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Lescol (Fluvastatin Sodium) - Summary

 
 



LESCOL SUMMARY

LESCOL is a water-soluble cholesterol lowering agent which acts through the inhibition of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase.

Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other non-pharmacologic measures alone has been inadequate.

Hypercholesterolemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia

LESCOL and LESCOL XL are indicated

  • as an adjunct to diet to reduce elevated total cholesterol (Total-C), low-density lipoprotein cholesterol (LDL-C), triglyceride (TG) and apolipoprotein B (Apo B) levels, and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson Type IIa and IIb).
  • as an adjunct to diet to reduce Total-C, LDL-C, and Apo B levels in adolescent boys and adolescent girls who are at least one year post-menarche, 10-16 years of age, with heterozygous familial hypercholesterolemia and the following findings are present:
      LDL-C remains ≥ 190 mg/dL or
    • LDL-C remains ≥ 160 mg/dL and:
        there is a positive family history of premature cardiovascular disease or
      • two or more other cardiovascular disease risk factors are present

The NCEP classification of cholesterol levels in pediatric patients with a familial history of hypercholesterolemia or premature CVD is summarized below.

Category Total-C (mg/ dL ) LDL-C (mg/ dL )
Acceptable <170 <110
Borderline 170-199 110-129
High ≥200 ≥130

Children treated with fluvastatin in adolescence should be re-evaluated in adulthood and appropriate changes made to their cholesterol-lowering regimen to achieve adult treatment goals.

Secondary Prevention of Cardiovascular Disease

In patients with clinically evident CHD, LESCOL and LESCOL XL are indicated to:

  • reduce the risk of undergoing coronary revascularization procedures
  • slow the progression of coronary atherosclerosis
Limitations of Use

Neither LESCOL nor LESCOL XL have been studied in conditions where the major abnormality is elevation of chylomicrons, VLDL, or IDL (i.e., hyperlipoproteinemia Types I, III, IV, or V).


See all Lescol indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Lescol (Fluvastatin)

Hyperlipidemia: Causes, Diagnosis and Treatments
Source: Statins News From Medical News Today [2015.06.18]
Hyperlipidemia refers to increased levels of lipids in the blood, including cholesterol and triglycerides. Managing hyperlipidemia means controlling cholesterol and triglycerides.

more news >>

Published Studies Related to Lescol (Fluvastatin)

Fluvastatin does not prevent the acute-phase response to intravenous zoledronic acid in post-menopausal women. [2011.07]
The acute-phase response (APR) to aminobisphosphonates is triggered by activation of gammadelta T cells, resulting in pro-inflammatory cytokine release... In conclusion, intravenous zoledronic acid induced pro-inflammatory cytokine release and APR symptoms in the majority of study participants, which was not prevented by co-administration of fluvastatin.

Subtherapeutic, low-dose fluvastatin improves functional and morphological arterial wall properties in apparently healthy, middle-aged males--a pilot study. [2011.04]
OBJECTIVE: Early arterial wall changes are already present in the apparently healthy, middle-aged population and continuously progress with age. The aim of our study was to investigate whether 30 days low-dose fluvastatin treatment could improve and reverse these arterial changes that are primarily associated with ageing, in otherwise healthy middle-aged males... CONCLUSIONS: We found that subtherapeutic low-dose fluvastatin (10mg daily; 30 days) considerably improves and reverses early functional and morphological arterial wall impairments that are present in apparently healthy, middle-aged males. It might be supposed that such a new and original approach could be valuable in cardiovascular prevention. Copyright (c) 2011 Elsevier Ireland Ltd. All rights reserved.

Comparative study between high-dose fluvastatin and low-dose fluvastatin and ezetimibe with regard to the effect on endothelial function in diabetic patients. [2011]
It is well established that statins improve the prognosis of patients with coronary artery disease. However, it is still unclear whether the protective effects of statins relate to lipid lowering alone or whether other pleiotropic effects may contribute... These results suggest that high-dose fluvastatin might have pleiotropic effects of potential clinical benefit, and that the combination of ezetimibe with a reduced dose of fluvastatin may also significantly improve endothelial function with reduction of LDL-C and RLP-C.

Effects of add-on fluvastatin therapy in patients with chronic proteinuric nephropathy on dual renin-angiotensin system blockade: the ESPLANADE trial. [2010.11]
BACKGROUND AND OBJECTIVES: This open, prospective, randomized trial aimed to assess the effects of statins in chronic kidney disease patients on optimized antiproteinuric treatment with combined angiotensin-converting enzyme inhibition and angiotensin receptor blockade... CONCLUSIONS: In chronic kidney disease patients with residual proteinuria despite combined angiotensin-converting enzyme inhibitor and angiotensin receptor blockade therapy, add-on fluvastatin does not affect urinary proteins, but further reduces serum lipids and is safe. Whether combined angiotensin-converting enzyme inhibitor, angiotensin receptor blockade, and statin therapy may improve cardiovascular outcomes in this high-risk population is worth investigating.

Effects of fluvastatin therapy on serum interleukin-18 and interleukin-10 levels in patients with acute coronary syndrome. [2010.06]
CONCLUSION: Inflammation plays an important role in the initiation of acute coronary syndromes. Fluvastatin possesses an anti-inflammatory effect, independent of its lipid-lowering action.

more studies >>

Clinical Trials Related to Lescol (Fluvastatin)

Fluvastatin 80 mg Ret. vs Combination With Ezetimibe 10 mg in Patients With High Cardiovascular Risk [Completed]
Patients with coronary heart disease (CHD) or CHD equivalent (e. g. diabetes mellitus) often have abnormalities in lipids (hypercholesterolemia). Besides, hypercholesterolemia is an evident risk factor for atherosclerosis. Hitherto, there are only few studies of patients with primary hypercholesterolemia where the combination therapy with statins (HMG-Co-reductase inhibitors) and ezetimib was investigated. This combination therapy should be more effective in reducing low density lipoprotein cholesterol (LDL-C) and total cholesterol levels compared to monotherapy.

A Phase I Study to Determine the Effect of Mifepristone on the Pharmacokinetics of Fluvastatin in Healthy Volunteers [Completed]

The Effect of Fluvastatin XL� Treatment in Patients With Metabolic Syndrome [Completed]

This study evaluated safety, tolerability and efficacy of Fluvastatin XL - extended release

(80 mg once daily) in patients with metabolic syndrome

Fluvastatin, Rosuvastatin Added to Pegylated Interferon and Ribavirin [Completed]
Hypothesis: addition of fluvastatin will increase the cure rate of standard anti-HCV therapy. Summary: This trial is limited to veterans in Oklahoma who qualify for care with the Veterans Administration. It is a randomized control format including genotypes 1 and 3. There will also be pilot arms for HCV carriers who present for screening already on a statin, who will be allowed to stay on their current statin or switched to another statin. In all ways, standard therapy as noted on pegylated interferon and ribavirin will be given per FDA package insert.

Efficacy and Safety of Fluvastatin Sodium Extended Release Tablets 80 mg Once Daily in Chinese Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia [Completed]
This study is to demonstrate therapeutic comparability of Fluvastatin sodium Extended Release Tablets 80 mg QD and Fluvastatin sodium Immediate Release Capsules 40 mg BID in LDL-C lowering from baseline to week 12 (endpoint) in patients with primary hypercholesterolemia or mixed dyslipidemia at moderate or high CV risk who did not achieve their lipid goals when treated with Fluvastatin sodium Immediate Release Capsules 40 mg QD.

more trials >>

Reports of Suspected Lescol (Fluvastatin) Side Effects

Acute Respiratory Distress Syndrome (12)Eosinophilic Pneumonia (12)Myalgia (7)Arthralgia (5)Hypoxia (4)Pain in Extremity (4)Muscular Weakness (4)Respiratory Failure (4)Rhabdomyolysis (3)Fall (3)more >>


Page last updated: 2015-06-18

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