Healthcare Industry News: familial hypercholesterolemia
News Release - March 13, 2006
Data Analysis Showed VYTORIN(R) (ezetimibe/simvastatin) Significantly Reduced LDL ''bad'' Cholesterol and C-reactive Protein (CRP) in Patients with High Cholesterol Compared to Zocor(R) (simvastatin)ATLANTA--(HSMN NewsFeed)--March 13, 2006--In a new analysis presented today VYTORIN® (ezetimibe/simvastatin) significantly reduced LDL "bad" cholesterol by an average of 52.5 percent and C-reactive protein (CRP) by an average of 31.0 percent, compared to averages of 38.0 percent and 14.3 percent, respectively, achieved with Zocor® (simvastatin) (p<0.001). These results were observed in a combined post-hoc analysis of three studies involving patients with high cholesterol and were presented today at the 55th Annual Scientific Session of the American College of Cardiology.
C-reactive protein, a marker of inflammation, is considered an emerging risk factor for cardiovascular disease (CVD), according to the American Heart Association.(1) Studies of CRP have demonstrated that higher levels are associated with a higher risk for developing coronary events.(2) The specific relationship between reductions in CRP and reduction of CVD risk has not been established and no drugs are approved specifically for use in reducing CRP.
"In this analysis, while both treatments yielded LDL cholesterol and CRP reductions, we saw that VYTORIN lowered LDL cholesterol and CRP by a significantly greater amount in more patients than Zocor," said Christie M. Ballantyne, M.D., director of the Center for Cardiovascular Disease Prevention, Methodist DeBakey Heart Center, Houston, TX.
About the Analysis
This post-hoc analysis pooled data from three similar randomized, placebo-controlled, double-blind studies that included a total of 3,083 patients with primary hypercholesterolemia. After a six to eight week washout period and a four week recommended cholesterol-lowering diet, investigators randomized patients with LDL cholesterol levels between 145-250 mg/dL equally into one of the following drug regimens for 12 weeks: ZETIA 10 mg; Zocor 10, 20, 40 or 80 mg, VYTORIN 10/10, 10/20, 10/40 or 10/80 mg; or placebo.
Overall, in a pooled analysis across all doses of VYTORIN and Zocor that included all patients with valid baseline and endpoint LDL cholesterol and CRP measurements, the geometric mean CRP level declined in patients taking VYTORIN (n=1007) by 31 percent as compared to a 14.3 percent reduction in the group of patients taking Zocor (n=1031; p<0.001). The mean LDL cholesterol level declined in patients taking VYTORIN by 52.5 percent as compared to a 38 percent reduction in the group of patients taking Zocor (p<0.001).
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(i), 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.
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.
VYTORIN ® is a trademark of MSP Marketing Services © LLC. All other brands are trademarks of their respective owners and are not trademarks of MSP Marketing Services © LLC.
Source: Merck-Schering Plough
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