Drug

Atorvastatin

Atorvastatin is a statin (HMG-CoA reductase inhibitor) used to lower LDL cholesterol and cardiovascular risk.

Sources: FDA label · 3 registered trials · 4 guideline recommendations

Where experts stand

Latest: STAREE

NEJM · ESC Congress 2026

What 9 experts said about this trial's result

8supportive1neutral

Atorvastatin at a glance

Statins

Mechanism: HMG-CoA reductase inhibitor (statin) · FDA label (DailyMed)

Guideline:Class I · LOE ALipid management (as a class)

FDA-approved indications

To reduce the risk of myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD.
To reduce the risk of MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD.
To reduce the risk of non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD.

“The risk of heart attack and stroke is a concern for older people and knowing there is an effective measure for lowering that risk will be a huge reassurance to older people and their families. We hope to see updated guidelines to help clinicians make use of these new findings.”
Sophia Zoungas, Professor, Monash University School of Public Health · Source ·

Show all 8

As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia.
As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).
As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).
As an adjunct to diet for the treatment of adults with primary dysbetalipoproteinemia.
As an adjunct to diet for the treatment of adults with hypertriglyceridemia.

Guideline position

Lipid management

Class I · LOE A2025 ESC/EAS Dyslipidaemias Focused UpdateClass-level: names Statins, not atorvastatin
Non-statin therapies with proven cardiovascular benefit, taken alone or in combination, are recommended for patients who are unable to take statin therapy to lower LDL-C levels and reduce the risk of CV events. The choice should be based on the magnitude of additional LDL-C lowering needed.
Class I · LOE A2019 ESC/EAS DyslipidaemiasClass-level: names Statins, not atorvastatin
The use of statins or statin/ezetimibe combination is recommended in patients with non-dialysis-dependent stage 3–5 CKD.
Class I · LOE A2019 ESC/EAS DyslipidaemiasClass-level: names Statins, not atorvastatin
Treatment with statins is recommended for older people with ASCVD in the same way as for younger patients.
Class I · LOE A2019 ESC/EAS DyslipidaemiasClass-level: names Statins, not atorvastatin
Treatment with statins is recommended for primary prevention, according to the level of risk, in older people aged ≤75 years.

20 recommendations name a dose and are left to the guideline.

Landmark trials

Primary results of 3 trials behind the evidence on atorvastatin, as each trial’s own publication reports them.

Left of the line at 1 favours the intervention; square size tracks trial size.Favours the interventionNo significant differenceFavours the comparator

0.512

SPARCL
atorvastatin vs placebo · 4,731 patients · N Engl J Med 2006
In patients who had had a stroke or TIA within one to six months before study entry
Primary outcome: a first nonfatal or fatal stroke
HR 0.84 (0.71–0.99)
TNT
80 mg of atorvastatin vs 10 mg of atorvastatin · 10,001 patients · N Engl J Med 2005
In patients with clinically evident CHD and LDL cholesterol levels of less than 130 mg per deciliter (3.4 mmol per liter)
Primary outcome: the occurrence of a first major cardiovascular event, defined as death from CHD, nonfatal non-procedure-related myocardial infarction, resuscitation after cardiac arrest, or fatal or nonfatal stroke
HR 0.78 (0.69–0.89)
ASCOT-LLA
atorvastatin vs placebo · 10,305 patients · Lancet 2003
In hypertensive patients (aged 40-79 years with at least three other cardiovascular risk factors)
Primary outcome: non-fatal myocardial infarction and fatal CHD
HR 0.64 (0.50–0.83)

Results are quoted from each trial’s primary publication abstract (PubMed); the trial name links to the paper. Ratios below 1 favour the intervention.

Trials by indication

Registered trials with atorvastatin in an arm, past phase 1 with at least 50 participants: the largest in each indication, newest first. Trials that give it only as the comparator are tagged; trials that give it in every arm are listed last.

Lipid management

EASEGO Study: Doubling of Atorvastatin/Simvastatin or INEGY in Patients With Hypercholesterolemia and Coronary Artery Disease(CAD)(0653A-089)Comparator arm
NCT00166530 · Phase 4 · Completed · 367 participants · started 2005

Stroke

Atorvastatin Pretreatment in Cerebrovascular Events (APICES) After Flow Diverter Implantation: Protocol of a Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial
NCT06308952 · Phase 4 · Recruiting · 354 participants · started 2024

Other trials

The Potential Role of Allopurinol Versus Atorvastatin to Prevent Complications of Liver Cirrhosis: A Quadruple Blind Clinical StudyComparator arm
NCT05511766 · Phase 2/3 · Completed · 150 participants · started 2022

Source: ClinicalTrials.gov registry records.

Other Statins

The class has its own page: Statin therapy.

AtorvastatinLipitorThis page
Fluvastatin
Lovastatin
Pitavastatin
Pravastatin
RosuvastatinCrestor
Simvastatin

Class membership: Synapse curated drug classes

How this page is built

A clinical question appears here only when its condition matches this topic, an outcome and a comparator were extracted from the studies, at least two studies and a patient count are on file, and the certainty is low or higher.

Supports benefit, no benefit shown, and mixed describe the direction of the measured effect. No benefit shown means the evidence does not support a benefit. It is not a finding of harm. Too little evidence means the question did not clear that bar.

Study count, RCT count, and patient count are separate. The patient total adds only studies that are linked into a study family and whose sample size is not flagged as implausible. A reversal is listed only when at least one randomized trial sits on each side of the change.

The overview is drafted from the guideline recommendations, trials, papers, and questions on this page, and every sentence has to cite one of them. It stays unverified until an NPI-verified clinician or a Synapse admin approves it. Approving records that person's name.