New Study Showed VYTORIN® Superior to Lipitor in Reducing LDL ''Bad'' Cholesterol in Patients with Type II Diabetes at the Recommended Usual Starting Doses

Business Wire,  June 10, 2006  

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WASHINGTON -- Greater LDL Cholesterol Reduction with VYTORIN Compared to Lipitor Resulted in Greater LDL Cholesterol Goal Attainment

Results from a new clinical study conducted in 1,229 patients with type 2 diabetes mellitus and high cholesterol showed that VYTORIN(R) (ezetimibe/simvastatin) provided superior reduction in LDL "bad" cholesterol compared to Lipitor(R) (atorvastatin) in comparisons of the recommended usual starting doses, according to data presented today at the American Diabetes Association's (ADA) 66th Annual Scientific Session. The primary efficacy endpoint was the percent change from baseline to the end of the six-week treatment period in LDL cholesterol.

VYTORIN, which contains ezetimibe and simvastatin, is the first and only product approved to treat the two sources of cholesterol by inhibiting the production of cholesterol in the liver and blocking the absorption of cholesterol in the intestine, including cholesterol from food. VYTORIN is marketed as INEGY in many countries outside the U.S.

At the recommended usual starting doses of both agents, VYTORIN 10/20 mg demonstrated a 53.6 mean percent reduction from baseline in LDL cholesterol as compared to a 38.3 percent reduction observed with Lipitor 10 mg and a 44.6 percent reduction with Lipitor 20 mg. At the alternative starting dose for patients requiring greater LDL lowering for the two agents (> 55 percent for VYTORIN and > 45 percent for Lipitor), VYTORIN 10/40 mg, decreased LDL cholesterol significantly more than Lipitor 40 mg -- 57.6 percent compared to 50.9 percent, respectively, (p<0.001 for all three comparisons).

"Patients with diabetes and high cholesterol are considered to be in the high risk category for heart disease, according to the National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATP III)," said Ronald Goldberg, M.D., co-director, Southeastern Florida Regional Diabetes Program, Miami. "This study showed that VYTORIN was significantly more effective than Lipitor in reducing LDL "bad" cholesterol when comparing the recommended usual starting doses and the alternative starting doses for those patients that need greater LDL cholesterol lowering."

In this study, the greater LDL cholesterol reductions with VYTORIN 10/20 mg helped more patients with type 2 diabetes (90.3 percent) achieve the LDL cholesterol treatment goal (<100 mg/dL) set by the NCEP ATP III guidelines versus patients taking Lipitor 10 mg (70.0 percent; p<0.001) and Lipitor 20 mg (82.1 percent; p<0.05). VYTORIN 10/40 mg versus Lipitor 40 mg resulted in 93.4 percent and 88.8 percent of patients, respectively, reaching a LDL cholesterol goal of <100 mg/dL (p=ns).

At the doses studied, significantly more patients treated with VYTORIN achieved LDL cholesterol of less than 70 mg/dL, than patients taking Lipitor. Specifically, 59.7 percent of patients taking VYTORIN 10/20 mg reached this LDL cholesterol level versus 21.5 percent of patients taking Lipitor 10 mg and 35.0 percent taking Lipitor 20 mg (p<0.001 for both comparisons). Additionally, 74.4 percent of patients taking VYTORIN 10/40 mg reached LDL cholesterol of <70 mg/dL as compared to 55.2 percent of patients taking Lipitor 40 mg (p<0.001).

Additional results from the study demonstrated that VYTORIN (10/20 and 10/40 mg) increased HDL "good" cholesterol by 8.0 and 6.3 percent, respectively, as compared to the HDL increases of 4.3 (p<0.0001), 4.5, (p<0.01) and 2.3 percent (p<0.001) seen in patients taking Lipitor (10, 20, and 40 mg) across the same dose comparisons.

Significantly greater reductions in triglycerides (TG) were observed for those patients treated with VYTORIN 10/20 mg (25.7 percent) versus patients taking Lipitor 10 mg (22.7 percent; p<0.05). Additionally greater reductions in high sensitivity C-reactive protein (hs-CRP) were observed in patients treated with VYTORIN 10/20 mg (23.3 percent) versus Lipitor 10 mg (13.7 percent p<0.05). No significant differences were seen in triglycerides and hs-CRP changes at the other dose comparisons.

High triglycerides and low HDL cholesterol are both risk factors for cardiovascular disease (CVD); CRP is considered an emerging risk factor for CVD. The relationship between treatment-induced changes in triglycerides, HDL, and CRP and reduction of CVD risk has not been established.

About the Study

The clinical study was a randomized double-blind, six week, parallel-group study of 1,229 patients with type 2 diabetes and high cholesterol designed to evaluate the lipid modifying efficacy and safety of VYTORIN as compared to Lipitor across the recommended usual starting dose and alternative starting dose for people requiring greater reductions in LDL cholesterol comparisons. Baseline LDL cholesterol ranged from 144-147 mg/dL.

Patients were randomized to receive VYTORIN 10/20 mg, 10/40 mg or Lipitor 10 mg, 20 mg or 40 mg. This study enrolled patients with type II diabetes mellitus including those patients with cardiovascular disease or other forms of atherosclerosis. Both VYTORIN and Lipitor were generally well tolerated in this study.