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

Pravastatin 80 mg Tablets Dosed in Healthy Subjects Under Non-Fasting Conditions

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2009-01-27
Last Posted Date
2024-08-20
Lead Sponsor
Teva Pharmaceuticals USA
Target Recruit Count
16
Registration Number
NCT00829309
Locations
🇺🇸

PRACS Institute, Ltd., Fargo, North Dakota, United States

A Study to Determine the Effect of WelChol Tablets on Cholesterol in Patients Who Have Been Taking Pravastatin for at Least 4 Weeks.

First Posted Date
2008-09-18
Last Posted Date
2015-04-03
Lead Sponsor
Daiichi Sankyo
Target Recruit Count
67
Registration Number
NCT00755352

Left Ventricular Hypertrophy Reduction With Statins in Hypertensives Patients (MK0653A-168)

First Posted Date
2008-08-21
Last Posted Date
2013-08-26
Lead Sponsor
Fundación Lindavista del Corazón AC
Target Recruit Count
12
Registration Number
NCT00738972

Vytorin on Carotid Intima-media Thickness and Overall Rigidity

Phase 4
Completed
Conditions
Cardiovascular Diseases
Interventions
First Posted Date
2008-08-20
Last Posted Date
2015-06-24
Lead Sponsor
Hospital Universitario 12 de Octubre
Target Recruit Count
90
Registration Number
NCT00738296

Treatment of the Hutchinson-Gilford Progeria Syndrome With a Combination of Pravastatin and Zoledronic Acid

Phase 2
Completed
Conditions
Hutchinson-Gilford Progeria Syndrome
Interventions
First Posted Date
2008-08-08
Last Posted Date
2013-07-08
Lead Sponsor
Assistance Publique Hopitaux De Marseille
Target Recruit Count
15
Registration Number
NCT00731016
Locations
🇫🇷

Laboratoire de Génétique Moléculaire - Hopital de la Timone, Marseille, France

Pravastatin and Ventilatory Associated Pneumonia

Early Phase 1
Completed
Conditions
Ventilator Associated Pneumonia
Interventions
First Posted Date
2008-06-20
Last Posted Date
2011-11-30
Lead Sponsor
University of Thessaly
Target Recruit Count
152
Registration Number
NCT00702130
Locations
🇬🇷

General Hospital Larissa, Larissa, Thessalia, Greece

🇬🇷

Zakynthinos E. Dir-University Hospital Larisa, Mezourlo / Larissa, Greece

South Korean Pitavastatin Heart Failure Study

Phase 4
Completed
Conditions
Chronic Heart Failure
Interventions
First Posted Date
2008-06-19
Last Posted Date
2014-05-14
Lead Sponsor
JW Pharmaceutical
Target Recruit Count
70
Registration Number
NCT00701285
Locations
🇰🇷

SEOUL St. Mary's Hospital, Seoul, Seocho-Ku, Korea, Republic of

A Study to Assess the Effect of RO4607381 in Patients With Relatively Low Levels of High Density Lipoprotein-Cholesterol (HDL-C)

Phase 2
Completed
Conditions
Dyslipidemia
Interventions
First Posted Date
2008-06-13
Last Posted Date
2020-01-02
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
292
Registration Number
NCT00697203

Pravastatin for Acute Myocardial Infarction With Minimally to Mildly Increased Levels of Serum Cholesterol Study

Phase 4
Conditions
Acute Myocardial Infarction
First Posted Date
2008-06-03
Last Posted Date
2008-12-02
Lead Sponsor
Osaka Acute Coronary Insufficiency Study Group
Target Recruit Count
400
Registration Number
NCT00688922
Locations
🇯🇵

Higashi-Osaka City General Hospital, Higashi-Osaka, Osaka, Japan

🇯🇵

Kawachi General Hospital, Higashi-Osaka, Osaka, Japan

🇯🇵

Kansai Rosai Hospital, Amagasaki, Hyogo, Japan

and more 6 locations

The Influence of Raltegravir on Pravastatin Pharmacokinetics(GRAPPA)

Phase 1
Completed
Conditions
HIV Infections
Interventions
First Posted Date
2008-04-24
Last Posted Date
2020-10-19
Lead Sponsor
Radboud University Medical Center
Target Recruit Count
24
Registration Number
NCT00665717
Locations
🇳🇱

Radboud University Nijmegen Medical Centre, Nijmegen, Gelderland, Netherlands

© Copyright 2025. All Rights Reserved by MedPath