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GlaxoSmithKline Obtains Exclusive U.S. OTC Marketing Rights to MEVACOR(R) (lovastatin) from Merck & Co., Inc.
Date:11/26/2007

nse results).

The results of a study in patients with primary hypercholesterolemia are presented in Table I.

TABLE I

MEVACOR vs. Placebo

(Mean Percent Change from Baseline After 6 Weeks)

LDL-C/ TOTAL-C/

DOSAGE N TOTAL-C LDL-C HDL-C HDL-C HDL-C TG.

Placebo 33 -2 -1 -1 0 +1 +9

MEVACOR

10 mg q.p.m. 33 -16 -21 +5 -24 -19 -10

20 mg q.p.m. 33 -19 -27 +6 -30 -23 +9

10 mg b.i.d. 32 -19 -28 +8 -33 -25 -7

40 mg q.p.m. 33 -22 -31 +5 -33 -25 -8

20 mg b.i.d. 36 -24 -32 +2 -32 -24 -6

MEVACOR was compared to cholestyramine in a randomized open parallel study. The study was performed with patients with hypercholesterolemia who were at high risk of myocardial infarction. Summary results are presented in Table II.

TABLE II

MEVACOR vs. Cholestyramine

(Percent Change from Baseline After 12 Weeks)

LDL-C/ TOTAL-C/

TREATMENT N TOTAL-C LDL-C HDL-C HDL-C HDL-C VLDL-C TG.

(mean) (mean) (mean) (mean) (mean) (median) (mean)

MEVACOR

20 mg b.i.d. 85 -27 -32 +9 -36 -31 -34 -21

40 mg b.i.d. 88 -34 -42 +8 -44 -37 -31 -27

Cholestyramine

12 g b.i.d. 88 -17 -23 +8 -27 -21 +2 +11

MEVACOR was studied in controlled trials in hypercholesterolemic patients with well-controlled non-insulin dependent diabetes mellitus with normal renal function. The effect
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SOURCE GlaxoSmithKline
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