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.

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NEWS HIGHLIGHTS

Published Studies Related to Pravachol (Pravastatin)

Risk factors for stroke and lipid-lowering effect of pravastatin on the risk of stroke in Japanese patients with hypercholesterolemia: analysis of data from the MEGA Study, a large randomized controlled trial. [2009.09.15]
BACKGROUND: The aims of this study were to clarify the risk factors for stroke, and to investigate the effect of low-density lipoprotein cholesterol (LDL-C) lowering with pravastatin on the risk of stroke, in Japanese mild-to-moderately hypercholesterolemic patients enrolled in the MEGA Study... CONCLUSIONS: Male sex, aging, hypertension, diabetes, low HDL-C, high Lp(a), obesity, and smoking were determined as risk factors for stroke in Japanese patients with hypercholesterolemia, and the observed risk reduction could not be explained by pravastatin's LDL-C-lowering effect alone, suggesting pleiotropic effects.

Circulating angiopoietin-2 in essential hypertension: relation to atherosclerosis, vascular inflammation, and treatment with olmesartan/pravastatin. [2009.08]
BACKGROUND: Endothelial activation has emerged as an early event in the pathogenesis of cardiovascular disease. Angiopoietin-2 (Ang-2) has been identified as a nonredundant endothelial-specific facilitator of vascular responsiveness to inflammatory stimuli. We have earlier shown that angiotensin II receptor blocker (ARB) reduces mediators of vascular inflammation in hypertension and cardiovascular disease. We aimed at studying the effect of ARB and/or 3-hydroxy-3-methyl-glutaryl-CoA blockade on Ang-2 and the association between vascular inflammation markers and Ang-2 levels in hypertensive patients... CONCLUSION: Ang-2 concentrations are elevated in hypertensive patients, particularly those with atherosclerosis, possibly reflecting pronounced endothelial activation. ARBs effectively decreased several inflammatory mediators, but did not affect vascular responsiveness in an Ang-2-dependent manner. Elevated Ang-2 levels in hypertensive patients correlate with adhesion molecules.

Differential metabolic effects of pravastatin and simvastatin in hypercholesterolemic patients. [2009.06]
BACKGROUND: Lipophilic and hydrophilic statins have different effects on adiponectin and insulin resistance in experimental studies and different effects on the rate of onset of new diabetes in large scale clinical studies. Therefore, we hypothesized that simvastatin and pravastatin may have differential metabolic effects in hypercholesterolemic patients... CONCLUSIONS: Despite causing comparable changes in lipoprotein and endothelium-dependent dilation, simvastatin and pravastatin therapy had differential metabolic effects in hypercholesterolemic patients that may be clinically relevant.

Seasonal variation in lipids in patients following acute coronary syndrome on fixed doses of Pravastatin (40 mg) or Atorvastatin (80 mg) (from the Pravastatin or Atorvastatin Evaluation and Infection Therapy-Thrombolysis In Myocardial Infarction 22 [PROVE IT-TIMI 22] Study). [2009.04.15]
Previous studies have shown seasonal variation in lipids. To understand whether this variation exists in patients with acute coronary syndromes receiving statins, we examined data from the PROVE IT-TIMI 22 Study...

Effects of pravastatin on functional capacity in patients with chronic obstructive pulmonary disease and pulmonary hypertension. [2009.03]
PH (pulmonary hypertension) often complicates the disease course of patients with COPD (chronic obstructive pulmonary disease) and is an indication of a worse prognosis. In the present study, we assessed whether pravastatin administration was effective in improving PH and exercise capacity in COPD patients with PH, and whether the pulmonary protection was mediated by inhibiting ET-1 (endothelin-1) production...

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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.

Efficacy and Safety Study of JTT-705 in Combination With Pravastatin 40 mg in Patients With Type II Hyperlipidemia [Completed]
The purpose of this study is to evaluate the effect of two dose levels of JTT-705 when co-administered with pravastatin 40 mg on HDL-C and LDL-C and the inhibition rate of CETP activity and to document short term safety.

Comparison of the Combination of Fenofibrate and Simvastatin Versus Pravastatin [Active, not recruiting]
Mixed or combined hyperlipidemia is a common metabolic disorder characterized by both hypercholesterolemia and hypertriglyceridemia. Statins and fibrates have complementary mechanisms and can be coadministered to patients with mixed hyperlipidemia. The overall objective of the study is to compare the efficacy and safety of combining fenofibrate and simvastatin versus pravastatin monotherapy in patients with mixed hyperlipidemia at risk of cardiovascular diseases.

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