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References

  1. ADVICOR® Prescribing Information. Cranbury, NJ: Kos Pharmaceuticals, Inc. 2006.

  2. Robertson RM. Women and cardiovascular disease. The risks of misperception and the need for action. Circulation. 2001;103:2318-2320.

  3. Assmann G, Schulte H, von Eckardstein MD. Hypertriglyceridemia and elevated lipoprotein (a) are risk factors for major coronary events in middle-aged men. Am J Cardiol. 1996;77:1179-1184.

  4. Castelli WP. Cholesterol and lipids in the risk of coronary artery disease – the Framingham Heart Study. Can J Cardiol. 1988;4(Suppl A):5A-10A.

  5. Data on File. Kos Pharmaceuticals, Inc. Cranbury, NJ.

  6. Mosca L, Appel LJ, Benjamin EJ, et al. AHA Guidelines: evidence-based guidelines for cardiovascular disease prevention in women. Circulation. 2004;109:672-693.

  7. IMS Health NPA Plus, January 2006.

  8. American Heart Association. Women and Cardiovascular Disease –Statistics. Dallas, TX. Available at: http://www.americanheart.org/downloadable/heart/
    1136818052118Females06.pdf     Accessed: 04/17/2006.

  9. Jensen J, Nilas L, Christiansen C. Influence of menopause on serum lipids and lipoproteins. Maturitas. 1990;12:321-331.

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  11. Physician Drug & Diagnosis Audit (PDDA) from Versipan, L. L. C; July 2003-July 2004.

  12. Bass KM, Newschaffer CJ, Klog MJ, et al. Plasma lipoprotein levels as predictors of cardiovascular death in women. Arch Intern Med. 1993;153:2209-2216.

  13. Rubenfire M, for the Impact of Medical Subspecialty on Patient Compliance to Treatment (IMPACT) study. Safety and compliance with once-daily niacin extended-release lovastatin as initial therapy in the impact of medical sub-specialty on patient compliance to treatment. Am J Cardiol. 2004;94:306-311.

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  16. National Heart, Lung, and Blood Institute. Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Bethesda, MD: National Institutes of Health, US Department of Health and Human Services; 2002, NIH Publication 02-5215.

  17. Rubins HB, Robins SJ, Colllins D, et al. Gemfibrozil for the secondary prevention of coronary heart disease in men with low levels of high-density lipoprotein cholesterol. N Engl J Med. 1999;341:410-418.

  18. Blankenhorn DH, Nessim SA, Johnson RL, et al. Beneficial effects of combined colestipol-niacin therapy on coronary atherosclerosis and coronary venous bypass grafts. JAMA. 1987;257:3233-3240.

  19. Cashin-Hemphill L, Mack WJ, Pogoda JM, et al. Beneficial effects of colestipol-niacin on coronary atherosclerosis. A 4-year follow-up. JAMA. 1990;264:3013-3017.

  20. Brown G, Albers JJ, Fisher LD, et al. Regression of coronary artery disease as a result of intensive lipid-lowering therapy in men with high levels of apolipoprotein B. N Engl J Med. 1990;323:1289-1298.

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ADVICOR® (niacin extended-release/lovastatin tablets) is a fixed-dose combination product and is not indicated for initial therapy. Initial single-agent therapy is indicated as an adjunct to diet for patients who respond inadequately to restrictions in saturated fat and cholesterol and to other nonpharmacologic measures alone.

ADVICOR is indicated for the treatment of primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Frederickson Types IIa and IIb) in patients treated with (1) lovastatin who require further TG-lowering or HDL-C-raising who may benefit from having niacin added to their regimen, or (2) niacin who require further LDL-C-lowering who may benefit from having lovastatin added to their regimen.

The effect of combined therapy with niacin and lovastatin on cardiovascular morbidity and mortality has not been determined. Epidemiological investigations have established that cardiovascular morbidity and mortality vary directly with the level of TC and LDL-C, and inversely with the level of HDL-C.

IMPORTANT SAFETY INFORMATION

ADVICOR is contraindicated in patients with a hypersensitivity to product components; active liver disease or unexplained persistent elevations in serum transaminases; active peptic ulcer disease; arterial bleeding; nursing or pregnant.

ADVICOR should not be substituted for equivalent doses of immediate-release (crystalline) niacin. For patients switching from immediate-release niacin to NIASPAN® (niacin extended-release tablets), therapy with NIASPAN should be initiated with low doses (i.e., 500 mg once daily at bedtime) and the NIASPAN dose should then be titrated to the desired therapeutic response. Cases of severe hepatic toxicity, including fulminant hepatic necrosis, have occurred in patients who have substituted sustained-release (modified-release, timed-release) niacin products for immediate-release (crystalline) niacin at equivalent doses.

ADVICOR should be used with caution in patients who consume substantial quantities of alcohol and/or have a past history of liver disease. Liver function tests should be performed on all patients during therapy with ADVICOR. Serum transaminase levels should be monitored before treatment begins, every 6 to 12 weeks for the first 6 months, and periodically thereafter.

Myopathy and/or rhabdomyolysis have been reported when lovastatin is used in combination with lipid-altering doses (≥1g/day) of niacin. The incidence and severity of myopathy may be increased by concomitant administration of ADVICOR with drugs that can cause myopathy when given alone, such as gemfibrozil and other fibrates. Periodic CK determinations may be considered in such situations, but there is no assurance that such monitoring will prevent myopathy. ADVICOR therapy should be discontinued if myopathy is diagnosed or suspected.

Flushing episodes (i.e., warmth, redness, itching and/or tingling) were the most common treatment-emergent adverse events in controlled clinical studies occurring in 53% to 83% of patients; 8% of patients discontinued because of flushing. Spontaneous reports with NIASPAN and clinical studies with ADVICOR suggest that flushing may also be accompanied by symptoms of dizziness or syncope, tachycardia, palpitations, shortness of breath, sweating, chills, and/or edema. Other common adverse events (≥5% patients) with ADVICOR included asthenia, flu, headache, infection, pain, diarrhea, nausea, pruritus, and rash.

Diabetic patients may experience a dose-related rise in fasting blood sugar. Diabetic or potentially diabetic patients should be observed closely during treatment with ADVICOR, and adjustment of diet and/or hypoglycemic therapy may be necessary.

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