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| |  CCS: Patients Taking Baycol (Cerivastatin) Reach Target Cholesterol Levels VANCOUVER, BC -- November 2, 2000 -- CAVEAT study results presented at the 53rd Annual Meeting of the Canadian Cardiovascular Society (CCS) show an impressive 96 percent of patients on Baycol (cerivastatin sodium tablets) 0.8 mg reaching LDL cholesterol levels set out in Canadian guidelines and 84 percent reaching these targets with Baycol 0.4 mg. This is particularly good news for dyslipidemic patients in light of the recent Lipid Treatment Assessment Project (L-TAP) findings, published in the February 28, 2000 issue of the Archives of Internal Medicine. L-TAP showed that, on average, only 38 percent of patients are reaching their target LDL cholesterol levels with older statin medications such as simvastatin, fluvastatin, pravastatin and lovastatin. The Canadian Working Group on Hypercholesterolemia and Other Dyslipidemias recently updated Canadian guidelines to reflect the need for more aggressive lipid treatment goals. Sponsored by Bayer Inc. and Fournier Pharma, Thylmer Division, the all-Canadian CAVEAT study was a randomised, double-blind, parallel group comparison of Baycol 0.4 mg and 0.8 mg to Lipitor (atorvastatin calcium) 10 mg and 20 mg, once daily, in patients with type IIb mixed dyslipidemia (elevated LDL cholesterol and triglycerides). A total of 340 patients participated in the study. The primary and secondary endpoints of this clinical trial were to compare the efficacy of Baycol and Lipitor at modifying triglyceride (TG) levels, levels of total cholesterol (TC), levels of HDL and LDL cholesterol (HDL-C and LDL-C), very-low density lipoprotein cholesterol (VLDL-C) levels, the TC:HDL-C ratio and ApoB levels. The study used clinically comparable dosages of the two drugs. Baycol dosages used in the study were the recently approved 0.4 mg dose, expected to become the most prescribed Baycol dosage in the near future, and the new 0.8 mg dosage currently being reviewed by Health Canada. Dosages of Lipitor used in the study were the two most commonly prescribed dosages, 10 mg and 20 mg, that account for close to 90 percent of Lipitor prescriptions, according to IMS Health¹s September 2000 total prescription data. "The results of CAVEAT are very interesting in that they show Baycol is as effective at reaching lipid targets as Lipitor," says Dr. Patrick Ma, Director, Lipid Clinic, Heart Healthy Institute, Calgary, Alberta and the Principal Investigator for CAVEAT. "CAVEAT shows that patients and physicians have another powerful option to help them reach targets and that we can clearly do a better job of reaching lipid targets in clinical practice, considering only 40 percent of patients taking statins currently reach their lipid targets," adds Dr. Ma. Key findings of CAVEAT include the following: In addition to Baycol’s powerful LDL-C reduction, past studies have shown Baycol to be effective at increasing HDL-C and achieving greater reductions of triglycerides than older statins. In CAVEAT, the most frequently reported adverse events with Baycol 0.4 mg and Lipitor 10 mg were headache (19.8 and 19.6 percent, respectively), rhinitis, (15.5 and 16.1 percent, respectively) and arthralgia (8.6 and 8.9 percent, respectively). With Baycol 0.8 mg and Lipitor 20 mg, the events reported most often were rhinitis (19 and 5.4 percent, respectively), headache (8.6 and 12.5 percent, respectively) and dyspepsia (also 8.6 and 12.5 percent, respectively). The total of patients withdrawing from the study due to adverse events was two in the Baycol 0.4 mg arm, two in the Baycol 0.8 mg arm, two in the Lipitor 10 mg arm and three in the Lipitor 20 mg arm of the study. "The efficacy of Baycol at reaching lipid targets that was shown in CAVEAT, combined with its tolerability and low propensity for drug interactions should make Baycol an interesting choice for the treatment of mixed dyslipidemic patients," comments Dr. Jean-François Yale, Director , Metabolic Day Centre, McGill Nutrition and Food Science Centre, also a CAVEAT investigator. Baycol is unique among statins in that it is absorbed, metabolised and eliminated from the body via a dual metabolic pathway. This means there is a low risk of interaction with other medications and less likelihood of developing toxicity due to an accumulation of the drug if one of the metabolic pathways is inhibited by other commonly prescribed medications taken at the same time Although coronary artery disease (CAD) continues to be the leading cause of morbidity and mortality in Canada and the rest of the western world, studies have shown that treatment of lipid disorders with HMG-CoA inhibitors (statins), such as Baycol, has resulted in marked improvements in the quality of life and the life expectancy of patients. Numerous pivotal studies have established the link between high LDL-C, low HDL-C and high TG with an increased risk for coronary artery disease. Several new Canadian Baycol studies will be initiated in the coming months, including two more comparative studies with Lipitor. The PEBBLE study (Pleiotropic Effects of Baycol Beyond Lipid Elimination) will mainly assess the "secondary" benefits of Baycol 0.8 mg and Lipitor 80 mg on endothelial function in patients with coronary artery disease. "Clinical research with statins is now shifting focus to the secondary or pleiotropic benefits of statins," says Dr. François Charbonneau, Assistant Professor, Faculty of Medicine, at McGill University and the lead investigator for PEBBLE. "These are benefits that are not solely related to statins’ effects on lipids - for example, improvement of endothelial function, reduction in inflammatory mediators and plaque stabilisation." PEBBLE marks the first time that a study will compare the effects of two statins on endothelial function. The study also aims to prove that statins¹ effects on endothelial function are independent of LDL-C reduction. This 12 month study will take place in five Canadian centres located in Quebec, Ontario, Nova Scotia, British Columbia and Alberta, and will involve 114 patients. CHOIR (Cerivastatin and HDL-C: Optimizing Initial Response) is a comparative study between Baycol 0.8 mg and Lipitor 80 mg. CHOIR will assess the efficacy of both statins at raising HDL-C, as well as their safety, in patients with hyperlipidemia. Two target HDL-C levels will be determined for each patient, based on the National Cholesterol Education Program (NCEP) guidelines and Canadian guidelines. These targets will vary according to each patient¹s risk factors. This 14-month Canadian study will be conducted at 35 sites (eight in Quebec, 11 in Ontario, seven in Eastern Canada and nine in the West) and will involve 360 patients. Baycol is co-marketed in Canada by Bayer Inc. and the Thylmer Division of Fournier Pharma. Related Link: Baycol (cerivastatin).
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