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

Pilot Study of a Multi-Drug Regimen for Severe Pulmonary Fibrosis in Hermansky-Pudlak Syndrome

Phase 1
Terminated
Conditions
Hermansky-Pudlak Syndrome (HPS)
Pulmonary Fibrosis
Oculocutaneous Albinism
Platelet Storage Pool Deficiency
Metabolic Disease
Interventions
First Posted Date
2007-05-01
Last Posted Date
2013-08-02
Lead Sponsor
National Human Genome Research Institute (NHGRI)
Target Recruit Count
3
Registration Number
NCT00467831
Locations
🇺🇸

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

A Study to Evaluate Daily Pravastatin, Fenofibrate or Pravafen in the Treatment of Combined Hyperlipidemia

Phase 3
Completed
Conditions
Combined Hyperlipidemia
Interventions
First Posted Date
2007-04-12
Last Posted Date
2018-04-24
Lead Sponsor
Shionogi
Target Recruit Count
481
Registration Number
NCT00459745
Locations
🇺🇸

East-West Medical Research Institute, Honolulu, Hawaii, United States

🇺🇸

Welborn Clinic Gateway, Newburgh, Indiana, United States

🇺🇸

Memorial Research Medical Clinic, Long Beach, California, United States

and more 52 locations

Effect of Statin Therapy on Disease Progression in Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Phase 3
Completed
Conditions
Polycystic Kidney, Autosomal Dominant
Interventions
Drug: Placebo
First Posted Date
2007-04-04
Last Posted Date
2018-03-09
Lead Sponsor
University of Colorado, Denver
Target Recruit Count
110
Registration Number
NCT00456365
Locations
🇺🇸

University of Colorado at Denver and Health Sciences Center, Denver, Colorado, United States

Etoposide and Cisplatin or Carboplatin as First-Line Chemotherapy With or Without Pravastatin in Treating Patients With Small Cell Lung Cancer

First Posted Date
2007-02-12
Last Posted Date
2014-12-03
Lead Sponsor
University College, London
Target Recruit Count
846
Registration Number
NCT00433498
Locations
🇬🇧

Walsall Manor Hospital, Walsall, England, United Kingdom

🇬🇧

Weston General Hospital, Weston-super-Mare, England, United Kingdom

🇬🇧

Addenbrooke's Hospital, Cambridge, England, United Kingdom

and more 83 locations

Anti-Oxidant Therapy In Chronic Renal Insufficiency (ATIC) Study

Phase 4
Terminated
Conditions
Chronic Kidney Disease
First Posted Date
2006-10-06
Last Posted Date
2006-10-06
Lead Sponsor
Amsterdam UMC, location VUmc
Target Recruit Count
100
Registration Number
NCT00384618
Locations
🇳🇱

VU University Medical Center, Amsterdam, North Holland, Netherlands

Pravastatin or Atorvastatin Evaluation and Infection Therapy (TIMI22)

Phase 4
Completed
Conditions
Actue Coronary Syndromes
First Posted Date
2006-09-29
Last Posted Date
2011-04-15
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
4000
Registration Number
NCT00382460

This Study Uses Ultrasound to Determine Whether Atorvastatin or Pravastatin Effects the Progression of Coronary Plaque.

Phase 4
Completed
Conditions
Coronary Arteriosclerosis
First Posted Date
2006-09-27
Last Posted Date
2006-12-04
Lead Sponsor
Pfizer
Target Recruit Count
600
Registration Number
NCT00380939
Locations
🇺🇸

Pfizer Investigational Site, Seattle, Washington, United States

Comparison of the Combination of Fenofibrate and Simvastatin Versus Pravastatin

Phase 3
Completed
Conditions
Hyperlipidemia
Interventions
First Posted Date
2006-08-09
Last Posted Date
2009-07-08
Lead Sponsor
Solvay Pharmaceuticals
Target Recruit Count
423
Registration Number
NCT00362206
Locations
🇬🇷

Site 40, Athens, Greece

🇷🇴

Site 5, Arad, Romania

🇷🇴

Site 7, Bacau, Romania

and more 38 locations

Effects of Statin Medications on Mental Processes, Behavior, and Serotonin Levels

Phase 4
Completed
Conditions
Dyslipidemias
Interventions
First Posted Date
2006-05-29
Last Posted Date
2014-03-20
Lead Sponsor
University of California, San Diego
Target Recruit Count
1000
Registration Number
NCT00330980
Locations
🇺🇸

University of California, San Diego, La Jolla, California, United States

Cardiovascular Risk Markers and Response to Statins After Kawasaki Disease

Phase 2
Withdrawn
Conditions
Kawasaki Disease
First Posted Date
2006-03-21
Last Posted Date
2016-05-24
Lead Sponsor
Pontificia Universidad Catolica de Chile
Registration Number
NCT00305201
Locations
🇨🇱

Pontificia Universidad Catolica de Chile, School of Medicine, Santiago, Región Metropolitana, Chile

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