Table of contents
- Overview of Atorvastatin research
- Cardiovascular and brain trials
- Trials in other conditions
- Study design, phases, and participants
- Main endpoints used in the trials
- Trial status and what it means
Overview of Atorvastatin research
The trial data show that Atorvastatin is being studied in many different clinical settings, including prevention of heart and brain events, cancer care, migraine, and other diseases.[1][2] These are research studies, not a drug guide, and they focus on whether Atorvastatin helps in specific patient groups.[3]
Most trials are Phase 2 or Phase 3, which means researchers are testing whether the treatment works and how safe it is in larger groups.[4] A smaller number of studies are Phase 1 or low-intervention studies, and one bioequivalence study compared two formulations in healthy volunteers.[5]
Cardiovascular and brain trials
Several studies focus on people with cardiovascular disease or high risk of it, such as atherosclerosis, acute coronary syndrome, and high polygenic risk for coronary artery disease.[2][6] These trials measure outcomes like major cardiovascular events, cardiovascular death, heart attack, stroke, and plaque progression in blood vessels.[2][7]
One large Phase 3 study in people with high polygenic risk for coronary artery disease is testing whether preventive statin treatment can lower the chance of major cardiovascular events and death.[6] Another Phase 3 study in people with atherosclerotic cardiovascular disease is measuring time to cardiovascular death, non-fatal heart attack, or non-fatal ischemic stroke.[7]
Trials also include people with covert brain infarction, ischemic stroke, transient ischemic attack, and spontaneous lobar intracerebral hemorrhage.[1][8] In these studies, researchers are looking at outcomes such as MACCE, MACE-free survival, recurrent hemorrhage, and major bleeding or other safety events.[1][8]
Some studies compare continuing statins with stopping them after brain bleeding or stroke, while others test whether statin treatment helps older frail patients after ischemic stroke or transient ischemic attack.[8][4] One trial in frail adults aged 70 and older also measures health-related quality of life with PROMIS-10.[4]
Trials in other conditions
Atorvastatin is also being tested in non-cardiovascular conditions, showing that the trial program is broad.[9] These include bile acid diarrhoea, COPD, migraine, Graves ophthalmopathy, arrhythmogenic cardiomyopathy, and some cancer settings.[9]
In bile acid diarrhoea, one low-intervention study is measuring a bile acid synthesis marker called C4 to see whether Atorvastatin lowers bile acid production.[9] In COPD, a Phase 3 trial is comparing Atorvastatin with placebo to see whether it reduces exacerbations, which are flare-ups of symptoms.[6]
In migraine, Phase 2 studies are testing whether Atorvastatin can reduce the number of migraine days per 4 weeks in episodic and chronic migraine.[10] In Graves ophthalmopathy, researchers are studying whether Atorvastatin can prevent active eye disease after a new diagnosis of Graves’ disease, using the Clinical Activity Score as the main measure.[11]
In cancer trials, Atorvastatin is being studied as part of treatment strategies for breast cancer, prostate cancer, non-small cell lung cancer, triple negative breast cancer, and metastatic cancers.[12] These trials measure outcomes such as overall survival, invasive disease-free survival, progression, immune cell changes, and ctDNA changes, which are blood-based signs of tumor activity.[12]
Study design, phases, and participants
Most trials are interventional, meaning the research team assigns a treatment or placebo and then compares results between groups.[4] Some studies are blinded, which means patients or researchers may not know which treatment was given, helping reduce bias, or unfair influence on the results.[9][13]
The enrolled populations are very different from one study to another.[3] Some trials include healthy volunteers, while others focus on older frail adults, patients after stroke, people with atherosclerosis, people with cancer, or people with chronic inflammatory disease.[3][4][12]
Enrollment ranges from very small studies with 8, 14, 20, or 36 participants to very large trials with more than 17,000 participants.[5][7] This wide range shows that some studies are early or focused on special questions, while others are designed to give stronger answers in large patient groups.[4]
Main endpoints used in the trials
The main endpoint is the primary result the trial is trying to measure.[1] For Atorvastatin studies, common endpoints include major cardiovascular events, stroke, death, plaque volume, LDL-C change, quality of life, and disease progression.[1][7][4]
Some trials use imaging endpoints, such as atherosclerotic plaque volume in the aorta or coronary arteries, or echocardiography, which is an ultrasound test of the heart.[2][14] Other trials use lab endpoints, such as cholesterol and bile acid metabolism, sex steroid levels, inflammatory markers, or C4.[9][15]
Several studies measure patient-centered outcomes, such as health-related quality of life, daily functioning, and treatment adherence.[4][13] These outcomes help show how treatment affects daily life, not only test results.
Trial status and what it means
The trial list includes studies with different status labels: Authorised, Completed, and Withdrawn.[1][5] Authorised means the study is approved to run, completed means the study has finished, and withdrawn means the study was stopped before completion.[5]
Some trial titles include product names or drug combinations, but the main research question is still about Atorvastatin as part of a study strategy.[16] Across the trial list, the same medicine is being tested for many different goals, from prevention to treatment support to mechanistic research.[3]
