Effect of rosuvastatin 20 mg versus rosuvastatin 5 mg plus ezetimibe on statin side-effects in elderly patients with atherosclerotic cardiovascular disease: Rationale and design of a randomized, controlled SaveSAMS trial
DC Field | Value | Language |
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dc.contributor.author | Cha, Jung-Joon | - |
dc.contributor.author | Hong, Soon Jun | - |
dc.contributor.author | Kim, Ju Hyeon | - |
dc.contributor.author | Lim, Subin | - |
dc.contributor.author | Joo, Hyung Joon | - |
dc.contributor.author | Park, Jae Hyoung | - |
dc.contributor.author | Yu, Cheol Woong | - |
dc.contributor.author | Lee, Pil Hyung | - |
dc.contributor.author | Lee, Seung Whan | - |
dc.contributor.author | Lee, Cheol Whan | - |
dc.contributor.author | Moon, Jae Youn | - |
dc.contributor.author | Lee, Jong-Young | - |
dc.contributor.author | Kim, Jung-Sun | - |
dc.contributor.author | Park, Jae Suk | - |
dc.contributor.author | Lee, Kyounghoon | - |
dc.contributor.author | Lim, Sang Yup | - |
dc.contributor.author | Na, Jin Oh | - |
dc.contributor.author | Cho, Jin-Man | - |
dc.contributor.author | Kim, Seok Yeon | - |
dc.contributor.author | Lim, Do-Sun | - |
dc.date.accessioned | 2023-06-26T15:40:14Z | - |
dc.date.available | 2023-06-26T15:40:14Z | - |
dc.date.created | 2023-06-26 | - |
dc.date.issued | 2023-07 | - |
dc.identifier.issn | 0002-8703 | - |
dc.identifier.uri | https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/88232 | - |
dc.description.abstract | Background Current guidelines recommend that patients with established atherosclerotic cardiovascular disease (ASCVD) use high-intensity statin therapy to lower low-density lipoprotein (LDL)-cholesterol levels by at least 50%, irrespective of age. However, in real-world practice, there is reluctance to maintain statin use in response to side-effects, particularly statin-associated muscle symptoms (SAMS). Moreover, no randomized trial has been conducted on the safety of statin therapy in elderly patients. Trial design This investigator-initiated, multicenter, randomized clinical trial aimed to investigate the incidence of SAMS and its effect on LDL-cholesterol levels in elderly patients with established ASCVD. Eligible patients were aged 70 years or older with established ASCVD. Consecutive patients who met the inclusion criteria were randomized in a 1:1 fashion to receive either intensive statin monotherapy (rosuvastatin 20 mg) or combination therapy (rosuvastatin/ezetimibe, 5/10 mg). The primary endpoint of the study is SAMS at 6 months with regard to treatment strategy. Positive SAMS results are defined as patients with a proposed statin myalgia index score of 7 or higher. The key secondary end-points are target LDL-cholesterol achievement (LDL < 70 mg/dL), incidence of myopathy, rhabdomyolysis, frequency of drug discontinuation, and creatinine kinase, aspartate transaminase, alanine transaminase, total cholesterol, LDL-cholesterol, high-density lipoprotein-cholesterol, triglyceride, and highly sensitive C-reactive protein levels at 6 months. Conclusions The SaveSAMS study is a multicenter, randomized trial that will compare the incidence of SAMS in patients with established ASCVD who are 70 years or older on intensive statin monotherapy to that combination therapy. | - |
dc.language | 영어 | - |
dc.language.iso | en | - |
dc.publisher | MOSBY-ELSEVIER | - |
dc.relation.isPartOf | AMERICAN HEART JOURNAL | - |
dc.title | Effect of rosuvastatin 20 mg versus rosuvastatin 5 mg plus ezetimibe on statin side-effects in elderly patients with atherosclerotic cardiovascular disease: Rationale and design of a randomized, controlled SaveSAMS trial | - |
dc.type | Article | - |
dc.type.rims | ART | - |
dc.description.journalClass | 1 | - |
dc.identifier.wosid | 000986586600001 | - |
dc.identifier.doi | 10.1016/j.ahj.2023.03.002 | - |
dc.identifier.bibliographicCitation | AMERICAN HEART JOURNAL, v.261, pp.45 - 50 | - |
dc.description.isOpenAccess | N | - |
dc.identifier.scopusid | 2-s2.0-85152644175 | - |
dc.citation.endPage | 50 | - |
dc.citation.startPage | 45 | - |
dc.citation.title | AMERICAN HEART JOURNAL | - |
dc.citation.volume | 261 | - |
dc.contributor.affiliatedAuthor | Lee, Kyounghoon | - |
dc.type.docType | Article | - |
dc.subject.keywordAuthor | Elderly | - |
dc.subject.keywordAuthor | SAMS | - |
dc.subject.keywordAuthor | Statin side effect | - |
dc.subject.keywordAuthor | Ezetimibe | - |
dc.subject.keywordAuthor | Combination therapy | - |
dc.subject.keywordPlus | PLACEBO | - |
dc.subject.keywordPlus | EVENTS | - |
dc.relation.journalResearchArea | Cardiovascular System & Cardiology | - |
dc.relation.journalWebOfScienceCategory | Cardiac & Cardiovascular Systems | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
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