Lescol (Fluvastatin Sodium) - Summary

LESCOL SUMMARY

Lescol®

Lescol^® (fluvastatin sodium), 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 used in addition to a diet restricted in saturated fat and cholesterol (see National Cholesterol Education Program (NCEP) Treatment Guidelines, below).

Lescol^® (fluvastatin sodium) and Lescol^® XL (fluvastatin sodium) are indicated to reduce elevated total cholesterol (Total-C), LDL-C, TG and Apo B levels, and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson Type IIa and IIb) whose response to dietary restriction of saturated fat and cholesterol and other nonpharmacological measures has not been adequate.

In patients with coronary heart disease, Lescol and Lescol XL are indicated to reduce the risk of undergoing coronary revascularization procedures.

Lescol and Lescol XL are also indicated to slow the progression of coronary atherosclerosis in patients with coronary heart disease as part of a treatment strategy to lower total and LDL cholesterol to target levels.

Therapy with lipid-altering agents should be considered only after secondary causes for hyperlipidemia such as poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other medication, or alcoholism, have been excluded.

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NEWS HIGHLIGHTS

Published Studies Related to Lescol (Fluvastatin)

Fluvastatin and perioperative events in patients undergoing vascular surgery. [2009.09.03]
BACKGROUND: Adverse cardiac events are common after vascular surgery. We hypothesized that perioperative statin therapy would improve postoperative outcomes... CONCLUSIONS: In patients undergoing vascular surgery, perioperative fluvastatin therapy was associated with an improvement in postoperative cardiac outcome. (Current Controlled Trials number, ISRCTN83738615.) Massachusetts Medical Society

Does fluvastatin favour HCV replication in vivo? A pilot study on HIV-HCV coinfected patients. [2009.07]
Fluvastatin showed anti-hepatitis C virus (HCV) activity in vitro, through the inhibition of geranylgeranylation of cellular proteins, and a synergistic effect with interferon (IFN)-alpha. Nevertheless statins up-regulate low-density lipoprotein (LDL) receptor, required for HCV cell entry, and the closely related scavenger receptors SRBI and CD36; moreover they reduce class II major histocompatibility complex expression on antigen presenting cell, modulating T-cell activation.

Bisoprolol and fluvastatin for the reduction of perioperative cardiac mortality and myocardial infarction in intermediate-risk patients undergoing noncardiovascular surgery: a randomized controlled trial (DECREASE-IV). [2009.06]
OBJECTIVE: This study evaluated the effectiveness and safety of beta-blockers and statins for the prevention of perioperative cardiovascular events in intermediate-risk patients undergoing noncardiovascular surgery. SUMMARY BACKGROUND DATA: Beta-blockers and statins reduce perioperative cardiac events in high-risk patients undergoing vascular surgery by restoring the myocardial oxygen supply/demand balance and/or stabilizing coronary plaques. However, their effects in intermediate-risk patients remained ill-defined... CONCLUSION: Bisoprolol was associated with a significant reduction of 30-day cardiac death and nonfatal MI, while fluvastatin showed a trend for improved outcome.

Effect of fluvastatin on cardiac outcomes in kidney transplant patients with systemic lupus erythematosus: a randomized placebo-controlled study. [2009.04]
OBJECTIVE: Patients with systemic lupus erythematosus (SLE), with or without end-stage renal failure, are at increased risk of premature cardiovascular disease. Although statin therapy has been found to reduce cardiovascular risk in the general population, its effectiveness in kidney transplant recipients with SLE has not been examined. This study was undertaken to investigate the effect of fluvastatin on cardiac end points in a randomized controlled trial of renal transplant patients with SLE... CONCLUSION: Our results indicate that the effect of fluvastatin on cardiac events in renal transplant recipients with SLE is similar to that observed with statin therapy in the renal transplant population as a whole.

Reduced P-selectin in hearts pretreated with fluvastatin: a novel benefit for patients undergoing open heart surgery. [2009.03]
OBJECTIVE: P-selectin is an adhesion molecule that plays a role in the pathogenesis of atherosclerosis. The aim of this study was to assess whether or not the treatment with fluvastatin for 3 weeks preoperatively would reduce the levels of circulating P-selectin in patients with coronary heart disease undergoing coronary artery bypass grafting surgery (CABG)... CONCLUSIONS: Pretreatment with fluvastatin seemed to reduce P-selectin levels compared to patients given placebo, and hence, we think that pretreatment with a statin, fluvastatin in our study, might reduce the perioperative cardiac injury caused by cardiopulmonary bypass-induced inflammatory changes. We believe that routine preoperative use of fluvastatin should be carefully considered.

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Clinical Trials Related to Lescol (Fluvastatin)

Acetaminophen or Fluvastatin Compared to Placebo on the Transient Post-Dose Symptoms (PDS) Following an Intravenous (i.v.) Infusion of a Single Dose of Zoledronic Acid 5mg, in Post-Menopausal Women With Low Bone Mass [Completed]
This study will evaluate the efficacy of acetaminophen or fluvastatin in reducing the rate of occurrence and the severity of post dose symptoms that may occur during the 3 day period following a zoledronic acid infusion in post menopausal women with low bone mass.

Efficacy and Safety Study of Fluvastatin and Ezetimibe Combined Versus Fluvastatin Alone [Completed]
The objective of this study is to assess the effect of the combination treatment on C-reactive protein and inflammatory markers as well as the safety and tolerability in a Spanish population

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

Evaluation of the Effect of Fluvastatin 40 mg (b.i.d.) in the Prevention of the Development of Vasculopathy of the Graft in de Novo Renal Transplant Patients Transplant [Completed]
Principal objective is to investigate if the treatment with fluvastatin can prevent the progression of vascular graft disease in de novo renal transplant patients.

The Effect of Fluvastatin Treatment in Patients With Metabolic Syndrome [Completed]
This study will evaluate the safety, efficacy and tolerability of fluvastatin extended release (80 mg once daily) in patients with metabolic syndrome

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