Healthcare Industry News:  VYTORIN 

Biopharmaceuticals Cardiology

 News Release - March 13, 2006

New Analysis Showed VYTORIN(R) (ezetimibe/simvastatin) Superior to Lipitor(R) in Achieving Lower Levels of LDL (''bad'') Cholesterol, Apolipoprotein B and C-Reactive Protein

ATLANTA--(HSMN NewsFeed)--March 13, 2006--Results from a new post-hoc analysis of the previously presented VYTORIN Versus Atorvastatin (VYVA) study of 1,902 patients with high cholesterol showed that a significantly greater number of patients taking VYTORIN® (ezetimibe/simvastatin) achieved levels of LDL ("bad") cholesterol of less than 70 mg/dl and Apolipoprotein B(1) (Apo B) levels of less than 90 mg/dL compared with patients taking Lipitor® pooled across the dosing range (p<0.001). The analysis also showed that a significantly greater number of patients taking VYTORIN reached levels of LDL cholesterol less than 70 mg/dL and C-Reactive Protein (CRP) levels less than 2 mg/L, compared with patients taking Lipitor pooled across the dosing range (p<0.001). This new analysis was presented today at the American College of Cardiology's 55th Annual Scientific Session.

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. The active ingredients in VYTORIN are ezetimibe and simvastatin. 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.

High LDL ("bad") cholesterol is widely regarded as a major risk factor for the development of cardiovascular disease (CVD) with a causal relationship to atherosclerosis. Apolipoprotein B is also a well-recognized marker of cardiovascular risk (reflecting levels of LDL together with other atherogenic lipoproteins). According to the American Heart Association (AHA) CRP, a marker of inflammation, is considered an emerging risk factor for cardiovascular disease.(i) Studies of CRP have demonstrated that higher levels are associated with a higher risk for developing coronary events.(ii) The specific relationship between reductions in CRP and/or Apo B in the reduction of CVD risk has not been established. In addition, no drugs including VYTORIN are approved for use in reducing CRP.

"This post hoc analysis showed that VYTORIN was not only significantly better than Lipitor in helping patients achieve an LDL cholesterol of less than 70 mg/dL but significantly more of the patients taking VYTORIN also achieved lower levels of Apo B or CRP than those taking Lipitor," said Christie Ballantyne, M.D., director of the Center for Cardiovascular Disease Prevention, Methodist DeBakey Heart Center, Houston, TX, and lead investigator of the study. "This analysis is interesting; however the clinical significance of these comparisons has not been established and additional studies will be needed to confirm these findings," said Dr. Ballantyne. The NCEP ATP III update does include optional LDL cholesterol of less than 70 mg/dL for very high risk patients and does not include treatment targets for Apo B or CRP.

Overall results from the analysis pooled across the dose range, showed that 32.5 percent of the patients taking VYTORIN (n=891) achieved both levels of LDL cholesterol of less than 70 mg/dL as well as Apo B levels of less than 90 mg/dL as compared to 16 percent of patients taking Lipitor (n=899) across the dosing range. As for patients achieving an LDL cholesterol level of less than 70 mg/dL and a CRP level of less than 2 mg/L, 20.7 percent of the patients taking VYTORIN (n=915) achieved this as compared to 9.8 percent of patients taking Lipitor (n=917; p<0.001) across the dosing range. Mean baseline LDL cholesterol for VYTORIN and Lipitor were 178 mg/dL and 179. mg/dL. The mean baseline Apo B levels were 165 mg/dL in each group and the median baseline CRP was 2.3 mg/L for VYTORIN and 2.5 mg/L for Lipitor.

Study showed VYTORIN was well tolerated

Both VYTORIN and Lipitor were well tolerated in the study. The percentage of patients with clinical and laboratory adverse experiences was generally similar between the two treatment groups.

More on VYVA study

The VYVA study was a multi-center, double-blind, randomized, active-controlled, 8-arm, parallel-group study (6 weeks of active treatment) of 1,902 patients designed to evaluate the efficacy and safety of VYTORIN as compared to Lipitor across their respective dosing ranges in patients with hypercholesterolemia who had not met their LDL cholesterol goal as defined by NCEP ATP III. Mean pooled baseline LDL cholesterol values for VYTORIN and Lipitor were 178 mg/dL and 179 mg/dL, respectively. Mean baseline LDL cholesterol values for VYTORIN and Lipitor were comparable at each dose comparison.

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/dL reduced their LDL cholesterol by 51 percent as compared to the 36 percent reduction seen in patients taking Lipitor 10 mg (p<0.001).

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 (=>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.

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).

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, 2004, 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 Securities Litigation Reform Act of 1995, including statements relating to 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 2005 10-K.

Prescribing information and patient product information for VYTORIN® is attached.

VYTORIN® is a registered trademark of MSP Marketing Services © LLC. All other brands are trademarks of their respective owners and are not trademarks of MSP Marketing Services © LLC.

(1) Apo B is the protein component of lipoproteins that carry cholesterol in the blood, including LDL, IDL and VLDL.

(i) Pearson TA, Mensah G, Alexander RW, et al. AHA/CDC Scientific Statement: Markers of Inflammation and Cardiovascular Disease, Application to Clinical and Public Health Practice. Circulation. (2003;107:499-511)

(ii) American Heart Association. "Inflammation, Heart Disease and Stroke: The Role of C-Reactive Protein." Available at http://www.americanheart.org/presenter.jhtml?identifier=4648. Accessed on 2/06/06


Source: Merck-Schering Plough

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