Studies Demonstrate Greater Cholesterol Lowering Effect of Dual Inhibition of Two Sources of Cholesterol
SEVILLE, SPAIN, 19 APRIL, 2004 -- Merck & Co., Inc. and Schering-Plough Corporation today announced results from studies presented at the European Atherosclerosis Society (EAS) conference in Seville. The results from these studies consistently demonstrate that ezetimibe (EZETROL®) co-administered with simvastatin (ZOCOR®) produces greater reductions in low-density lipoprotein cholesterol (LDL-C or ‘bad’ cholesterol), allowing more patients to reach their cholesterol goals, than with statin therapy alone. The data confirms the greater efficacy benefits of Dual Inhibition, which targets both of the main sources of cholesterol in the body, production by hepatic and extra hepatic tissues, and absorption in the intestine.
Greater LDL-C efficacy Through Dual Inhibition Reinforced Through Additional Studies
In a study of 692 patients at high risk of cardiovascular events, 83.3 percent of patients on ezetimibe 10 mg co-administered with simvastatin 20 mg achieved the U.S.
National Cholesterol Education Program (NCEP) target LDL-C (<2.6 mmol/L) within five weeks, compared with only 45.5 percent of those taking simvastatin 20 mg alone (p<0.001). In patients taking ezetimibe 10 mg with simvastatin 40 mg, 87.5 percent
reached the NCEP goal at five weeks. After five weeks, and at the end of the 23-week study, ezetimibe 10 mg with any dose of simvastatin (10–80 mg) consistently produced greater reductions in LDL-C and greater goal attainment than simvastatin alone.
“Many patients on statin therapy continue to have LDL-C above recommended levels, putting them at increased risk of cardiovascular disease,” said Professor Alberico L. Catapano, director of the Center for the Study of Atherosclerosis, Marie Curie Training Centre for Cardiovascular Diseases, University of Milan. “This study reinforces the previous data demonstrating that ezetimibe co-administered with a statin is more effective at reducing LDL-C levels than statin therapy alone and that Dual Inhibition of two sources of cholesterol – production and absorption – helps more patients reach cholesterol goals.”
Previous studies with available statins have consistently demonstrated that ezetimibe together with a statin provides greater efficacy than the statin alone. Results of the first clinical trial to examine the effectiveness between ezetimibe and rosuvastatin (CRESTOR®) were also released today at the EAS conference. The study by Kosoglou et al was designed to investigate the potential pharmacokinetic (PK) and pharmacodynamic (PD) effects when ezetimibe is co-administered with rosuvastatin. Ezetimibe 10 mg
co-administered with rosuvastatin 10 mg in healthy volunteers reduced LDL-C by 61.4
percent compared with 44.9 percent with rosuvastatin 10 mg alone (p <0.01). The
co-administration was well-tolerated, with no significant pharmacokinetic PK interactions.
Ezetimibe co-administered together with a statin has consistently been found to be well-tolerated and to have a similar safety profile to statin therapy alone. These studies add to the growing evidence base that shows the cholesterol-lowering benefits of Dual Inhibition of two sources of cholesterol, production and absorption, compared with statin therapy alone.
EZETROL (ezetimibe), a cholesterol absorption inhibitor, has been developed and is being marketed by Merck & Co., Inc. (NYSE:MRK) and Schering-Plough Corporation
(NYSE:SGP) in connection with a partnership formed by both companies to develop and market worldwide (excluding Japan) new prescription medicines in cholesterol management. Ezetimibe was approved for marketing by the United States Food and Drug Administration on 25 October 2002, and is marketed in the United States as ZETIA™. Following the successful completion of the European Union Mutual Recognition Procedure, EZETROL has now been launched in seven European countries -- Germany, the United Kingdom, Switzerland, Sweden, Ireland, Portugal, and the Netherlands. Ezetimibe has also been launched in Canada, UAE, Israel Malaysia and the Philippines.
Merck & Co., Inc., which operates in many countries as Merck Sharp & Dohme, is a global research-driven pharmaceutical products company. Merck discovers, develops, manufactures and markets a broad range of innovative products to improve human and animal health, directly or through its joint ventures.
Schering-Plough Corporation is a research-based company engaged in the discovery, development, manufacturing and marketing of pharmaceutical products worldwide.
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