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High Cholesterol board


You should get a kick out of this FDA Approval memo - it's every bit as legit as yours, and is for Baycol, the statin drug which was recently pulled from the market due to safety concerns.

So much for 'FDA Approval"...

:cool: :cool: :cool:

For Immediate Release

FDA approves new dose of Baycol® for the treatment of elevated cholesterol
Powerful new dosage and additional indications broaden therapeutic use

May 25, 1999 ---- Bayer Corporation, Pharmaceutical Division, today announced the Food and Drug Administration's (FDA) approval of a 0.4mg strength of Baycol® (cerivastatin sodium tablets) as the recommended dose for patients with primary hypercholesterolemia (elevated cholesterol) and mixed dyslipidemia (elevated cholesterol and high triglycerides). This powerful new dose will be available at the same affordable price as the 0.3mg dose of Baycol®. Baycol® belongs to the statin class of agents and is co-marketed in the United States with SmithKline Beecham.

In one clinical study of 349 patients, 40% of patients on the 0.4mg of Baycol® achieved a greater than 40% 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. In addition, Baycol® received expanded indications to reduce triglycerides (TG) and apolipoprotein B (apo B) in patients with primary hypercholesterolemia and mixed dyslipidemia.

"These new indications are the first step toward achieving the enormous potential of Baycol®. We are continuing to scientifically evaluate higher doses of Baycol® as well as its unique potential in special patient populations," said Mel Sorensen, M.D., Director, Medical Research, CardioPulmonary and Oncology, Bayer Corporation.

The 0.4mg approval is based on clinical data from two large (n= 571), multicenter, 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% and 24% respectively. Reductions in apo B levels of 26% were also observed.

EA median TG reduction from baseline of 30% was observed in a pool of seven studies where patients with hypercholesterolemia and TG levels ranging from 250mg/dL to 500 mg/dL (n=105) were treated with the 0.4mg dose of Baycol® for eight weeks. The median reduction for all patients in the studies was 16%. 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 £ 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), e.g., 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 6 and 12 weeks after initiation of therapy or elevation in dose, and periodically thereafter, e.g. 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% of cerivastatin sodium tablet-treated patients and in 2.2% of patients treated with placebo. In worldwide clinical trials with over 4,000 patients, the most common adverse events regardless of causality were pharyngitis, rhinitis, headache and sinusitis.

The sNDA for the 0.4mg dose of Baycol® was filed on July 16, 1998 and approved on May 25, 1999. The label change to indicate reduction in TG and apo B was also approved on May 25, 1999. Baycol® was initially cleared for marketing by the FDA on June 26, 1997.

Baycol® is currently available in numerous countries including, Argentina, Australia, Canada, France, Germany, Italy, Japan, Mexico, the Philippines, Spain and the United Kingdom.

SmithKline Beecham - one of the world's leading healthcare companies - discovers, develops, manufactures, and markets pharmaceuticals, vaccines, over-the-counter medicines, and health-related consumer products, and provides healthcare services including clinical-laboratory testing, disease management, and pharmaceutical-benefit management.

Bayer Corporation is a research-based company with major businesses in health care and life sciences and chemicals. The company had 1998 sales of $8.1 billion and employs more than 23,000 people. Bayer Corporation is investing $15 billion in capital expenditures and research and development from 1995 through the year 2004. 1999 capital investment and R&D expenditures are projected to total $1.6 billion. Bayer Corporation, with headquarters in Pittsburgh, is a member of the worldwide Bayer Group, a $31 billion international life sciences, polymers and specialty chemicals group based in Leverkusen, Germany.