Lescol XL (fluvastatin sodium) extended-release tablets - 3 indications

Scroll down for information on each indication:

• adjunctive therapy to diet in adult patients with primary hypercholesterolemia and mixed dyslipidemia; approved October 2000
• patients with coronary heart disease to reduce the risk of undergoing coronary revascularization procedures and to slow the progression of atherosclerosis in patients with CHD; approved May of 2003
• treatment of heterozygous familial hypercholesterolemia in adolescent boys and post-menarchal girls, ages 10 to 16 years old; approved April of 2006

General Information

Lescol XL (fluvastatin sodium) is an HMG-CoA reductase inhibitor (statin). 

Lescol XL is specifically indicated for the following conditions:

• 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

In patients with clinically evident Coronary Heart Disease (CHD):

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

Lescol XL is supplied extended-release tablets for oral administration. The recommended dose/administration is as follows:

Adult Patients:

• The recommended starting dose is one 80 mg tablet administered as a single dose at any time of the day.

Pediatric Patients (10 to 16 years of age) With Heterozygous Familial Hypercholesterolemia:

• The recommended starting dose is one 20 mg fluvastatin capsule. Dose adjustments, up to a maximum daily dose administered one Lescol XL 80 mg tablet once daily should be made at 6-week intervals. Doses should be individualized according to the goal of therapy.

Indication 1 -  adjunctive therapy to diet in adult patients with primary hypercholesterolemia and mixed dyslipidemia

approved October 2000

Clinical Trial Results

Lescol XL has been studied in five controlled studies of patients with primary hypercholesterolemia and mixed dyslipidemia. Lescol XL was administered to over 900 patients in trials from 4 to 26 weeks in duration. In the three largest of these studies, Lescol XL given as a single daily dose of 80 mg significantly reduced Total-C, LDL-C, TG and Apo B and resulted in increases in HDL-C. In patients with primary mixed dyslipidemia as defined by baseline plasma TG levels ≥ 200 mg/dL and < 400 mg/dL, treatment with Lescol XL produced significant decreases in Total-C, LDL-C, TG and Apo B and variable increases in HDL-C. 

Indication 2 - patients with coronary heart disease to reduce the risk of undergoing coronary revascularization procedures and to slow the progression of atherosclerosis in patients with CHD

approved May of 2003

Clinical Trial Results

In the LESCOL Intervention Prevention Study (LIPS), the effect of fluvastatin capsules 40 mg administered twice daily on the risk of recurrent cardiac events (time to first occurrence of cardiac death, nonfatal myocardial infarction, or revascularization) was assessed in 1677 patients with CHD who had undergone a percutaneous coronary intervention (PCI) procedure (mean time from PCI to randomization = 3 days). In this multicenter, randomized, double-blind, placebocontrolled study, patients were treated with dietary/lifestyle counseling and either fluvastatin 40 mg (n = 844) or placebo (n = 833) given twice daily for a median of 3.9 years. Fluvastatin capsules significantly reduced the risk of recurrent cardiac events by 22%. Revascularization procedures comprised the majority of the initial recurrent cardiac events (143 revascularization procedures in the fluvastatin capsules group and 171 in the placebo group). Consistent trends in risk reduction were observed in patients > 65 years of age. 

Indication 3 - heterozygous familial hypercholesterolemia in adolescent boys and post-menarchal girls, ages 10 to 16 years old

approved April of 2006

Clinical Trial Results

Fluvastatin sodium was studied in two open-label, uncontrolled, dose-titration studies. The first study enrolled 29 prepubertal boys, 9 to 12 years of age, who had an LDL-C level > 90th percentile for age and one parent with primary hypercholesterolemia and either a family history of premature ischemic heart disease or tendon xanthomas. The mean baseline LDL-C was 226 mg/dL (range 137-354 mg/dL). All patients were started on fluvastatin capsules 20 mg daily with dose adjustments every 6 weeks to 40 mg daily then 80 mg daily (40 mg twice daily) to achieve an LDL-C goal between 96.7 to 123.7 mg/dL. Endpoint analyses were performed at Year 2. Fluvastatin sodium decreased plasma levels of Total-C and LDL-C by 21% and 27%, respectively. The mean achieved LDL-C was 161 mg/dL (range 74-336 mg/dL).

The second study enrolled 85 male and female patients, 10 to 16 years of age, who had an LDL-C > 190 mg/dL or LDL-C > 160 mg/dL and one or more risk factors for coronary heart disease, or LDL-C > 160 mg/dL and a proven LDL-receptor defect. The mean baseline LDL-C was 225 mg/dL (range 148-343 mg/dL). All patients were started on fluvastatin capsules 20 mg daily with dose adjustments every 6 weeks to 40 mg daily then 80 mg daily (LESCOL 80 mg XL tablet) to achieve an LDL-C goal of < 130 mg/dL. Endpoint analyses were performed at Week 114. Fluvastatin sodium decreased plasma levels of Total-C and LDL-C by 22% and 28%, respectively. The mean achieved LDL-C was 159 mg/dL (range 90 to 295 mg/dL).