To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Approves New Dose Of Baycol, Adds New Indications URL: http://www.pslgroup.com/dg/1005FA.htm Doctor's Guide May 26, 1999
WEST HAVEN, CT and PHILADELPHIA, PA -- May 26, 1999 -- The United States Food and Drug Administration has approved a 0.4mg strength of Bayer Corporation, Pharmaceutical Division's and SmithKline Beecham's Baycol(R) (cerivastatin sodium tablets) as the recommended dose for patients with primary hypercholesterolemia (elevated cholesterol) and mixed dyslipidemia (elevated cholesterol and high triglycerides). In addition, Baycol received expanded indications to reduce triglycerides (TG) and apolipoprotein B (apo B) in patients with primary hypercholesterolemia and mixed dyslipidemia. Baycol belongs to the statin class of agents. In one clinical study of 349 patients, 40 percent of patients on the 0.4mg of Baycol achieved a greater than 40 percent reduction of low-density lipoprotein cholesterol (LDL-C). The 0.4mg dose of Baycol will help treat a wider range of the 91 million Americans who suffer from elevated cholesterol. The 0.4mg approval is based on clinical data from two large, multicentre, placebo-controlled dose response studies of patients with primary hypercholesterolemia. Results showed that with 0.4mg of Baycol every day in conjunction with dietary therapy for eight weeks, patients achieved mean reductions in low-density-lipoprotein cholesterol (LDL-C) and total cholesterol (TC) of 34 percent and 24 percent respectively. Reductions in apo B levels of 26 percent were also observed. A median TG reduction from baseline of 30 percent was observed in a pool of seven studies where patients with hypercholesterolemia and TG levels ranging from 250mg/dL to 500 mg/dl were treated with the 0.4mg dose of Baycol(R) for eight weeks. The median reduction for all patients in the studies was 16 percent. Reductions in patients' TG are baseline dependent. Baycol was initially launched in 1998 at 0.2 and 0.3mg strengths as an adjunct to diet for the reduction of elevated total cholesterol and LDL-C in patients with hypercholesterolemia and mixed dyslipidemia, when the response to dietary restriction of saturated fat and cholesterol and other non-pharmacological measures alone had been inadequate. Baycol, an HMG-CoA reductase inhibitor, is now indicated as an adjunct to diet for the reduction of elevated TC, LDL-C, apo B and TG levels in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson Types IIa and IIb) when response to dietary restriction of saturated fat and cholesterol and other non-pharmacological measures alone has been inadequate. Patients with hypercholesterolemia should be placed on a standard cholesterol-lowering diet. If the response to dietary restrictions of saturated fat and cholesterol and other non-pharmacological measures is inadequate, patients should continue on their diet and then begin treatment with Baycol. The recommended dose of Baycol is 0.4mg once daily, in the evening, with or without food. In patients with significant renal impairment (creatine clearance less than or equal to 60mL/min/1.73m2) lower doses are recommended. No dosing adjustment is required in the elderly, with the exception of those patients with significant renal impairment. Baycol is contraindicated in patients with hypersensitivity to any component of this medication, in patients with active liver disease or unexplained persistent elevations of serum transaminases, in women during pregnancy and in nursing mothers. Baycol should be temporarily withheld from any patient experiencing an acute or serious condition predisposing to the development of renal failure secondary to rhabdomyolysis (acute serious muscle disease), such as: sepsis; hypotension; major surgery; trauma; severe metabolic, endocrine or electrolyte disorders or uncontrolled epilepsy. Rare cases of rhabdomyolysis have been reported with cerivastatin and with other drugs in this class. Myopathy (a disorder of muscle tissues or muscle) should be considered in any patient with diffuse myalgias, muscle tenderness or weakness, and/or marked elevation of plasma creatine kinase (CK). Patients should be advised to report promptly unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever. The combined use of Baycol and gemfibrozil should be avoided. It is recommended that liver function tests be performed before the initiation of treatment, at six and 12 weeks after initiation of therapy or elevation in dose and periodically thereafter, (semi-annually). The risk of myopathy is increased with concurrent administration of cyclosporine, fibric acid derivatives, erythromycin, azole antifungals or lipid-lowering doses of niacin. In pharmacokinetic studies, no drug to drug interactions were observed with warfarin, digoxin, cimetidine, omeprazole and nifedipine. Baycol is generally well tolerated. In the U.S. placebo-controlled clinical studies, discontinuations due to adverse events occurred in 2.8 percent of cerivastatin sodium tablet-treated patients and in 2.2 percent of patients treated with placebo. In world-wide clinical trials with over 4,000 patients, the most common adverse events regardless of causality were pharyngitis, rhinitis, headache and sinusitis. 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