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| |  EAS MEETING: Lescol Improves Major Lipid Parameters In Dyslipidemic Patients EAST HANOVER, NJ -- May 28, 1999 -- According to a pooled analysis of 12 clinical trials, patients with mixed dyslipidemia who were treated with Novartis Pharmaceuticals Corp.’s Lescol(R) (fluvastatin sodium) demonstrated significant improvement of triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B) and high-density lipoprotein cholesterol (HDL-C). The results of this analysis were presented at the 71st annual European Atherosclerosis Society congress in Athens, Greece. Mixed dyslipidemia is a lipid disorder of elevated LDL-C and TG that appears to significantly increase the risk of coronary artery disease and is the most common disorder in young survivors of myocardial infarction. "This analysis shows that fluvastatin is effective in mixed dyslipidemic patients who require a variety of lipid modifications," said study author Evan Stein, MD, Medical Research Laboratories, Highland Heights, Kentucky. "Traditional therapeutic options have favoured fibrates or niacin, but this new data also supports the use of statins, including fluvastatin, in these patients." Across a dosage range of 20 to 80 mg (40 mg, BID), Lescol produced significant reductions of TG (17 to 25 percent), LDL-C (23 to 37 percent), Apo B (19 to 28 percent) and an increase of HDL-C (six to 11 percent) compared to placebo in patients with mixed dyslipidemia. Based on these studies, the United States Food and Drug Administration recently approved a new indication for Lescol to additionally decrease TG and Apo B in patients with mixed dyslipidemia. The pooled analysis was based on 12 placebo- and diet-controlled, double-blind studies involving 228 mixed dyslipidemic patients (defined as LDL-C greater than 160 mg/dl and TG greater than 250 mg/dl) conducted over the last 10 years. All lipid analyses were performed by two Centers for Disease Control and Prevention standardised laboratories. Lescol is currently indicated as an adjunct to diet and exercise for the treatment of elevated total cholesterol, LDL-C, TG and Apo B in patients with primary hypercholesterolemia and mixed dyslipidemia and to slow the progression of atherosclerosis in patients with coronary heart disease (CHD). There are more than 100 recently completed or ongoing clinical trials world-wide with Lescol among various populations, including patients with diabetes, hypertension, CHD and kidney disease. Lescol is also being evaluated in a primary prevention trial involving renal transplant patients and in a secondary prevention trial involving patients with CHD. In clinical trials, adverse events to Lescol were generally mild and similar to placebo. Common adverse events were fatigue, nausea, diarrhea, dyspepsia, abdominal pain and rash. Lescol should not be used by pregnant or nursing women, in patients who currently have liver disease or unexplained increases in liver enzyme levels and in patients who are allergic to any ingredient in this medication. It is recommended that liver function tests be performed before the initiation of therapy and at 12 weeks following initiation of treatment or elevation in dose. If serum transaminase levels rise, monitor more often; if they persist at greater than or equal to three times the upper limit of normal, discontinue Lescol. Treatment with Lescol should be discontinued if myopathy and rhabdomyolysis are diagnosed or suspected. Related Links: Lescol, Novartis Pharmaceuticals Corp.
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