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
- Authors
- Cha, Jung-Joon; Hong, Soon Jun; Kim, Ju Hyeon; Lim, Subin; Joo, Hyung Joon; Park, Jae Hyoung; Yu, Cheol Woong; Lee, Pil Hyung; Lee, Seung Whan; Lee, Cheol Whan; Moon, Jae Youn; Lee, Jong-Young; Kim, Jung-Sun; Park, Jae Suk; Lee, Kyounghoon; Lim, Sang Yup; Na, Jin Oh; Cho, Jin-Man; Kim, Seok Yeon; Lim, Do-Sun
- Issue Date
- Jul-2023
- Publisher
- MOSBY-ELSEVIER
- Keywords
- Elderly; SAMS; Statin side effect; Ezetimibe; Combination therapy
- Citation
- AMERICAN HEART JOURNAL, v.261, pp.45 - 50
- Journal Title
- AMERICAN HEART JOURNAL
- Volume
- 261
- Start Page
- 45
- End Page
- 50
- URI
- https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/88232
- DOI
- 10.1016/j.ahj.2023.03.002
- ISSN
- 0002-8703
- 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.
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