Inhibits HMG-CoA reductase, an enzyme in cholesterol synthesis. Source
Community-dwelling Australian adults aged at least 70, without cardiovascular disease, diabetes, or dementia.
Study contextSelected approval record (1996-12-17): FDA approved atorvastatin as Lipitor. Its later prevention trials addressed clinical events beyond the original lipid-lowering evidence.
Status sourceStatus & indicationsMajor cardiovascular events: HR 0.7 (95% CI 0.61–0.82). Cardiovascular death, nonfatal heart attack or stroke, or coronary revascularization.
STAREE · 40 mg orally daily · Atorvastatin versus placebo, alongside usual general-practice care. · Median randomized follow-up: 5.9 years.
Evidence & limitationsReported serious adverse events: 2.7% in both groups. Musculoskeletal, hepatobiliary, and diabetes-related events were more frequent with atorvastatin.
Safety contextA next milestone is not summarized for this therapy.
Milestone detailsStudy results apply to their own population, dose and analysis. They do not establish a ranking between therapies.
Each result belongs to its own study population, dose and analysis. Open a result for its chart, comparator, safety findings and limitations.
LDL-C: 60% reduction within arm · 6 weeks
80 mg daily
Adults with primary hyperlipidemia
Adjusted mean change from baseline; two trials pooled.
Label risks: muscle injury, liver enzyme elevations and increased glucose.
Limitations: Small displayed arm. Baseline concentrations and total trial N are not supplied for this table; no placebo-adjusted estimate is reported.
Major cardiovascular events: HR 0.7 (95% CI 0.61–0.82). Cardiovascular death, nonfatal heart attack or stroke, or coronary revascularization.
40 mg orally daily
Community-dwelling Australian adults aged at least 70, without cardiovascular disease, diabetes, or dementia.
Background treatment & comparator: Atorvastatin versus placebo, alongside usual general-practice care.
Median randomized follow-up: 5.9 years. The primary abstract reports 10.9 versus 15.5 events per 1,000 person-years; these are not cumulative percentages.
Reported serious adverse events: 2.7% in both groups. Musculoskeletal, hepatobiliary, and diabetes-related events were more frequent with atorvastatin.
Limitations: The other co-primary outcome, disability-free survival, was not significantly improved (HR 0.94; 95% CI 0.84–1.05). Separate mortality HRs were not verified in the available primary abstract.
Status in this atlas: Selected approval record (1996-12-17): FDA approved atorvastatin as Lipitor. Its later prevention trials addressed clinical events beyond the original lipid-lowering evidence. Status source
Inhibits HMG-CoA reductase, an enzyme in cholesterol synthesis.
Mechanism sourceMechanism & side effects: Statins
Uses, doses and availability depend on the formulation, indication and country. Study doses below describe research; they are not prescribing instructions.
Chemical structure of the atorvastatin parent molecule.
Shown: Atorvastatin free acid; the calcium counterion and waters of hydration are omitted.
Lipitor contains atorvastatin calcium. This drawing identifies the parent active moiety rather than the full salt crystal. The optional 3D view is a computed PubChem conformer, not an experimentally measured or protein-bound shape.
PubChem CID 60823Atorvastatin · compound history across indications
Selected sourced milestones, not a complete development history. Dates distinguish study starts, publications, announcements and approvals; the first listed date is not necessarily when development began.
A six-week randomized study tested atorvastatin in 81 people with primary hypercholesterolemia, demonstrating dose-dependent LDL-C lowering before approval.
Nawrocki et al. — early atorvastatin trialA study in 22 healthy volunteers characterized tolerability and pharmacokinetics of investigational atorvastatin. This date is the publication, not the start of human testing.
Posvar et al. — clinical pharmacologyFDA approved atorvastatin as Lipitor. Its later prevention trials addressed clinical events beyond the original lipid-lowering evidence.
FDA — original Lipitor approval letterAtorvastatin reduced coronary events in hypertensive adults with additional risk factors in this primary-prevention trial.
ASCOT-LLA — LancetThe trial in adults aged 70 or older without cardiovascular disease, diabetes or dementia reported fewer major cardiovascular events. Disability-free survival was not significantly improved. The cardiovascular estimate is plotted here.
STAREE — NEJMSelected sources checked Sep 14, 2026. This is not an exhaustive history.
