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Changes in High-Density Lipoprotein Cholesterol and Risks of Cardiovascular Events: A Post Hoc Analysis from the PICASSO Trial
BACKGROUND AND PURPOSE: Whether pharmacologically altered high-density lipoprotein cholesterol (HDL-C) affects the risk of cardiovascular events is unknown. Recently, we have reported the Prevention of Cardiovascular Events in Asian Patients with Ischaemic Stroke at High Risk of Cerebral Haemorrhage...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Korean Stroke Society
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7005357/ https://www.ncbi.nlm.nih.gov/pubmed/32027796 http://dx.doi.org/10.5853/jos.2019.02551 |
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author | Lee, Eun-Jae Kwon, Sun U. Park, Jong-Ho Kim, Yong-Jae Hong, Keun-Sik Yu, Sungwook Hwang, Yang-Ha Lee, Ji Sung Lee, Juneyoung Rha, Joung-Ho Heo, Sung Hyuk Ahn, Sung Hwan Seo, Woo-Keun Park, Jong-Moo Lee, Ju-Hun Kwon, Jee-Hyun Sohn, Sung-Il Jung, Jin-Man Kim, Hahn Young Kim, Eung-Gyu Kim, Sung Hun Cha, Jae-Kwan Park, Man-Seok Nam, Hyo Suk Kang, Dong-Wha |
author_facet | Lee, Eun-Jae Kwon, Sun U. Park, Jong-Ho Kim, Yong-Jae Hong, Keun-Sik Yu, Sungwook Hwang, Yang-Ha Lee, Ji Sung Lee, Juneyoung Rha, Joung-Ho Heo, Sung Hyuk Ahn, Sung Hwan Seo, Woo-Keun Park, Jong-Moo Lee, Ju-Hun Kwon, Jee-Hyun Sohn, Sung-Il Jung, Jin-Man Kim, Hahn Young Kim, Eung-Gyu Kim, Sung Hun Cha, Jae-Kwan Park, Man-Seok Nam, Hyo Suk Kang, Dong-Wha |
author_sort | Lee, Eun-Jae |
collection | PubMed |
description | BACKGROUND AND PURPOSE: Whether pharmacologically altered high-density lipoprotein cholesterol (HDL-C) affects the risk of cardiovascular events is unknown. Recently, we have reported the Prevention of Cardiovascular Events in Asian Patients with Ischaemic Stroke at High Risk of Cerebral Haemorrhage (PICASSO) trial that demonstrated the non-inferiority of cilostazol to aspirin and superiority of probucol to non-probucol for cardiovascular prevention in ischemic stroke patients (clinicaltrials.gov: NCT01013532). We aimed to determine whether on-treatment HDL-C changes by cilostazol and probucol influence the treatment effect of each study medication during the PICASSO study. METHODS: Of the 1,534 randomized patients, 1,373 (89.5%) with baseline cholesterol parameters were analyzed. Efficacy endpoint was the composite of stroke, myocardial infarction, and cardiovascular death. Cox proportional hazards regression analysis examined an interaction between the treatment effect and changes in HDL-C levels from randomization to 1 month for each study arm. RESULTS: One-month post-randomization mean HDL-C level was significantly higher in the cilostazol group than in the aspirin group (1.08 mmol/L vs. 1.00 mmol/L, P<0.001). The mean HDL-C level was significantly lower in the probucol group than in the non-probucol group (0.86 mmol/L vs. 1.22 mmol/L, P<0.001). These trends persisted throughout the study. In both study arms, no significant interaction was observed between HDL-C changes and the assigned treatment regarding the risk of the efficacy endpoint. CONCLUSIONS: Despite significant HDL-C changes, the effects of cilostazol and probucol treatment on the risk of cardiovascular events were insignificant. Pharmacologically altered HDL-C levels may not be reliable prognostic markers for cardiovascular risk. |
format | Online Article Text |
id | pubmed-7005357 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Korean Stroke Society |
record_format | MEDLINE/PubMed |
spelling | pubmed-70053572020-02-13 Changes in High-Density Lipoprotein Cholesterol and Risks of Cardiovascular Events: A Post Hoc Analysis from the PICASSO Trial Lee, Eun-Jae Kwon, Sun U. Park, Jong-Ho Kim, Yong-Jae Hong, Keun-Sik Yu, Sungwook Hwang, Yang-Ha Lee, Ji Sung Lee, Juneyoung Rha, Joung-Ho Heo, Sung Hyuk Ahn, Sung Hwan Seo, Woo-Keun Park, Jong-Moo Lee, Ju-Hun Kwon, Jee-Hyun Sohn, Sung-Il Jung, Jin-Man Kim, Hahn Young Kim, Eung-Gyu Kim, Sung Hun Cha, Jae-Kwan Park, Man-Seok Nam, Hyo Suk Kang, Dong-Wha J Stroke Original Article BACKGROUND AND PURPOSE: Whether pharmacologically altered high-density lipoprotein cholesterol (HDL-C) affects the risk of cardiovascular events is unknown. Recently, we have reported the Prevention of Cardiovascular Events in Asian Patients with Ischaemic Stroke at High Risk of Cerebral Haemorrhage (PICASSO) trial that demonstrated the non-inferiority of cilostazol to aspirin and superiority of probucol to non-probucol for cardiovascular prevention in ischemic stroke patients (clinicaltrials.gov: NCT01013532). We aimed to determine whether on-treatment HDL-C changes by cilostazol and probucol influence the treatment effect of each study medication during the PICASSO study. METHODS: Of the 1,534 randomized patients, 1,373 (89.5%) with baseline cholesterol parameters were analyzed. Efficacy endpoint was the composite of stroke, myocardial infarction, and cardiovascular death. Cox proportional hazards regression analysis examined an interaction between the treatment effect and changes in HDL-C levels from randomization to 1 month for each study arm. RESULTS: One-month post-randomization mean HDL-C level was significantly higher in the cilostazol group than in the aspirin group (1.08 mmol/L vs. 1.00 mmol/L, P<0.001). The mean HDL-C level was significantly lower in the probucol group than in the non-probucol group (0.86 mmol/L vs. 1.22 mmol/L, P<0.001). These trends persisted throughout the study. In both study arms, no significant interaction was observed between HDL-C changes and the assigned treatment regarding the risk of the efficacy endpoint. CONCLUSIONS: Despite significant HDL-C changes, the effects of cilostazol and probucol treatment on the risk of cardiovascular events were insignificant. Pharmacologically altered HDL-C levels may not be reliable prognostic markers for cardiovascular risk. Korean Stroke Society 2020-01 2020-01-31 /pmc/articles/PMC7005357/ /pubmed/32027796 http://dx.doi.org/10.5853/jos.2019.02551 Text en Copyright © 2020 Korean Stroke Society This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted noncommercial use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Original Article Lee, Eun-Jae Kwon, Sun U. Park, Jong-Ho Kim, Yong-Jae Hong, Keun-Sik Yu, Sungwook Hwang, Yang-Ha Lee, Ji Sung Lee, Juneyoung Rha, Joung-Ho Heo, Sung Hyuk Ahn, Sung Hwan Seo, Woo-Keun Park, Jong-Moo Lee, Ju-Hun Kwon, Jee-Hyun Sohn, Sung-Il Jung, Jin-Man Kim, Hahn Young Kim, Eung-Gyu Kim, Sung Hun Cha, Jae-Kwan Park, Man-Seok Nam, Hyo Suk Kang, Dong-Wha Changes in High-Density Lipoprotein Cholesterol and Risks of Cardiovascular Events: A Post Hoc Analysis from the PICASSO Trial |
title | Changes in High-Density Lipoprotein Cholesterol and Risks of Cardiovascular Events: A Post Hoc Analysis from the PICASSO Trial |
title_full | Changes in High-Density Lipoprotein Cholesterol and Risks of Cardiovascular Events: A Post Hoc Analysis from the PICASSO Trial |
title_fullStr | Changes in High-Density Lipoprotein Cholesterol and Risks of Cardiovascular Events: A Post Hoc Analysis from the PICASSO Trial |
title_full_unstemmed | Changes in High-Density Lipoprotein Cholesterol and Risks of Cardiovascular Events: A Post Hoc Analysis from the PICASSO Trial |
title_short | Changes in High-Density Lipoprotein Cholesterol and Risks of Cardiovascular Events: A Post Hoc Analysis from the PICASSO Trial |
title_sort | changes in high-density lipoprotein cholesterol and risks of cardiovascular events: a post hoc analysis from the picasso trial |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7005357/ https://www.ncbi.nlm.nih.gov/pubmed/32027796 http://dx.doi.org/10.5853/jos.2019.02551 |
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