CRP is considered an emerging risk marker for CHD. In an American Heart Association/Centers for Disease Control Scientific Statement published in the January 2003 issue of Circulation, high-sensitivity CRP was recognized as a potentially valuable marker and an optional adjunct to major risk factors in the assessment of risk for coronary disease in patients at moderate cardiovascular risk. (1) The relationship between reductions in CRP and reduction of CHD risk has not been established.

Study design

The 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 equiv
'"/>

Contact: Skip Irvine, Merck & Co., Inc.
267-305-5397
Porter Novelli
28-Oct-2004