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News Release - December 21, 2006
Data Recently Published in Mayo Clinic Proceedings Showed VYTORIN(R) (ezetimibe/simvastatin) Superior to Lipitor (atorvastatin) in Reducing LDL ''Bad'' Cholesterol in Patients with Type II Diabetes at the Dose Comparisons StudiedGreater LDL Cholesterol Reduction with VYTORIN Compared to Lipitor Resulted in Greater LDL Cholesterol Goal Attainment
WHITEHOUSE STATION, N.J. & KENILWORTH, N.J.--(HSMN NewsFeed)--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 percent 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 U.S.
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 - 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 percent compared to 50.9 percent, respectively, (p less than 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 Theodore Mazzone, M.D., 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 (less than 100 mg/dL) set by the NCEP ATP III guidelines versus patients taking Lipitor 10 mg (70.0 percent; p less than 0.001) and Lipitor 20 mg (82.1 percent; p=0.007). 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 less than 100 mg/dL (p=.07,NS).
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 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 of patients taking Lipitor 20 mg (p less than 0.001 for both comparisons). Additionally, 74.4 percent of patients taking VYTORIN 10/40 mg reached LDL cholesterol of less than 70 mg/dL as compared to 55.2 percent of patients taking Lipitor 40 mg (p less than 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 of4 .3 (p less than 0.001), 4.5, (p=0.001) and 2.3 percent (p less than 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 less than 0.05). 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.
About the Study
The clinical study was a randomized double-blind, six-week, parallel-group study of 1,229 patients with type II 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 next highest dose comparisons. Mean baseline LDL cholesterol ranged from 144-147 mg/dL in the treatment arms.
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 coronary heart disease or other forms of atherosclerosis. Both VYTORIN and Lipitor were generally well tolerated in this study.
Important information about VYTORIN
VYTORIN contains simvastatin and ezetimibe. VYTORIN is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol, LDL cholesterol, Apo B(1), triglycerides and non-HDL cholesterol and to increase HDL cholesterol in patients with primary (heterozygous familial and non-familial) hypercholesterolemia or mixed hyperlipidemia.
VYTORIN is also indicated for the reduction of elevated total cholesterol and LDL cholesterol in patients with homozygous familial hypercholesterolemia, as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable.
VYTORIN is a prescription medicine and should not be taken by people who are hypersensitive to any of its components. VYTORIN should not be taken by anyone with active liver disease or unexplained persistent elevations of serum transaminases. Women who are of childbearing age (unless highly unlikely to conceive), are nursing or who are pregnant should not take VYTORIN.
VYTORIN is available as tablets containing 10 mg of ezetimibe combined with 10, 20, 40 or 80 mg of simvastatin (VYTORIN 10/10, 10/20, 10/40 or 10/80 mg, respectively).
Selected cautionary information for VYTORIN
Muscle pain, tenderness or weakness in people taking VYTORIN should be reported to a doctor promptly because these could be signs of a serious side effect. VYTORIN should be discontinued if myopathy is diagnosed or suspected. To help avoid serious side effects, patients should talk to their doctor about medicine or food they should avoid while taking VYTORIN. In three placebo-controlled, 12-week trials, the incidence of consecutive elevations (greater than or equal to3 X ULN) in serum transaminases were 1.7 percent overall for patients treated with VYTORIN and 2.6 percent for patients treated with VYTORIN 10/80 mg. In controlled long-term (48-week) extensions, which included both newly-treated and previously-treated patients, the incidence of consecutive elevations (greater than or equal to3 X ULN) in serum transaminases was 1.8 percent overall and 3.6 percent for patients treated with VYTORIN 10/80 mg. These elevations in transaminases were generally asymptomatic, not associated with cholestasis and returned to baseline after discontinuation of therapy or with continued treatment. Doctors should perform blood tests before, and periodically during treatment with VYTORIN when clinically indicated to check for liver problems. People taking VYTORIN 10/80 mg should receive an additional liver function test prior to and three months after titration and periodically during the first year.
Due to the unknown effects of increased exposure to ezetimibe (an ingredient in VYTORIN) in patients with moderate or severe hepatic insufficiency, VYTORIN is not recommended in these patients. The safety and effectiveness of VYTORIN with fibrates have not been established; therefore, co-administration with fibrates is not recommended. Caution should be exercised when initiating VYTORIN in patients treated with cyclosporine and in patients with severe renal insufficiency.
VYTORIN has been evaluated for safety in more than 3,800 patients in clinical trials and was generally well tolerated at all doses (10/10 mg, 10/20 mg, 10/40 mg, 10/80 mg). In clinical trials, the most commonly reported side effects, regardless of cause, included headache (6.8 percent), upper respiratory tract infection (3.9 percent), myalgia (3.5 percent), influenza (2.6 percent) and extremity pain (2.3 percent).
About Merck/Schering-Plough Pharmaceuticals
Merck/Schering-Plough Pharmaceuticals is a joint venture between Merck & Co., Inc. and Schering-Plough Corporation formed to develop and market in the United States new prescription medicines in cholesterol management. The collaboration includes worldwide markets (excluding Japan). VYTORIN is marketed as INEGY in many countries outside the U.S.
Merck forward-looking statement
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the cautionary statements in Item 1 of Merck's Form 10-K for the year ended Dec. 31, 2005, and in its periodic reports on Form 10-Q and Form 8-K, which the Company incorporates by reference.
Schering-Plough Disclosure Notice
The information in this press release includes certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the product potential for VYTORIN. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough's forward-looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties. For further details about these and other factors that may impact the forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including Item 1A. Risk Factors in the Company's second quarter 2006 10-Q.
(1) Apo B is the protein compound of lipoproteins, LDL and VLDL, which carry cholesterol in the blood.
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