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

Study to Evaluate Organic Anion Transporting Polypeptide (OATP) Transporter-Mediated Drug-Drug Interactions Between Filgotinib and Statins as Probe Drugs in Healthy Participants

Phase 1
Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2020-10-29
Last Posted Date
2022-06-14
Lead Sponsor
Gilead Sciences
Target Recruit Count
27
Registration Number
NCT04608344
Locations
🇺🇸

Prism Research, LLC, Saint Paul, Minnesota, United States

Evaluation of Pharmacokinetic Interaction Between GSK3640254 and Caffeine, Metoprolol, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin in Healthy Adults

First Posted Date
2020-06-11
Last Posted Date
2024-01-05
Lead Sponsor
ViiV Healthcare
Target Recruit Count
20
Registration Number
NCT04425902
Locations
🇺🇸

GSK Investigational Site, Las Vegas, Nevada, United States

Improving Theempowerment in Patients With Severe Breast Fibrosis Radio-induced Treated by Pravastatin : Benefit of e-PROs (Electronic " Patient Reported Outcome ") on Breast-related Quality of Life

Phase 2
Recruiting
Conditions
Breast Cancer
Interventions
Other: e-PRO Intervention
First Posted Date
2020-04-22
Last Posted Date
2025-02-12
Lead Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
Target Recruit Count
105
Registration Number
NCT04356209
Locations
🇫🇷

ICM Val d'Aurelle, Montpellier, France

Pravastatin and Alkali Therapy in Patients With Autosomal Dominant Polycystic Kidney Disease

Phase 2
Conditions
Autosomal Dominant Polycystic Kidney Disease
Interventions
First Posted Date
2020-02-26
Last Posted Date
2024-04-29
Lead Sponsor
University of Southern California
Target Recruit Count
30
Registration Number
NCT04284657
Locations
🇺🇸

Keck School of Medicine of University of Southern California, Los Angeles, California, United States

Autophagy Activation for the Alleviation of Cardiomyopathy Symptoms After Anthracycline Treatment, ATACAR Trial

Phase 2
Withdrawn
Conditions
Lymphoma
Hematopoietic and Lymphoid Cell Neoplasm
Breast Carcinoma
Sarcoma
Interventions
First Posted Date
2019-12-09
Last Posted Date
2023-05-24
Lead Sponsor
Mayo Clinic
Registration Number
NCT04190433

Pravastatin to Prevent Preeclampsia

Phase 3
Terminated
Conditions
Preeclampsia
Obstetric Labor Complications
Hypertension in Pregnancy
Interventions
Other: Placebo
First Posted Date
2019-05-09
Last Posted Date
2024-07-09
Lead Sponsor
The George Washington University Biostatistics Center
Target Recruit Count
50
Registration Number
NCT03944512
Locations
🇺🇸

Magee Women's Hospital of UPMC, Pittsburgh, Pennsylvania, United States

🇺🇸

University of Texas Medical Branch, Galveston, Texas, United States

🇺🇸

Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States

and more 9 locations

StAT-TB (Statin Adjunctive Therapy for TB): A Phase 2b Dose-finding Study of Pravastatin in Adults With Tuberculosis

Phase 2
Completed
Conditions
Tuberculosis
Pulmonary Tuberculosis
Interventions
Drug: Rifafour
Dietary Supplement: Vitamin B6
First Posted Date
2019-03-20
Last Posted Date
2023-09-18
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
16
Registration Number
NCT03882177
Locations
🇿🇦

PHRU Non-Network CRS, Johannesburg, Gauteng, South Africa

Drug-Drug Interaction Study of Vadadustat With Rosuvastatin, Sulfasalazine, Pravastatin, Atorvastatin and Simvastatin

First Posted Date
2019-01-11
Last Posted Date
2019-03-22
Lead Sponsor
Akebia Therapeutics
Target Recruit Count
134
Registration Number
NCT03801733
Locations
🇨🇦

InVentiv Health Clinique Inc., Québec City, Quebec, Canada

Indonesia Pravastatin to Prevent Preeclampsia Study

Phase 2
Conditions
Pre-Eclampsia
Interventions
First Posted Date
2018-08-28
Last Posted Date
2018-08-28
Lead Sponsor
Universitas Airlangga
Target Recruit Count
280
Registration Number
NCT03648970
Locations
🇮🇩

Adam Malik General Hospital, Medan, North Sumatra, Indonesia

🇮🇩

Dr. Wahidin Sudirohusodo General Hospital, Makasar, South Sulawesi, Indonesia

🇮🇩

Hasan Sadikin General Hospital, Bandung, West Java, Indonesia

and more 4 locations

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

First Posted Date
2018-04-27
Last Posted Date
2023-05-06
Lead Sponsor
Sanofi
Target Recruit Count
153
Registration Number
NCT03510884
Locations
🇪🇸

Investigational Site Number :7240003, Pamplona, Navarra, Spain

🇵🇱

Investigational Site Number :6160002, Gdansk, Pomorskie, Poland

🇲🇽

Investigational Site Number :4840007, Oaxaca, Mexico

and more 40 locations
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