Lovastatin (Page 4 of 11)

Eye

There was a high prevalence of baseline lenticular opacities in the patient population included in the early clinical trials with lovastatin. During these trials the appearance of new opacities was noted in both the lovastatin and placebo groups. There was no clinically significant change in visual acuity in the patients who had new opacities reported nor was any patient, including those with opacities noted at baseline, discontinued from therapy because of a decrease in visual acuity.

A three-year, double-blind, placebo-controlled study in hypercholesterolemic patients to assess the effect of lovastatin on the human lens demonstrated that there were no clinically or statistically significant differences between the lovastatin and placebo groups in the incidence, type or progression of lenticular opacities. There are no controlled clinical data assessing the lens available for treatment beyond three years.

Clinical Studies in Adolescent Patients

Efficacy of Lovastatin in Adolescent Boys With Heterozygous Familial Hypercholesterolemia

In a double-blind, placebo-controlled study, 132 boys 10 to 17 years of age (mean age 12.7 yrs) with heterozygous familial hypercholesterolemia (heFH) were randomized to lovastatin (n = 67) or placebo (n = 65) for 48 weeks. Inclusion in the study required a baseline LDL-C level between 189 and 500 mg/dL and at least one parent with an LDL-C level > 189 mg/dL. The mean baseline LDL-C value was 253.1 mg/dL (range: 171 to 379 mg/dL) in the lovastatin group compared to 248.2 mg/dL (range: 158.5 to 413.5 mg/dL) in the placebo group. The dosage of lovastatin (once daily in the evening) was 10 mg for the first 8 weeks, 20 mg for the second 8 weeks, and 40 mg thereafter.

Lovastatin significantly decreased plasma levels of total-C, LDL-C and apolipoprotein B (see TABLE V).

TABLE V: Lipid-Lowering Effects of Lovastatin in Adolescent Boys With Heterozygous Familial Hypercholesterolemia (Mean Percent Change From Baseline at Week 48 in Intention-to-Treat Population)

DOSAGE

N

TOTAL-C

LDL-C

HDL-C

TG.1

Apolipoprotein B

Placebo

61

-1.1

-1.4

-2.2

-1.4

-4.4

Lovastatin

64

-19.3

-24.2

+1.1

-1.9

-21

  1. data presented as median percent changes

The mean achieved LDL-C value was 190.9 mg/dL (range: 108 to 336 mg/dL) in the lovastatin group compared to 244.8 mg/dL (range: 135 to 404 mg/dL) in the placebo group.

Efficacy of Lovastatin in Post-Menarchal Girls With Heterozygous Familial Hypercholesterolemia

In a double-blind, placebo-controlled study, 54 girls 10 to 17 years of age who were at least 1 year post-menarche with heFH were randomized to lovastatin (n = 35) or placebo (n = 19) for 24 weeks. Inclusion in the study required a baseline LDL-C level of 160 to 400 mg/dL and a parental history of familial hypercholesterolemia. The mean baseline LDL-C value was 218.3 mg/dL (range: 136.3 to 363.7 mg/dL) in the lovastatin group compared to 198.8 mg/dL (range: 151.1 to 283.1 mg/dL) in the placebo group. The dosage of lovastatin (once daily in the evening) was 20 mg for the first 4 weeks, and 40 mg thereafter.

Lovastatin significantly decreased plasma levels of total-C, LDL-C, and apolipoprotein B (see TABLE VI).

TABLE VI: Lipid-Lowering Effects of Lovastatin in Post-Menarchal Girls With Heterozygous Familial Hypercholesterolemia (Mean Percent Change From Baseline at Week 24 in Intention-to-Treat Population)

DOSAGE

N

TOTAL-C

LDL-C

HDL-C

TG.1

Apolipoprotein B

Placebo

18

+3.6

+2.5

+4.8

-3.0

+6.4

Lovastatin

35

-22.4

-29.2

+2.4

-22.7

-24.4

  1. data presented as median percent changes

The mean achieved LDL-C value was 154.5 mg/dL (range: 82 to 286 mg/dL) in the lovastatin group compared to 203.5 mg/dL (range: 135 to 304 mg/dL) in the placebo group.

The safety and efficacy of doses above 40 mg daily have not been studied in children. The long-term efficacy of lovastatin therapy in childhood to reduce morbidity and mortality in adulthood has not been established.

INDICATIONS AND USAGE

Therapy with Lovastatin Tablets should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. Lovastatin Tablets should be used in addition to a diet restricted in saturated fat and cholesterol as part of a treatment strategy to lower total-C and LDL-C to target levels when the response to diet and other nonpharmacological measures alone has been inadequate to reduce risk.

Primary Prevention of Coronary Heart Disease

In individuals without symptomatic cardiovascular disease, average to moderately elevated total-C and LDL-C, and below average HDL-C, Lovastatin Tablets are indicated to reduce the risk of:

- Myocardial infarction

- Unstable angina

- Coronary revascularization procedures

(See CLINICAL PHARMACOLOGY , Clinical Studies in Adults.)

Coronary Heart Disease

Lovastatin Tablets are indicated to slow the progression of coronary atherosclerosis in patients with coronary heart disease as part of a treatment strategy to lower total-C and LDL-C to target levels.

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