MedPath

Pravastatin

Generic Name
Pravastatin
Brand Names
-
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
Associated Therapies
-

Statin Distribution

Phase 1
Completed
Conditions
Drug Distribution
Interventions
First Posted Date
2015-02-11
Last Posted Date
2017-07-19
Lead Sponsor
Children's Mercy Hospital Kansas City
Target Recruit Count
32
Registration Number
NCT02360826
Locations
🇺🇸

Children's Mercy Hospital, Kansas City, Missouri, United States

Pharmacodynamics, Preliminary Pharmacokinetics and Tolerability of BIBB 515 BS or Pravastatin in Hyperlipemic Healthy Male Subjects

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: BIBB 515 BS
Drug: Placebo
Drug: Pravastatin
First Posted Date
2014-10-17
Last Posted Date
2014-10-17
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
60
Registration Number
NCT02266485

Pharmacodynamics, Preliminary Pharmacokinetics and Tolerability of BIBB 1464 (Tablet) in Hyperlipemic Healthy Male Subjects

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: BIBB 1464 MS medium dose
Drug: BIBB 1464 MS low dose
Drug: BIBB 1464 MS high dose
Drug: Placebo
Drug: Pravastatin
First Posted Date
2014-09-01
Last Posted Date
2014-09-01
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
100
Registration Number
NCT02229773

Statins: A New Therapeutic Option for Treatment of Patients With Endometriosis

Not Applicable
Withdrawn
Conditions
Endometriosis
Interventions
First Posted Date
2014-03-06
Last Posted Date
2020-08-28
Lead Sponsor
Dr. Robert F. Casper
Registration Number
NCT02079974
Locations
🇨🇦

Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada

A Study of Evacetrapib in Japanese and Non-Japanese Participants

Phase 1
Completed
Conditions
Healthy Volunteers
Interventions
First Posted Date
2013-10-09
Last Posted Date
2018-10-09
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
24
Registration Number
NCT01958489
Locations
🇬🇧

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Leeds, West Yorkshire, United Kingdom

Repeated Dose Study for the Investigation of Heritability of and Genetic Influences on Drug Pharmacokinetics

Phase 1
Completed
Conditions
Drug Biotransformation
Membrane Transport
Interventions
First Posted Date
2013-05-03
Last Posted Date
2014-04-21
Lead Sponsor
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
Target Recruit Count
117
Registration Number
NCT01845194
Locations
🇩🇪

Dept. of Clinical Pharmacology, Georg-August-University of Goettingen, Goettingen, Germany

Lipid Lowering Agents to Limit Lipid Oxidation and Activation of Clotting System in Nephrotic Syndrome

Phase 1
Completed
Conditions
Nephrotic Syndrome
Hyperlipidemia
Interventions
First Posted Date
2013-05-03
Last Posted Date
2018-08-29
Lead Sponsor
University of North Carolina, Chapel Hill
Target Recruit Count
7
Registration Number
NCT01845428
Locations
🇺🇸

Unc Kidney Center, Chapel Hill, North Carolina, United States

Idarubicin, Cytarabine, and Pravastatin Sodium in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes

Not Applicable
Completed
Conditions
Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Adult Pure Erythroid Leukemia (M6b)
Chronic Myelomonocytic Leukemia
Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
Untreated Adult Acute Myeloid Leukemia
Adult Acute Megakaryoblastic Leukemia (M7)
Adult Acute Monoblastic Leukemia (M5a)
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Monocytic Leukemia (M5b)
Interventions
First Posted Date
2013-04-15
Last Posted Date
2017-11-17
Lead Sponsor
Fred Hutchinson Cancer Center
Target Recruit Count
24
Registration Number
NCT01831232
Locations
🇺🇸

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

The Statins on Glucose Homeostasis in Subjects With Impaired Fasting Glucose

Phase 4
Conditions
Diabetes
Interventions
First Posted Date
2013-03-22
Last Posted Date
2013-11-18
Lead Sponsor
Taipei Veterans General Hospital, Taiwan
Target Recruit Count
160
Registration Number
NCT01816997
Locations
🇨🇳

Taipei Veterans General Hospital, Taipei, Taiwan

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

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