Merck Expresses Confidence in the Efficacy and Safety Profiles of ZETIA® (ezetimibe) and VYTORIN® (ezetimibe/simvastatin) as Effective Medicines for Managing Elevated Cholesterol
ORLANDO, Fl., Nov. 15, 2009 - At the American Heart Association meeting today, Merck & Co., Inc. said it is confident in the safety and efficacy profiles of ZETIA® (ezetimibe) and VYTORIN® (ezetimibe/simvastatin), and issued the following comment in response to misinterpretation of results from a small 200-patient imaging study called ARBITER 6.
"The results of the small ARBITER 6 study do not, in any way, change our view of ZETIA and VYTORIN as effective medicines for fighting high LDL cholesterol," said Peter S. Kim, Ph.D., president, Merck Research Laboratories. "Nothing from this study, which a New England Journal of Medicine editorial says has 'several limitations,' changes the well established understanding that lowering LDL cholesterol is the primary target of therapy according to the guidelines. ZETIA and VYTORIN, when used as a supplement to a healthy diet, are effective in reducing LDL cholesterol," said Dr. Kim. "We encourage patients to continue taking their medication as prescribed by their physicians, and of course to speak to their physician if they have concerns."
The results of ARBITER 6 were widely predicted because the study design favored niacin as the patient population selected had well-controlled LDL cholesterol and relatively low HDL cholesterol. Also, it is important to remember that ARBITER 6 is not an outcomes study, and does not have the rigor or size to provide meaningful insight into the effect of either niacin or ezetimibe on clinical outcomes. Merck has reviewed the data from 43 completed shorter-term clinical trials involving approximately 2,400 patients who received ezetimibe alone and 13,600 patients who received ezetimibe with statins, as well as two longer-term studies, and is confident that the data support the safety profiles of ZETIA and VYTORIN as described in their labels.
"Any suggestion that the results of ARBITER 6 can definitively answer the question of the impact of ezetimibe on cardiovascular outcomes or that its results have implications for clinical use should be met with skepticism," said Dr. Kim. "Given the broadly accepted, scientifically validated importance of lowering LDL and the millions of people in the United States alone who are not at their recommended treatment goals, VYTORIN and ZETIA remain effective options for physicians to treat their appropriate patients."
Both niacin and ezetimibe have established effects on lipids, as noted in the prescribing information for these medicines. We look forward to the results from IMPROVE-IT, the large, longer-term clinical outcomes trial underway to understand whether additional LDL-lowering with ezetimibe reduces cardiovascular outcomes. There are other separate large, longer-term clinical outcomes trials being conducted to understand the role of raising HDL in reducing cardiovascular outcomes.
Physicians need multiple options to help manage their patients' cholesterol
There are millions of patients with high LDL cholesterol. There are also millions of patients with elevated LDL cholesterol in addition to other lipid abnormalities like elevated triglycerides. Physicians need multiple options like ezetimibe and niacin to help manage patients' different lipid abnormalities. Ezetimibe remains an effective medicine to do what it is approved by FDA and 89 other regulatory agencies to do: help lower LDL cholesterol as an adjunct to diet when diet alone is not enough.
According to Lipid Treatment Assessment Project 2 (Circulation 2009), approximately 65 percent of very high-risk patients in the United States did not reach their optimal LDL goal of less than 70 mg/dL.
In separate head-to-head clinical studies, VYTORIN was shown to be more effective than simvastatin, Lipitor, or Crestor at lowering LDL cholesterol at the doses compared: VYTORIN provided >50 percent mean LDL cholesterol reduction. In addition, in these separate studies, VYTORIN helped more patients achieve a goal of <70 mg/dL than did simvastatin a, Lipitor b, or Crestor c1. The clinical impact of comparative differences in lipid changes between products is not known. VYTORIN has not been shown to reduce heart attacks and strokes more than simvastatin alone.
Merck is well prepared to help our customers understand our position on the ARBITER 6 study and that ZETIA and VYTORIN are effective options for physicians to use to manage their patients' cholesterol.
Merck's commitment to cardiovascular medicine
Following the merger of Merck with Schering-Plough, today's Merck has a robust research effort aimed at cardiovascular disease.
"No other health care company is doing more to study cardiovascular disease than today's Merck," said Dr. Kim.