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Pravachol (Pravastatin Sodium) - Summary



PRAVACHOL® (pravastatin sodium) is one of a new class of lipid-lowering compounds, the HMG-CoA reductase inhibitors, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the enzyme catalyzing the early rate-limiting step in cholesterol biosynthesis, conversion of HMG-CoA to mevalonate.

Therapy with PRAVACHOL (pravastatin sodium) should be considered in those individuals at increased risk for atherosclerosis-related clinical events as a function of cholesterol level, the presence or absence of coronary heart disease, and other risk factors.


In hypercholesterolemic patients without clinically evident coronary heart disease, PRAVACHOL is indicated to:

- Reduce the risk of myocardial infarction

- Reduce the risk of undergoing myocardial revascularization procedures

- Reduce the risk of cardiovascular mortality with no increase in death from non-cardiovascular causes.


In patients with clinically evident coronary heart disease, PRAVACHOL is indicated to:

- Reduce the risk of total mortality by reducing coronary death

- Reduce the risk of myocardial infarction

- Reduce the risk of undergoing myocardial revascularization procedures

- Reduce the risk of stroke and stroke/transient ischemic attack (TIA)

- Slow the progression of coronary atherosclerosis.


PRAVACHOL (pravastatin sodium) is indicated as an adjunct to diet to reduce elevated Total-C, LDL-C, Apo B, and TG levels and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson Type IIa and IIb). 8

PRAVACHOL is indicated as adjunctive therapy to diet for the treatment of patients with elevated serum triglyceride levels (Fredrickson Type IV).

PRAVACHOL is indicated for the treatment of patients with primary dysbetalipoproteinemia (Fredrickson Type III) who do not respond adequately to diet.

PRAVACHOL is indicated as an adjunct to diet and life-style modification for treatment of HeFH in children and adolescent patients ages 8 years and older if after an adequate trial of diet the following findings are present.

  1. LDL-C remains >/=190 mg/dL or
  2. LDL-C remains >/=160 mg/dL and;
    - there is a positive family history of premature cardiovascular disease or
    - two or more other CVD risk factors are present in the patient.

Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when the response to diet and other nonpharmacological measures alone has been inadequate.

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Published Studies Related to Pravachol (Pravastatin)

Pravastatin Therapy and Biomarker Changes in Children and Young Adults with Autosomal Dominant Polycystic Kidney Disease. [2015]
mechanisms have not been elucidated... CONCLUSIONS: Pravastatin therapy diminished the increase of cyclooxygenase- and

Effect of pravastatin on endothelial function and endothelial progenitor cells in healthy postmenopausal women. [2012]
cholesterol and triglyceride levels... CONCLUSIONS: Despite beneficial effect on lipids and EPC, short term pravastatin

Effect of dalcetrapib plus pravastatin on lipoprotein metabolism and high-density lipoprotein composition and function in dyslipidemic patients: results of a phase IIb dose-ranging study. [2012]
with low or average HDL-C... CONCLUSIONS: Dalcetrapib up to 600 mg, combined with pravastatin, increased HDL-C

The differential effect of statins on oxidative stress and endothelial function: atorvastatin versus pravastatin. [2012]
oxidative stress and endothelial function... CONCLUSION: In hyperlipidemic subjects with metabolic syndrome, atorvastatin is

Long-term safety and efficacy of fenofibrate/pravastatin combination therapy in high risk patients with mixed hyperlipidemia not controlled by pravastatin monotherapy. [2011.11]
OBJECTIVE: To assess the long-term safety and efficacy of a fenofibrate/pravastatin 160/40 mg fixed-dose combination in high-risk patients with mixed hyperlipidemia not controlled by pravastatin 40 mg monotherapy... CONCLUSIONS: Long-term co-administration of fenofibrate/pravastatin 160/40 mg in a single capsule was well tolerated and produced complementary benefits on the overall lipid profile of high-risk patients with mixed hyperlipidemia not controlled by pravastatin 40 mg.

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Clinical Trials Related to Pravachol (Pravastatin)

Genetic Predictors of Variability in the Drug-drug Interaction Between Darunavir/Ritonavir and Pravastatin [Completed]
Pravastatin (Pravachol) is approved by the Food and Drug Administration (FDA) and is used to treat high cholesterol. Darunavir (Prezista) and ritonavir (Norvir) are approved by the Food and Drug Administration (FDA) to treat HIV infection. When darunavir and ritonavir are given with pravastatin, they can increase the blood levels of pravastatin. The degree of this interaction varies from person to person. The way that darunavir and ritonavir interact with pravastatin may be affected by a person's genetic make-up. Genetic factors (or DNA) are those that people are born with and that make each person unique. Genetic differences are the reason why one person's body traits such as height and hair color are different from another person's body traits. Genetic differences can also affect the way a medication works in the body or the way two medications interact in the body. The purpose of this clinical study is to determine if a person's genetic make-up affects the way darunavir and ritonavir interact with pravastatin in the body.

Pravastatin for Prevention of Preeclampsia [Completed]
The primary purpose of this pilot study is to determine the pharmacokinetic (PK) parameters and collect preliminary safety data for pravastatin when used as a prophylactic daily treatment in pregnant women at high risk of preeclampsia.

Pravastatin 80 mg Tablets Dosed in Healthy Subjects Under Non-Fasting Conditions [Completed]
This study compared the relative bioavailability (rate and extent of absorption) of Pravastatin Sodium Tablets 80 mg by Teva Pharmaceutical Industries, Ltd. with that of Pravachol« Tablets 80 mg by Bristol-Myers Squibb Company following a single oral dose (1 x 80 mg tablet)in healthy adult male subjects administered under non-fasting conditions.

The Influence of Raltegravir on Pravastatin Pharmacokinetics(GRAPPA) [Completed]

Effects of Pravastatin on Cholesterol, Inflammation and Cognition in Schizophrenia [Completed]
This study involves people with schizophrenia or schizoaffective disorder, who are currently taking antipsychotic medications. Some antipsychotic medications may cause an increase in cholesterol levels, which may lead to inflammation in the body. Inflammation poses a risk in developing heart disease, diabetes and problems with brain function. The purpose of this study is to see if pravastatin can:

- Lower cholesterol

- Decrease inflammation

- Improve cognition in patients with schizophrenia

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Reports of Suspected Pravachol (Pravastatin) Side Effects

Myalgia (21)Pain in Extremity (15)Arthralgia (14)Drug Ineffective (13)Drug Hypersensitivity (13)LOW Density Lipoprotein Increased (11)Musculoskeletal Pain (9)High Density Lipoprotein Decreased (7)Blood Cholesterol Increased (7)Nausea (7)more >>


Based on a total of 1 ratings/reviews, Pravachol has an overall score of 10. The effectiveness score is 10 and the side effect score is 10. The scores are on ten point scale: 10 - best, 1 - worst.

Pravachol review by 58 year old female patient

Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
Treatment Info
Condition / reason:   LDL Cholesterol
Dosage & duration:   20 mg taken once daily for the period of 60 days
Other conditions:   asthma and digestive disorder
Other drugs taken:   Albuterol, Zantac
Reported Results
Benefits:   Initial LDL cholesterol reduced from 320 to 230 after 60 days. Continuing to take Pravastatin to further reduce LDL cholesterol. HDL cholesterol is within normal range. Change in diet and weight reduction as recommended by Doctor is contributing to adjustment of cholesterol levels.
Side effects:   It is undetermined whether Pravastatin is responsible for the muscle pain and diarrhea I am experiencing daily. I had cronic back pain prior to taking Pravastatin and I am now having muscle cramps and significant joint pain. The chronic diarrhea began in 07/2009 before I started taking Pravastatin and lab testing has not revealed any cause for it.
Comments:   After taking Pravastatin for 60 days lab tests were performed to test liver function and cholesterol levels. After reviewing the test results I was told to continue taking Pravastatin for another 30 days and then get lab testing done again. My doctor also advised me to exercise more, loose some weight and eat more fruits and vegetables and less dairy and meat. I have lost 8 pounds and have committed to some regulation of my diet. I have eliminated eating from fast food restaurants.

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Page last updated: 2015-08-10

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