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

Rosuvastatin Versus Pravastatin in HIV Patients Treated With Boosted Protease Inhibitors (PI) (ANRS126)

Phase 4
Completed
Conditions
Hyperlipidemia
HIV Infections
First Posted Date
2005-07-07
Last Posted Date
2011-12-22
Lead Sponsor
French National Agency for Research on AIDS and Viral Hepatitis
Target Recruit Count
86
Registration Number
NCT00117494
Locations
🇫🇷

service de Médecine Interne Hopital Hotel Dieu, Paris, France

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

Phase 1
Completed
Conditions
Leukemia
First Posted Date
2005-04-06
Last Posted Date
2010-09-21
Lead Sponsor
Fred Hutchinson Cancer Center
Registration Number
NCT00107523
Locations
🇺🇸

M.D. Anderson Cancer Center at University of Texas, Houston, Texas, United States

🇺🇸

Fred Hutchinson Cancer Research Center, Seattle, Washington, United States

Prevention of Atherosclerosis and Heart Disease in Patients With Systemic Lupus Erythematosis (SLE)

Phase 2
Completed
Conditions
Lupus
Systemic Lupus Erythematosus
First Posted Date
2003-02-14
Last Posted Date
2013-12-24
Lead Sponsor
Brigham and Women's Hospital
Target Recruit Count
150
Registration Number
NCT00054938
Locations
🇺🇸

Brigham and Women's Hospital, RBB Brigham Arthritis Center, Boston, Massachusetts, United States

Endothelial Dysfunction as a Risk Factor in HIV Study

Phase 1
Completed
Conditions
HIV Infections
First Posted Date
2002-06-07
Last Posted Date
2008-03-04
Lead Sponsor
National Institutes of Health Clinical Center (CC)
Target Recruit Count
75
Registration Number
NCT00039663
Locations
🇺🇸

National Institutes of Health Clinical Center (CC), Bethesda, Maryland, United States

Safety and Effectiveness of Fenofibrate and Pravastatin in HIV-Positive Patients With Abnormal Blood Lipids

Phase 3
Completed
Conditions
HIV Infections
Lipodystrophy
First Posted Date
2001-08-31
Last Posted Date
2021-11-01
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
630
Registration Number
NCT00006412
Locations
🇺🇸

Philadelphia Veterans Administration Med Ctr, Philadelphia, Pennsylvania, United States

🇺🇸

Univ of Pittsburgh, Pittsburgh, Pennsylvania, United States

🇺🇸

Case Western Reserve Univ, Cleveland, Ohio, United States

and more 55 locations

Prevention of Kidney Transplant Rejection

Phase 3
Completed
Conditions
End-Stage Renal Disease
Chronic Allograft Nephropathy
First Posted Date
2001-08-31
Last Posted Date
2013-01-25
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Registration Number
NCT00005010
Locations
🇺🇸

Ilene Blechman-Krom, Rockville, Maryland, United States

The Effect of Efavirenz and Nelfinavir on the Blood Levels of Certain Lipid-Lowering Drugs

Phase 1
Completed
Conditions
HIV Infections
HIV Seronegativity
Lipodystrophy
First Posted Date
2001-08-31
Last Posted Date
2006-03-14
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
56
Registration Number
NCT00017758
Locations
🇺🇸

Univ of Colorado Health Sciences Ctr, Denver, Colorado, United States

🇺🇸

Univ of Minnesota, Minneapolis, Minnesota, United States

🇺🇸

Washington Univ School of Medicine, St Louis, Missouri, United States

and more 7 locations

A Study on Possible Interactions Between Protease Inhibitors (Anti-HIV Drugs) and Drugs Which Lower the Level of Fat in Your Blood

Phase 1
Completed
Conditions
HIV Infections
First Posted Date
2001-08-31
Last Posted Date
2021-10-29
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
56
Registration Number
NCT00000941
Locations
🇺🇸

Univ of Southern California / LA County USC Med Ctr, Los Angeles, California, United States

🇺🇸

San Francisco Gen Hosp, San Francisco, California, United States

🇺🇸

Stanford Univ Med Ctr, Stanford, California, United States

and more 10 locations

Effect of Pravastatin on Endothelial Dysfunction Following a Single High Fat Meal

Not Applicable
Conditions
Heart Diseases
First Posted Date
2000-04-19
Last Posted Date
2005-06-24
Lead Sponsor
National Center for Research Resources (NCRR)
Registration Number
NCT00005117
Locations
🇺🇸

4200 E. 9th Avenue, Box B133, Denver, Colorado, United States

Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT)

Phase 3
Completed
Conditions
Myocardial Infarction
Coronary Disease
Myocardial Ischemia
Heart Failure
Hypercholesterolemia
Diabetes Mellitus
Hypertension
Cardiovascular Diseases
Heart Diseases
First Posted Date
1999-10-28
Last Posted Date
2016-07-29
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Registration Number
NCT00000542
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