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Pravachol (Pravastatin Sodium) - Summary

 
 



PRAVACHOL 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.

PRIMARY PREVENTION OF CORONARY EVENTS

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.

SECONDARY PREVENTION OF CARDIOVASCULAR EVENTS

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.

HYPERLIPIDEMIA

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.


See all Pravachol indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Pravachol (Pravastatin)

Early use of statins decreases progression of serious form of kidney disease in children
Source: Statins News From Medical News Today [2014.05.13]
Results from a study by University of Colorado School of Medicine researchers show that pravastatin, a medicine widely used for treatment of high cholesterol, also slows down the growth of kidney...

more news >>

Published Studies Related to Pravachol (Pravastatin)

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.

Effect of pravastatin on the frequency of ventilator-associated pneumonia and on intensive care unit mortality: open-label, randomized study. [2011.11]
OBJECTIVE: To investigate whether the use of pravastatin reduces the frequency of ventilator-associated pneumonia and whether it is related to favorable outcomes in critical care patients... CONCLUSION: This study provides evidence that pravastatin may favorably affect the outcome of critical care patients.

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Clinical Trials Related to Pravachol (Pravastatin)

Fed, Bioequivalence Study of Pravastatin Sodium 80 mg Tablets Versus Pravachol® 80 mg Tablets In Subjects [Completed]
This study was designed to compare the rate and extent of absorption of pravastatin sodium from the following formulations under fed conditions:

1. Pravastatin Sodium 80 mg Tablets (Genpharm Inc. Canada)

2. Pravachol® 80 mg Tablets (Bristol-Myers Squibb Co., U. S.A.) Bioequivalence of these formulations was assessed for pravastatin.

Based on the results from this study, these two 80 mg pravastatin tablet formulations demonstrated bioequivalence under the single-dose fed conditions.

Fasting Bioequivalence Study of Pravastatin Sodium 80 mg Tablets Versus Pravachol® 80 mg Tablets In Normal Healthy Subjects [Completed]
The objective of this study was to compare the rate and extent of absorption of pravastatin sodium from a test formulation of Pravastatin Sodium 80 mg Tablets versus the reference Pravachol® 80 mg Tablets under fasting conditions.

Based on the results from this study, the two 80 mg pravastatin tablet formulations demonstrated bioequivalence under the single-dose fasting conditions.

A Study to Evaluate Daily Pravastatin, Fenofibrate or Pravafen in the Treatment of Combined Hyperlipidemia [Active, not recruiting]
This is a multi-center, double blind, prospective, longitudinal, randomized, 12-week study with a 52-week open-label follow-up to evaluate the safety and efficacy of daily administration of Pravastatin 40 mg or Fenofibrate 160 mg or Pravafen (the combination of both Pravastatin and Fenofibrate 40/160 mg) in the treatment of combined hyperlipidemia. There will be an open-label, 8-week, Selection Phase prior to randomization in which all patients will be stabilized on Pravastatin 40 mg/day. Following the Selection Phase, and if the patients meet all inclusion/exclusion criteria, they will be randomized to a three arm, double blind, 12-week Efficacy Phase during which they would receive either Pravastatin 40 mg or Fenofibrate 160 mg or Pravafen (the combination of Pravastatin and Fenofibrate 40/160 mg). The 12-week Efficacy Phase will be followed by an open-label, 52-week, Safety Phase in which all patients will receive Pravafen.

After the 8-week Selection Phase, patients that still meet the inclusion/exclusion criteria will be randomized on a 1: 1:2 ratio to Pravastatin 40 mg or Fenofibrate 160 mg or Pravafen (the combination of both Pravastatin and Fenofibrate 40/160 mg) for 12 weeks. After the completion of the 12-week double-blind phase of the study, all patients that haven't had changes in their well being, will be allowed to roll-over into the 52-week, open-label, follow-up portion of the study. During the 52 week, open label, Safety Phase of the study, all patients will receive Pravafen (the combination of Pravastatin and Fenofibrate 40/160 mg).

Patients will be evaluated at baseline and every three weeks thereafter throughout the initial 12-week Efficacy Phase of the study. Patients that roll-over into the 52-week, open-label, follow-up Safety Phase will be evaluated at 12, 24, 36 and 52 weeks.

Participation in the study can be up to 72 weeks.

Effects of Pravastatin on Cholesterol, Inflammation and Cognition in Schizophrenia [Recruiting]
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

Pravastatin for Prevention of Preeclampsia [Recruiting]
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.

more trials >>

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 >>


PATIENT REVIEWS / RATINGS / COMMENTS

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

  Rating
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: 2014-05-13

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