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

Open Label Study for the Functional Characterization of Drug Metabolism and Transport

Phase 1
Completed
Conditions
Genotype-related Drug Metabolism
Interventions
First Posted Date
2013-02-11
Last Posted Date
2015-05-27
Lead Sponsor
Matthias Schwab
Target Recruit Count
144
Registration Number
NCT01788254
Locations
🇩🇪

Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology, Stuttgart, Germany

🇩🇪

Abteilung Klinische Pharmakologie, Tübingen, Germany

Pravastatin for Prevention of Preeclampsia

Phase 1
Completed
Conditions
Preeclampsia
Interventions
Drug: Placebo
First Posted Date
2012-10-30
Last Posted Date
2025-05-04
Lead Sponsor
The University of Texas Medical Branch, Galveston
Target Recruit Count
48
Registration Number
NCT01717586
Locations
🇺🇸

Northwestern University, Chicago, Illinois, United States

🇺🇸

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

🇺🇸

University of Pittsburgh, Pittsburgh, Pennsylvania, United States

Type II Diabetes Mellitus in Patients Exposed to Pravastatin and Paroxetine

First Posted Date
2012-05-21
Last Posted Date
2014-07-02
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
1
Registration Number
NCT01602913

Aspirin Mono Therapy 12-months After Drug-eluting Stents Implantation

First Posted Date
2012-03-19
Last Posted Date
2012-03-19
Lead Sponsor
Yonsei University
Target Recruit Count
2000
Registration Number
NCT01557075
Locations
🇰🇷

Hong Myeong-Ki, Seoul, Korea, Republic of

Effect of HAART Vs. Statin Treatment on Endothelial Function and Inflammation/Coagulation

First Posted Date
2012-01-24
Last Posted Date
2016-02-01
Lead Sponsor
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Registration Number
NCT01515813
Locations
🇺🇸

UCLA CARE Center CRS (601), Los Angeles, California, United States

🇺🇸

Regional Center for Infectious Disease, Wendover Medical Center CRS (3203), Greensboro, North Carolina, United States

🇺🇸

Houston AIDS Research Team CRS (31473), Houston, Texas, United States

and more 6 locations

Neointimal Coverage After Implantation of Biolimus Eluting Stent With Biodegradable Polymer: Optical Coherence Tomographic Assessment According to the Treatment of Dyslipidemia and Hypertension and the Types of Implanted Drug-eluting Stents

Phase 4
Completed
Conditions
Stable Angina or Acute Coronary Syndrome Considered for Percutaneous Coronary Intervention With Dyslipidemia or Hypertension
Interventions
Device: Sirolimus-eluting stent
Device: Biolimus-eluting stents
Drug: Non-ARB /day after DES implantation
Drug: Eposartan 600mg/day after DES implantation
First Posted Date
2012-01-02
Last Posted Date
2016-07-27
Lead Sponsor
Yonsei University
Target Recruit Count
120
Registration Number
NCT01502904
Locations
🇰🇷

Severance Hospital, Seoul, Korea, Republic of

Drug-Drug Interaction Study With Pravastatin and Cyclosporine

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2011-12-22
Last Posted Date
2015-01-16
Lead Sponsor
University of California, San Francisco
Target Recruit Count
21
Registration Number
NCT01497483
Locations
🇺🇸

San Francisco General Hosptail, San Francisco, California, United States

Longitudinal Study of Multi-Analyte Profile for Dyslipidemia

Not Applicable
Conditions
Dyslipidemia
Interventions
First Posted Date
2011-09-28
Last Posted Date
2012-04-16
Lead Sponsor
MaiHealth Inc
Target Recruit Count
40
Registration Number
NCT01441908
Locations
🇺🇸

Wake Research Associates, Raleigh, North Carolina, United States

Efficacy and Safety Study of Sorafenib Plus Pravastatin to Treat Advanced Hepatocarcinoma

Phase 2
Completed
Conditions
Advanced Hepatocarcinoma
Interventions
First Posted Date
2011-08-17
Last Posted Date
2017-09-20
Lead Sponsor
Hospital Donostia
Target Recruit Count
216
Registration Number
NCT01418729
Locations
🇪🇸

Hospital Donostia, Instituto Biodonostia, San Sebastian, Gipuzkoa, Spain

Palliative Treatment of Hepatocellular Carcinoma in Patient With CHILD B Cirrhosis

Phase 2
Completed
Conditions
Hepatocellular Carcinoma
CHILD B
Interventions
Other: patients receiving best supportive care
First Posted Date
2011-05-20
Last Posted Date
2017-05-01
Lead Sponsor
University Hospital, Bordeaux
Target Recruit Count
160
Registration Number
NCT01357486
Locations
🇫🇷

CHU Le Bocage, Dijon, France

🇫🇷

CHU de Nantes Hôpital de l'Hotel Dieu, Nantes, France

🇫🇷

CH d'Abbeville, Abbeville, France

and more 32 locations
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