MedPath

Atorvastatin

Generic Name
Atorvastatin
Brand Names
Atorvaliq, Caduet, Lipitor, Lypqozet
Drug Type
Small Molecule
Chemical Formula
C33H35FN2O5
CAS Number
134523-00-5
Unique Ingredient Identifier
A0JWA85V8F
Background

Atorvastatin (Lipitor®), is a lipid-lowering drug included in the statin class of medications. By inhibiting the endogenous production of cholesterol in the liver, statins lower abnormal cholesterol and lipid levels, and ultimately reduce the risk of cardiovascular disease. More specifically, statin medications competitively inhibit the enzyme hydroxymethylglutaryl-coenzyme A (HMG-CoA) Reductase, which catalyzes the conversion of HMG-CoA to mevalonic acid. This conversion is a critical metabolic reaction involved in the production of several compounds involved in lipid metabolism and transport, including cholesterol, low-density lipoprotein (LDL) (sometimes referred to as "bad cholesterol"), and very-low-density lipoprotein (VLDL). Prescribing statins is considered standard practice for patients following any cardiovascular event, and for people who are at moderate to high risk of developing cardiovascular disease. The evidence supporting statin use, coupled with minimal side effects and long term benefits, has resulted in wide use of this medication in North America.

Atorvastatin and other statins including lovastatin, pravastatin, rosuvastatin, fluvastatin, and simvastatin are considered first-line treatment options for dyslipidemia. The increasing use of this class of drugs is largely attributed to the rise in cardiovascular diseases (CVD) (such as heart attack, atherosclerosis, angina, peripheral artery disease, and stroke) in many countries. An elevated cholesterol level (elevated low-density lipoprotein (LDL) levels in particular) is a significant risk factor for the development of CVD. Several landmark studies demonstrate that the use of statins is associated with both a reduction in LDL levels and CVD risk. Statins were shown to reduce the incidences of all-cause mortality, including fatal and non-fatal CVD, as well as the need for surgical revascularization or angioplasty following a heart attack. Some evidence has shown that even for low-risk individuals (with <10% risk of a major vascular event occurring within five years) statin use leads to a 20%-22% relative reduction in the number of major cardiovascular events (heart attack, stroke, coronary revascularization, and coronary death) for every 1 mmol/L reduction in LDL without any significant side effects or risks.

Atorvastatin was first synthesized in 1985 by Dr. Bruce Roth and approved by the FDA in 1996. It is a pentasubstituted pyrrole formed by two contrasting moieties with an achiral heterocyclic core unit and a 3,5-dihydroxypentanoyl side chain identical to its parent compound. Unlike other members of the statin group, atorvastatin is an active compound and therefore does not require activation.

Indication

Atorvastatin is indicated for the treatment of several types of dyslipidemias, including primary hyperlipidemia and mixed dyslipidemia in adults, hypertriglyceridemia, primary dysbetalipoproteinemia, homozygous familial hypercholesterolemia, and heterozygous familial hypercholesterolemia in adolescent patients with failed dietary modifications.

Dyslipidemia describes an elevation of plasma cholesterol, triglycerides or both as well as to the presence of low levels of high-density lipoprotein. This condition represents an increased risk for the development of atherosclerosis.

Atorvastatin is indicated, in combination with dietary modifications, to prevent cardiovascular events in patients with cardiac risk factors and/or abnormal lipid profiles.

Atorvastatin can be used as a preventive agent for myocardial infarction, stroke, revascularization, and angina, in patients without coronary heart disease but with multiple risk factors and in patients with type 2 diabetes without coronary heart disease but multiple risk factors.

Atorvastatin may be used as a preventive agent for non-fatal myocardial infarction, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure and angina in patients with coronary heart disease.

Prescribing of statin medications is considered standard practice following any cardiovascular events and for people with a moderate to high risk of development of CVD. Statin-indicated conditions include diabetes mellitus, clinical atherosclerosis (including myocardial infarction, acute coronary syndromes, stable angina, documented coronary artery disease, stroke, trans ischemic attack (TIA), documented carotid disease, peripheral artery disease, and claudication), abdominal aortic aneurysm, chronic kidney disease, and severely elevated LDL-C levels.

Associated Conditions
Anginal Pain, Cardiovascular Complications, Cardiovascular Disease (CVD), Coronary Artery Disease (CAD), Coronary artery thrombosis, Dysbetalipoproteinemia, Fredrickson Type III lipidemia, Heterozygous Familial Hypercholesterolemia (HeFH), High Cholesterol, Homozygous Familial Hypercholesterolaemia (HoFH), Hospitalizations, Hypertension, Essential Hypertension, Hypertriglyceridemias, Mixed Dyslipidemias, Mixed Hyperlipidemia, Myocardial Infarction, Non-familial hypercholesterolemia, Nonfatal Myocardial Infarction, Postoperative Thromboembolism, Primary Hypercholesterolemia, Stroke, Thrombosis, Transient Ischemic Attack, Elevation of serum triglyceride levels, Heterozygous familial hyperlipidemia, Non-familial hyperlipidemia, Primary Hyperlipidemia, Revascularization procedures

Impact of Atorvastatin Versus Rosuvastatin on 25 Hydroxy Vitamin D Levels in Patients With Acute Coronary Syndrome

Phase 4
Recruiting
Conditions
Acute Coronary Syndromes
Interventions
First Posted Date
2025-01-09
Last Posted Date
2025-03-11
Lead Sponsor
King Edward Medical University
Target Recruit Count
152
Registration Number
NCT06765265
Locations
🇵🇰

King Edward Medical University, Lahore, Punjab, Pakistan

Statin and Beta Blocker Use in Patients with Decompensated Cirrhosis

Phase 2
Not yet recruiting
Conditions
Decompensated Liver Cirrhosis
Cirrhosis
Decompensated Cirrhosis of Liver
Decompensated Cirrhosis and Ascites
Interventions
First Posted Date
2025-01-09
Last Posted Date
2025-01-09
Lead Sponsor
CAMC Health System
Target Recruit Count
50
Registration Number
NCT06764966
Locations
🇺🇸

Charleston Area Medical Center, Charleston, West Virginia, United States

Influence of HRS9531 on Gastric Emptying and Pharmacokinetics of Metformin, Atorvastatin, Warfarin, and Digoxin in Healthy Subjects

Phase 1
Active, not recruiting
Conditions
Type 2 Diabetes
Interventions
First Posted Date
2024-12-09
Last Posted Date
2025-01-07
Lead Sponsor
Fujian Shengdi Pharmaceutical Co., Ltd.
Target Recruit Count
57
Registration Number
NCT06723691
Locations
🇨🇳

The Second Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China

A Study to Evaluate the Drug-Drug Interaction Between Enlicitide Decanoate (MK-0616) and Atorvastatin in Healthy Adult Participants (MK-0616-024)

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2024-11-21
Last Posted Date
2024-11-21
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
18
Registration Number
NCT06699355
Locations
🇺🇸

Celerion (Site 0001), Lincoln, Nebraska, United States

Study on the Effect of Atorvastatin Co-administered With Omeprazole on Statin Lactone

Phase 4
Not yet recruiting
Conditions
Metabolite
Interventions
First Posted Date
2024-11-15
Last Posted Date
2024-11-15
Lead Sponsor
National University Hospital, Singapore
Target Recruit Count
78
Registration Number
NCT06690164

A Study of Bempedoic Acid in Combination With Ezetimibe and Either Rosuvastatin or Atorvastatin in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia

Recruiting
Conditions
Primary Hypercholesterolemiia
Mixed Dyslipidemia
Interventions
First Posted Date
2024-11-13
Last Posted Date
2025-05-14
Lead Sponsor
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Target Recruit Count
2000
Registration Number
NCT06686615
Locations
🇩🇪

Kardiologische Gemeinschaftspraxis am Park Sanssouci, Potsdam, Germany

AtorvaStatin Postpartum and Reduction of Cardiovascular RisK

Phase 4
Not yet recruiting
Conditions
Hypertensive Disorders of Pregnancy
Preeclampsia
Gestational Hypertension
Interventions
First Posted Date
2024-10-09
Last Posted Date
2025-03-25
Lead Sponsor
Ohio State University
Target Recruit Count
76
Registration Number
NCT06632379
Locations
🇺🇸

The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine, Columbus, Ohio, United States

A Drug-Drug Interaction (DDI) Study of HDM1002 With Repaglinide, Atorvastatin, Digoxin and Rosuvastatin in Healthy Subjects

Phase 1
Not yet recruiting
Conditions
Healthy Adult Subject
Overweight Subject
Interventions
First Posted Date
2024-09-19
Last Posted Date
2024-09-19
Lead Sponsor
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Target Recruit Count
30
Registration Number
NCT06601517
Locations
🇨🇳

Peking University Third Hospital, Beijing, China

A Study to Learn How the Study Medicine Danuglipron is Taken Up Into the Blood and If Danuglipron Changes How the Body Processes Other Study Medicines (Atorvastatin and Rosuvastatin) in Healthy Adults Who Are Overweight or Obese

Phase 1
Active, not recruiting
Conditions
Obesity
Interventions
First Posted Date
2024-08-22
Last Posted Date
2025-03-28
Lead Sponsor
Pfizer
Target Recruit Count
82
Registration Number
NCT06567327
Locations
🇺🇸

Qps - Mra, Llc., South Miami, Florida, United States

🇺🇸

Anaheim Clinical Trials, LLC, Anaheim, California, United States

🇺🇸

Qps-Mra, Llc, South Miami, Florida, United States

Ultra-early STatin in Patients With Aneurysmal subaRachnoid Hemorrhage (Ue-STAR): a Randomized Controlled Trial

Phase 3
Not yet recruiting
Conditions
Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Aneurysmal
Aneurysmal Subarachnoid Hemorrhage
Hemorrhage, Aneurysmal Subarachnoid
Interventions
First Posted Date
2024-08-19
Last Posted Date
2024-08-19
Lead Sponsor
The George Institute
Target Recruit Count
522
Registration Number
NCT06559072
Locations
🇨🇳

Tianjin Medical University General Hospital, Tianjin, China

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