Statins

This research investigates the relationship between serum levels of statins and SGLT2 inhibitors (SGLT2i) when used together in patients with ischemic heart failure. The study aims to understand how these drugs affect cholesterol, LDL, HDL, and triglyceride levels over time. Conducted by Fayoum University's Department of Cardiology, this prospective study involves 90 outpatient participants diagnosed with ischemic heart disease. Participants are divided into three groups of 30 each: one group takes statins, another takes SGLT2i, and the third group takes both medications. Blood samples are collected at the start and after three months to measure serum statin and plasma SGLT2i levels using high-performance liquid chromatography (HPLC). Researchers monitor the impact of each drug on the other and track changes in lipid profiles and any adverse effects. During the study, patients provide informed consent and attend scheduled visits for blood sampling and laboratory tests. The main outcome is to evaluate the combined effect of statin and SGLT2i therapy on ischemic heart disease after three months. Safety and side effects are also observed. The study spans from April to July 2024, ensuring detailed monitoring of participants' responses to the treatments.

Researchers are evaluating the effects of short-term intensified statin therapy on coronary artery plaque characteristics using advanced imaging technology called photon-counting detector CT (PCD-CT). This trial focuses on statin-naive patients who have stable chest pain and suspected coronary artery disease. The study aims to understand how intensified statin treatment changes the anatomy and blood flow of coronary arteries and to explore long-term changes in plaque features, testing the "plaque memory" hypothesis over a 24-month follow-up. Participants are randomly assigned to one of two groups: one receives 40 mg of rosuvastatin daily for three months, and the other receives a matching placebo for the same period. After the initial 3-month period, all patients receive rosuvastatin according to standard care. Coronary CT angiography scans and blood tests are performed at baseline, 3 months, and 24 months using a low radiation dose protocol with PCD-CT. The imaging includes detailed analysis of plaque volume, composition, and blood flow dynamics. During the study, patients undergo scheduled coronary CTA scans and blood tests to monitor changes in plaque volume, composition, and coronary blood flow. Researchers use multiple detailed measurements such as fractional flow reserve from CT (FFR-CT) and radiomic features to assess the impact of treatment. Safety is monitored through laboratory tests including liver and kidney function. The primary outcome is the change in non-calcified plaque volume after 3 months, with additional assessments continuing through 24 months. Participation lasts up to two years with ongoing evaluations.

Researchers are evaluating two cholesterol-lowering approaches to see which has a lower risk of causing new-onset diabetes in people with prediabetes and established atherosclerotic cardiovascular disease (ASCVD). This multicenter, randomized study involves 2,000 non-diabetic participants and compares a combination of pitavastatin and ezetimibe with high-intensity statin therapy using rosuvastatin. The main goal is to measure new cases of diabetes over a 36-month follow-up, along with other cardiovascular outcomes and changes in blood markers. Participants will be randomly assigned to receive either a fixed-dose single-pill combination of pitavastatin 4 mg plus ezetimibe 10 mg or rosuvastatin 20 mg alone. The study lasts up to 3 years with ongoing treatment. Both treatment strategies aim to manage cholesterol levels while monitoring the risk of developing diabetes. The trial is organized by Korea University Anam Hospital and is conducted without masking, meaning both participants and researchers know the treatment given. Throughout the study, participants will undergo regular assessments including blood tests for fasting glucose, HbA1c, and insulin resistance, as well as monitoring for cardiovascular events like heart attacks and strokes. Researchers will track adherence to a cholesterol-lowering diet and collect safety data. The primary outcome is the occurrence of new diabetes cases meeting standard diagnostic criteria, while secondary outcomes include cardiovascular health and cholesterol changes. Participants' health will be followed for up to three years to evaluate these outcomes.

Researchers are evaluating the use of an n-of-1 trial to help patients with prior statin intolerance tolerate rosuvastatin, a cholesterol-lowering medication. The trial focuses on individuals aged 21 years and older who are eligible for statin therapy but have stopped using at least two different statins due to side effects. The study aims to better identify true statin intolerance, which could improve treatment decisions and cost-effectiveness of lipid-lowering therapies, especially for those at risk of cardiovascular disease. Participants will be randomly assigned to receive either placebo or rosuvastatin first, followed by the other treatment, in a double-blinded manner. They will take three 28-day packs of placebo and two 28-day packs of rosuvastatin during the study period. This design helps determine whether patients can tolerate rosuvastatin when unblinded after the initial blinded phase. During the 9-month study, researchers will monitor the presence or absence of musculoskeletal symptoms, statin tolerance, and factors associated with statin intolerance. Participants may continue their other lipid-lowering treatments if stable for at least one month. The study involves regular assessments to track symptoms and response, with safety and tolerance carefully evaluated throughout the trial.

Researchers are evaluating whether combining Probucol with statin therapy can better reduce vascular event risks and improve atherosclerosis outcomes in adults who have had an ischemic stroke and confirmed atherosclerosis. This prospective, open-label study investigates if adding Probucol to guideline-recommended statin therapy decreases plaque burden and lowers the chance of cardiovascular and cerebrovascular events compared to statins alone. Participants will either receive standard lipid-lowering therapy based on current guidelines, which may include statins, ezetimibe, or PCSK9 inhibitors, or the same therapy combined with Probucol 0.5 grams twice daily. The study will include at least 100 participants in each group and follow them over a period of three years to monitor effects on atherosclerosis progression and vascular outcomes. During the study, participants will attend regular follow-up visits to assess changes in plaque burden and atherosclerotic features through imaging studies and blood tests. Researchers will measure lipid levels and biomarkers such as LDL-C, Ox-LDL, and Lp(a), while monitoring for cardiovascular events and safety outcomes. The primary measurement is the change in plaque burden from baseline to 12 months, with additional assessments at 1, 12, and 24 months to evaluate functional outcomes and vascular event occurrence.

Researchers are evaluating how different types and intensities of exercise affect muscle recovery in people taking statin medications compared to healthy individuals not using statins. The study aims to understand muscle-related side effects linked to statins, especially when combined with physical activity, to help create safer exercise guidelines for statin users. This is a non-randomized, dose-escalation trial comparing statin users with matched controls based on age, sex, and body mass index. Participants will undergo a stepwise exercise program starting with aerobic cycling for 40 minutes at 60% heart rate reserve, followed by resistance training at increasing intensities of 40%, 60%, and 80% of an estimated one-repetition maximum. Resistance training includes eight machine-based exercises with repetitions decreasing as intensity rises. Each intensity phase consists of two sessions separated by a 5 to 21-day rest period, with all sessions supervised for safety and proper technique. During the study, participants will have medical screening and baseline tests including blood samples and pain assessments. Before and after each exercise session, muscle damage markers, pain thresholds, heart rate, blood lactate, and perceived exertion will be recorded. Participants will also complete daily questionnaires on muscle symptoms and recovery needs. The main measure is the change in blood creatine kinase levels 24 hours after exercise, with study duration per participant under four months.

Researchers are investigating the liver safety of statin use among inpatients in the neurology department in China. This study uses both a cross-sectional design and a retrospective cohort study to analyze statin effects from different perspectives. The goal is to provide additional evidence-based guidance for clinical use of statins in patients with neurological conditions, including cerebrovascular disease, headache, dizziness, and vertigo. The research consists of two phases. First, a cross-sectional study examines the relationship between statin use before hospital admission and the initial liver enzyme levels of patients. Next, a retrospective cohort study divides patients who were not on statins prior to admission into two groups based on whether they started statins after admission. Liver enzymes such as aspartate aminotransferase (AST) and alanine aminotransferase (ALT) are measured four weeks after admission to assess liver safety. Participants are hospitalized adults aged 18 to 85 years with specific neurological diagnoses. Researchers review medical histories and liver enzyme tests, focusing on AST and ALT levels four weeks after admission. The study excludes patients with incomplete medical records, short prior statin use, malignant tumors, or blood diseases. The total participation involves data analysis from hospital records during the defined study period from June 2020 to February 2023.

This research aims to evaluate whether using a combination of low dose rosuvastatin (5 mg) and ezetimibe (10 mg) is not less effective than using a higher dose of rosuvastatin (20 mg) alone in reducing major adverse cardiac events for patients with acute myocardial infarction treated with percutaneous coronary intervention. Previous studies have shown the importance of lowering LDL cholesterol in reducing heart disease risk, but the combined treatment's clinical effectiveness needs further study. Participants will be randomly assigned to receive either rosuvastatin 5 mg plus ezetimibe 10 mg once daily or rosuvastatin 20 mg once daily for 24 months. This open-label trial compares the two regimens over two years to assess their impact on heart-related outcomes. The trial is led by Kiyuk Chang, MD, PhD. During the study, participants will be monitored for major adverse cardiovascular events over 24 months, including death, heart attacks, strokes, and need for revascularization. Additional assessments include LDL cholesterol levels at 3 months, medication adherence, muscle symptoms, new diabetes onset, and cataract occurrence. Safety and effectiveness data will be collected regularly to understand the treatments' impact over the two-year period.

Researchers are investigating whether a heart disease prevention approach using coronary computed tomography angiography (CCTA) can improve the management of cholesterol-lowering treatments and control of cardiovascular risk factors compared to the traditional method based on cardiovascular risk scores. This study focuses on an asymptomatic Chinese population aged 40 to 69 years without known cardiovascular events. It aims to better understand the impact of CCTA screening on personalized prevention strategies and the prevalence of hidden coronary artery disease. Participants will be randomly assigned to one of two groups: one receiving prevention programs guided by CCTA results, and the other managed using traditional cardiovascular risk scores based on Chinese guidelines for lipid management. The study will include baseline assessments with questionnaires and objective evaluations on the same day as consent. Both groups will follow their respective prevention strategies, with lipid-lowering treatment and risk factor control monitored over time. During the 12 months of follow-up, researchers will assess how many participants regularly take lipid-lowering medications and achieve LDL cholesterol targets, as well as monitor cardiovascular events, blood pressure, diabetes control, smoking cessation, exercise habits, and quality of life measures including anxiety and depression. The study will also report on the prevalence of subclinical coronary atherosclerosis detected by CCTA at baseline. The overall participation involves regular assessments to evaluate the effectiveness of the prevention strategies over one year.

Researchers are evaluating the safety and effectiveness of low-dose colchicine (LODOCO), an anti-inflammatory medication, in people who cannot tolerate statins due to side effects. Statins are cholesterol-lowering drugs that help reduce the risk of heart problems, but some patients must stop using them, increasing their cardiovascular risk. This study focuses on whether LODOCO can help reduce inflammation, a key factor in heart disease, in statin-intolerant patients. Participants will be randomly assigned to receive either low-dose colchicine (0.5 mg once daily) followed by a placebo for four weeks, or a placebo followed by low-dose colchicine for four weeks. This crossover design allows researchers to compare the effects of colchicine against placebo within the same participants. LODOCO is FDA approved for reducing cardiac event risk in people with heart disease or multiple risk factors. During the study, participants will be monitored for side effects and changes in inflammatory markers, including high-sensitivity C-reactive protein and interleukin-6 levels, over four weeks. Researchers will also assess lipid profiles from baseline to 30 days. Safety is measured by tracking adverse events, and efficacy by changes in inflammation. The study is conducted by Virginia Commonwealth University and lasts about one month per treatment phase.