Results from a clinical study conducted in 1,229 patients with type II diabetes mellitus and high cholesterol showed that Vytorin (ezetimibe/simvastatin) provided superior reduction in LDL "bad" cholesterol compared to Lipitor (atorvastatin) at the dose comparisons studied, according to data published in the December 2006 issue of Mayo Clinic Proceedings.

The primary efficacy endpoint was the per cent change from baseline in LDL cholesterol at the end of the six-week treatment period.

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 US.

Vytorin 10/20 mg demonstrated a 53.6 mean per cent reduction from baseline in LDL cholesterol as compared to a 38.3 per cent reduction observed with Lipitor 10 mg and a 44.6 per cent reduction with Lipitor 20 mg - the recommended usual starting doses of both agents. At the next highest doses, vytorin 10/40 mg decreased LDL cholesterol significantly more than Lipitor 40 mg - 57.6 per cent compared to 50.9 per cent, respectively.

"Patients with diabetes and high cholesterol are considered to be in the high risk category for heart disease, according to the National Cholesterol Education Programme (NCEP) Adult Treatment Panel III (ATP III)," said Theodore Mazzone, MD, professor, Departments of Medicine and Pharmacology, chief, section of endocrinology, diabetes and metabolism, university of Illinois, Chicago. "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 next highest doses."

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 set by the NCEP ATP III guidelines versus patients taking Lipitor 10 mg and Lipitor 20 mg.

Vytorin 10/40 mg versus Lipitor 40 mg resulted in 93.4 per cent and 88.8 per cent of patients, respectively, reaching a LDL cholesterol goal of <100 mg/dL.

In a pre-specified analysis 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 per cent of patients taking Vytorin 10/20 mg reached this LDL cholesterol level versus 21.5 per cent of patients taking Lipitor 10 mg and 35.0 per cent of patients taking Lipitor 20 mg.

Additionally, 74.4 per cent of patients taking Vytorin 10/40 mg reached LDL cholesterol of <70 mg/dL as compared to 55.2 per cent of patients taking Lipitor 40 mg.

Additional results from the study demonstrated that Vytorin (10/20 and 10/40 mg) increased HDL "good" cholesterol by 8.0 and 6.3 per cent, respectively, as compared to the HDL increases of 4.3, 4.5, and 2.3 per cent 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. No significant differences were seen in triglyceride changes at the other dose comparisons.

High triglycerides and low HDL cholesterol are both risk factors for cardiovascular disease (CVD). The relationship between treatment-induced changes in triglycerides and HDL cholesterol and reduction of CVD risk has not been established.

Vytorin contains simvastatin and ezetimibe. Vytorin is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol, LDL cholesterol, Apo B1, triglycerides and non-HDL cholesterol and to increase HDL cholesterol in patients with primary hypercholesterolemia or mixed hyperlipidemia.