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

Cyclosporine, Pravastatin Sodium, Etoposide, and Mitoxantrone Hydrochloride in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

Phase 1
Terminated
Conditions
Adult Acute Monoblastic Leukemia (M5a)
Adult Erythroleukemia (M6a)
Adult Pure Erythroid Leukemia (M6b)
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Acute Megakaryoblastic Leukemia (M7)
Recurrent Adult Acute Myeloid Leukemia
Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
Adult Acute Monocytic Leukemia (M5b)
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Del(5q)
Interventions
First Posted Date
2011-04-27
Last Posted Date
2017-07-02
Lead Sponsor
Fred Hutchinson Cancer Center
Target Recruit Count
6
Registration Number
NCT01342887
Locations
🇺🇸

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington, United States

A 12-Week Study Comparing Pitavastatin 4 mg vs. Pravastatin 40 mg in HIV-Infected Subjects

Phase 4
Completed
Conditions
Dyslipidemia
Interventions
First Posted Date
2011-02-23
Last Posted Date
2014-04-29
Lead Sponsor
Kowa Research Institute, Inc.
Target Recruit Count
252
Registration Number
NCT01301066

Curative Efficacy of Pravastatine in Patients Presented Delayed Cutaneous and Subcutaneous Radio-induced Fibrosis

Phase 2
Completed
Conditions
Fibrosis
Interventions
First Posted Date
2010-12-29
Last Posted Date
2019-06-13
Lead Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Target Recruit Count
61
Registration Number
NCT01268202
Locations
🇫🇷

Hôpital Européen Georges Pompidou, Paris, France

🇫🇷

Institut Gustave Roussy, Villejuif, France

🇫🇷

Centre Val d'Aurelle, Montpellier, France

Prevail-Us: A Study Of Pitavastatin 4 mg Vs. Pravastatin 40 mg In Patients With Primary Hyperlipidemia Or Mixed Dyslipidemia

Phase 4
Completed
Conditions
Primary Dyslipidemia
Mixed Dyslipidemia
Interventions
First Posted Date
2010-12-08
Last Posted Date
2012-05-08
Lead Sponsor
Kowa Research Institute, Inc.
Target Recruit Count
328
Registration Number
NCT01256476

A Drug-Drug Interaction Study Between AZD1981 and Pravastatin to Study the Effect of AZD1981 on the Kinetics of Pravastatin

Phase 1
Completed
Conditions
Drug Interaction
Interventions
First Posted Date
2010-12-06
Last Posted Date
2011-04-29
Lead Sponsor
AstraZeneca
Target Recruit Count
30
Registration Number
NCT01254461
Locations
🇸🇪

Research Site, Uppsala, Sweden

Primary Prevention of Major Adverse Cardiac Events (MACE) With Standard and Intensive Statin Treatment in Patients With Diabetes: Survival and Cardiovascular Event Assessments

Not Applicable
Terminated
Conditions
Hypercholesterolemia
Type 2 Diabetes
Hypertension
Interventions
First Posted Date
2010-08-02
Last Posted Date
2011-06-01
Lead Sponsor
Positive Trial Group
Target Recruit Count
10000
Registration Number
NCT01173939
Locations
🇯🇵

Seiwadai Clinic, Kitakatsuragi gun, Nara pref., Japan

🇯🇵

Sato Clinic, Suzaka city, Nagano pref., Japan

🇯🇵

Abies Clinic, Fukuoka city, Fukuoka pref., Japan

and more 306 locations

Bioequivalence Study of Pravastatin Sodium Tablets 80 mg Under Fed Conditions

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2010-06-17
Last Posted Date
2012-01-13
Lead Sponsor
Dr. Reddy's Laboratories Limited
Target Recruit Count
24
Registration Number
NCT01146093

Bioequivalence Study of Pravastatin Sodium Tablets 80 mg Under Fasting Conditions

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2010-06-17
Last Posted Date
2010-06-17
Lead Sponsor
Dr. Reddy's Laboratories Limited
Target Recruit Count
43
Registration Number
NCT01146106

Effects of Pravastatin on Cholesterol, Inflammation and Cognition in Schizophrenia

Phase 4
Completed
Conditions
Schizophrenia
Schizophreniform Disorders
Schizoaffective Disorders
Interventions
Drug: Placebo
First Posted Date
2010-03-08
Last Posted Date
2014-04-28
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
60
Registration Number
NCT01082588
Locations
🇺🇸

Freedom Trail Clinic, Boston, Massachusetts, United States

Sorafenib Tosylate With or Without Pravastatin in Treating Patients With Liver Cancer and Cirrhosis

Phase 3
Completed
Conditions
Liver Cancer
Interventions
First Posted Date
2010-02-25
Last Posted Date
2020-03-30
Lead Sponsor
Federation Francophone de Cancerologie Digestive
Target Recruit Count
323
Registration Number
NCT01075555
Locations
🇫🇷

Hopital Du Bocage, Dijon, France

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