulticentrestudytoevaluateplasmaatheroscleroticbiomarkersinpatientswithtype2diabetesmellitusandarteriosclerosisobliteranswhentreatedwithprobucolandcilostazol AT guolixin arandomizedopenlabelmulticentrestudytoevaluateplasmaatheroscleroticbiomarkersinpatientswithtype2diabetesmellitusandarteriosclerosisobliteranswhentreatedwithprobucolandcilostazol AT lvxiaofeng arandomizedopenlabelmulticentrestudytoevaluateplasmaatheroscleroticbiomarkersinpatientswithtype2diabetesmellitusandarteriosclerosisobliteranswhentreatedwithprobucolandcilostazol AT liquanmin arandomizedopenlabelmulticentrestudytoevaluateplasmaatheroscleroticbiomarkersinpatientswithtype2diabetesmellitusandarteriosclerosisobliteranswhentreatedwithprobucolandcilostazol AT gaoyan arandomizedopenlabelmulticentrestudytoevaluateplasmaatheroscleroticbiomarkersinpatientswithtype2diabetesmellitusandarteriosclerosisobliteranswhentreatedwithprobucolandcilostazol AT maxiaowei randomizedopenlabelmulticentrestudytoevaluateplasmaatheroscleroticbiomarkersinpatientswithtype2diabetesmellitusandarteriosclerosisobliteranswhentreatedwithprobucolandcilostazol AT guoxiaohui randomizedopenlabelmulticentrestudytoevaluateplasmaatheroscleroticbiomarkersinpatientswithtype2diabetesmellitusandarteriosclerosisobliteranswhentreatedwithprobucolandcilostazol AT xiaoxinhua randomizedopenlabelmulticentrestudytoevaluateplasmaatheroscleroticbiomarkersinpatientswithtype2diabetesmellitusandarteriosclerosisobliteranswhentreatedwithprobucolandcilostazol AT guolixin randomizedopenlabelmulticentrestudytoevaluateplasmaatheroscleroticbiomarkersinpatientswithtype2diabetesmellitusandarteriosclerosisobliteranswhentreatedwithprobucolandcilostazol AT lvxiaofeng randomizedopenlabelmulticentrestudytoevaluateplasmaatheroscleroticbiomarkersinpatientswithtype2diabetesmellitusandarteriosclerosisobliteranswhentreatedwithprobucolandcilostazol AT liquanmin randomizedopenlabelmulticentrestudytoevaluateplasmaatheroscleroticbiomarkersinpatientswithtype2diabetesmellitusandarteriosclerosisobliteranswhentreatedwithprobucolandcilostazol AT gaoyan randomizedopenlabelmulticentrestudytoevaluateplasmaatheroscleroticbiomarkersinpatientswithtype2diabetesmellitusandarteriosclerosisobliteranswhentreatedwithprobucolandcilostazol |