Rosuvastatin and Ezetimibe
DrugRosuvastatin Versus Rosuvastatin plus Ezetimibe
NCT Number: NCT04826354
High-dose statins can reduce mortality and cardiovascular events in patients with established atherosclerotic cardiovascular disease (ASCVD). Therefore, US and European recommendations recommend that established ASCVD patients (coronary artery disease, cerebrovascular disease, peripheral vascular disease) use high-dose statins to lower LDL cholesterol levels by at least 50%. However, in actual practice, high-dose statins are relatively less used, and the reason is unclear, but it is believed to be due to concerns about the side effects of high-dose statins. Most of the side effects of statins are statin-associated muscle symptoms (SAMS), which are more common than the incidence in clinical studies, especially in frontline care. These muscle side effects are dose-dependent and are common at high doses, and the incidence is known to increase in the elderly over 70 years of age. However, the US recommendation recommends using high-dose statins to lower LDL cholesterol by 50% or more to prevent cardiovascular events even in ASCVD patients over 70 years of age.
Most early studies on lowering LDL cholesterol in ASCVD patients used high doses of statins. However, after introducing cholesterol absorption inhibitors ezetimibe and PCSK9 inhibitor, large-scale clinical studies have been conducted to lower LDL cholesterol using these drugs. In this study, as in the statin study, cardiovascular events were significantly reduced, and together with statins, it became a standard treatment for ASCVD patients. On the other hand, the clinical benefit shown in clinical studies using cholesterol-lowering agents so far depends entirely on how much LDL cholesterol is lowered and how long it is maintained in a low state, indicating that LDL cholesterol management is the core of arteriosclerosis treatment. In addition to high-dose statins, a combination of low-dose statins and ezetimibe can be cited as a method for lowering LDL cholesterol to more than 50%. In the latter case, it is expected that there will be an advantage of reducing muscle side effects by reaching the target LDL cholesterol level by using a low-dose statin. However, no studies compare the difference in muscle side effects between low-dose statins and ezetimibe combination drugs, which reduce LDL cholesterol to the same extent compared to high-dose statins, in elderly patients over 70 years of age with ASCVD. In this study, the association of low-dose rosuvastatin 5mg and ezetimibe combination (rosuvastatin 10/5mg) compared to high-dose rosuvastatin 20mg in elderly patients 70 years of age or older with established ASCVD. This study aims to compare and analyze the incidence of muscle symptoms (SAMS) and their effect on LDL cholesterol.
Looking for future studies?
Notify Me70 year and older
All sexes
Interventional
Phase 4
Kangbuk Samsung Hospital, Seoul, South Korea
Established Atherosclerotic Cardiovascular Disease (ASCVD)
A. Coronary artery disease meeting at least one of the following criteria:
B. Cerebrovascular Disease meeting at least one of the following criteria:
C. Peripheral arterial disease meeting at least one of the following criteria:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(must satisfy all of the following selection criteria) :
Exclusion criteria
Rosuvastatin Versus Rosuvastatin plus Ezetimibe
Rosuvastatin
Time frame: 6 month
Patients with a Proposed Statin Myalgia Index score of 7 or higher (Cardiovasc Drugs Ther 2003;17:459-465):
Time frame: 6 month
Target LDL-C achievement (LDL <70mg/dL)
Time frame: 6 month
Creatinine Kinase levels
Time frame: 6 month
Aspartate Transaminase (Glutamic Oxaloacetic Transaminase levels
Time frame: 6 month
Alanine Transaminase (Glutamic Pyruvic Transaminase) levels
Time frame: 6 month
Levels of Total cholesterol, LDL cholesterol, HDL cholesterol
Time frame: 6 month
Level of Triglyceride
Time frame: 6 month
Level of high sensitive-CRP
Time frame: 6 month
Incidence of myopathy, rhabdomyolysis
Time frame: 6 month
Frequency of drug discontinuation due to SAMS side effects
Time frame: 6 month
Frequency of drug discontinuation due to side effects other than SAMS
Korea University Anam Hospital
Other
Effects of High-dose StAtin Versus Low-dose Statin Plus Ezetimibe on Statin-Associated Muscle Symptoms & on Reaching Target LDL-C Levels Among Elderly Patients With Atherosclerotic Cardiovascular Disease
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05619042
Arterial Occlusive Diseases, Arteriosclerosis
Buenos Aires, Argentina
View Trial DetailsNCT05536960
Arterial Occlusive Diseases, Arteriosclerosis
Amsterdam, Netherlands
View Trial DetailsNCT04835467
Arterial Occlusive Diseases, Arteriosclerosis
Seoul, South Korea
View Trial DetailsNCT04125992
Acute Coronary Syndrome, Angina Pectoris
Nablus, Palestinian Territories
View Trial Details