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| |  Study Shows Atorvastatin Most Effective Product For Lowering Cholesterol TORONTO, ON. -- October 22, 1997 -- Treatment with the cholesterol-lowering drug atorvastatin caused impressive reductions of LDL-cholesterol when compared with other drugs in the same class, according to the results of the CURVES study presented recently at the annual European Society of Cardiology meeting in Stockholm. The results of the study suggest the ability to lower cholesterol, a battle being fought by physicians around the world, may be helped by the recent introduction of atorvastatin. CURVES is the first clinical trial to compare the lipid-lowering efficacy and evaluate the safety of all doses of all the marketed HMG-CoA reductase inhibitors (also known as statins). In the study, atorvastatin (marketed in most countries as Lipitor(R) by Parke-Davis and Pfizer) provided significantly greater reductions of LDL-cholesterol at its starting dose of 10 mg per day than once-daily doses of simvastatin 10 mg, pravastatin 10 and 20 mg, lovastatin 20 and 40 mg and fluvastatin 20 and 40 mg. In addition, atorvastatin is available in 20 and 40 mg. “LDL-cholesterol is the primary focus of lipid-lowering therapy and reductions in LDL-cholesterol clearly result in a decrease in coronary artery disease progression and a decrease in the risk of fatal and non-fatal heart attacks,” said Dr. Ruth McPherson, associate professor of medicine at the University of Ottawa Heart Institute. “This study demonstrates that currently available statins make the attainment of LDL-cholesterol targets entirely feasible.” According to the United States National Health and Nutrition Examination Survey (NHANES), nearly 80 percent of coronary heart disease patients eligible for drug therapy require a greater than 30 percent reduction in LDL-cholesterol to reach U.S. National Cholesterol Education Program goals. In CURVES, atorvastatin provided a greater than 30 percent reduction of LDL-cholesterol at all dosage levels. In the study, atorvastatin 10 mg achieved a mean LDL-cholesterol reduction of 38 percent, which was significantly greater than simvastatin 10 mg (28 percent), pravastatin 20 mg (24 percent), lovastatin 20 mg (29 percent) and fluvastatin 20 mg (17 percent). Additionally, atorvastatin 20 mg reduced LDL-cholesterol by 46 percent, which was significantly greater than simvastatin 20 mg (35 percent), pravastatin 40 mg (34 percent), lovastatin 40 mg (31 percent) and fluvastatin 40 mg (23 percent). The CURVES data expand the results of earlier comparative trials that showed the recommended 10 mg starting dose of atorvastatin produced greater reductions in LDL-cholesterol than the recommended starting doses of simvastatin (10 mg), pravastatin (20 mg) and lovastatin (20 mg). In addition, the overall degree of LDL-cholesterol reduction by atorvastatin was consistent with findings of previous studies which showed LDL reductions of 39 percent to 60 percent across the dosage range (10 mg to 80 mg). The multi-centre, randomized, open-label study was conducted over eight weeks to compare the lipid-lowering efficacy and evaluate the safety of milligram-equivalent doses of atorvastatin (10, 20, 40, and 80 mg), simvastatin (10, 20, and 40 mg), pravastatin (10, 20, and 40 mg), lovastatin (20, 40, and 80 mg dosed as 40 mg bid) and fluvastatin (20 and 40 mg). It enrolled 534 patients with LDL-cholesterol greater than or equal to 4.1 mmol/L (greater than or equal to 160 mg/dL) and triglycerides less than or equal to 4.5 mmol/L (less than or equal to 400 mg/dL), ranging in age from 18 to 80 years. In CURVES, the most frequent treatment-associated adverse events (occurring in one percent of patients or more) were abdominal pain, diarrhea, nausea, flatulence and myalgia, none of which were dose related. Atorvastatin is well tolerated and adverse reactions usually have been mild and transient. Fewer than two percent of patients were discontinued from clinical trials due to side effects related to atorvastatin. In head-to-head trials, the rate of discontinuation was comparable to that of other statins. The most frequent associated adverse effects of atorvastatin are constipation, flatulence, dyspepsia and abdominal pain. Atorvastatin can be taken once daily at any time of the day or night, with or without food. Atorvastatin is cleared for marketing in 23 countries and is used in the management of patients with high cholesterol. It was discovered and developed by the Parke-Davis Research Division of Warner-Lambert. Parke-Davis and Pfizer Inc. are collaborating on clinical, marketing and sales support for the product in Canada and other key countries. Curves was funded by Parke-Davis and Pfizer Inc.
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