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Lovastatin

  • Prescription medicine
  • Prescription only
  • Identity checked
  • Sources last checked 2026-09-04

This page shows what was measured, who it was measured in, and what that does not settle.

What Lovastatin does in the body

High cholesterol, and the prevention of a first heart attack in people with average cholesterol and low HDL

Lovastatin is made by a mould, and like the mould compound it came from it is a closed-ring molecule that the body has to open before it does anything. The opened form blocks the enzyme performing the slowest step in building cholesterol, so the liver cell runs short and responds by putting more LDL receptors on its surface, pulling cholesterol-carrying particles out of the blood. Because it is broken down almost entirely by the liver enzyme CYP3A4, anything that blocks that enzyme sends its levels up sharply, which is why its list of forbidden combinations is the longest of any statin.

What happened in people

Sudden cardiac death within that composite: 8 events against 9

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.

The limit that matters most

That lovastatin has been shown to reduce death — its primary-prevention indication lists myocardial infarction, unstable angina and revascularisation, and no mortality claim

Where it acts
Hepatocyte cytoplasm — the endoplasmic reticulum membrane of the liver cell, reached after extensive CYP3A4-dependent first-pass extraction
Kind of result
Living longer, or avoiding a major event
Supervision
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

What the registries record it as

  • The substance registry classes this as chemical.

    FDA substance registry · 9LHU78OQFD · read 2026-08-29

  • The supplement label database classes it as non-nutrient/non-botanical, under the name Lovastatin.

    NIH Dietary Supplement Label Database · 7564 · read 2026-08-29

Where each sentence above came from

No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.

Shown as the opening line on this page.

A limit recorded against this substance. Not signed off as a reviewed claim.

The four opening statements run to 131 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 peopleRead 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 21 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.
GoalLife outcomeWhat a body can doHow a person feelsA test resultA step in the bodyHarmsHow longWho was studied
CholesterolNothing 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 moved2 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.
Blood sugarNothing 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.Nothing in the sources checkedNo registered study lists a test result for this goal.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
fasting plasma low density lipoprotein cholesterol; low density lipoprotein cholesterol
Blood sugar
incident type 2 diabetes

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
2 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 peopleRead 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.

First acute major coronary event — fatal or non-fatal myocardial infarction, unstable angina or sudden cardiac death — in adults without clinically evident cardiovascular disease with average cholesterol and below-average HDL

The study showed what it set out to show

Who was studied
AFCAPS/TexCAPS (JAMA 1998;279:1615-1622)
How many people
6605
Study design
Phase 3, randomised, double-blind, placebo-controlled
Compared against
A dummy treatment
Kind of result
Living longer, or avoiding a major event
What was found
116 first events against 183; relative risk 0.63 (95% CI 0.50 to 0.79), p<0.001, over an average 5.2 years; 3.5% against 5.5% on the label’s presentation
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 composite was driven by its non-fatal components: myocardial infarction 54 against 94 and unstable angina 54 against 80, while sudden cardiac death was 8 against 9. The label states that too few events occurred among participants whose only risk factor was age for the effect in that subgroup to be assessed. Women were 997 of 6,605 participants.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral tablet at 10, 20 and 40 mg with the evening meal; also an extended-release tablet (Altoprev) taken at bedtime

Interval reported. 95% CI 0

Written into the record, not signed off as a reviewed claim.

Lipid response and safety across lovastatin 20 to 80 mg daily under monitoring with some interacting drugs excluded

The study showed what it set out to show

Who was studied
EXCEL — Expanded Clinical Evaluation of Lovastatin (reported in the NDA 019643 label)
How many people
6582
Study design
Phase 3, randomised, double-blind, 48-week safety and efficacy study
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Myopathy in one of 4,933 patients on 20 to 40 mg daily against four of 1,649 on 80 mg daily over 48 weeks
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. Interacting drugs were excluded and monitoring was close, so the myopathy rates are a floor rather than a population estimate. The 48-week duration means no cardiovascular endpoint was measured; the sample size shown here is the sum of the two randomised groups the label quotes.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral tablet at 10, 20 and 40 mg with the evening meal; also an extended-release tablet (Altoprev) taken at bedtime

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

Per-patient change in percent diameter stenosis by quantitative coronary angiography, lovastatin 80 mg daily against placebo, in patients aged 37 to 67 with angiographically defined coronary disease

The study did not show it

Who was studied
MARS — Monitored Atherosclerosis Regression Study (Ann Intern Med 1993;119:969-976)
How many people
270
Study design
Phase 3, randomised, double-blind, placebo-controlled angiographic trial
Compared against
A dummy treatment
Kind of result
A number that stands in for health
What was found
Average percent diameter stenosis increased 2.2% on placebo and 1.6% on lovastatin, p>0.20, despite LDL cholesterol falling 38% and total cholesterol 32% (p<0.001)
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. The secondary global change score did separate: +0.9 against +0.4, p=0.002, with 28 lovastatin recipients against 13 on placebo scored as regressing, and in lesions of 50% stenosis or more the drug arm improved 4.1% while placebo worsened 0.9% (p=0.005). The trial is consequently cited as positive in the literature and reported as negative on the label. The companion trial CCAIT did find significant slowing on its own primary measurement.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral tablet at 10, 20 and 40 mg with the evening meal; also an extended-release tablet (Altoprev) taken at bedtime

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

What we know
RNAWiki holds 3 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 peopleRead 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.

  1. Living longer, or avoiding a major event Evidence recorded. Death, a heart attack, a stroke, a hospital stay.2 registered measures of this kind. No reviewed result.
  2. What a body can do day to day No evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
  3. Measured performance No evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
  4. Symptoms and quality of life No evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.No registered study measures this.
  5. A number that stands in for health Evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.4 registered measures of this kind.
  6. A step measured inside a person Evidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
  7. Animals Evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.Stored records in C. elegans (roundworm), Mouse, Rat. A result in animals says what to test next. It does not say what happens in people.
  8. Cells in a dish Evidence recorded. Cells or chemistry on a bench, far from a whole body.Stored mechanism abstracts describe steps measured in cells or tissue.
  9. A guess from software No 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 bodyRead 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.

  1. Start

    Lovastatin

    What a person takes: Oral tablet at 10, 20 and 40 mg with the evening meal; also an extended-release tablet (Altoprev) taken at bedtime.

    The measurement behind this step

    Absorbed as the lactone and hydrolysed in vivo to the active β-hydroxyacid. First-pass extraction by the liver is extensive and CYP3A4-dependent, so systemic exposure to the active inhibitors is a small fraction of the dose and rises steeply when that enzyme is inhibited. The immediate-release tablet is taken with the evening meal because absorption is greater with food and because hepatic cholesterol synthesis peaks overnight. In severe renal insufficiency, with creatinine clearance below 30 mL/min, the label directs that increases above 20 mg a day be considered carefully and implemented cautiously.

  2. Getting in

    A mould makes it, and the ring starts closed

    Lovastatin is a natural product of the mould Aspergillus terreus, and what you swallow is a closed-ring form that does not inhibit anything until the body opens it.

    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 label describes lovastatin as a lactone readily hydrolysed in vivo to the corresponding β-hydroxyacid, a strong inhibitor of HMG-CoA reductase. The decalin core is assembled by the polyketide synthase LovB with LovC, and the 2-methylbutyryl side chain installed by the acyltransferase LovD.

  3. Reaching the cell

    One liver enzyme decides how much survives

    Almost all of the dose is destroyed on its first pass through the liver by a single enzyme. Anything that blocks that enzyme raises the drug level sharply.

    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

    Lovastatin is a CYP3A4 substrate with extensive first-pass extraction. The label contraindicates twelve named strong CYP3A4 inhibitors outright and caps the dose in the presence of ciclosporin, danazol, diltiazem, dronedarone, verapamil and amiodarone; grapefruit juice appears in the same table.

  4. What it acts on

    The opened acid blocks the rate-limiting enzyme

    Inside the liver cell, the opened form jams the enzyme that performs the slowest step in cholesterol synthesis.

    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

    Specific inhibition of HMG-CoA reductase, the enzyme catalysing conversion of HMG-CoA to mevalonate, an early step in cholesterol biosynthesis. The hydroxyacid is a transition-state analogue of the substrate; the lactone is essentially inactive.

  5. The change it makes

    LDL receptors go up and cholesterol comes down

    Short of cholesterol, the liver cell makes more receptors and pulls LDL out of the blood. The label describes the effect as both making less and clearing more.

    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 label states that the LDL-lowering effect may involve both reduction of VLDL cholesterol concentration and induction of the LDL receptor, leading to reduced production and increased catabolism of LDL. Apolipoprotein B also falls. Lovastatin 20 to 40 mg reduced LDL by 25% in AFCAPS/TexCAPS.

  6. What that does for a person

    Fewer first heart attacks

    In people with average cholesterol, low HDL and no known heart disease, first major coronary events fell by a bit over a third.

    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

    AFCAPS/TexCAPS: first acute major coronary event 116 against 183, RR 0.63 (95% CI 0.50 to 0.79), p<0.001, or 3.5% against 5.5%. Myocardial infarction 1.7% against 2.9% (p=0.002); unstable angina 1.8% against 2.6% (p=0.023); revascularisation 3.2% against 4.8% (p=0.001).

  7. What that does for a person

    What the licence does not claim

    Not death. The primary-prevention indication lists heart attack, unstable angina and revascularisation, and stops there.

    Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.

    The measurement behind this step

    Sudden cardiac death within the AFCAPS/TexCAPS primary composite was 8 events against 9. The indication makes no mortality claim, unlike the simvastatin and pravastatin labels. The label also states the effect could not be adequately assessed in participants whose only risk factor was age.

No suggested links are held for this record, so nothing is hidden from this path.

What we know
The record describes 6 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 takeRead 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.

  • fasting plasma low density lipoprotein cholesterol
  • maximum plasma concentration
  • low density lipoprotein cholesterol
  • total number of an increase in liver function tests

Meaningful

Things that change how a life goes, not only a number.

  • complete remission rate
  • overall survival

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 (15)
  • severity of proximal stenosis
  • incidence of dose limiting toxicities
  • metabolic syndrome
  • general cardiovascular risk profile framingham heart study
  • time to progression of disease
  • physician global assessment of severity
  • pharmacodynamics
  • incident type 2 diabetes
  • hospitalized for acute kidney injury
  • eeg relative gamma power
  • clinical global impressions improvement
  • bone defect fill
  • statin use on secondary prevention
  • statin use on primary prevention
  • objective response rate

These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.

What is missing or unclearRead 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.

  • Adults with high cholesterol; adults with average cholesterol and low HDL at raised coronary risk; adolescents with familial hypercholesterolaemia. Not people on strong CYP3A4 inhibitors, in whom it is contraindicated outright.

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: “Safety and effectiveness in patients 10 to 17 years of age with heFH have been evaluated in controlled clinical trials of 48 weeks duration in adolescent boys and controlled clinical trials of 24 weeks duration in girls who were at least 1 year post-menarche.”

    US prescribing information · 4444573e-9df1-01e6-e054-00144ff8d46c · read 2026-08-30

  • On older people, the label states: “A pharmacokinetic study with lovastatin showed the mean plasma level of HMG-CoA reductase inhibitory activity to be approximately 45% higher in elderly patients between 70 to 78 years of age compared with patients between 18 to 30 years of age; however, clinical study experience in the elderly indicates that dosage adjustment based on this age-related pharmacokinetic difference is not needed.”

    US prescribing information · 4444573e-9df1-01e6-e054-00144ff8d46c · read 2026-08-30

  • On people who are pregnant, the label states: “Safety in pregnant women has not been established.”

    US prescribing information · 4444573e-9df1-01e6-e054-00144ff8d46c · read 2026-08-30

  • On people who are breastfeeding, the label states: “It is not known whether lovastatin is excreted in human milk.”

    US prescribing information · 4444573e-9df1-01e6-e054-00144ff8d46c · read 2026-08-30

Where the result stopped carrying

  • MARS missed its primary angiographic endpoint — percent diameter stenosis +2.2% on placebo against +1.6% on lovastatin, p>0.20 — while CCAIT met its own
  • The fatal component of the AFCAPS/TexCAPS composite, sudden cardiac death, did not separate: 8 events against 9
  • The effect in participants whose only risk factor was age could not be assessed for want of events
  • Total dependence on CYP3A4 produced the longest contraindication table in the class and is the reason the drug has been displaced clinically
  • 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 takeRead 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 takeRead 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 at 10, 20 and 40 mg with the evening meal; also an extended-release tablet (Altoprev) taken at bedtime

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

Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Suppression classes recorded: S3.

No source is stored against this line.

What is in the pack

Absorbed as the lactone and hydrolysed in vivo to the active β-hydroxyacid.

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: First-pass extraction by the liver is extensive and CYP3A4-dependent, so systemic exposure to the active inhibitors is a small fraction of the dose and rises steeply when that enzyme is inhibited. The immediate-release tablet is taken with the evening meal because absorption is greater with food and because hepatic cholesterol synthesis peaks overnight. In severe renal insufficiency, with creatinine clearance below 30 mL/min, the label directs that increases above 20 mg a day be considered carefully and implemented cautiously.

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 takeRead 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

Contraindicated in hypersensitivity, in active liver disease or unexplained persistent transaminase elevation, in pregnancy and lactation, and with strong CYP3A4 inhibitors — ketoconazole, itraconazole, posaconazole, voriconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, boceprevir, telaprevir, nefazodone and cobicistat-containing products. Gemfibrozil should be avoided; ciclosporin and danazol cap the dose at 20 mg daily; diltiazem, dronedarone, verapamil and amiodarone cap it at 40 mg daily; grapefruit juice should be avoided. Myopathy with creatine kinase above ten times normal occurs and is dose related, sometimes as rhabdomyolysis with or without acute renal failure, and rare fatalities have occurred. Immune-mediated necrotising myopathy has been reported rarely and persists after discontinuation. Persistent transaminase rises above three times the upper limit of normal occurred in 1.9% of adults treated for at least a year in early trials, and fell slowly when the drug was interrupted.

Nobody counted how many people took this and were fine, so this cannot be turned into a rate.

Where this came from

Reports sent to a regulator

  • 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.

Lovastatin appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 786 reaction mentions were counted. One report can name several reactions.

The recorded terms (10)
  • drug hypersensitivity — 173 reaction mentions
  • myalgia — 153 reaction mentions
  • rhabdomyolysis — 128 reaction mentions
  • drug interaction — 57 reaction mentions
  • blood creatine phosphokinase increased — 53 reaction mentions
  • asthenia — 52 reaction mentions
  • myopathy — 52 reaction mentions
  • muscular weakness — 46 reaction mentions
  • muscle spasms — 44 reaction mentions
  • alanine aminotransferase increased — 28 reaction mentions
  • 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 unclearRead 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 at 10, 20 and 40 mg with the evening meal; also an extended-release tablet (Altoprev) taken at bedtime

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: First-pass extraction by the liver is extensive and CYP3A4-dependent, so systemic exposure to the active inhibitors is a small fraction of the dose and rises steeply when that enzyme is inhibited. The immediate-release tablet is taken with the evening meal because absorption is greater with food and because hepatic cholesterol synthesis peaks overnight. In severe renal insufficiency, with creatinine clearance below 30 mL/min, the label directs that increases above 20 mg a day be considered carefully and implemented cautiously.

No source is stored against this line.

What is recorded as being sold

  • 82 products list this as an active ingredient in the United States drug directory. 82 of them contain it and nothing else.

    FDA National Drug Code directory · 71610-775 · read 2026-08-29

  • They are sold as powder and tablet, taken oral.

    FDA National Drug Code directory · 71610-775 · read 2026-08-29

  • The regulator's established pharmacologic class for it is hmg-coa reductase inhibitor [epc] and hydroxymethylglutaryl-coa reductase inhibitors [moa].

    FDA National Drug Code directory · 71610-775 · read 2026-08-29

  • 56 published labels name it as an active ingredient. 56 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · 4444573e-9df1-01e6-e054-00144ff8d46c · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 4444573e-9df1-01e6-e054-00144ff8d46c · read 2026-08-29

  • 5 marketed supplement labels list this ingredient, classed as botanical with nutrients, non-nutrient/non-botanical and other combinations.

    NIH Dietary Supplement Label Database · 23513 · read 2026-08-29

  • Those labels carry all other 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.

    NIH Dietary Supplement Label Database · 23513 · read 2026-08-29

  • Lovastatin is oral at HOW SUPPLIED Lovastatin Tablets USP (white to off white round, unscored tablets) containing 40mg of lovastatin and engraved with “CTI” 143 ---- Bottle of 30 (NDC 66267-461-30), Bottle of 90 (NDC 66267-561-90) __________…, recorded as fda label in effect 2024-08-14 in the United States.

    US prescribing information · 4444573e-9df1-01e6-e054-00144ff8d46c · read 2026-08-30

  • Recorded price in US: 0.03716–0.05581 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 31 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 takeRead 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.

Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.

Questions worth asking

  • Which of the trials of Lovastatin 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 unclearRead 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 lovastatin has been shown to reduce death — its primary-prevention indication lists myocardial infarction, unstable angina and revascularisation, and no mortality claim

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 AFCAPS/TexCAPS establishes benefit in low-risk primary prevention, when 63% of participants had a further risk factor and the label says the age-only subgroup could not be assessed

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 angiographic slowing translates reliably into fewer events, when this drug’s two imaging trials disagreed and MARS missed its own primary endpoint at p>0.20

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 red yeast rice is a botanical alternative rather than the same molecule at an undeclared dose

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 unclearRead from sources, not yet reviewed

What nobody knows yet

Open questions, each with why it is open and what would close it.

How fast does the body clear it?

The sources RNAWiki checked hold nothing for this field.

Why it matters. Without this, nothing on this page can say how long anything lasts.

What would answer it

A stored source that records 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 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 Lovastatin 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 peopleRead 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.

AFCAPS/TexCAPS: fewer first heart attacks in people with unremarkable cholesterol
In plain words
Six and a half thousand people with average cholesterol and low HDL, none of whom had known heart disease, took lovastatin or placebo for five years. First major coronary events fell from 5.5% to 3.5%.
What was measured
First acute major coronary event — myocardial infarction, unstable angina or sudden cardiac death — over an average 5.2 years
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
AFCAPS/TexCAPS randomised 6,605 participants — 5,608 men aged 45 to 73 and 997 women aged 55 to 73 — without symptomatic cardiovascular disease, with total cholesterol 180 to 264 mg/dL, LDL 130 to 190 mg/dL and HDL at or below 45 mg/dL in men and 47 mg/dL in women, to lovastatin 20 to 40 mg daily or placebo. Over an average 5.2 years the primary endpoint of first acute major coronary event occurred 116 times against 183: relative risk 0.63 (95% CI 0.50 to 0.79), p<0.001, or 3.5% against 5.5% on the label’s presentation. Myocardial infarction fell 40% (1.7% against 2.9%, p=0.002), unstable angina 32% (1.8% against 2.6%, p=0.023) and coronary revascularisation 33% (3.2% against 4.8%, p=0.001). Lovastatin lowered LDL by 25% to 115 mg/dL and raised HDL 6%. The trial is important because it treated people whose cholesterol no guideline of the time flagged, and it found a benefit.
Source
Downs JR, Clearfield M, Weis S, et al. JAMA 1998;279:1615-1622 (AFCAPS/TexCAPS)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
The licence lists heart attacks and revascularisations, and not death
In plain words
Read the indication carefully. For primary prevention, lovastatin is licensed to reduce heart attacks, unstable angina and stenting or bypass. Death is not on the list, and the fatal component of its own trial did not move.
What was measured
That the AFCAPS/TexCAPS composite demonstrates a survival benefit, when its fatal component was 8 events against 9 and the licensed indication makes no mortality claim
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The lovastatin primary prevention indication reads: in individuals without symptomatic cardiovascular disease, average to moderately elevated total and LDL cholesterol and below-average HDL, lovastatin is indicated to reduce the risk of myocardial infarction, unstable angina and coronary revascularisation procedures. There is no mortality claim, and the contrast with sibling molecules is deliberate rather than accidental: simvastatin is licensed to reduce the risk of total mortality, and pravastatin is licensed to reduce the risk of total mortality by reducing coronary death. Within AFCAPS/TexCAPS itself, the label reports the three components of the primary composite as myocardial infarction 54 against 94, unstable angina 54 against 80 and sudden cardiac death 8 against 9. The composite moved because two non-fatal components moved. The fatal component did not, and the trial was never large enough to expect it to. A reader told that a statin "prevents death" should check which statin and which label.
Source
Lovastatin United States prescribing information, Indications and Usage, Primary Prevention of Coronary Heart Disease, and Clinical Pharmacology, Clinical Studies in Adults (NDA 019643)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
Two angiographic trials of the same drug, and they disagreed
In plain words
The label reports two studies that photographed coronary arteries before and after. One found lovastatin slowed the disease. The other found no significant difference at all on its main measurement.
What was measured
Per-patient change in percent diameter stenosis by quantitative coronary angiography, primary endpoint of MARS: +2.2% on placebo against +1.6% on lovastatin, p>0.20
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
The label describes the Canadian Coronary Atherosclerosis Intervention Trial (CCAIT), in which lovastatin 20 to 80 mg daily significantly slowed lesion progression and reduced the proportion of patients with disease progression (33% against 50%) and with new lesions (16% against 32%). It then states that in the Monitored Atherosclerosis Regression Study (MARS), of similar design at lovastatin 80 mg daily, no statistically significant difference between lovastatin and placebo was seen for the primary endpoint. The MARS publication bears that out and shows how the disagreement arose: in 270 patients, average percent diameter stenosis — the primary endpoint — increased 2.2% on placebo and 1.6% on lovastatin, p>0.20. The secondary global change score did separate, +0.9 against +0.4, p=0.002, with 28 lovastatin recipients against 13 on placebo showing regression, and in lesions of 50% or more stenosis the drug arm improved by 4.1% while placebo worsened by 0.9%, p=0.005. So the trial missed its primary endpoint, hit its secondary one, and is described in the literature as positive and on the label as negative. Both descriptions are accurate about different measurements, which is exactly the problem with imaging surrogates — the same problem ENHANCE later demonstrated for simvastatin and carotid wall thickness.
Source
Blankenhorn DH, Azen SP, Kramsch DM, et al. Ann Intern Med 1993;119:969-976 (MARS); lovastatin United States prescribing information, Clinical Pharmacology, Atherosclerosis (NDA 019643)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
contested
Review state
Written into the record, not signed off as a reviewed claim
EXCEL measured the dose-dependence of muscle injury directly
In plain words
A 48-week safety study in over six and a half thousand people found one case of muscle injury among those on 20 to 40 mg, and four among the smaller group on 80 mg.
What was measured
Myopathy incidence at 20 to 40 mg against 80 mg over 48 weeks under monitored conditions with interacting drugs excluded
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The label reports that in EXCEL, a clinical study in which patients were carefully monitored and some interacting drugs were excluded, there was one case of myopathy among 4,933 patients randomised to lovastatin 20 to 40 mg daily for 48 weeks, and four among 1,649 patients randomised to 80 mg daily. Myopathy is defined as muscle pain, tenderness or weakness with creatine kinase above ten times the upper limit of normal, and the label states plainly that the risk of myopathy and rhabdomyolysis is dose related and is increased by high plasma levels of HMG-CoA reductase inhibitory activity. Reading across the class, the same dose-dependence appears in the simvastatin record at 20, 40 and 80 mg, which is the mechanistic reason a class-wide interaction table exists at all.
Source
Lovastatin United States prescribing information, Warnings, Myopathy/Rhabdomyolysis — EXCEL (NDA 019643)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
The same molecule is a prescription drug and a supplement
In plain words
Monacolin K in red yeast rice is structurally identical to lovastatin. So a capsule sold as a food contains a statin, at a dose that varies more than sixtyfold between brands and is not printed on the label.
What was measured
That a red yeast rice supplement is a gentler botanical alternative to a statin, when it is the same molecule at an undeclared and highly variable dose
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
NCCIH states that monacolin K is structurally identical to the medicine lovastatin, that in 26 brands found to contain monacolin K the quantity ranged more than 60-fold from 0.09 to 5.48 mg per 1,200 mg of red yeast rice, and that red yeast rice products with enhanced or added lovastatin cannot be marketed as dietary supplements in the United States. EFSA reached a compatible conclusion from the other direction in 2018: it was unable to identify a dietary intake of monacolins from red yeast rice that does not give rise to concerns about harmful effects to health, having received case reports of severe musculoskeletal and liver injury at intakes as low as 3 mg a day, and noted that monacolin K in lactone form is identical to lovastatin. The regulatory conclusion has shifted in one direction over three decades: from treating red yeast rice as a food, to treating monacolin content as the thing that determines whether it is a food or a drug.
Source
NCCIH, Red Yeast Rice: What You Need To Know (National Center for Complementary and Integrative Health); EFSA Journal 2018;16(8):5368
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
The longest contraindication table of any statin
In plain words
Twelve named drug classes are contraindicated outright, two more cap the dose at 20 mg, four more cap it at 40 mg, and grapefruit juice is on the same list. This is what total dependence on one liver enzyme costs.
What was measured
The label’s enumerated contraindications and dose caps arising from CYP3A4 dependence
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
The label contraindicates lovastatin with strong CYP3A4 inhibitors: ketoconazole, itraconazole, posaconazole, voriconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, boceprevir, telaprevir, nefazodone and cobicistat-containing products. Gemfibrozil is to be avoided. Ciclosporin and danazol cap the dose at 20 mg daily; diltiazem, dronedarone, verapamil and amiodarone cap it at 40 mg daily; grapefruit juice is to be avoided. Because CYP3A4 is the enzyme that clears the majority of small-molecule drugs, this is not a rare edge case — it is a routine collision, and it is the practical reason lovastatin has been displaced. Compare pravastatin, which is cleared by isomerisation and ring hydroxylation and whose entire interaction section consists of two dose caps and three cautions.
Source
Lovastatin United States prescribing information, Contraindications and Warnings, Myopathy/Rhabdomyolysis interaction table (NDA 019643)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
The trial could not tell whether it helps people whose only risk factor is age
In plain words
AFCAPS/TexCAPS enrolled people who mostly had another risk factor alongside their age. For the group whose only risk factor was being older, the label says there were too few events to say anything.
What was measured
That AFCAPS/TexCAPS demonstrates benefit in genuinely low-risk primary prevention, when the label states the effect could not be assessed in participants whose only risk factor was age
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The label records that 63% of AFCAPS/TexCAPS participants had at least one risk factor beyond age — HDL below 35 mg/dL, hypertension, family history, smoking or diabetes — and that participants with two or more risk factors had risk reductions of 43% in acute major coronary events and 37% in revascularisation. It then states that because there were too few events among participants with age as their only risk factor, the effect of lovastatin on outcomes could not be adequately assessed in that subgroup. Women were 997 of 6,605 participants, and the trend across sexes is described as consistent rather than separately significant. The trial is often cited as establishing statin benefit in low-risk primary prevention; what it establishes is benefit in people with average lipids and at least one additional risk factor, which is a narrower and more useful claim.
Source
Lovastatin United States prescribing information, Clinical Pharmacology, AFCAPS/TexCAPS subgroup findings (NDA 019643); Downs JR et al. JAMA 1998;279:1615-1622
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim

How many documents were read

  • 56 documents were read for this substance.

    RNAWiki source record

  • 56 of them state the same tMax, and they agree.

    RNAWiki source record

Where else this substance is registered

FDA substance identifier (UNII)
9LHU78OQFD
RxNorm concept
197905

Checks this page had to pass

  • Passed

    Identity resolved

    no open identity hold

  • Passed

    No unresolved merge across substance families

    no quarantine open

  • Passed

    Every public sentence names a source

    The opening statement carries the origin: Written into the record, not signed off.

  • Not passed

    Trial roles classified for highlighted evidence

    No registered study is classified as testing this substance.

  • Passed

    No internal keys in reader text

    enforced by the copy-contract test over the rendered page

  • Passed

    Safety mode resolved

    Suppression classes recorded: S3.

  • Passed

    Canonical metadata present

    slug and display name present

What is missing or unclearRead from sources, not yet reviewed

How this medicine reached us

Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.

What the approval register records

  • 12 approved applications cover products containing this substance. The earliest was NDA019643, approved 19870831 to MERCK.

    Drugs@FDA application register · NDA019643 · read 2026-08-29

  • Marketing status on the register: discontinued and prescription.

    Drugs@FDA application register · NDA019643 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 19960917.

    FDA National Drug Code directory · 71610-775 · read 2026-08-29

What is missing or unclearRead from sources, not yet reviewed

What to learn next

Ordered by what would most change how you read this page, starting with what is easiest to misunderstand.

This order is fixed in code and does not count clicks or time on the page.

What is not here

4 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.

  • How long anything takes — found nothing in the sources checked.
  • 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 first statin ever approved, which in 6,605 people with average cholesterol and low HDL cut first acute major coronary events from 5.5% to 3.5% over a median 5.1 years (p<0.001) while sudden cardiac death was 8 against 9 — and whose primary-prevention indication accordingly lists myocardial infarction, unstable angina and revascularisation, and does not list death.

Recorded evidence blocks (13)

What did Lovastatin's largest trial (2133900 people) and its longest (12 years) measure?


2133900 people in Lovastatin's largest registered study, 12 years in its longest registered window, measuring Change From Baseline in Albumin, Total Protein, Hemoglobin, and Mean Corpuscular Hemoglobin Concentration (MCHC) at Day 84. ClinicalTrials.gov · 2026-09-01

31 phase2, 9 phase1, 8 phase3, 3 na, 3 na or unstated, 3 phase4, 2 early phase1; NCT00583102; 2013-06; no ageing endpoint recorded. Last human test completed 2024, NCT06789497.

Interpretation These counts include studies where Lovastatin 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
  • phase2
    31
  • phase1
    9
  • phase3
    8
  • na
    3
  • na or unstated
    3
  • phase4
    3
2 more recorded rows
  • early phase1
    2
  • Last recorded human test NCT06789497
    2024-04-01

recorded 2026-09-01 · last checked 2026-09-04

From C. elegans to human: where has Lovastatin shown biomarker?


C. elegans: surrogate, mouse: mechanism-only, rat: mechanism-only and human: biomarker (55): the rungs where Lovastatin has a recorded finding. Europe PMC and ClinicalTrials.gov · organism ladder · 2026-09-01

Change From Baseline in Albumin, Total Protein, Hemoglobin, and Mean Corpuscular Hemoglobin Concentration (MCHC) at Day 84 — the recorded outcome words.

Yeast C. elegans surrogateDrosophila Mouse mechanism-onlyRat mechanism-onlyDog Non-human primate Human biomarker
Show the evidence
  • C. elegans
    surrogate
  • mouse
    mechanism-only
  • rat
    mechanism-only
  • human NCT00302952
    biomarker; Change From Baseline in Albumin, Total Protein, Hemoglobin, and Mean Corpuscular Hemoglobin Concentration (MCHC) at Day 84; 55

recorded 2026-09-01 · last checked 2026-09-04

13 of Lovastatin's trials stopped: safety, futility/efficacy, accrual/recruitment, funding/business, other?


safety (1), futility/efficacy (1), accrual/recruitment (6), funding/business (1) and other (4): Lovastatin's stop wording, clustered. ClinicalTrials.gov · 2026-09-01

"Slow accrual"; 13 of 55 registered studies

Show the evidence

Trial

  • NCT00285857
    terminated; "Slow accrual"
  • NCT00302952
    terminated; "Slow enrollment \&Study Drug Expiration (Target: 40 randomized participants /arm)"
  • NCT00532311
    terminated; "Overall profile of the compound does not offer significant clinical advantage to patients over currently available lipid lowering agents"
  • NCT00583102
    terminated; "Slow accrual, PI left institution"
  • NCT00584012
    terminated; "Funding issues"
  • NCT00585052
    terminated; "Slow accrual, PI left the institution"
7 further recorded trials
  • NCT00689806
    withdrawn; "Study never opened"
  • NCT00902668
    terminated; "Slow accrual"
  • NCT00963664
    withdrawn; "Modifications will be necessary before full IRB approval will be secured."
  • NCT01110642
    withdrawn; "Study was withdrawn due to lack of eligible population for study"
  • NCT01478828
    terminated; "The study was stopped due to an unanticipated serious adverse event."
  • NCT03504501
    terminated; "The study has been terminated prematurely due to recruitment difficulties. Current status: recruitment stopped and cleaning of the database is ongoing."
  • NCT03763175
    terminated; "Interim Futility Analysis"

recorded 2026-09-01 · last checked 2026-09-04

Human studies of Lovastatin used Lovastatin 40 mg Tablets — over how long?


studies of Lovastatin used the recorded amount. ClinicalTrials.gov · 2026-09-01

5 recorded entries; human; also "Lovastatin 40 mg Tablets", "Lovastatin (Mevacor®) 40 mg Tablets", "Lovastatin 40 mg tablets"

Show the evidence

human

  • NCT00684723
    Lovastatin 40 mg Tablets
  • NCT00684723
    Lovastatin (Mevacor®) 40 mg Tablets
  • NCT00685685
    Lovastatin 40 mg tablets
  • NCT03826940
    Lovastatin 60 MG
  • NCT03981601
    Lovastatin 40 MG

recorded 2026-09-01 · last checked 2026-09-04

More Lovastatin was worse in human: at what point?


Hormetic in human: "Hormetic dose responses were commonly observed following administration of a number of agents, including dietary supplements [e.g., berberine, curcumin, (-)-epigallocatechin-3-gallate (EGCG), Ginkgo Biloba, resveratrol], pharmaceuticals (e.g., lithium, lovastatin, melatonin), endogenous ligands [e.g., hydrogen sulfide…" Europe PMC · dose-response search · 2023-01-30

6 recorded sentences naming Lovastatin; Hormetic, dose-response

Show the evidence
  • Hormetic PMID 34871764
    "Hormetic dose responses were commonly observed following administration of a number of agents, including dietary supplements [e.g., berberine, curcumin, (-)-epigallocatechin-3-gallate (EGCG), Ginkgo Biloba, resveratrol], pharmaceuticals (e.g., lithium, lovastatin, melatonin), endogenous ligands [e.g., hydrogen sulfide (H<sub>2</sub>S), magnesium, progesterone, taurine], environmental contaminants…"

dose-response

  • PMID 36627836
    "We observed previously established medical associations for MND and an inverse dose-response association between lovastatin and MND, with 28% reduced risk at 40 mg/day."
  • PMID 25808421
    "Stronger dose-response association was seen when using lovastatin."
  • PMID 22960033
    "Using significant dose-response models from literature clinical trial data or epidemiology, the BMD values were 63mg/day for caffeine, 5g/day for alcohol, 6mg/day for lovastatin, 769mg/day for glucosamine sulfate, 151mg/day for Ginkgo biloba extract, and 0.4mg/day for melatonin."
  • PMID 12685616
    "This study evaluated dose-response relationships and safety of a new dual-component drug product containing niacin extended-release (niacin ER) and lovastatin."
  • PMID 12685616
    "Niacin ER/lovastatin was more effective than each of its components for improving levels of low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglycerides (TG), and exhibited a clear dose-response effect and additivity across the dosage range."

recorded 2023-01-30 · last checked 2026-09-04

Which of bone defect fill, clinical global impressions improvement and complete remission rate did Lovastatin's trials measure?


bone defect fill, clinical global impressions improvement and complete remission rate lead 21 outcome terms across Lovastatin's trials. ClinicalTrials.gov · 2026-09-01

Interpretation incidence of dose limiting toxicities, maximum plasma concentration, metabolic syndrome, general cardiovascular risk profile framingham heart study, overall survival and time to progression of disease follow.

Show the evidence
  • severity of proximal stenosis
    1
  • fasting plasma low density lipoprotein cholesterol
    1
  • complete remission rate
    1
  • incidence of dose limiting toxicities
    1
  • maximum plasma concentration
    1
  • metabolic syndrome
    1
14 more recorded rows
  • general cardiovascular risk profile framingham heart study
    1
  • overall survival
    1
  • time to progression of disease
    1
  • physician global assessment of severity
    1
  • pharmacodynamics
    1
  • low density lipoprotein cholesterol
    1
  • total number of an increase in liver function tests
    1
  • incident type 2 diabetes
    1
  • hospitalized for acute kidney injury
    1
  • eeg relative gamma power
    1
  • clinical global impressions improvement
    1
  • bone defect fill
    1
  • statin use on secondary prevention
    1
  • statin use on primary prevention
    1

recorded 2026-09-01 · last checked 2026-09-04

Which of Lovastatin's 3 ongoing trials reports first?


3 registered trials of Lovastatin are open; earliest completion 2027-01. ClinicalTrials.gov · 2026-09-01

Woodcock Johnson Tests of Achievement IV; Objective response rate (ORR); latest 2031-08-31

Show the evidence

Trial

  • NCT02964884
    "Interventions for Reading Disabilities in NF1"; n 120; "Woodcock Johnson Tests of Achievement IV"; 2027-01
  • NCT06636734
    "Lovastatin and Pembrolizumab for the Treatment of Patients With Recurrent or Metastatic Head and Neck Cancer, LAPP Trial"; n 28; "Objective response rate (ORR)"; 2028-12-31
  • NCT07619365
    "Trastuzumab Deruxtecan and Lovastatin in HER2-low and Ultralow Advanced or Metastatic Breast Cancer"; n 60; "Objective Response Rate (ORR)"; 2031-08-31

recorded 2026-09-01 · last checked 2026-09-04

Which 22 trials of Lovastatin posted no result?


Posted no result
22 of 22 completed trials
Registrations
NCT00000512, NCT00116870, NCT00000477, NCT00000469, NCT00000463 and NCT00243880, and 16 more
Completion dates
oldest 1989-08; newest 2024-04-01
Show the evidence

Trial

  • NCT00000512
    1989-08
  • NCT00116870
    1992-02
  • NCT00000477
    1992-06
  • NCT00000469
    1998-08
  • NCT00000463
    1998-12
  • NCT00243880
    2008-05
14 further recorded trials
  • NCT00718796
    2009-10
  • NCT01269762
    2011-04
  • NCT00721305
    2011-07
  • NCT01250535
    2011-12
  • NCT01527669
    2012-02
  • NCT00700921
    2012-11
  • NCT02518516
    2013-01
  • NCT02518503
    2013-02
  • NCT00352599
    2014-03
  • NCT02389868
    2015-06
  • NCT02603770
    2016-02
  • NCT03178526
    2016-02-13
  • NCT02680379
    2017-11
  • NCT03826940
    2020-08-31

At the median, Lovastatin's trials enrolled 30 people — anything larger?


Median enrolment
30
Largest enrolment
2133900
Registered trials counted
52

What do 786 spontaneous reports say about Lovastatin — 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.

Lovastatin appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 786 reaction mentions were counted: drug hypersensitivity 173; myalgia 153; rhabdomyolysis 128; drug interaction 57. open-targets-adr · CHEMBL503 · 2026-06-24

Show the evidence
  • drug hypersensitivity
    173
  • myalgia
    153
  • rhabdomyolysis
    128
  • drug interaction
    57
  • blood creatine phosphokinase increased
    53
  • asthenia
    52
4 more recorded rows
  • myopathy
    52
  • muscular weakness
    46
  • muscle spasms
    44
  • alanine aminotransferase increased
    28

recorded 2026-06-24 · last checked 2026-09-04

Lovastatin and CYP3A4: shared by which compounds?


CYP3A4 appear in Lovastatin's recorded interaction sentences, 3 in all. openfda-label+europepmc · 2026-08-30

Interpretation pharmacokinetics

Show the evidence

CYP3A4

  • pharmacokinetics
    Lovastatin is a substrate for cytochrome P450 isoform 3A4 (CYP3A4) (see PRECAUTIONS , Drug Interactions .) Grapefruit juice contains one or more components that inhibit CYP3A4 and can increase the plasma concentrations of drugs metabolized by CYP3A4.
  • pharmacokinetics
    The increase in AUC for lovastatin and lovastatin acid is presumably due, in part, to inhibition of CYP3A4.
  • pharmacokinetics
    Strong inhibitors of CYP3A4 can raise the plasma levels of HMG-CoA reductase inhibitory activity and increase the risk of myopathy (see WARNINGS , Myopathy/Rhabdomyolysis and PRECAUTIONS , Drug Interactions ).

recorded 2026-08-30 · last checked 2026-09-04

Was Lovastatin studied with fasting and exercise?


fasting and exercise are named in Lovastatin's label sentences: "In a randomized, double-blind, placebo-controlled trial, 300 patients with stable coronary disease, a positive exercise treadmill test, 48-hour ambulatory ECG with > or =1 episode of ischemia, and fasting total cholesterol of 180 to 250 mg/dL were assigned to 1-year treatment with intensive…" openfda-label+europepmc · 2026-08-30

2 recorded statements; fasting, exercise

Show the evidence
  • fasting
    In a randomized, double-blind, placebo-controlled trial, 300 patients with stable coronary disease, a positive exercise treadmill test, 48-hour ambulatory ECG with > or =1 episode of ischemia, and fasting total cholesterol of 180 to 250 mg/dL were assigned to 1-year treatment with intensive atorvastatin to reduce LDL to <80 mg/dL (n=96), intensive atorvastatin to reduce LDL to <80 mg/dL plus…
  • exercise
    In a randomized, double-blind, placebo-controlled trial, 300 patients with stable coronary disease, a positive exercise treadmill test, 48-hour ambulatory ECG with > or =1 episode of ischemia, and fasting total cholesterol of 180 to 250 mg/dL were assigned to 1-year treatment with intensive atorvastatin to reduce LDL to <80 mg/dL (n=96), intensive atorvastatin to reduce LDL to <80 mg/dL plus…

recorded 2026-08-30 · last checked 2026-09-04

What is recorded about Lovastatin and sirtuin?


"Conversely, sterol depletion via lovastatin inhibited SIRT6 activity, leading to the compensatory upregulation of cholesterol biosynthetic genes." — where Lovastatin and sirtuin appear together. Europe PMC · pathway abstract search · 2026-08-31

sirtuin, AMPK, mTOR, autophagy; PMID 42676034, 39741316, 36306000, 39117601

Show the evidence

sirtuin

  • PMID 42676034
    "Conversely, sterol depletion via lovastatin inhibited SIRT6 activity, leading to the compensatory upregulation of cholesterol biosynthetic genes."
  • PMID 42676034
    "Notably, SIRT6 overexpression or pharmacological activation reversed lovastatin-induced upregulation of SREBP2 and its target genes."

AMPK

  • PMID 39741316
    "Mechanistically, daidzein inhibited lovastatin-induced FOXO3a phosphorylation caused by AMPK activation, thereby inhibiting FOXO3a nuclear translocation to restrain the expression of muscle-related proteins Atrogin-1 and MuRF-1."
  • PMID 39741316
    "In C2C12 myotube, administration of AMPK-selective inhibitor Compound C recapitulated the therapeutic effects of daidzein against lovastatin-induced myotubes atrophy, while the anti-atrophy effects of daidzein were lost in the presence of AMPK-selective agonist MK-3903."
  • PMID 39741316
    "In lovastatin-induced mice muscle atrophy models, Compound C elicited similar anti-atrophy effects as daidzein, but this effect was not potentiated when it was applied in combination with daidzein, suggesting that daidzein exerted therapeutic efficacy dependent on blockage of AMPK activity."
  • mTOR PMID 36306000
    "Lovastatin inhibited AMPK/mTOR signaling pathway after ICH."

autophagy

  • PMID 39117601
    "We observed that autophagy of mitochondria is inhibited by lovastatin, affecting esophageal squamous cell proliferation."
  • PMID 36186902
    "The present study suggests that lovastatin might exert anti-tumor activity by reprogramming glycolysis toward autophagy in TNBC cells through HK2-VDAC1 interaction."
  • mTOR PMID 33608672
    "Energy depletion markedly activated AMPK, inhibited mTOR and RAS signaling pathways, eventually inducing autophagy, the cellular pro-survival process under metabolic stress, whereas inhibition of autophagy by chloroquine (6.25 μM) enhanced the cytotoxic effect of the combination of lovastatin and 2-deoxy-D-glucose."
  • autophagy PMID 33608672
    "Energy depletion markedly activated AMPK, inhibited mTOR and RAS signaling pathways, eventually inducing autophagy, the cellular pro-survival process under metabolic stress, whereas inhibition of autophagy by chloroquine (6.25 μM) enhanced the cytotoxic effect of the combination of lovastatin and 2-deoxy-D-glucose."
  • mTOR PMID 31662972
    "Lovastatin triggered autophagy initiation possibly by inhibiting the Akt/mTOR signaling pathway."
  • sirtuin PMID 23657807
    "In the present study, monacolin K increased protein expression of SIRT1 and phosphorylation level of AMP-activated protein kinase (AMPK) in HepG2 cells."

recorded 2026-08-31 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL503
PubChem CID
53232
CAS number
75330-75-5
RxCUI
6472
InChIKey
PCZOHLXUXFIOCF-BXMDZJJMSA-N
Also called
6.alpha.-methylcompactin, Lovastatina, Lovastatine, Mevinolin, Mevlor, Monacolin k, Simvastatin impurity, lovastatin-, Sivlor, statins, (2S)-2-METHYLBUTANOIC ACID (1S,3R,7S,8S,8AR)-1,2,3,7,8,8A-HEXAHYDRO-3,7-DIMETHYL-8-(2-((2R,4R)-TETRAHYDRO-4-HYDROXY-6-OXO-2H-PYRAN-2-YL)ETHYL)-1-NAPHTHALENYL ESTER, (S)-2-Methylbutyric acid, 8-ester with (4R,6R)-6-[2-[(1S,2S,6R,8S,8aR)-1,2,6,7,8,8a-hexahydro-8-hydroxy-2,6-dimethyl-1-naphthyl]ethyl]tetrahydro-4-hydroxy-2H-pyran-2-one, ADVICOR COMPONENT LOVASTATIN
Trade name
Altoprev, Lovastatin component of advicor, Mevacor, Mevinacor, Mevinacor 10, Mevinacor 40, Mevacor / Altoprev
Development code
C10AA02, L-154803, MK-803, NSC-758662
Salt form
lipocol forte capsules, mevacor tablet
Sources (10)

Sources

  • ClinicalTrials.gov clinicaltrials.gov ·
  • ClinicalTrials.gov ClinicalTrials.gov API v2 snapshot 2026-09-01T09:00:05 ·
  • this record's own fields 2,3,5 ·
  • Europe PMC dose-response search ·
  • Europe PMC pathway abstract search ·
  • Europe PMC search ·
4 more sources

ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · Open Targets 26.06 — CC0 · derived from this page's own recorded fields; no external licence · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work

How these records are assembled · Which registers were checked

Index-quality checks
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  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 10 source rows
  • no critical contamination: no quarantine open
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