Results from clinical studies presented at the 2005 European Atherosclerosis Society (EAS) annual meeting show that INEGY(tm) (ezetimibe/simvastatin) provided greater reductions in LDL-C than atorvastatin, and INEGY also has a positive effect on key atherogenic particles - apolipoprotein B (Apo B), apolipoprotein A-1 (Apo A-1) and C-reactive protein, a risk marker for atherosclerosis.1,2 INEGY is the first single tablet to provide powerful LDL cholesterol reduction by treating two sources of cholesterol - inhibiting the production of cholesterol mainly in the liver and inhibiting the absorption of cholesterol in the intestine. Atherogenic particles are found in the blood stream and are associated with atherosclerosis, the process by which arteries become narrow over time due to the formation of cholesterol plaques. In addition, INEGY demonstrated a greater reduction in Apo B/Apo A-1, an interesting finding as evaluating plasma levels of Apo B, Apo A-1 and CRP are emerging as possible additional ways to assess cardiovascular disease (CVD) risk.

Christie Ballantyne, M.D., director of the Center for Cardiovascular Disease Prevention, Methodist DeBakey Heart Center, Houston, Texas, U.S.A., and lead investigator of the clinical studies noted, "Recent data shows that INEGY, which treats the two sources of cholesterol, was more effective than atorvastatin in reducing LDL-C and achieving greater goal attainment. In addition, INEGY demonstrated a greater reduction in Apo B and Apo A-1, an interesting finding given ongoing research in identifying additional risk markers for heart disease."

Dr. Ballantyne presented similar data at the 2005 American College of Cardiology Annual Scientific Sessions. In that clinical study, INEGY demonstrated superior LDL-C lowering and greater goal attainment in comparison to atorvastatin, as well as comparable reductions in CRP.

INEGY was more effective than atorvastatin at reducing the ratio Apo B and Apo A-

The study, involving 1,902 patients with hypercholesterolemia, aimed to investigate the ratios between atherogenic particles (that increase atherosclerosis) and cardioprotective particles (that reduce atherosclerosis) after six weeks of treatment with either atorvastatin or INEGY, thus providing an indication of a potential cholesterol-depositing capacity of the blood during treatment with either therapy. The efficacy of INEGY and atorvastatin was monitored in terms of percent change improvement of Apo B/Apo A-I and non-HDL-C/HDL-C ratios at four milligram-equivalent statin dose comparisons (10, 20, 40, 80 mg) and averaged across dose ranges after six weeks of treatment, by total population and by baseline triglyceride level ( Commenting further on the data, Dr. Ballantyne said, "There is mounting evidence that aggressive lipid-lowering efficacy shows cardiovascular benefits for the patients studied. This leads many practitioners to conclude that lower LDL cholesterol is better, particularly when treating patients with multiple risk factors."

INEGY lowered hs-CRP similarly to atorvastatin

Further results of the study show that INEGY provides the same reduction in highly sensitive C-reactive protein (hs-CRP), an independent marker of CVD risk, as atorvastatin. Geometric mean reductions from baseline hs-CRP levels were similar averaged across dose ranges (INEGY 24.8 percent vs. atorvastatin 25.1 percent), and similar by milligram-equivalent statin does suggesting INEGY lowers hs-CRP similarly to atorvastatin across the dose ranges and by milligram-equivalent statin doses.

The lipid lowering effects of INEGY are consistent across gender, race, age and baseline LDL-C levels

Results of another trial presented at the meeting confirm the enhanced and consistently greater lipid-lowering effects of INEGY versus simvastatin across gender, race, age and baseline LDL-C levels, highlighting INEGY as an effective and reliable therapeutic option for the treatment of primary hypercholesterolemia.3 In the study, pooled data from three similarly designed studies was analyzed. After a six to eight week washout of lipid lowering drugs and four week diet / placebo run-in, 3,083 patients with LDL-C 3.8 - 6.5 mmol/L and triglycerides (TG) ??4.0mmol/L were randomized to receive either INEGY (10/10, 10/20, 10/40, 10/80 mg), simvastatin (10, 20, 30, 80 mg), EZETROL (10 mg), or placebo, for 12 weeks. The primary endpoint in each study was the percent change from baseline in LDL-C. Patient subgroups were defined according to gender, race, baseline age, and baseline LDL-C.

Treatment with INEGY led to significantly greater improvements in LDL-C, non HDL-C, Apo B, TG and CRP compared to simvastatin alone. Additionally, more patients attained LDL-C goal levels (