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Rosuvastatin versus atorvastatin treatment in adults with coronary artery disease: secondary analysis of the randomised LODESTAR trial
OBJECTIVE: To compare the long term efficacy and safety of rosuvastatin with atorvastatin treatment in adults with coronary artery disease. DESIGN: Randomised, open label, multicentre trial. SETTING: 12 hospitals in South Korea, September 2016 to November 2019. PARTICIPANTS: 4400 adults (age ≥19 yea...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group Ltd.
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10583134/ https://www.ncbi.nlm.nih.gov/pubmed/37852649 http://dx.doi.org/10.1136/bmj-2023-075837 |
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author | Lee, Yong-Joon Hong, Sung-Jin Kang, Woong Chol Hong, Bum-Kee Lee, Jong-Young Lee, Jin-Bae Cho, Hyung-Jin Yoon, Junghan Lee, Seung-Jun Ahn, Chul-Min Kim, Jung-Sun Kim, Byeong-Keuk Ko, Young-Guk Choi, Donghoon Jang, Yangsoo Hong, Myeong-Ki Hong, Myeong-Ki Choi, Donghoon Ko, Young-Guk Kim, Byeong-Keuk Kim, Jung-Sun Ahn, Chul-Min Hong, Sung-Jin Lee, Seung-Jun Lee, Yong-Joon Hong, Bum-Kee Kwon, Hyuck Moon Kim, Jong-Youn Min, Pil Ki Yoon, Young Won Lee, Byoung Kwon Rim, Se-Joong Choi, Eui-Young Kang, Woong Chol Oh, Pyung Chun Lee, Jong-Young Lee, Jin-Bae Kim, Kee Sik Choi, Ji Yong Ryu, Jae Kean Hong, Seung Pyo Kim, Chang Yeon Yang, Tae-Hyun Cho, Hyung-Jin Yoon, Junghan Ahn, Min-Soo Ahn, Sung Gyun Lee, Jun-Won Son, Jung-Woo Jang, Yangsoo Yoon, Hyuck-Jun Lee, Cheol Hyun Hwang, Jongmin Cho, Yun-Kyeong Hur, Seung-Ho Han, Seongwook Nam, Chang-Wook Kim, Hyoungseop Park, Hyoung-Seob Kim, In-Cheol Cho, Yun-Hyeong Jeong, Hyeon-Ju Kim, Jin-Ho Lim, Chewan Suh, Yongsung Hwang, Eui Seok Lee, Ji Hyun Lee, Sung Yun Kwon, Sung Uk Kim, Song-Yi Park, Keun-Ho Kim, Hyun Kuk |
author_facet | Lee, Yong-Joon Hong, Sung-Jin Kang, Woong Chol Hong, Bum-Kee Lee, Jong-Young Lee, Jin-Bae Cho, Hyung-Jin Yoon, Junghan Lee, Seung-Jun Ahn, Chul-Min Kim, Jung-Sun Kim, Byeong-Keuk Ko, Young-Guk Choi, Donghoon Jang, Yangsoo Hong, Myeong-Ki Hong, Myeong-Ki Choi, Donghoon Ko, Young-Guk Kim, Byeong-Keuk Kim, Jung-Sun Ahn, Chul-Min Hong, Sung-Jin Lee, Seung-Jun Lee, Yong-Joon Hong, Bum-Kee Kwon, Hyuck Moon Kim, Jong-Youn Min, Pil Ki Yoon, Young Won Lee, Byoung Kwon Rim, Se-Joong Choi, Eui-Young Kang, Woong Chol Oh, Pyung Chun Lee, Jong-Young Lee, Jin-Bae Kim, Kee Sik Choi, Ji Yong Ryu, Jae Kean Hong, Seung Pyo Kim, Chang Yeon Yang, Tae-Hyun Cho, Hyung-Jin Yoon, Junghan Ahn, Min-Soo Ahn, Sung Gyun Lee, Jun-Won Son, Jung-Woo Jang, Yangsoo Yoon, Hyuck-Jun Lee, Cheol Hyun Hwang, Jongmin Cho, Yun-Kyeong Hur, Seung-Ho Han, Seongwook Nam, Chang-Wook Kim, Hyoungseop Park, Hyoung-Seob Kim, In-Cheol Cho, Yun-Hyeong Jeong, Hyeon-Ju Kim, Jin-Ho Lim, Chewan Suh, Yongsung Hwang, Eui Seok Lee, Ji Hyun Lee, Sung Yun Kwon, Sung Uk Kim, Song-Yi Park, Keun-Ho Kim, Hyun Kuk |
author_sort | Lee, Yong-Joon |
collection | PubMed |
description | OBJECTIVE: To compare the long term efficacy and safety of rosuvastatin with atorvastatin treatment in adults with coronary artery disease. DESIGN: Randomised, open label, multicentre trial. SETTING: 12 hospitals in South Korea, September 2016 to November 2019. PARTICIPANTS: 4400 adults (age ≥19 years) with coronary artery disease. INTERVENTIONS: Participants were assigned to receive either rosuvastatin (n=2204) or atorvastatin (n=2196) using 2×2 factorial randomisation. MAIN OUTCOME MEASURES: The primary outcome was a three year composite of all cause death, myocardial infarction, stroke, or any coronary revascularisation. Secondary outcomes were safety endpoints: new onset diabetes mellitus; hospital admissions due to heart failure; deep vein thrombosis or pulmonary thromboembolism; endovascular revascularisation for peripheral artery disease; aortic intervention or surgery; end stage kidney disease; discontinuation of study drugs owing to intolerance; cataract surgery; and a composite of laboratory detected abnormalities. RESULTS: 4341 of the 4400 participants (98.7%) completed the trial. Mean daily dose of study drugs was 17.1 mg (standard deviation (SD) 5.2 mg) in the rosuvastatin group and 36.0 (12.8) mg in the atorvastatin group at three years (P<0.001). The primary outcome occurred in 189 participants (8.7%) in the rosuvastatin group and 178 (8.2%) in the atorvastatin group (hazard ratio 1.06, 95% confidence interval 0.86 to 1.30; P=0.58). The mean low density lipoprotein (LDL) cholesterol level during treatment was 1.8 mmol/L (SD 0.5 mmol/L) in the rosuvastatin group and 1.9 (0.5) mmol/L in the atorvastatin group (P<0.001). The rosuvastatin group had a higher incidence of new onset diabetes mellitus requiring initiation of antidiabetics (7.2% v 5.3%; hazard ratio 1.39, 95% confidence interval 1.03 to 1.87; P=0.03) and cataract surgery (2.5% v 1.5%; 1.66, 1.07 to 2.58; P=0.02). Other safety endpoints did not differ between the two groups. CONCLUSIONS: In adults with coronary artery disease, rosuvastatin and atorvastatin showed comparable efficacy for the composite outcome of all cause death, myocardial infarction, stroke, or any coronary revascularisation at three years. Rosuvastatin was associated with lower LDL cholesterol levels but a higher risk of new onset diabetes mellitus requiring antidiabetics and cataract surgery compared with atorvastatin. TRIAL REGISTRATION: ClinicalTrials.gov NCT02579499. |
format | Online Article Text |
id | pubmed-10583134 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | BMJ Publishing Group Ltd. |
record_format | MEDLINE/PubMed |
spelling | pubmed-105831342023-10-19 Rosuvastatin versus atorvastatin treatment in adults with coronary artery disease: secondary analysis of the randomised LODESTAR trial Lee, Yong-Joon Hong, Sung-Jin Kang, Woong Chol Hong, Bum-Kee Lee, Jong-Young Lee, Jin-Bae Cho, Hyung-Jin Yoon, Junghan Lee, Seung-Jun Ahn, Chul-Min Kim, Jung-Sun Kim, Byeong-Keuk Ko, Young-Guk Choi, Donghoon Jang, Yangsoo Hong, Myeong-Ki Hong, Myeong-Ki Choi, Donghoon Ko, Young-Guk Kim, Byeong-Keuk Kim, Jung-Sun Ahn, Chul-Min Hong, Sung-Jin Lee, Seung-Jun Lee, Yong-Joon Hong, Bum-Kee Kwon, Hyuck Moon Kim, Jong-Youn Min, Pil Ki Yoon, Young Won Lee, Byoung Kwon Rim, Se-Joong Choi, Eui-Young Kang, Woong Chol Oh, Pyung Chun Lee, Jong-Young Lee, Jin-Bae Kim, Kee Sik Choi, Ji Yong Ryu, Jae Kean Hong, Seung Pyo Kim, Chang Yeon Yang, Tae-Hyun Cho, Hyung-Jin Yoon, Junghan Ahn, Min-Soo Ahn, Sung Gyun Lee, Jun-Won Son, Jung-Woo Jang, Yangsoo Yoon, Hyuck-Jun Lee, Cheol Hyun Hwang, Jongmin Cho, Yun-Kyeong Hur, Seung-Ho Han, Seongwook Nam, Chang-Wook Kim, Hyoungseop Park, Hyoung-Seob Kim, In-Cheol Cho, Yun-Hyeong Jeong, Hyeon-Ju Kim, Jin-Ho Lim, Chewan Suh, Yongsung Hwang, Eui Seok Lee, Ji Hyun Lee, Sung Yun Kwon, Sung Uk Kim, Song-Yi Park, Keun-Ho Kim, Hyun Kuk BMJ Research OBJECTIVE: To compare the long term efficacy and safety of rosuvastatin with atorvastatin treatment in adults with coronary artery disease. DESIGN: Randomised, open label, multicentre trial. SETTING: 12 hospitals in South Korea, September 2016 to November 2019. PARTICIPANTS: 4400 adults (age ≥19 years) with coronary artery disease. INTERVENTIONS: Participants were assigned to receive either rosuvastatin (n=2204) or atorvastatin (n=2196) using 2×2 factorial randomisation. MAIN OUTCOME MEASURES: The primary outcome was a three year composite of all cause death, myocardial infarction, stroke, or any coronary revascularisation. Secondary outcomes were safety endpoints: new onset diabetes mellitus; hospital admissions due to heart failure; deep vein thrombosis or pulmonary thromboembolism; endovascular revascularisation for peripheral artery disease; aortic intervention or surgery; end stage kidney disease; discontinuation of study drugs owing to intolerance; cataract surgery; and a composite of laboratory detected abnormalities. RESULTS: 4341 of the 4400 participants (98.7%) completed the trial. Mean daily dose of study drugs was 17.1 mg (standard deviation (SD) 5.2 mg) in the rosuvastatin group and 36.0 (12.8) mg in the atorvastatin group at three years (P<0.001). The primary outcome occurred in 189 participants (8.7%) in the rosuvastatin group and 178 (8.2%) in the atorvastatin group (hazard ratio 1.06, 95% confidence interval 0.86 to 1.30; P=0.58). The mean low density lipoprotein (LDL) cholesterol level during treatment was 1.8 mmol/L (SD 0.5 mmol/L) in the rosuvastatin group and 1.9 (0.5) mmol/L in the atorvastatin group (P<0.001). The rosuvastatin group had a higher incidence of new onset diabetes mellitus requiring initiation of antidiabetics (7.2% v 5.3%; hazard ratio 1.39, 95% confidence interval 1.03 to 1.87; P=0.03) and cataract surgery (2.5% v 1.5%; 1.66, 1.07 to 2.58; P=0.02). Other safety endpoints did not differ between the two groups. CONCLUSIONS: In adults with coronary artery disease, rosuvastatin and atorvastatin showed comparable efficacy for the composite outcome of all cause death, myocardial infarction, stroke, or any coronary revascularisation at three years. Rosuvastatin was associated with lower LDL cholesterol levels but a higher risk of new onset diabetes mellitus requiring antidiabetics and cataract surgery compared with atorvastatin. TRIAL REGISTRATION: ClinicalTrials.gov NCT02579499. BMJ Publishing Group Ltd. 2023-10-18 /pmc/articles/PMC10583134/ /pubmed/37852649 http://dx.doi.org/10.1136/bmj-2023-075837 Text en © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) . |
spellingShingle | Research Lee, Yong-Joon Hong, Sung-Jin Kang, Woong Chol Hong, Bum-Kee Lee, Jong-Young Lee, Jin-Bae Cho, Hyung-Jin Yoon, Junghan Lee, Seung-Jun Ahn, Chul-Min Kim, Jung-Sun Kim, Byeong-Keuk Ko, Young-Guk Choi, Donghoon Jang, Yangsoo Hong, Myeong-Ki Hong, Myeong-Ki Choi, Donghoon Ko, Young-Guk Kim, Byeong-Keuk Kim, Jung-Sun Ahn, Chul-Min Hong, Sung-Jin Lee, Seung-Jun Lee, Yong-Joon Hong, Bum-Kee Kwon, Hyuck Moon Kim, Jong-Youn Min, Pil Ki Yoon, Young Won Lee, Byoung Kwon Rim, Se-Joong Choi, Eui-Young Kang, Woong Chol Oh, Pyung Chun Lee, Jong-Young Lee, Jin-Bae Kim, Kee Sik Choi, Ji Yong Ryu, Jae Kean Hong, Seung Pyo Kim, Chang Yeon Yang, Tae-Hyun Cho, Hyung-Jin Yoon, Junghan Ahn, Min-Soo Ahn, Sung Gyun Lee, Jun-Won Son, Jung-Woo Jang, Yangsoo Yoon, Hyuck-Jun Lee, Cheol Hyun Hwang, Jongmin Cho, Yun-Kyeong Hur, Seung-Ho Han, Seongwook Nam, Chang-Wook Kim, Hyoungseop Park, Hyoung-Seob Kim, In-Cheol Cho, Yun-Hyeong Jeong, Hyeon-Ju Kim, Jin-Ho Lim, Chewan Suh, Yongsung Hwang, Eui Seok Lee, Ji Hyun Lee, Sung Yun Kwon, Sung Uk Kim, Song-Yi Park, Keun-Ho Kim, Hyun Kuk Rosuvastatin versus atorvastatin treatment in adults with coronary artery disease: secondary analysis of the randomised LODESTAR trial |
title | Rosuvastatin versus atorvastatin treatment in adults with coronary artery disease: secondary analysis of the randomised LODESTAR trial |
title_full | Rosuvastatin versus atorvastatin treatment in adults with coronary artery disease: secondary analysis of the randomised LODESTAR trial |
title_fullStr | Rosuvastatin versus atorvastatin treatment in adults with coronary artery disease: secondary analysis of the randomised LODESTAR trial |
title_full_unstemmed | Rosuvastatin versus atorvastatin treatment in adults with coronary artery disease: secondary analysis of the randomised LODESTAR trial |
title_short | Rosuvastatin versus atorvastatin treatment in adults with coronary artery disease: secondary analysis of the randomised LODESTAR trial |
title_sort | rosuvastatin versus atorvastatin treatment in adults with coronary artery disease: secondary analysis of the randomised lodestar trial |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10583134/ https://www.ncbi.nlm.nih.gov/pubmed/37852649 http://dx.doi.org/10.1136/bmj-2023-075837 |
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