To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: ACC SCIENTIFIC SESSIONS: Zocor and Lipitor May Have Different Effects on Lipids, Including HDL URL: http://www.pslgroup.com/dg/EB4FA.htm Doctor's Guide March 9, 1999
NEW ORLEANS, LA -- March 9, 1999 -- Results from a large head-to-head study comparing Merck's cholesterol-lowering agent Zocor(R) (simvastatin) 40 and 80 mg with Warner-Lambert Co.'s Lipitor(R) (atorvastatin) 20 and 40 mg showed Zocor raised HDL or good cholesterol levels significantly more than Lipitor. The results were presented yesterday at the 48th annual scientific session of the American College of Cardiology. The international, multi-centre study in 842 patients with high cholesterol analysed the efficacy of certain strengths of Zocor and Lipitor on all lipid parameters, including LDL and HDL cholesterol, triglycerides and apolipoprotein A-I (apo A-I, the principal protein of HDL). Patients in the study received one of four daily treatments for 12 weeks: Zocor 40 mg (202 patients) or 80 mg (214 patients), or Lipitor 20 mg (210 patients) or 40 mg (216 patients). The mean baseline values for LDL cholesterol, HDL cholesterol, triglycerides and apo A-I were 212.7 mg/dL, 46.4 mg/dL, 186 mg/dL and 145.4 mg/dL, respectively, with negligible baseline differences among treatment groups. The study showed that Zocor 40 mg raised HDL levels by 6.7 percent compared to 4.2 percent for Lipitor 20 mg. Zocor 80 mg raised HDL levels by 6.5 percent versus 3.1 percent for Lipitor 40 mg. A separate post-hoc analysis of 113 patients who started the study with HDL levels below 35 mg/dL showed a 16.9 percent increase in HDL cholesterol among those taking Zocor 80 mg, compared to a 6.5 percent HDL increase for those taking Lipitor 40 mg. These findings were all statistically significant. The independent effect of raising HDL cholesterol on the risk of coronary and cardiovascular disease and death has yet to be determined and neither product is indicated to raise HDL cholesterol levels. Both medicines effectively lowered LDL cholesterol and triglycerides. Zocor 40 and 80 mg strengths reduced LDL cholesterol by 43 to 49 percent and triglycerides by 23 to 25 percent. Lipitor 20 and 40 mg strengths reduced LDL cholesterol by 45 to 51 percent and triglycerides by 23 to 30 percent. These differences were small but statistically significant in favour of Lipitor. At the lower strengths, both drugs increased apo A-I, with Zocor 40 mg raising apo A-I by 6.3 percent and Lipitor 20 mg raising apo A-I by 5.4 percent. Zocor 80 mg significantly increased levels of apo A-I (+5.7 percent), whereas Lipitor 40 mg failed to increase apo A-I levels at all (-0.3 percent). In the study, both agents were well tolerated, with adverse experiences comparable between the groups treated with Zocor and Lipitor. The clinical significance of comparative differences in lipid effects between statins has not been established. "The study suggests that different statins may differ in certain metabolic effects, particularly in their ability to raise the good cholesterol. This may have important implications since low HDL is considered by the National Cholesterol Education Program to be a risk factor for heart disease," said John Crouse, M.D., lead author of the study and professor of internal medicine and public health sciences at Wake Forest University School of Medicine, Winston-Salem, N.C. "The mechanisms underlying the difference are unknown and deserve further investigation." HDL is important for its beneficial role in cholesterol metabolism. Often referred to as the good cholesterol, HDL picks up cholesterol in blood vessels and transports it back to the liver, where it can be eliminated from the body. According to the National Cholesterol Education Program (NCEP), HDL cholesterol levels above 60 mg/dL appear to be protective against heart disease. HDL cholesterol levels that are below 35 mg/dL constitute a risk factor for CHD, the NCEP notes. Another study presented here today on the use of Zocor in patients with combined hyperlipidemia (LDL greater than 130 mg/dL, triglycerides 300-700 mg/dL) showed Zocor favourably impacted all lipid parameters. The multi-centre, cross-over study evaluated 130 patients with combined hyperlipidemia, who received Zocor 40 mg, Zocor 80 mg, or placebo over a three- to six-week period. The study showed that LDL cholesterol levels in patients receiving Zocor 80 mg dropped by 35.5 percent from a baseline of 156 mg/dL (versus 2.1 percent with placebo), triglycerides dropped by 33 percent from a baseline of 391 mg/dL (versus 3.5 percent with placebo) and HDL cholesterol levels rose by 15.7 percent from a baseline of 38.9 mg/dL (versus 3.3 percent with placebo). Related Links: Zocor, Merck, Lipitor, Warner-Lambert Co. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. 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