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

Reversing External-beam Radiotherapy-associated Fibrosis Syndrome: an Interventional Bayesian Adaptive Randomized-controlled Orphan Drug Platform Trial for Orodental Sequelae (Reverse-fibrose)

Phase 2
Not yet recruiting
Conditions
Fibrosis Syndrome
Lymphedema
Head &Amp; Neck Cancer
Fibrosis
Interventions
First Posted Date
2025-04-06
Last Posted Date
2025-04-06
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
250
Registration Number
NCT06912763
Locations
🇺🇸

MD Anderson Cancer Center, Houston, Texas, United States

Systemic Therapy of Open-label Prophylactic Pravastatin or Pentoxifylline/Tocopherol Prevention of Lymphedema Advancing to Eventual Fibrosis: an Interventional Registry-embedded Bayesian Randomized Trial for Radiation Sequelae (STOP4-LATE-FIBROSE)

Phase 2
Not yet recruiting
Conditions
Lymphedema
Fibrosis
Interventions
First Posted Date
2024-07-10
Last Posted Date
2025-01-24
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
295
Registration Number
NCT06494111
Locations
🇺🇸

MD Anderson Cancer Center, Houston, Texas, United States

Detoxification From the Lipid Tract

Phase 4
Completed
Conditions
COVID-19 Vaccine Adverse Reaction
Interventions
Device: electroencephalogram biofeedback
Device: electrical brain stimulation
Device: ultra-low frequency transcranial magnetic stimulation
First Posted Date
2024-04-10
Last Posted Date
2024-04-10
Lead Sponsor
Pachankis, Yang I., M.D.
Target Recruit Count
1
Registration Number
NCT06357104
Locations
🇨🇳

Residential Address, Chongqing, Chongqing, China

IMProving DRug Dosing and Outcomes for Single VEntricle Patients With Fontan Associated Liver Disease

First Posted Date
2024-03-22
Last Posted Date
2025-03-17
Lead Sponsor
Children's Mercy Hospital Kansas City
Target Recruit Count
15
Registration Number
NCT06324396
Locations
🇺🇸

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

A Study to Evaluate the Drug-drug Interaction Potential of BMS-986196 in Healthy Participants

First Posted Date
2023-05-10
Last Posted Date
2023-09-26
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
18
Registration Number
NCT05852769
Locations
🇺🇸

ICON plc, Millcreek, Utah, United States

Pravastatin as a Prophylactic to Reduce Endothelial Injury in Pediatric Patients With Elevated Body Mass Index

Phase 1
Completed
Conditions
Hematopoietic Stem Cell Transplant (HSCT)
Endothelial Injury
Interventions
First Posted Date
2022-09-01
Last Posted Date
2025-04-18
Lead Sponsor
Children's Hospital Medical Center, Cincinnati
Target Recruit Count
25
Registration Number
NCT05524246
Locations
🇺🇸

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States

An Observational Study Investigating the Change in Blood Cholesterol With Mevalotin® Tablet Administration in Korean Menopausal Women Aged 50 Years or More Who Require Treatment of Dyslipidemia

Active, not recruiting
Conditions
Dyslipidemia
Interventions
First Posted Date
2021-11-15
Last Posted Date
2024-07-05
Lead Sponsor
Daiichi Sankyo
Target Recruit Count
3300
Registration Number
NCT05120895
Locations
🇰🇷

Inje University Haeundae Paik Hospital - Site 0031, Busan, Korea, Republic of

🇰🇷

Pusan National University Hospital - Site 0033, Busan, Korea, Republic of

🇰🇷

Hallym University Medical Center - Chuncheon, Chuncheon, Korea, Republic of

and more 55 locations

An Observational Study Investigating the Effectiveness of Pravastatin on Renal Function in Korean Dyslipidemic Patients With Type 2 Diabetes

Completed
Conditions
Dyslipidemia Associated With Type II Diabetes Mellitus
Interventions
First Posted Date
2021-11-04
Last Posted Date
2021-11-04
Lead Sponsor
Daiichi Sankyo
Target Recruit Count
2972
Registration Number
NCT05107063
Locations
🇰🇷

Dongguk University Ilsan Hospital, Goyang, Korea, Republic of

🇰🇷

Daegu Catholic University Medical Center, Daegu, Korea, Republic of

🇰🇷

HANIL General Hospital, Seoul, Korea, Republic of

and more 44 locations

Pravastatin Reduces Acute Phase Response of Zoledronic Acid

Phase 4
Conditions
Postmenopausal Osteoporosis
Interventions
First Posted Date
2021-01-22
Last Posted Date
2021-06-23
Lead Sponsor
Peking University Third Hospital
Target Recruit Count
110
Registration Number
NCT04719481

Impact of Metformin and Polysorbate 80 on Drug Absorption and Disposition

Phase 4
Completed
Conditions
Polysorbate 80
Bile Salt Export Pump (BSEP) Transporter
Interventions
Drug: valacyclovir, chenodeoxycholic acid, and enalaprilat, after polysorbate 80 and placebo
First Posted Date
2020-11-23
Last Posted Date
2024-07-16
Lead Sponsor
University of Maryland, Baltimore
Target Recruit Count
18
Registration Number
NCT04640571
Locations
🇺🇸

University of Maryland, Baltimore, Maryland, United States

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