INEGY Better Than Lipitor™ In Achieving Recommended Levels Of LDL-Cholesterol In Diabetes 2 Patients With Hypercholesterolemia

INEGY™ (ezetimibe/simvastatin) was significantly more effective at influencing coronary Heart Disease (CHD) risk factors than Lipitor (atorvastatin) in type 2 Diabetes patients with hypercholesterolemia according to results of two analyses presented at the European Atherosclerosis Society (EAS) meeting in Helsinki, Finland.1,2 Data showed that treatment with INEGY resulted in significantly more patients with type 2 diabetes reaching optional recommended levels of LDL ("bad") Cholesterol (LDL-C) and achieved predefined values for apolipoprotein B (ApoB), non-HDL-cholesterol (non-HDL-C), compared to those treated with atorvastatin, at all doses investigated.1 In addition, INEGY also produced significantly greater reductions in a variety of lipoprotein and apolipoprotein ratios. 2 Type 2 diabetes is associated with a two- to fourfold increased risk for cardiovascular disease (CVD), 3 and one study showed that up to 80 percent of adult type 2 diabetic patients die from CVD.4 The risk of CVD in diabetes patients is so great that the NCEP ATP III* guidelines consider diabetes patients with no history of cardiovascular disease at equivalent risk to patients with diagnosed CHD.5,6 However, intensive lipid lowering therapy can be beneficial for diabetes patients and using the UKPDS risk engine model, it was calculated to contribute approximately 70 percent of the total calculated risk reduction in CVD events in a multi-factorial interventional study in type 2 diabetics with microalbuminuria.7,8 * NCEP ATP III is the U.S. National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults, a set of guidelines for effective patient identification, assessment, diagnosis, and treatment. "A high proportion of people with type 2 diabetes also suffers from elevated cholesterol levels and are at high risk of developing coronary heart disease. Therefore, it is important that such patients reach their LDL-C goal as quickly and effectively as possible through aggressive lipid management in line with treatment guidelines by the Taskforce on Diabetes and Cardiovascular Diseases of the ESC and of the EASD, which recommend LDL-C goals of INEGY improved attainment of optional recommended levels of LDL-C and other CVD risk factors compared to atorvastatin in patients with type 2 diabetes and hypercholesterolemia The first analysis was a post-hoc analysis based on data obtained from a multicenter, randomized, double-blind, six week parallel study in which the usual and alternate starting doses of INEGY (10/20 mg and 10/40 mg) and atorvastatin (10, 20, and 40 mg) were compared in patients with type 2 diabetes and hypercholesterolemia.1 The study assessed the proportion of type 2 diabetes patients treated with INEGY versus atorvastatin who attained LDL-C INEGY more favorably influenced lipoprotein/apolipoprotein ratios in patients with type 2 diabetes and with LDL-C ≥100mg/dL than atorvastatin even when the atorvastatin dose was doubled Results of the second analysis of the same randomized, double-blind, parallel-group trial involving 1,198 patients with type 2 diabetes with LDL-C ≥100mg/dL - showed that INEGY was significantly more effective at lowering LDL-C than atorvastatin at each dose comparison (ezetimibe/simvastatin 10/20 mg, 10/40 mg versus atorvastatin 10 mg, 20 mg and 40 mg; p Defining "inhibition of cholesterol absorption and production" Cholesterol in the body originates from two main sources: absorption in the intestine of both biliary and dietary cholesterol, and production in the liver and peripheral tissues.10,11 Approximately two-thirds of intestinal cholesterol comes from biliary sources; only one third comes from dietary sources.9 Approximately 50 percent of cholesterol in the intestine is absorbed and re-circulated in the blood; the remainder is excreted.10 Cholesterol-lowering agents (statins) reduce cholesterol levels by inhibiting the production (synthesis) of cholesterol in the liver. INEGY™ contains the statin simvastatin, plus the active ingredient of EZETROL™ (ezetimibe), the first and only cholesterol absorption inhibitor which works by inhibiting intestinal absorption of cholesterol. About INEGY™ INEGY™ has been developed and is being marketed by Merck & Co., Inc., Whitehouse Station, N.J., U.S.A. (NYSE: MRK) and Schering-Plough Corporation (NYSE: SGP) in connection with a partnership formed by both companies to develop and market worldwide (excluding Japan) new prescription Medicines in cholesterol management. Branded as INEGY™ in Europe, Middle East and Africa, the product is indicated (in the EU) as adjunctive therapy to diet for use in patients with primary (heterozygous familial and non-familial) hypercholesterolemia or mixed hyperlipidemia where use of a combination product is appropriate: 1) patients not appropriately controlled with a statin alone; and 2) patients already treated with a statin and ezetimibe. INEGY™ has an additional indication for homozygous familial hypercholesterolemia. It has been approved in more than 60 countries around the world including the United States, where the Food and drug Administration approved it in 2004 - under the brand name VYTORIN - for the treatment of high LDL-C as adjuvant therapy to diet. The tolerability profile of INEGY™ is similar to simvastatin and atorvastatin, and is maintained over long-term therapy. About Merck Merck & Co., Inc., Whitehouse Station, N.J., U.S.A., which operates in many countries as MSD (Merck Sharp & Dohme), is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit

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