Journal Article

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

Hong, Soon Jun, Lim, Sang Yup, Joo, Hyung Joon, Kim, Ju Hyeon, Lee, Seung Whan, Lee, Jong-Young, Lee, Kyounghoon, Moon, Jae Youn, Cha, Jung-Joon, Kim, Seok Yeon, Lim, Do-Sun, Yu, Cheol Woong, Lim, Subin, Kim, Jung-Sun, Lee, Pil Hyung, Lee, Cheol Whan, Na, Jin Oh, Cho, Jin-Man, Park, Jae Hyoung, Park, Jae Suk

2023

Overview

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. 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. 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.

• Publisher: Elsevier Inc,Elsevier Limited
• Subject: Aged / Alanine / Alanine transaminase / Anticholesteremic Agents - therapeutic use / Arteriosclerosis / Aspartate transaminase / Atherosclerosis / Atherosclerosis - drug therapy / C-reactive protein / Cardiovascular disease / Cardiovascular diseases / Cardiovascular Diseases - chemically induced / Cardiovascular Diseases - epidemiology / Cardiovascular Diseases - prevention & control / Cholesterol / Cholesterol, LDL / Combination therapy / Creatinine / Data collection / Density / Drug dosages / Drug Therapy, Combination / Elderly / Ezetimibe / Ezetimibe - adverse effects / High density lipoprotein / Humans / Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use / Kinases / Low density lipoprotein / Metabolic disorders / Multicenter Studies as Topic / Myalgia / Myopathy / Older people / Patients / Randomized Controlled Trials as Topic / Rhabdomyolysis / Rosuvastatin Calcium - adverse effects / SAMS / Side effects / Signs and symptoms / Statin side effect / Statins / Therapy / Treatment Outcome / Triglycerides