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| |  DALM: Combined Analysis Underscores Safety, Efficacy of Lescol (Fluvastatin)/Lescol XL For Cholesterol Reduction NEW YORK, NY -- September 10, 2001 -- In the wake of concerns about the safety of cholesterol-lowering drugs belonging to the statin class, Novartis has conducted a rigorous analysis of data pooled from controlled clinical trials conducted in nearly 200 centers in fifteen countries, representative of the use of Lescol® (fluvastatin) and Lescol® XL (fluvastatin sodium) in nearly 9000 patients(1). This analysis focused on the frequency of elevations in creatinine phosphokinase (CPK), an indication of muscle breakdown. Dr. Christie Ballantyne, MD, Associate Director of Medicine at Baylor College of Medicine in Houston, Texas, presented the data today at the Drugs Affecting Lipid Metabolism (DALM) meeting in New York, New York. These data confirm that the frequency of clinically relevant creatinine phosphokinase (CPK) elevations with 20 mg and 40 mg Lescol and 80mg Lescol XL was not significantly different from that in patients receiving placebo. Furthermore, there were no cases of rhabdomyolysis observed in these studies. Moreover, the studies confirm Lescol and Lescol XL are effective in lowering blood lipids to the levels specified in international treatment guidelines. "These findings provide additional evidence that Lescol and Lescol XL have favorable safety profiles and are effective treatments for the majority of patients who need to manage their cholesterol levels," stated Dr. Ballantyne. A variety of small studies involving approximately 700 patients treated with Lescol in combination with either gemfibrozil, fenofibrate or bezafibrate did not show safety concerns(2). However, the combined use of any statin, including Lescol and Lescol XL and fibrates should be avoided, unless the benefit on lipid levels outweighs the increased risk of this combination. Lescol XL, the only approved extended-release, once-daily Lescol formulation, provides effective and comprehensive lipid management. In patients with Type IIb hyperlipidemia and triglycerides (TG) greater than 300 mg/dl, Lescol XL 80 mg showed excellent lipid reductions of up to 38 percent in harmful low-density lipoprotein (LDL)-cholesterol, up to 31 percent in TG, combined with elevations of up to 21 percent in favorable high-density lipoprotein (HDL)-cholesterol. In clinical trials, Lescol XL 80 mg produced a median reduction in TG of 19 percent in patients with dyslipidemia and 25 percent in patients with primary mixed dyslipidemia (Fredrickson Type IIb). In addition, Lescol XL 80 mg produced HDL-C increases ranging from 3-20 percent (25th - 75th percentile: median 11 percent) in patients with dyslipidemia and increases ranging from 0 - 15 percent (25th - 75th percentile: median 7 percent) in patients with primary mixed dyslipidemia (Fredrickson Type IIb). These data underscore the favorable efficacy/safety profile of Lescol/Lescol XL. As a result, Lescol and Lescol XL may be considered an excellent choice in the management of patients who need effective, comprehensive lipid management. In October 2000, the U.S. Food and Drug Administration (FDA) approved Lescol XL for use in patients with primary hypercholesterolemia and mixed dyslipidemia as an adjunct to diet, in order to reduce elevated total cholesterol, LDL-C, TG, and apolipoprotein B (Apo B) levels and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia. Lescol XL also received FDA approval for the indication to slow the progression of atherosclerosis in patients with coronary heart disease. Through its unique gel-matrix formulation, the slower delivery system of Lescol XL may decrease the systemic drug levels. Lescol and Lescol XL are well tolerated. In controlled studies with Lescol, adverse events 1.5 times greater than placebo are dyspepsia (7.9 percent versus 3.2 percent), insomnia (2.7 percent versus 1.4 percent), and nausea (3.2 percent versus 2.0 percent). In studies with Lescol XL, the most common side effects were upper respiratory tract infection, influenza-like symptoms, back pain, and headache. Lescol and Lescol XL are contraindicated in patients with active liver disease or persistent transaminase elevations, in pregnant or nursing patients, and in patients with hypersensitivity to Lescol or Lescol XL. It is recommended that liver function tests be performed before 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 occur at greater than or equal to three times the upper limit of normal on two consecutive occasions, discontinue Lescol or Lescol XL. Discontinue Lescol or Lescol XL if myopathy or rhabdomyolysis is diagnosed or suspected. The combined use of any statin (including Lescol and Lescol XL) and fibrates should be avoided unless the benefit on lipid levels outweighs the increased risk of this combination. References: 1. Abstract accepted by Drugs Affecting Lipid Metabolism (DALM) NY, September 2001. 2. Smit et al, Am J Cardiol 1995; 76:126A-128A; Farnier et al 1995;76:76A-79A; Cortellario et al 2000, Thrombosis and Haemostasis;83 (4):549-553; Jacobson et al 1994, Am J Cardiol; 73:25D-29D. SOURCE: Reliant Pharmaceuticals, LLC
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