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

A Study Comparing the Mechanisms of Action of Lifibrol and Pravastatin

Phase 3
Completed
Conditions
Hypercholesterolemia
Hyperlipoproteinemia
Interventions
First Posted Date
2010-01-27
Last Posted Date
2010-01-27
Lead Sponsor
University Hospital, Bonn
Target Recruit Count
18
Registration Number
NCT01057654
Locations
🇩🇪

Dept. of Clinical Pharmacology, University of Bonn, Bonn, Germany

Study to Evaluate the Efficacy of Pravastatin on Survival and Recurrence of Advanced Gastroesophageal Cancer

Phase 4
Conditions
Esophageal Cancer
Stomach Cancer
Interventions
First Posted Date
2009-12-23
Last Posted Date
2011-06-27
Lead Sponsor
Hospital Donostia
Target Recruit Count
146
Registration Number
NCT01038154
Locations
🇪🇸

Department Gastroenterology. Hospital Donostia, San Sebastián, Guipúzcoa, Spain

Cardiovascular Prevention for Persons With HIV

Not Applicable
Completed
Conditions
Cardiovascular Disease Risk
HIV Infection
Interventions
First Posted Date
2009-09-23
Last Posted Date
2017-11-22
Lead Sponsor
Hennepin Healthcare Research Institute
Target Recruit Count
37
Registration Number
NCT00982189
Locations
🇺🇸

Hennepin County Medical Center, Minneapolis, Minnesota, United States

Study of Zoledronic Acid, Pravastatin, and Lonafarnib for Patients With Progeria

Phase 2
Active, not recruiting
Conditions
Progeria
Interventions
First Posted Date
2009-06-09
Last Posted Date
2023-02-27
Lead Sponsor
Boston Children's Hospital
Target Recruit Count
85
Registration Number
NCT00916747
Locations
🇺🇸

Children's Hospital Boston, Boston, Massachusetts, United States

A Study of Zoledronic Acid, Pravastatin, and Lonafarnib for Patients With Progeria

Phase 2
Completed
Conditions
Progeria
Hutchinson-Gilford Syndrome
Interventions
First Posted Date
2009-04-09
Last Posted Date
2019-06-13
Lead Sponsor
Boston Children's Hospital
Target Recruit Count
5
Registration Number
NCT00879034
Locations
🇺🇸

Children's Hospital Boston, Boston, Massachusetts, United States

Coadministration of Ezetimibe With Fenofibrate Versus Pravastatin Monotherapy for the Treatment of Hyperlipidaemia in HIV-infected Patients

Phase 4
Conditions
HIV
Hyperlipidemia
HIV Infections
Interventions
First Posted Date
2009-02-13
Last Posted Date
2011-08-02
Lead Sponsor
Ospedale di Circolo - Fondazione Macchi
Target Recruit Count
60
Registration Number
NCT00843661
Locations
🇮🇹

Ospedale di Circolo and Fondazione Macchi, Varese, Italy

S0919 Idarubicin, Cytarabine, and Pravastatin in Treating Patients With Relapsed Acute Myeloid Leukemia

Phase 2
Completed
Conditions
Leukemia
Interventions
First Posted Date
2009-02-10
Last Posted Date
2023-05-03
Lead Sponsor
SWOG Cancer Research Network
Target Recruit Count
115
Registration Number
NCT00840177
Locations
🇺🇸

Cancer Center of Kansas-Independence, Independence, Kansas, United States

🇺🇸

Genesee Hematology Oncology PC, Flint, Michigan, United States

🇺🇸

Southeastern Medical Oncology Center-Jacksonville, Jacksonville, North Carolina, United States

and more 182 locations

Bioavailability Study of Pravastatin Sodium 40 mg Tablets Under Fasting Conditions

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: Pravachol®
First Posted Date
2009-02-03
Last Posted Date
2020-10-08
Lead Sponsor
Teva Pharmaceuticals USA
Target Recruit Count
58
Registration Number
NCT00834379
Locations
🇨🇦

Pharma Medica Research Inc., Toronto, Ontario, Canada

Pravastatin Sodium 40 mg Tablets Food Challenge Study

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: Pravachol®
First Posted Date
2009-02-03
Last Posted Date
2020-01-09
Lead Sponsor
Teva Pharmaceuticals USA
Target Recruit Count
24
Registration Number
NCT00834847
Locations
🇨🇦

Pharma Medica Research Inc., Toronto, Ontario, Canada

Pravastatin Sodium 80 mg Tablets Under Fasting Conditions

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: Pravachol® 80 mg tablets
First Posted Date
2009-01-27
Last Posted Date
2024-08-19
Lead Sponsor
Teva Pharmaceuticals USA
Target Recruit Count
60
Registration Number
NCT00830258
Locations
🇨🇦

Pharma Medica Research Inc., Toronto, Ontario, Canada

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