This page shows what was measured, who it was measured in, and what that does not settle.
What Ezetimibe does in the body
Ezetimibe blocks the specific doorway on intestinal lining cells that lets cholesterol back in.
Most of the cholesterol your gut absorbs is not from food; it is cholesterol your own liver put into bile and is reclaiming. Less returns to the liver, the liver responds by pulling more LDL out of the blood, and the blood number falls by around a fifth.
Why people take it. High cholesterol, usually alongside a statin
What happened in people
A 7-year event rate of 32.7% against 34.7% in 18,144 patients, an absolute difference of 2.0 percentage points
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The recorded finding that sits closest to something a person would notice. Written into the record, not signed off, and it carries no population or interval.
That carotid intima-media thickness predicts event benefit — ENHANCE moved the wrong way and the drug went on to reduce events
Where it acts
Brush border of the jejunal enterocyte
Kind of result
The kind of result is not recorded
Supervision
RNAWiki has not recorded a supervision or regulatory status for this substance.
What the registries record it as
The substance registry classes this as chemical.
FDA substance registry · EOR26LQQ24 · read 2026-08-29
Its recorded molecular formula is C24H21F2NO3, weighing 409.4.
US prescribing information · 57d19491-cba1-4720-b69d-481574459201 · read 2026-08-30
Where each sentence above came from
A person wrote this explanation into the record, with the studies named in the path below.
The recorded use, written for a reader without medical training. Not signed off.
A limit recorded against this substance. Not signed off as a reviewed claim.
The four opening statements run to 90 words.
Words this page uses
Four words worth knowing first
Chosen from what this page shows, with each one explained before the word it depends on.
Stand-in result
A stand-in result is a number measured because the real result takes too long.
A picture of it, and where the picture fails
It is like judging a journey by the speedometer rather than by arriving.
Where that stops being true. Speed does predict arrival. Many stand-in results do not predict the real one.
What people get wrong. A stand-in result is often reported as the result itself.
A surrogate endpoint substituted for a clinical endpoint, valid only where the substitution has been shown to hold.
Randomisation
Randomisation means chance decides who gets which treatment.
A picture of it, and where the picture fails
It is like a coin toss deciding the groups.
Where that stops being true. A coin toss is fair once. Fairness here comes from doing it for everyone.
What people get wrong. It is thought to make groups identical. It makes them similar on average, including on things nobody measured.
Allocation of participants to arms by a chance process, so that unmeasured factors are balanced in expectation.
Confidence interval
A confidence interval is the range the true answer is likely to sit in.
A picture of it, and where the picture fails
It is like a weather forecast giving a range rather than one number.
Where that stops being true. A forecast range covers tomorrow. This one covers what the study could resolve.
What people get wrong. The middle number is read as the answer. A range crossing zero means no change is still possible.
An interval estimate that would contain the true parameter in a stated proportion of repeated studies.
Pathway
A pathway is a chain of steps inside a cell, each one setting off the next.
A picture of it, and where the picture fails
A pathway is like a row of dominoes.
Where that stops being true. Dominoes fall one way. Pathways loop back and can switch themselves off.
What people get wrong. Changing one step is read as changing the outcome. Other steps often absorb it.
An ordered series of molecular interactions producing a defined cellular change.
What happened in people◇Read from sources, not yet reviewed
What was measured, goal by goal
One row for each goal a registered study measured something for. One column for each kind of thing that could be measured.
Registered studies list 40 outcome measures that RNAWiki could read. A registered study says what someone planned to measure. It does not say what they found. 0 of the matched studies tested this substance, and 0 posted a result.
There is no single score. A strong test result and a weak life result are different facts.
Goals down the side, kinds of measurement across the top. Each cell says what kind of thing was registered, not what was found.
Goal
Life outcome
What a body can do
How a person feels
A test result
A step in the body
Harms
How long
Who was studied
Cholesterol
∅Nothing in the sources checkedNo registered study lists a life outcome for this goal.
∅Nothing in the sources checkedNo registered study lists a performance measure for this goal.
∅Nothing in the sources checkedNo registered study lists a symptom measure for this goal.
△Only a number moved16 registered test measure.
∅Nothing in the sources checkedNo registered study lists a body-step measure for this goal.
—Not recordedHarms were not a registered measure for this goal.
—Not recordedNo finished study window is recorded.
…Waiting for a reviewerWho was studied is listed further down the page.
Which registered measures put each goal on this table
Cholesterol
ldl c from baseline to week 12; ldl c from the start of the study; ldl goal attainment; fasting plasma low density lipoprotein cholesterol; ldl receptor mrna expression; ldl receptor protein; ldl c from baseline; triglycerides from baseline to final visit
Sorted by fixed word lists, version v1. A name the rules do not recognise stays unsorted rather than moving to the nearest column.
What each mark on this table means
∅ Nothing in the sources checked
No registered study lists a life outcome for this goal.
△ Only a number moved
16 registered test measure.
— Not recorded
Harms were not a registered measure for this goal.
… Waiting for a reviewer
Who was studied is listed further down the page.
What happened in people◇Read from sources, not yet reviewed
What happened in people
Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.
Composite of cardiovascular death, non-fatal myocardial infarction, unstable angina requiring rehospitalisation, coronary revascularisation at ≥30 days, or non-fatal stroke
✓ The study showed what it set out to show
Who was studied
IMPROVE-IT (NCT00202878)
How many people
18144
Study design
Randomised double-blind active-controlled trial, median 6 years
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
HR 0.936 (95% CI 0.89-0.99), P = 0.016; absolute risk difference 2.0 percentage points at 7 years
Repeated elsewhere
Partially Replicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. The confidence interval reaches 0.99 in 18,144 patients over six years — the trial only just excluded no effect.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral tablet, and fixed combinations with simvastatin, atorvastatin and rosuvastatin
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
Change in mean carotid-artery intima-media thickness
✗ The study did not show it
Who was studied
ENHANCE (NCT00552097)
How many people
720
Study design
Randomised double-blind imaging trial, 24 months
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
0.0111 mm on combination against 0.0058 mm on simvastatin alone, P = 0.29 — numerically the wrong direction
Repeated elsewhere
Failed to Replicate
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. LDL fell 16.5% further on the combination (p<0.01), with greater reductions in triglycerides and C-reactive protein. The surrogate did not follow the lipid change.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral tablet, and fixed combinations with simvastatin, atorvastatin and rosuvastatin
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
Composite of aortic-valve events and ischaemic cardiovascular events in asymptomatic aortic stenosis
✗ The study did not show it
Who was studied
SEAS (NCT00092677)
How many people
1873
Study design
Randomised double-blind placebo-controlled trial, median 52.2 months
Compared against
A dummy treatment
Kind of result
A number that stands in for health
What was found
HR 0.96 (95% CI 0.83-1.12), P = 0.59
Repeated elsewhere
Failed to Replicate
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. Cancer occurred in 105 against 70 patients, p=0.01 — a signal that SHARP, with 9,270 patients, subsequently did not reproduce (438 against 439, p=0.89).
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral tablet, and fixed combinations with simvastatin, atorvastatin and rosuvastatin
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
First major atherosclerotic event in advanced chronic kidney disease including dialysis
✓ The study showed what it set out to show
Who was studied
SHARP (NCT00125593, ISRCTN54137607)
How many people
9270
Study design
Randomised double-blind placebo-controlled trial, median 4.9 years
Compared against
A dummy treatment
Kind of result
A number that stands in for health
What was found
Rate ratio 0.83 (95% CI 0.74-0.94), log-rank P = 0.0021
Repeated elsewhere
Replicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. Non-fatal infarction or coronary death alone was not significant (RR 0.92, p=0.37); the composite was carried by stroke and revascularisation. Compliance was about two thirds.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral tablet, and fixed combinations with simvastatin, atorvastatin and rosuvastatin
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
RNAWiki holds 4 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.
What happened in people◇Read from sources, not yet reviewed
How close this is to real life
The top step is something a person would feel or care about. The bottom is a guess from software. Filled steps are where evidence exists for this substance.
□Living longer, or avoiding a major eventNo evidence recorded. Death, a heart attack, a stroke, a hospital stay.No registered study measures this.
□What a body can do day to dayNo evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
□Measured performanceNo evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
□Symptoms and quality of lifeNo evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.No registered study measures this.
■A number that stands in for healthEvidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.17 registered measures of this kind.
■A step measured inside a personEvidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
■AnimalsEvidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.Stored records in Mouse. A result in animals says what to test next. It does not say what happens in people.
■Cells in a dishEvidence recorded. Cells or chemistry on a bench, far from a whole body.Stored mechanism abstracts describe steps measured in cells or tissue.
□A guess from softwareNo evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.
Higher on these steps means closer to something a person would feel. It does not mean better done.
What it changes in the body◇Read from sources, not yet reviewed
The path through the body
From what a person takes to what changes. A solid line is a step measured in people. A dashed line is a step nobody has measured that way.
Start
Ezetimibe
What a person takes: Oral tablet, and fixed combinations with simvastatin, atorvastatin and rosuvastatin.
The measurement behind this step
Once daily, with or without food. The drug glucuronidates in the intestinal wall and recirculates through bile back to the gut lumen, which keeps it at its own site of action and gives an effective half-life of about 22 hours despite low systemic exposure.
Getting in
Swallowed, and immediately converted into something that stays in the gut
The intestinal wall attaches a sugar group to the drug as it passes through. That modified form is at least as active and keeps being recycled back into the gut, so the drug stays where it works.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Ezetimibe undergoes extensive first-pass glucuronidation in the intestinal wall and liver to ezetimibe-glucuronide, which is equipotent or more potent at NPC1L1. The glucuronide is secreted into bile and delivered back to the intestinal lumen, producing enterohepatic recirculation and a half-life of roughly 22 hours with sustained delivery to the site of action.
It reaches the brush border of the jejunum from the luminal side
The transporter it blocks sits on the surface of the cells lining the small intestine, facing the gut contents. The drug meets it from inside the gut, not from the blood.
╌╌Measured in animals. A result in animals says what to test next. It does not say what happens in people.
The measurement behind this step
NPC1L1 is a 13-transmembrane sterol-sensing protein localised to the apical brush border of jejunal enterocytes, and in humans also to the hepatocyte canalicular membrane. It mediates clathrin-AP2-dependent internalisation of cholesterol from micelles. The hepatic localisation is why the drug also reduces biliary cholesterol reuptake, and it is a species difference from the mouse.
A strained four-membered ring blocks the sterol doorway
The drug binds the transporter and stops it internalising cholesterol. The scaffold was discovered by watching for reduced cholesterol absorption, not by designing against a known target — the target was identified afterwards.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
The 2-azetidinone beta-lactam scaffold binds NPC1L1 and prevents sterol internalisation. Ezetimibe emerged from a phenotypic acyl-CoA cholesterol acyltransferase programme at Schering-Plough and was optimised on cholesterol absorption in vivo; NPC1L1 was identified as its molecular target in 2004, two years after approval. The same transporter explains why ezetimibe treats sitosterolaemia, a disease of unrestrained plant sterol absorption.
Less cholesterol returns to the liver, so the liver clears more LDL
Deprived of the cholesterol it was reclaiming from the gut, the liver puts out more LDL collection receptors and pulls particles from the blood.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Reduced delivery of intestinal cholesterol to the liver in chylomicron remnants depletes the hepatic sterol pool, releasing SREBP-2 and upregulating LDLR transcription. Surface LDL receptor density rises and circulating LDL clearance increases. Because this happens downstream of a different lever than statins use, the two are additive: the statin blocks synthesis, the compensatory rise in absorption is blocked by ezetimibe.
LDL falls by around a fifth, and events fall by about the predicted amount
Adding it to a statin lowers cholesterol by roughly another fifth. In the trial that counted events, that produced two fewer events per hundred people over seven years.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
In IMPROVE-IT the time-weighted average LDL was 53.7 mg/dL on combination against 69.5 mg/dL on simvastatin alone, and the 7-year primary event rate was 32.7% against 34.7% (hazard ratio 0.936, p=0.016). In SHARP an LDL difference of 0.85 mmol/L produced a 17% proportional reduction in major atherosclerotic events.
No suggested links are held for this record, so nothing is hidden from this path.
What we know
The record describes 5 steps from taking it to an effect in a person.
How we know it
Each step names the study behind it in the technical detail beside it.
What this does not prove
A change inside the body is a reason to look. It is not a result in a person.
Why it matters
A reader can see exactly where the chain stops being measured in people.
What we still do not know
No reviewed claim binds any of these steps to a named population.
What it would be like to take◇Read from sources, not yet reviewed
Felt, measured, or meaningful
Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.
Felt
Things a person could notice without a test.
No registered study measured anything of this kind.
Measured
Things only a test, a scale or a device shows.
ldl c from baseline to week 12
ldl c from the start of the study
ldl goal attainment
fasting plasma low density lipoprotein cholesterol
ldl receptor mrna expression
ldl receptor protein
flow mediated dilation
ldl c from baseline
triglycerides from baseline to final visit
ldl c from baseline to endpoint
and 7 more.
Meaningful
Things that change how a life goes, not only a number.
No registered study measured anything of this kind.
A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.
Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.
Measured, but not felt. A number moves. The person notices nothing. Both can be true.
Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.
Matters, but takes years. The result that counts may take longer than anyone would keep watching.
Names that fit none of the three (23)
hmg coa reductase activity
hmg coa reductase mrna expression
auc0 t simvastatin
auc0 t simvastatin acid
auc0 t rosuvastatin
auc0 t fenofibric acid
auc0 t atorvastatin acid
auc0 t nicotinic acid
auc0 t nicotinuric acid
neurocognitive function
cerebrovascular lesions on mri
cholesteryl ester fractional clearance rate
low density lipoprotein
plaque volume
perfusion index
lipid profile
adverse events and adverse reactions
pk interaction
incidence of adverse events
safety as measured by number of at least one adverse event
These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.
What it would be like to take◇Read from sources, not yet reviewed
How long anything takes
Nine different lengths of time that get confused with each other. None of them is worked out from another.
Before anything is noticed.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before a test result moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before performance moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
How long the result was watched.No finished study window is recorded for a study that tested this substance.
How long people took it.How long people actually took it is not stored. The study window is not the same thing.
How long people were followed.Follow-up length is not stored separately. It is never read off the study window, which would be a different thing.
How fast the body clears it. 22 hours hours
Read from the label, which states: “Both ezetimibe and ezetimibe-glucuronide are eliminated from plasma with a half-life of approximately 22 hours for both ezetimibe and ezetimibe-glucuronide.”
How long effects linger.RNAWiki does not store this separately, and never works it out from another figure on this page.
Beyond the studies. Nothing is recorded about the long term.
The longest finished study sets the edge of what anyone measured.
A study window is not how long people took it, and neither is how long they were followed. Where RNAWiki holds only one of the three, it shows one.
What is missing or unclear◇Read from sources, not yet reviewed
Were people like you studied?
RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.
Who was studied
People similar to this profile were included.
People who need further LDL reduction on a statin, people who cannot tolerate a statin dose high enough to reach target, and people with familial hypercholesterolaemia. It is on the WHO Model List of Essential Medicines.
Who is missing from the studies
Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What the label states about particular groups
On pediatric, the label states: “The safety and effectiveness of ezetimibe have not been established in pediatric patients younger than 10 years of age with HeFH or HoFH, in pediatric patients younger than 9 years of age with homozygous familial sitosterolemia, or in pediatric patients with other types of hyperlipidemia.”
US prescribing information · 57d19491-cba1-4720-b69d-481574459201 · read 2026-08-30
On older people, the label states: “Of the 2,396 patients who received ezetimibe in clinical trials, 669 (28%) were 65 years of age and older, and 111 (5%) were 75 years of age and older.”
US prescribing information · 57d19491-cba1-4720-b69d-481574459201 · read 2026-08-30
On people who are pregnant, the label states: “The effect of ezetimibe on prenatal and postnatal development and maternal function was evaluated in pregnant rats at doses of 100, 300 or 1,000 mg/kg/day from gestation day 6 through lactation day 21.”
US prescribing information · 57d19491-cba1-4720-b69d-481574459201 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There is no information about the presence of ezetimibe in human milk.”
US prescribing information · 57d19491-cba1-4720-b69d-481574459201 · read 2026-08-30
On people with reduced liver function, the label states: “Ezetimibe is not recommended for use in patients with moderate to severe hepatic impairment (Child-Pugh B or C) due to the unknown effects of the increased exposure to ezetimibe [see Clinical Pharmacology (12.3) ] .”
US prescribing information · 57d19491-cba1-4720-b69d-481574459201 · read 2026-08-30
On people with reduced kidney function, the label states: “No dosage adjustment of ezetimibe is necessary in patients with renal impairment.”
US prescribing information · 57d19491-cba1-4720-b69d-481574459201 · read 2026-08-30
Where the result stopped carrying
ENHANCE: the primary imaging endpoint was numerically worse on the combination, p=0.29, despite a much larger LDL reduction
SEAS: no effect on aortic-valve events (HR 1.00) and no effect on the composite (HR 0.96), with a cancer imbalance that took a larger trial to retire
IMPROVE-IT itself only just excluded no effect, with a confidence interval reaching 0.99 after six years and 18,144 patients
This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to take◇Read from sources, not yet reviewed
Why it might seem to do nothing
A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.
It was studied for a different goal
The studies measured something else entirely.
On this record: Some registered studies measured things that match no goal on this page.
It was studied in different people
The people in the studies were not much like the reader.
On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
The evidence may simply be wrong
Small early studies often do not hold up.
On this record: RNAWiki has not yet published a reviewed conclusion for this use.
Other reasons RNAWiki checked and found nothing for (10)
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to take◇Read from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
Prescription only
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Oral tablet, and fixed combinations with simvastatin, atorvastatin and rosuvastatin
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form and route recorded on this substance.
No source is stored against this line.
Who oversees it
RNAWiki has not recorded a supervision or regulatory status for this substance.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
No register row and no identity class settled the question.
No source is stored against this line.
What is in the pack
Once daily, with or without food.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold. The rest of the recorded wording: The drug glucuronidates in the intestinal wall and recirculates through bile back to the gut lumen, which keeps it at its own site of action and gives an effective half-life of about 22 hours despite low systemic exposure.
No source is stored against this line.
Where it is registered
Regulatory records are listed in the technical disclosure at the foot of this page.
# Counted from records
Where this came from
A count of rows RNAWiki holds. It describes our records, not your body.
Register entries are stored per jurisdiction and shown with their dates.
No source is stored against this line.
Why people stop
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
What it would be like to take◇Read from sources, not yet reviewed
What can go wrong
Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.
·Worth asking a clinician aboutWritten into the record from the studies named on this page
Unusually clean. In IMPROVE-IT, rates of prespecified muscle, gallbladder and hepatic adverse effects and of cancer were similar to statin monotherapy across 18,144 patients over six years. In SHARP the excess of myopathy on simvastatin plus ezetimibe was two per 10,000 patient-years, with no excess of hepatitis, gallstones or cancer. The SEAS cancer imbalance was not reproduced in the larger SHARP population. Bile acid sequestrants reduce its absorption if taken together.
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
These are reports people sent to a regulator. They do not show the medicine caused the reaction.
Nobody counted how many people took the medicine and reported nothing.
The same event can be reported more than once, and many reports are incomplete.
News coverage, lawsuits and new warnings change how often people report.
A count is not a rate and not a risk.
Ezetimibe appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 4671 reaction mentions were counted. One report can name several reactions.
open-targets-adr · recorded 2026-06-24 · a recorded source, not a stored snapshot
Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.
Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What is missing or unclear◇Read from sources, not yet reviewed
Does the exact form matter?
Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.
The form that was studied
Oral tablet, and fixed combinations with simvastatin, atorvastatin and rosuvastatin
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form used in the studies cited on this page.
No source is stored against this line.
What is sold
A recorded note compares this form with the others that are sold. It is kept below, word for word.
§ A fixed RNAWiki sentence
Where this came from
Wording RNAWiki always uses, not a finding about this substance.
The recorded note, unchanged: The drug glucuronidates in the intestinal wall and recirculates through bile back to the gut lumen, which keeps it at its own site of action and gives an effective half-life of about 22 hours despite low systemic exposure.
No source is stored against this line.
What is recorded as being sold
104 products list this as an active ingredient in the United States drug directory. 62 of them contain it and nothing else.
FDA National Drug Code directory · 76333-170 · read 2026-08-29
They are sold as granule, powder, tablet and tablet, film coated, taken oral.
FDA National Drug Code directory · 76333-170 · read 2026-08-29
The regulator's established pharmacologic class for it is decreased cholesterol absorption [pe] and dietary cholesterol absorption inhibitor [epc].
FDA National Drug Code directory · 76333-170 · read 2026-08-29
52 published labels name it as an active ingredient. 41 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 57d19491-cba1-4720-b69d-481574459201 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 57d19491-cba1-4720-b69d-481574459201 · read 2026-08-29
2 marketed supplement labels list this ingredient, classed as botanical with nutrients and other combinations.
Those labels carry all other, nutrient and structure/function claims. A claim of that kind is written by the manufacturer and is not assessed by any regulator, so its presence says nothing about whether it is true.
Recorded price in US: 0.06747 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 33 priced products whose strengths and pack forms differ, as of 2026-08-26, paid by retail pharmacies buying the product, as surveyed by the Centers for Medicare & Medicaid Services. It is not a list price, an insurance price, or what anyone pays at a counter..
Recorded source · 2026-08-26 · read 2026-08-28
Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.
What it would be like to take◇Read from sources, not yet reviewed
What you could measure
This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.
RNAWiki could not confidently classify this substance, so no self-experiment plan is offered.
Questions worth asking
Which of the trials of Ezetimibe studied people like me?
What was measured, and for how long?
Was the result a laboratory value or a health outcome?
What would we watch for, and when would we stop?
Tracking can show whether something changed for you. It cannot show what caused it.
RNAWiki records evidence. It does not say whether this substance is right for you.
What is missing or unclear◇Read from sources, not yet reviewed
Claims that go past the evidence
Things said about this substance that sound reasonable, and the exact step that is missing between the evidence and the claim.
✗Goes past the evidence
That carotid intima-media thickness predicts event benefit — ENHANCE moved the wrong way and the drug went on to reduce events
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That the SEAS cancer imbalance was a drug effect — SHARP found 438 cancers against 439 in a larger and longer study
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That a significant composite reduction implies a large benefit — the absolute difference was 2.0 percentage points over 7 years in the highest-risk population studied
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That ezetimibe can replace a statin — every outcome trial on this page added it to one
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
What is missing or unclear◇Read from sources, not yet reviewed
What nobody knows yet
Open questions, each with why it is open and what would close it.
Missing populations
Which groups were under-represented in the studies has not been recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing long-term data
No completed tested study window is recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
No reviewed conclusion
RNAWiki has not yet published a reviewed conclusion for this use.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing interaction studies
No interaction was found in the registers checked. Not finding one is not the same as showing there is none.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Formulation uncertainty
Several salts, forms or products of Ezetimibe are recorded. Results from one form may not transfer to another.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Mechanism not reviewed
No reviewed mechanism story exists for this substance.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
What happened in people◇Read from sources, not yet reviewed
Check any of this yourself
Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.
Every line above can be traced to the study named beside it. Follow the link and read it.
IMPROVE-IT: 32.7% against 34.7% over seven years in 18,144 patients
In plain words
Adding ezetimibe to a statin after a heart attack lowered cholesterol further and prevented events. The absolute difference over seven years was two people in a hundred.
What was measured
Kaplan-Meier rate at 7 years of a five-component cardiovascular composite, and time-weighted average LDL cholesterol
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
IMPROVE-IT randomised 18,144 patients hospitalised for an acute coronary syndrome within the preceding 10 days, with LDL cholesterol of 50 to 100 mg/dL on lipid-lowering therapy or 50 to 125 mg/dL if not, to simvastatin 40 mg plus ezetimibe 10 mg or simvastatin 40 mg plus placebo, median follow-up 6 years. Median time-weighted average LDL during the study was 53.7 mg/dL on the combination against 69.5 mg/dL on simvastatin alone (p<0.001). The Kaplan-Meier event rate at 7 years for the primary composite of cardiovascular death, non-fatal myocardial infarction, unstable angina requiring rehospitalisation, coronary revascularisation at 30 days or later, or non-fatal stroke was 32.7% against 34.7%: absolute risk difference 2.0 percentage points, hazard ratio 0.936 (95% CI 0.89 to 0.99), p=0.016. Prespecified muscle, gallbladder and hepatic adverse effects and cancer were similar between groups.
Written into the record, not signed off as a reviewed claim
Why a 2-point difference mattered: it separated the LDL number from the statin
In plain words
For years it was argued that statins work through something other than cholesterol. Ezetimibe lowers cholesterol by an unrelated mechanism, and when it lowered events by roughly the amount the cholesterol hypothesis predicted, that argument became much harder to make.
What was measured
Observed relative risk reduction against the LDL dose-response established across 26 randomised trials
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The Cholesterol Treatment Trialists established across 26 randomised trials and 170,000 participants that each 1.0 mmol/L reduction in LDL cholesterol reduces the annual rate of major vascular events by just over a fifth. In IMPROVE-IT the LDL difference was 15.8 mg/dL, roughly 0.41 mmol/L, and the observed relative reduction in the primary composite was 6.4% — close to what that dose-response predicts for a difference that size over that follow-up. The mechanistic point is that ezetimibe achieves the LDL reduction by inhibiting an intestinal sterol transporter, sharing nothing with HMG-CoA reductase inhibition and none of the isoprenoid-depletion biochemistry invoked to explain statin pleiotropy. IMPROVE-IT is therefore evidence about the LDL number rather than about the drug class, and it also demonstrated benefit at achieved LDL levels below any target then in guidelines.
Written into the record, not signed off as a reviewed claim
ENHANCE: LDL fell 16.5% further and the artery wall got slightly thicker
In plain words
A trial in familial hypercholesterolaemia measured the thickness of artery walls by ultrasound over two years. Cholesterol fell much further on ezetimibe. The artery walls thickened marginally more, not less.
What was measured
Change in mean carotid-artery intima-media thickness over 24 months
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
ENHANCE randomised 720 patients with familial hypercholesterolaemia to simvastatin 80 mg with placebo or with ezetimibe 10 mg for 24 months, measuring carotid and femoral intima-media thickness by B-mode ultrasound. The primary outcome, mean change in carotid-artery intima-media thickness, was 0.0058 plus or minus 0.0037 mm on simvastatin alone and 0.0111 plus or minus 0.0038 mm on the combination: p=0.29, numerically in the wrong direction. No secondary intima-media thickness measure differed significantly. End-of-study LDL was 192.7 mg/dL on simvastatin alone against 141.3 mg/dL on the combination, a 16.5% between-group difference, p<0.01, with greater reductions in triglycerides and C-reactive protein as well. Safety profiles were similar. The trial produced years of controversy about whether ezetimibe lowered a number without doing anything.
Written into the record, not signed off as a reviewed claim
SEAS: no effect on aortic stenosis, and more cancer
In plain words
A second trial tested whether lowering cholesterol slowed a narrowing heart valve. It did not. It did reduce ischaemic events, and it recorded more cancers, which took years to resolve.
What was measured
Composite of aortic-valve and ischaemic events over a median 52.2 months, and cancer incidence
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
SEAS randomised 1,873 patients with mild-to-moderate asymptomatic aortic stenosis to simvastatin 40 mg plus ezetimibe 10 mg or placebo, median follow-up 52.2 months. The primary composite of major cardiovascular events including cardiovascular death, aortic-valve replacement, non-fatal infarction, hospitalisation for unstable angina, heart failure, bypass grafting, percutaneous intervention and non-haemorrhagic stroke occurred in 333 patients (35.3%) against 355 (38.2%): hazard ratio 0.96 (95% CI 0.83 to 1.12), p=0.59. Aortic-valve replacement occurred in 28.3% against 29.9% (1.00, 0.84 to 1.18, p=0.97). Ischaemic cardiovascular events were fewer on treatment, 148 against 187 (0.78, 0.63 to 0.97, p=0.02), mainly through less bypass grafting. Cancer occurred more frequently on treatment: 105 against 70, p=0.01.
Written into the record, not signed off as a reviewed claim
SHARP: a 17% reduction in atherosclerotic events in chronic kidney disease
In plain words
In more than nine thousand people with advanced kidney disease, simvastatin plus ezetimibe reduced heart attacks, strokes and revascularisations by about a sixth over five years.
What was measured
First major atherosclerotic event over a median 4.9 years, and cancer incidence, in 9,270 patients
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
SHARP randomised 4,650 patients to simvastatin 20 mg plus ezetimibe 10 mg daily and 4,620 to matching placebo in advanced chronic kidney disease, including patients on dialysis. Allocation produced an average LDL difference of 0.85 mmol/L over a median 4.9 years with about two-thirds compliance, and a 17% proportional reduction in first major atherosclerotic event: 526 (11.3%) against 619 (13.4%), rate ratio 0.83 (95% CI 0.74 to 0.94), log-rank p=0.0021. Non-fatal infarction or coronary death was non-significantly lower (213 against 230; 0.92, 0.76 to 1.11, p=0.37); non-haemorrhagic stroke fell significantly (131 against 174; 0.75, 0.60 to 0.94, p=0.01) as did arterial revascularisation (284 against 352; 0.79, 0.68 to 0.93, p=0.0036). Excess myopathy was two per 10,000 patient-years (9 against 5 cases). There was no excess of hepatitis, gallstones or cancer (438 against 439, p=0.89) — which retired the SEAS cancer signal.
Written into the record, not signed off as a reviewed claim
The absolute benefit is small, and relative framing routinely obscures how small
In plain words
The relative reduction sounds modest and the absolute one is smaller still: two events prevented per hundred people over seven years, in a group who had all just had a heart attack.
What was measured
That a statistically significant composite reduction implies a clinically large benefit — the absolute difference was 2.0 percentage points over 7 years in the highest-risk population studied
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
IMPROVE-IT reported an absolute risk difference of 2.0 percentage points at 7 years, corresponding to a number needed to treat of about 50 over that period, in a secondary-prevention population within 10 days of an acute coronary syndrome — approximately the highest-risk group in which the drug is used. The hazard ratio of 0.936 with a confidence interval reaching 0.99 means the trial only just excluded no effect, in 18,144 patients over six years. The result is real, statistically sound and replicated in direction by SHARP. It is also a modest effect, and the two facts belong together: a page that reports "ezetimibe reduces cardiovascular events" without the 2.0 percentage points has not told the reader what the drug does.
This order is fixed in code and does not count clicks or time on the page.
What is not here
3 questions this page could not answer
These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.
What it may clash with — found nothing in the sources checked.
Other ways to the same goal — found nothing in the sources checked.
What changed on this page — found nothing in the sources checked.
The record as stored
The full record, for auditing
Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.
The older medicine-wide conclusion held in this record
Written for a clinical reader, and about the medicine as a whole rather than about one indication, population and set of trials. RNAWiki does not treat it as a programme conclusion and no reviewer has signed it off in that form. It is here word for word because it is what the record holds.
The drug that tested whether the benefit follows the LDL number rather than the statin: after missing its endpoint in a 720-patient carotid ultrasound trial and a 1,873-patient aortic stenosis trial, it lowered the primary composite from 34.7% to 32.7% in 18,144 patients over seven years — a real, replicated, small effect that arrived exactly where the LDL hypothesis predicted it.
Recorded evidence blocks (13)
Q1
What did Ezetimibe's largest trial (204691 people) and its longest (7.9 years) measure?
204691 people in Ezetimibe's largest registered study, 7.9 years in its longest registered window, measuring Total Cholesterol Concentration of Chylomicron (Sf≥400) Fractions After a Cholesterol-Rich Test Meal. ClinicalTrials.gov · 2026-09-01
68 phase3, 60 phase4, 26 phase1, 25 phase2, 15 na, 14 na or unstated, 2 early phase1; NCT04347434; 2027-12-30; no ageing endpoint recorded. Last human test completed 2026, NCT07268625.
Interpretation These counts include studies where Ezetimibe was a comparison treatment, a background treatment or an exposure in an observational study, and the longest window may be a planned end date. Trial roles have not yet been classified for this record.
Show the evidence
phase3
68
phase4
60
phase1
26
phase2
25
na
15
na or unstated
14
2 more recorded rows
early phase1
2
Last recorded human testNCT07268625
2026-02-24
recorded 2026-09-01 · last checked 2026-09-04
Q2
From mouse to human: where has Ezetimibe shown biomarker?
Total Cholesterol Concentration of Chylomicron (Sf≥400) Fractions After a Cholesterol-Rich Test Meal — the recorded outcome words.
Show the evidence
mouse
mechanism-only
humanNCT00101439
biomarker; Total Cholesterol Concentration of Chylomicron (Sf≥400) Fractions After a Cholesterol-Rich Test Meal; 209
recorded 2026-09-01 · last checked 2026-09-04
Q3
14 of Ezetimibe's trials stopped: safety, futility/efficacy, accrual/recruitment, funding/business, other?
safety (1), futility/efficacy (1), accrual/recruitment (6), funding/business (3) and other (3): Ezetimibe's stop wording, clustered. ClinicalTrials.gov · 2026-09-01
"Independent steering committee has stopped the trial based on results of a prespecified, blinded interim analysis. It was not stopped due to safety concerns."; 14 of 209 registered studies
Show the evidence
Trial
NCT00397657
terminated; "Independent steering committee has stopped the trial based on results of a prespecified, blinded interim analysis. It was not stopped due to safety concerns."
NCT00634140
withdrawn; "Study was never initiated due to lack of funding support."
NCT00651014
terminated; "slow subject recruitment and lack of medical and scientific merit due to change in new standard of therapy during that same period."
20 recorded entries; human; tablet; also "Ezetimibe 10 mg", "Simvastatin 20mg plus ezetimibe 10mg", "Ezetimibe 10 mg plus statin or ezetimibe 10 mg plus fenofibrate"
Show the evidence
human
NCT00125593
Ezetimibe 10mg
NCT00423488
Ezetimibe 10 mg
NCT00481351
Simvastatin 20mg plus ezetimibe 10mg
NCT00726856
Ezetimibe 10 mg plus statin or ezetimibe 10 mg plus fenofibrate
NCT00762229
Ezetimibe 5 mg
NCT01154036
ezetimibe 10 mg
14 more recorded rows
humanNCT01218204
10mg ezetimibe
humanNCT01236430
Ezetimibe/atorvastatin 10mg/10mg FDC
humanNCT01236430
Ezetimibe/atorvastatin 10mg/80mg FDC
humanNCT01384058
Ezetrol 10 mg
humanNCT01597700
10mg Ezetimibe
humanNCT01597700
10 mg Ezetimibe - wash out period
humanNCT02127320
Rosuvastatin 20mg + Ezetimibe 10mg
humanNCT02288338
Ezetrol® 10mg
humanNCT02288338
Lipitor® 40mg, Ezetrol® 10mg
humanNCT02550288
tablet; Placebo for Ezetimibe 10 mg tablet
humanNCT02971033
20mg ezetimibe
humanNCT02971033
20mg Zetia
humanNCT02971033
40mg ezetimibe
humanNCT02971033
40mg Zetia
recorded 2026-09-01 · last checked 2026-09-04
Q5
Ezetimibe's half-life is 22 hours — which schedules were studied?
22 hours, the half-life Ezetimibe's label states. openfda-label · 090776cf-f211-49a3-a993-ff5d707311f2 · 2026-08-30
Show the evidence
half life
22 hours hours; Both ezetimibe and ezetimibe-glucuronide are eliminated from plasma with a half-life of approximately 22 hours for both ezetimibe and ezetimibe-glucuronide.
tmax
After a single 10-mg dose of ezetimibe to fasted adults, mean ezetimibe peak plasma concentrations (C max ) of 3.4 to 5.5 ng/mL were attained within 4 to 12 hours (T max ).
bioavailability
There was no substantial deviation from dose proportionality between 5 and 20 mg. The absolute bioavailability of ezetimibe cannot be determined, as the compound is virtually insoluble in aqueous media suitable for injection.
metabolism
Elimination Metabolism Ezetimibe is primarily metabolized in the small intestine and liver via glucuronide conjugation (a phase II reaction) with subsequent biliary and renal excretion.
recorded 2026-08-30 · last checked 2026-09-04
Q6
Could one person measure Ezetimibe's effect on ldl c from baseline to week 12?
Ldl c from baseline to week 12: measured in Ezetimibe's trials.
ldl c from baseline to week 12 is the recorded endpoint.
Show the evidence
biomarkers
ldl c from baseline to week 12; 2026-09-01
ldl c from the start of the study; 2026-09-01
ldl goal attainment; 2026-09-01
fasting plasma low density lipoprotein cholesterol; 2026-09-01
0; NCT00634140; NA; the smallest recorded human enrolment at or below 30; the registry states no direction of its result; WITHDRAWN
Q7
Which of adverse events and adverse reactions, auc0 t atorvastatin acid and auc0 t fenofibric acid did Ezetimibe's trials measure?
adverse events and adverse reactions, auc0 t atorvastatin acid and auc0 t fenofibric acid lead 40 outcome terms across Ezetimibe's trials. ClinicalTrials.gov · 2026-09-01
fasting plasma low density lipoprotein cholesterol, hmg coa reductase activity, hmg coa reductase mrna expression, ldl receptor mrna expression, ldl receptor protein and auc0 t simvastatin follow.
Show the evidence
ldl c from baseline to week 12
1
ldl c from the start of the study
1
ldl goal attainment
1
fasting plasma low density lipoprotein cholesterol
1
hmg coa reductase activity
1
hmg coa reductase mrna expression
1
14 more recorded rows
ldl receptor mrna expression
1
ldl receptor protein
1
auc0 t simvastatin
1
auc0 t simvastatin acid
1
auc0 t rosuvastatin
1
auc0 t fenofibric acid
1
auc0 t atorvastatin acid
1
auc0 t nicotinic acid
1
auc0 t nicotinuric acid
1
flow mediated dilation
1
ldl c from baseline
1
neurocognitive function
1
cerebrovascular lesions on mri
1
cholesteryl ester fractional clearance rate
1
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which of Ezetimibe's 12 ongoing trials reports first?
Ventricular arrhythmias; Rate of prevention of HCV viremia in recipients of HCV viremic solid organs; latest 2029-07-31
Show the evidence
Trial
NCT04347434
"Assessment of the Effects of Long-term Lipid-lowering Therapy in Patients With Primary STEMI or NSTEMI"; n 300; "Ventricular arrhythmias"; 2027-12-30
NCT04508907
"A Study to Evaluate Preemptive Therapy in Hepatitis C (HCV) Organ Transplant Recipients"; n 200; "Rate of prevention of HCV viremia in recipients of HCV viremic solid organs"; 2026-11-01
NCT04968509
"Effect of PCSK9 Inhibitors on Calcific Aortic Valve Stenosis"; n 160; "The average annual change in peak aortic jet velocity"; 2028-01
NCT05641753
"Cholesterol Lowering and Residual Risk in Diabetes, Type 1"; n 125; "Change in Monocyte Platelet Aggregation (MPA) from Baseline"; 2027-07-31
NCT06437574
"Intensive Cholesterol-Lowering and CD8+ T Cells in Prostate Cancer"; n 140; "Pre/Post-change in percent prostate infiltrating CD8+ T lymphocytes."; 2028-05-31
NCT06686615
"A Study of Bempedoic Acid in Combination With Ezetimibe and Either Rosuvastatin or Atorvastatin in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia"; n 2000; "Relative LDL-C change between untreated and 8 week after triple therapy start"; 2028-01-31
6 further recorded trials
NCT06858332
"Lipoprotein(a) Levels in Patients With Atherosclerotic Cardiovascular Diseases in Russia"; n 2382; "Percentage of patients (%) with Lp(a) ≥125 nmol/L"; 2027-09-30
NCT07442630
"Long-term Comparison of Pitavastatin/Ezetimibe and Pitavastatin in Patients With Hypercholesterolemia and Elevated Triglycerides"; n 88; "Percentage change from baseline in LDL Cholesterol at Week 8 after the first dose of study treatment"; 2026-11-30
NCT07474649
"A Study of Bempedoic Acid/Ezetimibe/High-intensity Statin in Patients Without Cardiovascular Events"; n 103; "Annualised change in percentage plaque burden (Δ%PB)"; 2028-10-02
NCT07508254
"Triple vs Dual Lipid-Lowering Therapy for LDL-C Reduction in Acute Coronary Syndrome"; n 120; "Change in LDL cholesterol level"; 2026-10-31
NCT07605130
"Efficacy and Safety Study of Digital Cognitive Training and PCSK9 Inhibitor-Enhanced Lipid-lowering Strategy in Patients With Intracranial Atherosclerotic Stenosis: A 2×2 Randomized Controlled Trial"; n 420; "Change from baseline in composite cognitive Z-score at week 24"; 2029-07-31
NCT07752758
"Ezetimibe for Arrhythmia Recurrence After AF Ablation"; n 120; "Recurrence of atrial tachyarrhythmia (≥30 seconds) after blanking period within 6 months post-ablation"; 2028-06-30
recorded 2026-09-01 · last checked 2026-09-04
Q9
Which 77 trials of Ezetimibe posted no result?
Posted no result
77 of 77 completed trials
Registrations
NCT03884452, NCT03867110, NCT03882905, NCT03867318, NCT03882892 and NCT03882996, and 71 more
Completion dates
oldest 2001-05-24; newest 2024-03-01
Show the evidence
Trial
NCT03884452
2001-05-24
NCT03867110
2001-07-27
NCT03882905
2001-07-27
NCT03867318
2001-11-16
NCT03882892
2002-08-08
NCT03882996
2003-02-04
14 further recorded trials
NCT00651144
2003-05
NCT03885921
2003-07-08
NCT00653276
2004-01
NCT00045812
2004-04
NCT00652301
2004-04
NCT00317993
2004-07
NCT00652444
2004-08
NCT00651274
2004-08-01
NCT00653796
2004-08-01
NCT00653835
2004-08-01
NCT00653913
2004-09
NCT00650663
2004-09-01
NCT00650689
2004-12
NCT00651404
2004-12
Q10
At the median, Ezetimibe's trials enrolled 110 people — anything larger?
Median enrolment
110
Largest enrolment
204691
Registered trials counted
208
Q11
What do 4671 spontaneous reports say about Ezetimibe — and not say?
These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.
Ezetimibe appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 4671 reaction mentions were counted: myalgia 1280; rhabdomyolysis 787; blood creatine phosphokinase increased 639; pain in extremity 392. open-targets-adr · CHEMBL1138 · 2026-06-24
Show the evidence
myalgia
1280
rhabdomyolysis
787
blood creatine phosphokinase increased
639
pain in extremity
392
muscular weakness
295
muscle spasms
289
4 more recorded rows
alanine aminotransferase increased
254
liver function test abnormal
249
aspartate aminotransferase increased
244
hepatic enzyme increased
242
recorded 2026-06-24 · last checked 2026-09-04
Q12
Was Ezetimibe studied with fasting?
fasting is named in Ezetimibe's label sentences: "In this randomized, open-label, phase 1 study, 12 healthy volunteers were randomized to three treatment groups: 10 mg rosuvastatin plus 10 mg ezetimibe, 10 mg rosuvastatin alone, and 10 mg ezetimibe alone under fasting conditions." openfda-label+europepmc · 2022-11-27
1 recorded statement; fasting
Show the evidence
fasting
In this randomized, open-label, phase 1 study, 12 healthy volunteers were randomized to three treatment groups: 10 mg rosuvastatin plus 10 mg ezetimibe, 10 mg rosuvastatin alone, and 10 mg ezetimibe alone under fasting conditions.
recorded 2022-11-27 · last checked 2026-09-04
Q13
What is recorded about Ezetimibe and AMPK?
"To investigate whether ezetimibe attenuates naloxone-precipitated tramadol withdrawal in mice through modulation of the AMPK/TFEB pathway." — where Ezetimibe and AMPK appear together. Europe PMC · pathway abstract search · 2026-06-18
"To investigate whether ezetimibe attenuates naloxone-precipitated tramadol withdrawal in mice through modulation of the AMPK/TFEB pathway."
PMID 41944914
"Ezetimibe ameliorates tramadol-withdrawal-induced neurobehavioral and molecular alterations, most likely via AMPK-mediated activation of TFEB and enhancement of autophagy, highlighting its therapeutic potential in opioid withdrawal."
autophagyPMID 41944914
"Ezetimibe ameliorates tramadol-withdrawal-induced neurobehavioral and molecular alterations, most likely via AMPK-mediated activation of TFEB and enhancement of autophagy, highlighting its therapeutic potential in opioid withdrawal."
AMPKPMID 38981225
"Interestingly, ezetimibe is an antihyperlipidemic agent that was recently reported to possess pleiotropic properties in neurology by triggering the phosphorylation and activation of AMPK."
autophagyPMID 38981225
"Together, this work revealed that ezetimibe exerts a neuroprotective impact in rotenone-induced PD by activating AMPK/SIRT-1/PGC-1α signaling, enhancing autophagy, and attenuating apoptosis."
mTOR
"Network pharmacology analysis identified 62 overlapping genes between ezetimibe targets and anti Inflammation-associated genes, including TLR4, PIK3CA, PTGS2, MTOR, and BTK."
autophagyPMID 36843944
"In this study, we preliminarily evaluated the effects and mechnisms of ezetimibe against CRC through the blockage of lipid absorption in small intesine. <b>Methods:</b> In this study, CRC cell proliferation, invasion, apoptosis, and autophagy were evaluated using cellular and molecular assays."
mTOR
PMID 36843944
"Ezetimibe-induced mitochondrial dysfunction in CRC cells was found to be correlated with mTOR signaling activity. <b>Discussion:</b> Ezetimibe exhibits effects against CRC through the promotion of cancer cell death <i>via</i> mTOR signaling-dependent mitochondrial dysfunction, highlighting its potential value in CRC therapy."
PMID 38359963
"Ezetimibe inhibited myofibroblast differentiation by restoring the mechanistic target of rapamycin complex 1-autophagy axis with fine control of intracellular cholesterol distribution."
IGF-1PMID 20015035
"No single specific therapeutic agent can treat diabetic cardiomyopathy because once the disease is overt, the management may require a variety of approaches such as risk factors and lifestyle modification, glucose control (insulin, alpha glucosidase inhibitors, sulfonylureas, biguanides, meglitinides, thiazolidinediones and dipeptidyl peptidase 4 (DPP-4) inhibitors); hormones (IGF-1); ACE…"
recorded 2026-06-18 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
Ezetimibe component of k-924, Ezetimibe component of liptruzet, Ezetimibe component of nexlizet, Ezetimibe component of roszet, Ezetimibe component of vytorin, Ezetrol, Zetia, Evlarco, Nustendi
Development code
MK0653, NSC-758923, SCH-58235, SCH58235
Sources (11)
Sources
ClinicalTrials.govclinicaltrials.gov ·
ClinicalTrials.govClinicalTrials.gov API v2 snapshot 2026-09-01T09:00:05 ·
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