(I-Newswire) July 24, 2005 - At the most commonly used starting doses,1 59 diabetic patients taking VYTORIN 10/20 mg, reduced their LDL cholesterol by 53 percent as compared to the 35 percent reduction seen in the 46 patients taking Lipitor 10 mg. This difference was similar to the results seen in the overall study population.
"The results seen in this new analysis, in patients with type 2 diabetes, showed that VYTORIN was more effective than Lipitor in reducing LDL cholesterol at all doses compared, including the most commonly used starting doses," said Christie Ballantyne, M.D., director of the Center for Cardiovascular Disease Prevention, Methodist DeBakey Heart Center, Houston, and lead investigator of the study. "These results are consistent with what was seen in the overall study."
VYTORIN is indicated for the treatment of high LDL cholesterol in patients with primary hypercholesterolemia or mixed hyperlipidemia as adjunctive therapy to diet when diet alone is not enough. VYTORIN 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. The active ingredients in VYTORIN are ezetimibe and simvastatin. The recommended starting dose of VYTORIN is 10/20 mg (10 mg ezetimibe/20 mg simvastatin).
The incremental benefit of VYTORIN on cardiovascular morbidity and mortality over and above that demonstrated by simvastatin has not been established.
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.
Results of the overall VYVA trial demonstrated that VYTORIN was superior to Lipitor in lowering LDL cholesterol The results from the overall study were presented earlier this year at the American College of Cardiology meeting and published in the American Heart Journal. In that study of 1,902 patients, VYTORIN lowered LDL cholesterol by 53 percent across the dosing range as compared to 45 percent lowering seen in those patients taking Lipitor across the dosing range. At the most commonly used starting doses, patients taking VYTORIN 10/20 mg reduced their LDL cholesterol by 51 percent as compared to the 36 percent reduction seen in patients taking Lipitor 10 mg (p<0.001).
While there were no pre-specified analysis of safety in this subgroup of patients with type 2 diabetes, results from the overall VYVA trial showed that both VYTORIN and Lipitor were well tolerated.
Study design for the VYVA trial
The VYVA study was a multicenter, randomized, double-blind, active controlled parallel-group study of 1,902 patients designed to evaluate the efficacy and safety of VYTORIN as compared to Lipitor across their respective dosing ranges. The primary efficacy endpoint was the percent change from baseline to the end of the 6-week treatment period in LDL cholesterol for patients treated with VYTORIN or Lipitor averaged across all doses. The study enrolled men and women 18 to 79 years of age with an LDL cholesterol level at or above drug treatment thresholds established by the NCEP ATP III who were deemed eligible if they met the following criteria: established coronary heart disease (CHD) or CHD risk equivalent, or two or more risk factors conferring a 10-year risk for CHD greater than 20 percent (by Framingham score) with an LDL cholesterol greater than or equal to 130 mg/dL; no established CHD or CHD risk equivalent, with two or more risk factors conferring a 10-year risk for CHD greater than or equal to 10 percent and less than or equal to 20 percent with an LDL cholesterol greater than or equal to 130 mg/dL; no established CHD or CHD risk equivalent, with two or more risk factors conferring a 10-year risk for CHD less than 10 percent with an LDL cholesterol greater than or equal to 160 mg/dL; and no established CHD or CHD risk equivalent, with less than two risk factors, and with LDL cholesterol greater than or equal to 190 mg/dL. Other criteria included fasting serum triglyceride (TG) level less than or equal to 350 mg/dL, alanine aminotransferase (ALT), aspartate aminotransferase (AST), or creatine kinase (CK) level less than or equal to 1.5 times the upper limit of normal, serum creatinine level less than or equal to 1.5 mg/dL, and a hemoglobin A1C less than nine percent in patients with diabetes.
Full indication for VYTORIN
VYTORIN is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol, LDL cholesterol, Apo B, triglycerides and non-HDL cholesterol and to increase HDL cholesterol in patients with primary (heterozygous familial and non-familial) hypercholesterolemia or mixed hyperlipidemia. VYTORIN also is 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.
Important 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 (≥3 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 (≥3 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.
In clinical studies VYTORIN was well tolerated with a low incidence of adverse events
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 (MSP) 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). MSP currently markets ZETIA ® (ezetimibe) a novel cholesterol absorption inhibitor approved for use as monotherapy or together with statins for the treatment of high cholesterol in addition to diet and exercise and VYTORIN™. Approved in July 2004, VYTORIN 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.
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 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, 2004, and in its periodic reports on Form 10-Q and Form 8-K, which the company incorporates by reference.
1Source for usual starting dose for atorvastatin: IMS HEALTH, NPA Plus™, January-September 2004.
VYTORIN is a trademark of MSP Singapore Company, LLC. All other brands are trademarks of their respective owners and are not trademarks of MSP Singapore Company, LLC.
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