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

of MEVACOR on lipids and lipoproteins and the safety profile of MEVACOR were similar to that demonstrated in studies in nondiabetics. MEVACOR had no clinically important effect on glycemic control or on the dose requirement of oral hypoglycemic agents.

Expanded Clinical Evaluation of Lovastatin (EXCEL) Study

MEVACOR was compared to placebo in 8,245 patients with hypercholesterolemia (total-C 240-300 mg/dL [6.2 mmol/L - 7.6 mmol/L], LDL-C >160 mg/dL [4.1 mmol/L]) in the randomized, double-blind, parallel, 48-week EXCEL study. All changes in the lipid measurements (Table III) in MEVACOR treated patients were dose-related and significantly different from placebo (p Less Than or Equal To 0.001). These results were sustained throughout the study.

TABLE III

MEVACOR vs. Placebo

(Percent Change from Baseline --

Average Values Between Weeks 12 and 48)

LDL-C/ TOTAL-C/

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

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

Placebo 1663 +0.7 +0.4 +2.0 +0.2 +0.6 +4

MEVACOR

20 mg q.p.m. 1642 -17 -24 +6.6 -27 -21 -10

40 mg q.p.m. 1645 -22 -30 +7.2 -34 -26 -14

20 mg b.i.d. 1646 -24 -34 +8.6 -38 -29 -16

40 mg b.i.d. 1649 -29 -40 +9.5 -44 -34 -19

**Patients enrolled

Air Force/Texas Coronary Atherosclerosis Prevention Study (AFCAPS/TexCAPS)

The Air Force/Texas Coronary Atherosclerosis Prevention Study (AFCAPS/TexCAPS), a double-blind, randomized, placebo-controlled, primary prevention study, demonstrated that treatment with MEVACOR decreased the rate of acute major coronary events (composite endpoi
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SOURCE GlaxoSmithKline
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