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

An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Homozygous Familial Hypercholesterolemia

First Posted Date
2018-04-27
Last Posted Date
2020-12-29
Lead Sponsor
Sanofi
Target Recruit Count
18
Registration Number
NCT03510715
Locations
🇩🇰

Investigational Site Number 2080001, Viborg, Denmark

🇪🇸

Investigational Site Number 7240001, A Coruna, Spain

🇸🇮

Investigational Site Number 7050001, Ljubljana, Slovenia

and more 7 locations

Statin Adjunctive Therapy for TB

Phase 2
Completed
Conditions
Tuberculosis
Interventions
First Posted Date
2018-03-07
Last Posted Date
2023-06-28
Lead Sponsor
Johns Hopkins University
Target Recruit Count
16
Registration Number
NCT03456102
Locations
🇿🇦

Chris Hani Baragwanath Hospital, Johannesburg, South Africa

Statin Therapy in Patients With Early Stage ADPKD

Phase 4
Active, not recruiting
Conditions
Autosomal Dominant Polycystic Kidney
ADPKD
Interventions
Drug: Placebo
First Posted Date
2017-09-06
Last Posted Date
2025-05-08
Lead Sponsor
University of Colorado, Denver
Target Recruit Count
150
Registration Number
NCT03273413
Locations
🇺🇸

University of Colorado Denver Anschutz Medical Campus, Denver, Colorado, United States

Pravastatin Intervention to Delay Hepatocellular Carcinoma Recurrence

Phase 2
Terminated
Conditions
Hepatocellular Carcinoma
Liver Cirrhoses
Interventions
Drug: Placebo Oral Tablet
First Posted Date
2017-07-17
Last Posted Date
2021-01-22
Lead Sponsor
Cedars-Sinai Medical Center
Target Recruit Count
1
Registration Number
NCT03219372
Locations
🇺🇸

Cedars-Sinai Medical Center, Los Angeles, California, United States

Effects of Concomitant Administration of BMS-986195 on Methotrexate, Caffeine, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin

First Posted Date
2017-04-27
Last Posted Date
2017-12-15
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
26
Registration Number
NCT03131973
Locations
🇺🇸

PPD Development, LP, Austin, Texas, United States

Prevention of Renal and Vascular Endstage Disease Intervention Trial

Phase 3
Completed
Conditions
Microalbuminuria
Renal Disease
Cardiovascular Diseases
Interventions
First Posted Date
2017-03-08
Last Posted Date
2017-03-10
Lead Sponsor
University Medical Center Groningen
Target Recruit Count
864
Registration Number
NCT03073018

Effect of Pravastatin on Erythrocyte Membrane Fatty Acid Contents in Patients With Chronic Kidney Disease

Phase 4
Completed
Conditions
Chronic Kidney Disease
Interventions
First Posted Date
2016-12-14
Last Posted Date
2019-03-11
Lead Sponsor
Dong-A University
Target Recruit Count
62
Registration Number
NCT02992548
Locations
🇰🇷

Inje University, Pusan Paik Hospital, Busan, Korea, Republic of

🇰🇷

Dong-A University, Busan, Korea, Republic of

Effect of Statin Use on Aldosterone Secretion

Phase 1
Completed
Conditions
Healthy Subjects
Interventions
First Posted Date
2016-08-18
Last Posted Date
2022-09-29
Lead Sponsor
Brigham and Women's Hospital
Target Recruit Count
103
Registration Number
NCT02871687
Locations
🇺🇸

Brigham and Women's Hospital- 221 Longwood Avenue, Boston, Massachusetts, United States

High Intensity Lipid Lowering Following Acute Coronary Syndromes for Persons Living With HIV

Phase 2
Completed
Conditions
Coronary Heart Disease
HIV Infection
Interventions
First Posted Date
2016-07-22
Last Posted Date
2022-10-18
Lead Sponsor
Matthew Feinstein
Target Recruit Count
10
Registration Number
NCT02841774
Locations
🇺🇸

Northwestern University, Chicago, Illinois, United States

Effect of Pravastatin in the Subjects With Prediabetes or Early Diabetes

Phase 4
Completed
Conditions
Prediabetic State
Diabetes Mellitus
Interventions
Behavioral: Nutritional education only
Drug: Placebo (for Pravastatin)
First Posted Date
2016-04-28
Last Posted Date
2018-09-13
Lead Sponsor
Samsung Medical Center
Target Recruit Count
44
Registration Number
NCT02754739
Locations
🇰🇷

Division of Endocrinology and Metabolism, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea, Republic of

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