Fluvastatin

Generic Name: Fluvastatin

Brand Names: Lescol

Drug Type: Small Molecule

Chemical Formula: C_₂₄H_₂₆FNO_₄

CAS Number: 93957-54-1

Unique Ingredient Identifier: 4L066368AS

Background: Fluvastatin is an antilipemic agent that competitively inhibits hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase. HMG-CoA reductase catalyzes the conversion of HMG-CoA to mevalonic acid, the rate-limiting step in cholesterol biosynthesis. Fluvastatin belongs to a class of medications called statins and is used to reduce plasma cholesterol levels and prevent cardiovascular disease. It is also the first entirely synthetic HMG-CoA reductase inhibitor and is structurally distinct from the fungal derivatives of this therapeutic class. Fluvastatin is a racemate comprising equimolar amounts of (3R,5S)- and (3S,5R)-fluvastatin.

Indication: To be used as an adjunct to dietary therapy to prevent cardiovascular events. May be used as secondary prevention in patients with coronary heart disease (CHD) to reduce the risk of requiring coronary revascularization procedures, for reducing progression of coronary atherosclerosis in hypercholesterolemic patients with CHD, and for the treatment of primary hypercholesterolemia and mixed dyslidipidemia.

Associated Conditions: Atherosclerosis, Heterozygous Familial Hypercholesterolemia (HeFH), Mixed Dyslipidemias, Primary Hypercholesterolemia, Revascularization procedures

Clinical Trials

Prevention of Recurrence and Metastasis in Genetically High-Risk Melanomas

Early Phase 1

Withdrawn

Conditions: Malignant Melanoma

Interventions: Drug: Fluvastatin
Other: RNA-sequencing
Other: Gene expression profiling

First Posted Date: 2020-02-26

Last Posted Date: 2020-07-27

Lead Sponsor: Case Comprehensive Cancer Center

Registration Number: NCT04285749

Drug-Drug Interaction Between Rifampin and Fluvastatin

Phase 4

Completed

Conditions: Drug-drug Interaction

Interventions: Drug: rifampin IV
Drug: Rifadin 300Mg Capsule
Drug: Fluvastatin 20 MG

First Posted Date: 2019-07-23

Last Posted Date: 2021-09-08

Lead Sponsor: University of California, San Francisco

Target Recruit Count: 10

Registration Number: NCT04029584

Locations: 🇺🇸
University of California San Francisco, San Francisco, California, United States

An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia

Phase 3

Completed

Conditions: Hypercholesterolaemia

Interventions: Drug: Alirocumab SAR236553 (REGN727)
Drug: Rosuvastatin
Drug: Atorvastatin
Drug: Simvastatin
Drug: Pravastatin
Drug: Lovastatin
Drug: Fluvastatin
Drug: Ezetimibe
Drug: Cholestyramine
Drug: Nicotinic acid
Drug: Fenofibrate
Drug: Omega-3 fatty acids
Drug: Placebo

First Posted Date: 2018-04-27

Last Posted Date: 2023-05-06

Lead Sponsor: Sanofi

Target Recruit Count: 153

Registration Number: NCT03510884

Locations: 🇪🇸
Investigational Site Number :7240003, Pamplona, Navarra, Spain
🇵🇱
Investigational Site Number :6160002, Gdansk, Pomorskie, Poland
🇲🇽
Investigational Site Number :4840007, Oaxaca, Mexico

and more 40 locations

An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Homozygous Familial Hypercholesterolemia

Phase 3

Completed

Conditions: Hypercholesterolemia

Interventions: Drug: Alirocumab SAR236553 (REGN727)
Drug: Atorvastatin
Drug: Simvastatin
Drug: Fluvastatin
Drug: Pravastatin
Drug: Lovastatin
Drug: Rosuvastatin
Drug: Ezetimibe
Drug: Cholestyramine
Drug: Nicotinic acid
Drug: Fenofibrate
Drug: Omega-3 fatty acids

First Posted Date: 2018-04-27

Last Posted Date: 2020-12-29

Lead Sponsor: Sanofi

Target Recruit Count: 18

Registration Number: NCT03510715

Locations: 🇩🇰
Investigational Site Number 2080001, Viborg, Denmark
🇪🇸
Investigational Site Number 7240001, A Coruna, Spain
🇸🇮
Investigational Site Number 7050001, Ljubljana, Slovenia

and more 7 locations