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Biotech / Medical : wla(warner lambert) -- Ignore unavailable to you. Want to Upgrade?

To: Captain Jack who wrote (793)	5/28/1999 2:01:00 PM
From: Anthony Wong	Read Replies (1) \| Respond to of 942

EAS MEETING: Lipitor More Effective Than Zocor And Baycol For Lowering Cholesterol ATHENS, GREECE - May 27, 1999 -- Building on existing data, two new studies presented at the annual congress of the European Atherosclerosis Society (EAS), now provide further evidence of the superior cholesterol-lowering efficacy of Parke-Davis' and Pfizer's Lipitor(R) (atorvastatin calcium tablets). In the first study known as Triple A (Australian Atorvastatin Assessment), a significantly greater number of patients reached total cholesterol goals on Lipitor than patients taking Zocor(R) (simvastatin). In the second study, Atorvastatin Versus Cerivastatin (Baycol[R]), Lipitor demonstrated a greater cholesterol-lowering effect than cerivastatin. This study completes the comparative review of Lipitor versus all available statin therapies. "Atorvastatin is the most efficacious of the HMG-CoA reductase inhibitors at reducing low density lipoprotein [LDL-C] cholesterol," said professor Phillip Barter, department of medicine, University of Adelaide, South Australia. "These studies provide further evidence of the impressive cholesterol-altering effects of atorvastatin." In the Atorvastatin Versus Cerivastatin study, atorvastatin was found to be a more effective cholesterol-lowering therapy at its starting dose of 10 mg/day than cerivastatin at its maximum approved dose of 300 micrograms/day in patients with high cholesterol. Cerivastatin is the latest addition to the class of drugs known as statins. Compared with the maximum approved dose of cerivastatin, the 10 mg starting dose of atorvastatin produced significantly greater reductions from baseline in LDL-C (37.7 percent versus 30.2 percent), total cholesterol (TC) (27.5 percent versus 22.2 percent) and apolipoprotein B (Apo B) (28.6 percent versus 21.2 percent) and a significantly greater increase from baseline in high density lipoprotein cholesterol (HDL-C) (6.8 percent versus 4.3 percent). Both atorvastatin and cerivastatin were well tolerated with safety profiles similar to other members of the statin class. In the six-week, multicentre, open-label, parallel-arm study, a total of 215 patients with high cholesterol were randomised to receive either atorvastatin 10 mg once daily or cerivastatin 300 micrograms once daily. Efficacy was determined by measuring changes in lipid parameters. The Australian Atorvastatin Assessment (Triple A) study supports the superiority of 10 mg of atorvastatin in achieving TC targets compared with 10 mg of simvastatin regardless of baseline cholesterol. Atorvastatin took significantly more patients to TC target of less than 5.0 mmol/L than simvastatin at all points within the study regardless of baseline cholesterol. After 24 weeks, 83.1 percent of atorvastatin treated patients reached target versus 65.9 percent on simvastatin (plus or minus cholestyramine). "The Triple A results are exciting because they show that the 10 mg starting dose of atorvastatin is an effective treatment for primary care patients with varying levels of baseline cholesterol," said Dr. Richard O'Brien, department of medicine, Monash University, Victoria, Australia. The 24-week, open-label, randomised study enrolled 1,028 hypercholesterolaemic men and women aged 18 to 76. Designed to replicate the real world where these patients are treated by general practitioners, the study involved more than 240 general practice offices. Patients with comparable baseline lipid levels were randomised to either atorvastatin or simvastatin. An initial drug dose of 10 mg daily for each agent was doubled at six-week intervals if the target TC level of less than 5.0 mmol/L (190 mg/dL) had not been achieved. The maximum dose of atorvastatin was 80 mg, while the maximum dose of simvastatin was 40 mg supplemented if necessary with 4 g of cholestyramine. Once a patient achieved the target of less than 5.0 mmol/L, the dose remained constant until the end of the six months. Atorvastatin is indicated as an adjunct to diet to reduce elevated total-C, LDL-C, Apo B, and TG levels in patients with primary hypercholesterolemia and mixed dyslipidemia. The recommended starting dose of atorvastatin is 10 mg once daily. The dosage range is 10 mg to 80 mg once daily. Atorvastatin is generally well tolerated. Adverse reactions usually have been mild and transient, with fewer than 2 percent of patients being discontinued from clinical trials due to side effects related to atorvastatin. This rate of discontinuation was comparable to that of placebo. The most frequent adverse effects of atorvastatin are constipation, flatulence, dyspepsia and abdominal pain. It is recommended that liver function tests be performed prior to and at 12 weeks following both the initiation of therapy and any elevation of dose, and periodically thereafter. Myopathy should be considered in any patient with diffuse myalgias, muscle tenderness or weakness and/or marked elevation of creatine phosphokinase (CPK). pslgroup.com