• Like other members of its class (the "statins"), simvastatin lowers total serum cholesterol and particularly low density lipoprotein (LDL) cholesterol concentrations, thereby reducing the risk of atherosclerosis and its complications - myocardial infarction and stroke. (nih.gov)
  • SILVER SPRING, MD - Citing a lack of cardiovascular benefit, the FDA is taking the unusual step of withdrawing approvals it had previously given for use of niacin and fenofibric acid with statins to treat high cholesterol [ 1 ] . (medscape.com)
  • Consistent with this conclusion, the FDA has determined that the benefits of niacin ER tablets and fenofibric-acid [delayed-release] capsules for coadministration with statins no longer outweigh the risks, and the approvals for this indication should be withdrawn," a document filed in the Federal Registry today states [ 1 ] . (medscape.com)
  • Cite this: FDA Pulls Approval of Niacin, Fibrate in Combo with Statins - Medscape - Apr 15, 2016. (medscape.com)
  • For those who have a bad reaction to statins or when statins do not lower cholesterol enough, other medications, such as ezetimibe, niacin, fibrates, or bile acid sequestrants, may be combined with statins. (rxfacts.org)
  • The decision affects the indication of niacin extended-release ( Niaspan , AbbVie) and fenofibric acid ( Trilipix , AbbVie), as well as AbbVie's Advicor and Simcor , both of which combine niacin with a statin. (medscape.com)
  • The same reasoning was cited for pulling its approval of Advicor (niacin extended-release/lovastatin) and Simcor (niacin extended-release/simvastatin) [ 2 ] . (medscape.com)
  • Simvastatin is also available as a fixed combination with ezetimibe under the brand name Vytorin. (nih.gov)
  • Niaspan was first approved for several indications by the FDA in 1997 and later indicated in combination with simvastatin or lovastatin for the treatment of primary hyperlipidemia and mixed dyslipidemia when monotherapy with any of the three drugs was inadequate. (medscape.com)
  • Simvastatin is a commonly used cholesterol lowering agent (statin) that is associated with mild, asymptomatic and self-limited serum aminotransferase elevations during therapy, and rarely with clinically apparent acute liver injury. (nih.gov)
  • Zocor (simvastatin) is a statin that lowers lipids and cholesterol levels used in conjunction with lifestyle changes such as a low-fat, low cholesterol diet, and exercise to reduce the chances of cardiovascular disease and ischemic strokes in patients with elevated lipids and cholesterol. (rxlist.com)
  • Despite the proven lipid changes, niacin has not been found useful for decreasing the risk of cardiovascular disease in those already on a statin. (wikipedia.org)
  • the effect is enhanced when niacin is combined with a statin. (patientcareonline.com)
  • The pharmaceutical company Merck & Co. showed an interest in the Japanese research in 1976, and isolated lovastatin (mevinolin, MK803), the first commercially marketed statin, from the mold Aspergillus terreus . (wikidoc.org)
  • Simvastatin is available generic forms and under the commercial name of Zocor in tablets of 5, 10, 20, 40 and 80 mg. the recommended dose is 5 to 80 mg daily based upon tolerability and lipid levels. (nih.gov)
  • Therapy to raise the concentration of HDL cholesterol includes weight loss, smoking cessation, aerobic exercise, and pharmacologic management with niacin and fibrates. (medscape.com)
  • Fibrates and niacin enhance myopathy risk by a. (moam.info)
  • Niacin, also known as nicotinic acid, is an organic compound and a vitamer of vitamin B3, an essential human nutrient. (wikipedia.org)
  • Use of simvastatin is contraindicated in medications that are strong inhibitors of cytochrome P450 activity (such as cyclosporine, ketoconazole, diltiazem, ciprofloxacin or amiodarone), and dose adjustments are appropriate for its use with other agents that inhibit CYP 3A4. (nih.gov)
  • Although niacin and nicotinamide are identical in their vitamin activity, nicotinamide does not have the same pharmacological, lipid-modifying effects or side effects as niacin, i.e., when niacin takes on the -amide group, it does not reduce cholesterol nor cause flushing. (wikipedia.org)
  • A 2010 review had concluded that niacin was effective as a mono-therapy, but a 2017 review incorporating twice as many trials concluded that prescription niacin, while affecting lipid levels, did not reduce all-cause mortality, cardiovascular mortality, myocardial infarctions, nor fatal or non-fatal strokes. (wikipedia.org)
  • Lovastatin belongs to the family of medications known as lipid metabolism regulators . (pharmachoice.com)
  • Simvastatin (sim" va stat' in) is an orally available inhibitor of hepatic 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the major rate-limiting enzyme in cholesterol synthesis. (nih.gov)
  • The cause of hepatic injury from simvastatin is unknown. (nih.gov)
  • Coadministration with these agents may cause increases in simvastatin levels and potentiate its hepatic or muscle toxicity. (nih.gov)
  • As a consequence of extensive hepatic extraction of lovastatin, the availability of drug to the general circulation is low and variable. (nih.gov)
  • Clinically apparent liver injury due to simvastatin is rare. (nih.gov)
  • Rare cases of acute liver failure and death have been attributed to simvastatin. (nih.gov)
  • But in view of the wide use of simvastatin, clinically apparent liver injury is exceeding rare and is estimated to occur in 1 per 100,000 patient years of exposure. (nih.gov)
  • Simvastatin is metabolized to some extent in the liver (via CYP 3A4) and is excreted in bile. (nih.gov)
  • In animal studies, after oral dosing, lovastatin had high selectivity for the liver, where it achieved substantially higher concentrations than in non-target tissues. (nih.gov)
  • Lovastatin undergoes extensive first-pass extraction in the liver, its primary site of action, with subsequent excretion of drug equivalents in the bile. (nih.gov)
  • Current indications for simvastatin are hypercholesterolemia and reduction in risk for death from coronary, cerebrovascular and peripheral artery disease in patients with these diseases. (nih.gov)
  • Lovastatin belongs to the medicine-group named HMG CoA reductase inhibitors. (tabletsmanual.com)
  • Inhibition of HMG-CoA reductase is the basis for an assay in pharmacokinetic studies of the β-hydroxyacid metabolites (active inhibitors) and, following base hydrolysis, active plus latent inhibitors (total inhibitors) in plasma following administration of lovastatin. (nih.gov)
  • In a single dose study in four hypercholesterolemic patients, it was estimated that less than 5% of an oral dose of lovastatin reaches the general circulation as active inhibitors. (nih.gov)
  • if you are taking a bile acid-binding resin such as colestipol (Colestid) or cholestyramine (Questran), take it at least 4 to 6 hours before or 4 to 6 hours after niacin. (medlineplus.gov)
  • Results of a clinical study in people with heart disease and well-controlled cholesterol levels that compared people who took niacin and simvastatin with people who took simvastatin alone and found similar results for the two groups in the rate of heart attacks or strokes. (medlineplus.gov)
  • tell your doctor and pharmacist if you are allergic to niacin, any other medications, or any of the ingredients in niacin tablets. (medlineplus.gov)
  • Enhancement of solubility and therapeutic potential of poorly soluble lovastatin by SMEDDS formulation adsorbed on directly compressed spray dried magnesium aluminometasilicate liquid loadable tablets: A study in diet induced hyperlipidemic rabbits. (rjptonline.org)
  • In the meantime there is 10 mg tablets of generic lovastatin are sold. (tabletsmanual.com)
  • Niacin has the formula C 6H 5NO 2 and belongs to the group of the pyridinecarboxylic acids. (wikipedia.org)
  • Niacin as a dietary supplement is used to treat pellagra, a disease caused by niacin deficiency. (wikipedia.org)
  • Nicotinamide is recommended as a treatment for niacin deficiency because it can be administered in remedial amounts without causing the flushing, considered an adverse effect. (wikipedia.org)
  • Severe deficiency of niacin in the diet causes the disease pellagra, characterized by diarrhea, sun-sensitive dermatitis involving hyperpigmentation and thickening of the skin (see image), inflammation of the mouth and tongue, delirium, dementia, and if left untreated, death. (wikipedia.org)
  • or E) changes to genome expression directly due to the niacin deficiency. (wikipedia.org)
  • Niacin is also used to prevent and treat pellagra (niacin deficiency), a disease caused by inadequate diet and other medical problems. (medlineplus.gov)
  • Niacin comes as a tablet and an extended-release (long-acting) tablet to take by mouth. (medlineplus.gov)
  • Lovastatin, USP is a cholesterol lowering agent isolated from a strain of Aspergillus terreus. (nih.gov)
  • Your doctor will probably start you on a low dose of niacin and gradually increase your dose. (medlineplus.gov)
  • If you take insulin or oral diabetes medication, your dose may need to be changed because niacin may increase the amount of sugar in your blood and urine. (medlineplus.gov)
  • Following an oral dose of 14C-labeled lovastatin in man, 10% of the dose was excreted in urine and 83% in feces. (nih.gov)
  • Absorption of lovastatin, estimated relative to an intravenous reference dose, in each of four animal species tested, averaged about 30% of an oral dose. (nih.gov)
  • The usual starting dose of simvastatin to reduce the risk of heart attack or stroke is 40 mg taken by mouth once a day, in the evening. (pharmasave.com)
  • Niacin is both a vitamin, i.e., an essential nutrient, marketed as a dietary supplement, and in the US, a prescription medicine. (wikipedia.org)
  • Niacin or nicotinamide (niacinamide) are used for prevention and treatment of pellagra, a disease caused by lack of the vitamin. (wikipedia.org)
  • Niacin is a B-complex vitamin. (medlineplus.gov)
  • Prescription niacin was shown to cause hepatotoxicity and increase risk of type 2 diabetes. (wikipedia.org)
  • Lovastatin is a specific inhibitor of HMG-CoA reductase, the enzyme which catalyzes the conversion of HMG-CoA to mevalonate. (nih.gov)
  • Lovastatin is a lactone which is readily hydrolyzed in vivo to the corresponding β-hydroxyacid, a strong inhibitor of HMG-CoA reductase. (nih.gov)
  • Each of the aliquot 2 µL diluted with acetonitrile and determination of concentration lovastatin using HPLC, with detector ultraviolet at 237 nm. (rjptonline.org)
  • The mechanism of the LDL-lowering effect of lovastatin may involve both reduction of VLDL-C concentration, and induction of the LDL receptor, leading to reduced production and/or increased catabolism of LDL-C. Apolipoprotein B also falls during treatment with lovastatin. (nih.gov)
  • Simvastatin was approved for use in the United States in 1991 and is still widely used with more than 40 million prescriptions being filled yearly. (nih.gov)
  • Niacin prescriptions in the U.S. had peaked in 2009, at 9.4 million,[citation needed] declining to 800 thousand by 2020. (wikipedia.org)
  • Niacin is obtained in the diet from a variety of whole and processed foods, with highest contents in fortified packaged foods, meat, poultry, red fish such as tuna and salmon, lesser amounts in nuts, legumes and seeds. (wikipedia.org)
  • Talk to your doctor if you have questions about the risks and benefits of treating increased amounts of cholesterol in your blood with niacin and other medications. (medlineplus.gov)
  • Up to 5% of patients taking simvastatin chronically may experience minor elevations in serum ALT levels during therapy, but confirmed elevations to above three times the upper limit of normal (ULN) occur in only 1% to 2% of patients. (nih.gov)
  • This study aimed to determine the solubility of lovastatin (LV) in different oil, surfactant, and co-surfactant using the high-performance liquid chromatography method. (rjptonline.org)
  • Lovastatin has high soluble in oleic acid, tween 80, and PEG 400. (rjptonline.org)