MedPath

Pravastatin

Generic Name
Pravastatin
Drug Type
Small Molecule
Chemical Formula
C23H36O7
CAS Number
81093-37-0
Unique Ingredient Identifier
KXO2KT9N0G
Background

Pravastatin is the 6-alpha-hydroxy acid form of mevastatin. Pravastatin was firstly approved in 1991 becoming the second available statin in the United States. It was the first statin administered as the active form and not as a prodrug. This drug was developed by Sankyo Co. Ltd.; however, the first approved pravastatin product was developed by Bristol Myers Squibb and FDA approved in 1991.

Pravastatin is made through a fermentation process in which mevastatin is first obtained. The manufacturing process is followed by the hydrolysis of the lactone group and the biological hydroxylation with Streptomyces carbophilus to introduce the allylic 6-alcohol group.

Indication

Pravastatin is indicated for primary prevention of coronary events hypercholesterolemic patients without clinical evidence of coronary heart disease. Its use includes the reduction of risk on myocardial infarction, undergoing myocardial revascularization procedures and cardiovascular mortality.

As well, pravastatin can be used as a secondary prevention agent for cardiovascular events in patients with clinically evident coronary heart disease. This indication includes the reduction of risk of total mortality by reducing coronary death, myocardial infarction, undergoing myocardial revascularization procedures, stroke, and stroke/transient ischemic attack as well as to slow the progression of coronary atherosclerosis.

The term cardiovascular events correspond to all the incidents that can produce damage to the heart muscle including the interruption of blood flow.

As adjunctive therapy to diet, pravastatin is used in:

In patients that do not respond adequately to diet, pravastatin is used to treat patients with primary dysbetalipoproteinemia (type III hyperlipidemia).

Dyslipidemia is defined as 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.

Associated Conditions
Acute Coronary Events, Cardiovascular Outcomes, Coronary Artery Atherosclerosis, Death, Dysbetalipoproteinemia, Heterozygous Familial Hypercholesterolemia (HeFH), High Cholesterol, Hyperlipidemias, Mixed Dyslipidemias, Myocardial Infarction, Myocardial Revascularization, Secondary prevention cardiovascular event, Stroke, Sudden Cardiac Death, Transient Ischemic Attack, Elevation of serum triglyceride levels

STELLAR-Rosuvastatin vs. Atorvastatin, Pravastatin, Simvastatin Across Dose Ranges

Phase 3
Completed
Conditions
Hypercholesterolemia
Interventions
First Posted Date
2008-04-08
Last Posted Date
2009-03-16
Lead Sponsor
AstraZeneca
Target Recruit Count
5625
Registration Number
NCT00654537

Fasting Bioequivalence Study of Pravastatin Sodium 80 mg Tablets Versus Pravachol® 80 mg Tablets In Normal Healthy Subjects

Phase 1
Completed
Conditions
Therapeutic Equivalency
Interventions
First Posted Date
2008-04-01
Last Posted Date
2024-04-24
Lead Sponsor
Mylan Pharmaceuticals Inc
Target Recruit Count
43
Registration Number
NCT00650221
Locations
🇨🇦

Biovail Contract Research, Toronto, Ontario, Canada

Fed, Bioequivalence Study of Pravastatin Sodium 80 mg Tablets Versus Pravachol® 80 mg Tablets In Subjects

Phase 1
Completed
Conditions
Therapeutic Equivalency
Interventions
First Posted Date
2008-04-01
Last Posted Date
2024-04-24
Lead Sponsor
Mylan Pharmaceuticals Inc
Target Recruit Count
44
Registration Number
NCT00648544
Locations
🇨🇦

Biovail Contract Reseach, Toronto, Ontario, Canada

Safety of Red Yeast Rice for High Cholesterol in Individuals With Statin Intolerance

Phase 2
Completed
Conditions
Hypercholesterolemia
Statin-Associated Myopathy
Interventions
Dietary Supplement: Red Yeast Rice
Behavioral: Lifestyle modification program
First Posted Date
2008-03-20
Last Posted Date
2010-01-18
Lead Sponsor
University of Pennsylvania
Target Recruit Count
43
Registration Number
NCT00639223
Locations
🇺🇸

Chestnut Hill Hospital, Philadelphia, Pennsylvania, United States

Evaluation of the Efficacy and Safety of Rosuvastatin 5 mg Versus Pravastatin 40 mg and Atorvastatin 10 mg in Type IIa and IIb Hypercholesterolaemic Patients

Phase 4
Completed
Conditions
Type IIa and IIb Hypercholesterolaemia
Interventions
First Posted Date
2008-03-07
Last Posted Date
2013-11-26
Lead Sponsor
AstraZeneca
Target Recruit Count
668
Registration Number
NCT00631189
Locations
🇫🇷

Research Site, Yffiniac, France

Genetic Predictors of Variability in the Drug-drug Interaction Between Darunavir/Ritonavir and Pravastatin

Phase 4
Completed
Conditions
Hyperlipidemia
HIV Infections
Interventions
First Posted Date
2008-03-07
Last Posted Date
2014-05-22
Lead Sponsor
University of Colorado, Denver
Target Recruit Count
32
Registration Number
NCT00630734
Locations
🇺🇸

University of Colorado Denver, Aurora, Colorado, United States

Pravastatin Therapy in Patients With Active Crohn's Disease: A Pilot Study

Not Applicable
Conditions
Crohn's Disease
Interventions
First Posted Date
2008-01-24
Last Posted Date
2011-03-08
Lead Sponsor
University of Virginia
Target Recruit Count
40
Registration Number
NCT00599625
Locations
🇺🇸

University of Virginia, Charlottesville, Virginia, United States

Single Dose Pravastatin Pharmacokinetics in Pediatric Peritoneal Dialysis Patients

Phase 1
Terminated
Conditions
End Stage Renal Disease
Interventions
First Posted Date
2007-12-11
Last Posted Date
2017-03-15
Lead Sponsor
Arkansas Children's Hospital Research Institute
Target Recruit Count
7
Registration Number
NCT00571194
Locations
🇺🇸

Arkansas Children's Hospital, Little Rock, Arkansas, United States

Yokohama Assessment of Fluvastatin, Pravastatin, Pitavastatin and Atorvastatin in Acute Coronary Syndrome (Yokohama-ACS)

Phase 4
Completed
Conditions
Coronary Disease
Hypercholesterolemia
Interventions
First Posted Date
2007-10-26
Last Posted Date
2010-02-17
Lead Sponsor
Yokohama City University Medical Center
Target Recruit Count
200
Registration Number
NCT00549926
Locations
🇯🇵

Yokohama City University Medical Center, Yokohama, Japan

Pravastatin Efficacy and Safety Trial in Hypercholesterolemic Patients With Chronic Liver Disease

Phase 4
Completed
Conditions
Hypercholesterolemia
First Posted Date
2007-09-14
Last Posted Date
2011-04-25
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
232
Registration Number
NCT00529178
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