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GlaxoSmithKline Obtains Exclusive U.S. OTC Marketing Rights to MEVACOR(R) (lovastatin) from Merck & Co., Inc.

nt boys and girls who are at least one year post-menarche, 10-17 years of age, with heFH if after an adequate trial of diet therapy the following findings are present:

1. LDL-C remains >189 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 adolescent


General Recommendations

Prior to initiating therapy with lovastatin, secondary causes for hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism) should be excluded, and a lipid profile performed to measure total-C, HDL-C, and TG. For patients with TG less than 400 mg/dL (<4.5 mmol/L), LDL-C can be estimated using the following equation:

LDL-C = total-C - [0.2 x (TG) + HDL-C]

For TG levels >400 mg/dL (>4.5 mmol/L), this equation is less accurate and LDL-C concentrations should be determined by ultracentrifugation. In hypertriglyceridemic patients, LDL-C may be low or normal despite elevated total-C. In such cases, MEVACOR is not indicated.

The National Cholesterol Education Program (NCEP) Treatment Guidelines are summarized below:

NCEP Treatment Guidelines:

LDL-C Goals and Cutpoints for Therapeutic Lifestyle Changes

and Drug Therapy in Different Risk Categories

LDL Level at Which

LDL Goal to Initiate LDL Level at Which

Risk Category (mg/dL) Therapeutic to Consider Drug

Lifestyle Changes Therapy

(mg/dL) (mg/dL)

CHD+ or CHD risk <100 Greater Than or Equal Greater Than or Equal


SOURCE GlaxoSmithKline
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