Clinical Pharmacology of Advicor (Niacin-Lovastatin):Kos Pharmaceuticals, Inc:"A variety of clinical studies have demonstrated that elevated levels of total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and apolipoprotein B-100 (Apo B) promote human atherosclerosis. Similarly, decreased levels of high-density lipoprotein cholesterol (HDL-C) are associated with the development of atherosclerosis. 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. Cholesterol-enriched triglyceride-rich lipoproteins, including very low-density lipoproteins (VLDL), intermediate-density lipoproteins (IDL), and their remnants, can also promote atherosclerosis. Elevated plasma triglycerides (TG) are frequently found in a triad with low HDL-C levels and small LDL particles, as well as in association with non-lipid metabolic risk factors for coronary heart disease (CHD). As such, total plasma TG have not consistently been shown to be an independent risk factor for CHD. As an adjunct to diet, the efficacy of niacin and lovastatin in improving lipid profiles (either individually, or in combination with each other, or niacin in combination with other statins) for the treatment of dyslipidemia has been well documented. The effect of combined therapy with niacin and lovastatin on cardiovascular morbidity and mortality has not been determined."
http://www.advicor.com/hcp.html

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Possible side effects of Advicor (Niacin-Lovastatin):gettingwell.com:"More common side effects may include: Abdominal pain, back pain, diarrhea, flu-like symptoms, flushing, headache, high blood sugar, indigestion, infection, itching, muscle pain, nausea, pain, rash, vomiting, weakness. Other possible side effects may include: Allergic reaction, anxiety, chest pain, chills, constipation, darkening of skin color, decreased sex drive, difficulty sleeping, dizziness, dry mouth, dry skin, enlarged breasts in men, eye irritation, fainting, gas, general feeling of unwellness, gout, hair loss, heartbeat irregularities, hives, inflammation of pancreas, impotence, joint pain, liver disorders, loss of appetite, low blood pressure, memory loss, mental changes, migraine, muscle cramps, muscle disorders, nerve disorders, runny nose, shortness of breath, skin and nail changes, sweating, swelling, tingling, tremor, ulcers, vertigo, vision disorders, yellowing of skin and eyes"
http://www.pdrhealth.com/drug_info/rxdrugprofiles/drugs/adv1608.shtml

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Clinical results and general information about Advicor (Niacin-Lovastatin):centerwatch:"Results of a multicenter, randomized, double-blind trial in subjects with type IIa and IIb hyperlipidemia supported the approval of Advicor. In this trial, Advicor was compared to monotherapy with Niaspan (extended-release niacin) or lovastatin. Dosage was escalated throughout the trial, with patients receiving each dose for at least four weeks. Subjects in the Advicor group received strengths ranging from 500mg/20mg to 2000mg/40mg. Those in the Niaspan monotherapy group received a similar titration from 500 mg to 2000 mg, and subjects in the lovastatin monotherapy group received 20mg titrated up to 40mg. Results showed that Advicor decreased LDL-C, triglycerides (TG) and lipoprotein a (Lp(a)), and increased HDL-C, in a dose-dependent fashion. Advicor produced greater LDL-lowering than lovastatin 40mg after 28 weeks of titration to a dose of 2000mg/40mg. Advicor also produced greater LDL-lowering than Niaspan at doses of 1000mg/20mg or higher. In terms of HDL, Advicor was superior in raising HDL compared to lovastatin and Niaspan monotherapy at all doses. Additionally, Advicor was more effective in lowering TG at doses of 1000 mg/20 mg or greater compared to lovastatin and Niaspan monotherapy."
http://www.centerwatch.com/patient/drugs/dru751.html

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Special Precautions while taking Advicor (Niacin-Lovastatin):healthsquare:"Advicor can cause liver problems. Your doctor will test your liver function before you start taking this medication, then every 6 to 12 weeks for the first 6 months after you begin therapy, and every 6 months thereafter. If the tests reveal a problem, you may have to stop taking Advicor. Individuals who regularly drink alcohol or have a history of liver disease should use this drug with caution. Avoid Advicor completely if you currently have liver disease. The extended-release niacin in Advicor is not interchangeable with immediate-release niacin. Substituting doses of extended release niacin for immediate-release niacin can cause severe liver damage. Drugs like Advicor may trigger a muscle-wasting condition that also can affect the kidneys. The risk is increased if Advicor is taken with certain drugs or grapefruit juice. Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness. You may have to stop taking Advicor. Use Advicor with caution if you have kidney disease, gout, or the chest pain of angina. Advicor may cause flushing. This side effect usually goes away after taking the medication for several weeks. Flushing can be accompanied by dizziness, fainting, heartbeat irregularities, chills, shortness of breath, or swelling. Notify your doctor if you experience dizziness. If you awaken because of flushing, rise slowly to avoid dizziness and fainting. Taking aspirin or ibuprofen before taking Advicor may help decrease the flushing. Avoid drinking alcohol or hot drinks near the time you take Advicor; these can increase flushing."
http://www.healthsquare.com/newrx/adv1608.htm

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What are Lovastatin and Niacin (the two components of Advicor)?:drugs.com:"Lovastatin blocks the production of cholesterol (a type of fat) in the body. Niacin, also known as nicotinic acid, is vitamin B3. It occurs naturally in plants and animals and is also added to many foods as a vitamin supplement. Niacin also blocks the production of cholesterol in the body. Together, lovastatin and niacin are used to reduce levels of LDL (or "bad") cholesterol, total cholesterol, and triglycerides and to raise levels of "good" (HDL)cholesterol. These actions are important in the prevention of heart disease and hardening of the arteries, which can lead to heart attacks, stroke, and peripheral vascular disease. Lovastatin and niacin may also be used for purposes other than those listed in this medication guide."
http://www.drugs.com/xq/cfm/pageID_0/htm_d04787A1.htm/bn_Advicor/qx/index.htm

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Advicor (Niacin-Lovastatin)- a significant player in cardiovascular therapeutics for patients with heart disease:kospharm.com:"Kos has emerged as a significant player in cardiovascular therapeutics for patients with heart disease, still the number one killer in America. The company currently markets Niaspan® and Advicor™, two products developed internally for the treatment of cholesterol problems. Available since 1997, Niaspan is the only FDA-approved, once-daily extended-release formulation of niacin for treating abnormal cholesterol levels. Kos’ solid-dose drug delivery technology transformed niacin (a B-vitamin that for decades had been known to be an effective cholesterol medication at high doses but was limited by significant side effects) into a highly effective, patient friendly therapy used by thousands of patients with coronary disease."
http://www.kospharm.com/kProducts/default.asp

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Food and drug interactions of Advicor (Niacin-Lovastatin):Thomson Healthcare:"Avoid drinking large amounts of grapefruit juice (more than a quart a day) while on Advicor therapy. It can increase the risk of muscle wasting. If Advicor is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Advicor with any of the following: Antifungal drugs such as Sporanox and Nizoral Blood pressure medications such as Inderal, Lopressor, and Tenormin Calcium channel blockers such as Norvasc, Plendil, and Procardia Cholesterol-lowering drugs called fibrates such as Lopid and Atromid Cimetidine (Tagamet) Clarithromycin (Biaxin) Cyclosporine (Sandimmune) Erythromycin (E.E.S., Erythrocin) HIV protease inhibitors such as Viracept and Norvir Nefazodone (Serzone) Nitroglycerin (Nitro-Bid, Nitro-Dur, Nitrostat) Nutritional supplements containing niacin or nicotinamide Spironolactone (Aldactone) Warfarin (Coumadin)"
http://health.yahoo.com/health/drug/500381/overview

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