Niacin extended-release/simvastatin

Drugs

Volumn 68, Issue 16, 2008, Pages 2373-2386

  Sanford, Mark ^a,b   Curran, Monique P ^a,b  

^a ADIS INTERNATIONAL LIMITED   (New Zealand)

^b WOLTERS KLUWER HEALTH   (United States)

Author keywords

Adis Drug Profiles; Hyperlipidaemia; Niacin simvastatin, general; Research and development

Indexed keywords

ACETYLSALICYLIC ACID; AMINOTRANSFERASE; AMIODARONE; APOLIPOPROTEIN A; APOLIPOPROTEIN A1; APOLIPOPROTEIN B; COLESTIPOL; COLESTYRAMINE; COUMARIN; DANAZOL; DIGOXIN; GANGLION BLOCKING AGENT; GEMFIBROZIL; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; IBUPROFEN; KETOCONAZOLE; LIPOPROTEIN; LOW DENSITY LIPOPROTEIN CHOLESTEROL; MACROLIDE; NEFAZODONE; NIACIN PLUS SIMVASTATIN; NICOTINIC ACID; NONSTEROID ANTIINFLAMMATORY AGENT; PLACEBO; PROTEINASE INHIBITOR; SIMCOR; SIMVASTATIN; TRIACYLGLYCEROL; UNCLASSIFIED DRUG; URIC ACID; VERAPAMIL; VERY LOW DENSITY LIPOPROTEIN CHOLESTEROL;

AMINOTRANSFERASE BLOOD LEVEL; ANTIINFLAMMATORY ACTIVITY; AREA UNDER THE CURVE; BACKACHE; BEDTIME DOSAGE; CARDIOVASCULAR RISK; CHOLESTEROL BLOOD LEVEL; CHOLESTEROL SYNTHESIS; CLINICAL TRIAL; CONTROLLED RELEASE FORMULATION; CORONARY ARTERY DISEASE; DIARRHEA; DRUG ABSORPTION; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG HALF LIFE; DRUG MEGADOSE; DRUG SUBSTITUTION; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSLIPIDEMIA; FOOD DRUG INTERACTION; GASTROINTESTINAL SYMPTOM; GLUCOSE BLOOD LEVEL; GRAPE JUICE; HEADACHE; HOT FLUSH; HUMAN; HYPERCHOLESTEROLEMIA; HYPERTRIGLYCERIDEMIA; HYPOTENSION; KIDNEY FAILURE; LIPOPROTEIN SYNTHESIS; LIVER TOXICITY; LOW DRUG DOSE; MAXIMUM PLASMA CONCENTRATION; METABOLIC SYNDROME X; MONOTHERAPY; MYALGIA; MYOPATHY; NAUSEA; NON INSULIN DEPENDENT DIABETES MELLITUS; PROTEIN SYNTHESIS INHIBITION; PRURITUS; RECOMMENDED DRUG DOSE; REVIEW; RHABDOMYOLYSIS; SIDE EFFECT; SYSTEMATIC REVIEW; TIME TO MAXIMUM PLASMA CONCENTRATION; TRIACYLGLYCEROL BLOOD LEVEL; URIC ACID BLOOD LEVEL;

EID: 55049090689     PISSN: 00126667     EISSN: 00126667     Source Type: Journal    
DOI: 10.2165/0003495-200868160-00008     Document Type: Review

References (36)

1. Plosker GL, McTavish D. Simvastatin: a reappraisal of its pharmacology and therapeutic efficacy in hypercholesterolaemia. Drugs 1995; 50 (2): 334-63
2. McCormack PL, Keating GM. Prolonged-release nicotinic acid: a review of its use in the treatment of dyslipidaemia. Drugs 2005; 65 (18): 2719-40
3. Scanu AM, Bamba R. Niacin and lipoprotein(a): facts, uncertainties, and clinical considerations. Am J Cardiol 2008 Apr 17; 101 Suppl.: 44-7B
4. Cannon CP. Combination therapy in the management of mixed dyslipidaemia. J Intern Med 2008 Apr; 263 (4): 353-65
5. Smith Jr SC, Allen J, Blair SN, et al. AHA/ACC Guidelines for secondary prevention for patients with coronary and other atherosclerotic vascular diseases: 2006 update (writing group for the American Heart Association/American College of Cardiology). Circulation 2006 May 16; 113 (19): 2363-72
6. Hackam DG. Intensive reduction of low-density lipoprotein-cholesterol: implications of recent trials. Am J Cardiovasc Drugs 2006; 6 (6): 367-71
7. Grundy SM, Cleeman JI, Merz CN, et al. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III guidelines. Circulation 2004 Jul 13; 110 (2): 227-39
8. National Cholesterol Education Program. Executive summary of the third report of the National Cholesterol Education Program (NCEP) expert panel on detection, evaluation, and treatment of high blood cholesterol in adults (Adult Treatment Panel III). JAMA 2001 May 16; 285 (19): 2486-97
9. Taylor AJ. Evidence to support aggressive management of high-density lipoprotein cholesterol: implications of recent imaging trials. Am J Cardiol 2008 Apr 17; 101 Suppl.: 36-43B
10. Hvizdos KM, Goa KL. Management of dyslipidaemias: the role of simvastatin. Dis Manage Health Outcomes 2000; 7 (2): 83-109
11. Brown GB, Zhao X-Q, Chait A, et al. Simvastatin and niacin, antioxidant vitamins, or the combination for the prevention of coronary disease. N Engl J Med 2001 Nov 29; 345 (22): 1583-92
12. Sleight P, Pouleur H, Zannad F. Benefits, challenges, and registerability of the polypill. Eur Heart J 2006 Jul; 27 (14): 1651-6
13. Abbott. Simcor®: prescribing information [online]. Available from URL: http://www.fda.gov/cder/foi/label/2008/022078lbl.pdf [Accessed 2008 Sep 30]
14. Todd PA, Goa KL. Simvastatin: a review of its pharmacological properties and therapeutic potential in hyperchlosterolaemia. Drugs 1990 Oct; 40 (4): 583-607
15. Gille A, Bodor ET, Ahmed K, et al. Nicotinic acid: pharmacological effects and mechanisms of action. Annu Rev Pharmacol Toxicol 2008; 48: 79-106
16. Kamanna VS, Kashyap M. Mechanism of action of niacin. Am J Cardiol 2008 Apr 17; 101 Suppl.: 20-6B
17. Tesfamariam B. The effects of HMG-CoA reductase inhibitors on endothelial function. Am J Cardiovasc Drugs 2006; 6 (2): 115-20
18. vanWijk JPH, Buirma R, vanTol A, et al. Effects of increasing doses of simvastatin on fasting lipoprotein subfractions, and the effect of high-dose simvastatin on postprandial chylomicron remnant clearance in normotriglyceridemic patients with premature coronary sclerosis. Atherosclerosis 2005 Jan; 178 (1): 147-55
19. Tavridou A, Efthimiadis A, Efthimiadis I, et al. Antioxidant effects of simvastatin in primary and secondary prevention of coronary heart disease. Eur J Clin Pharmacol 2006 Jun; 62 (6): 485-9
20. Giurgea AG, Margeta C, Maca T, et al. Simvastatin reduces serum level of vascular endothelial growth factor in hypercholesterolemic patients. J Cardiovasc Pharmacol 2006 Jan; 47 (1): 30-6
21. Jula A, Marniemi J, Rönnemaa T, et al. Effects of diet and simvastatin on fatty acid composition in hypercholesterolemic men: a randomized controlled trial. Arterioscler Thromb Vasc Biol 2005 Sep; 25 (9): 1952-9
22. McEvoy GK, Snow EK, editors. AHSF drug information 2008. Bethesda (MD): American Society of Health-System Pharmacists, Inc. 2008
23. Thoenes M, Oguchi A, Nagamia S, et al. The effects of extended-release niacin on carotid intimal media thickness, endothelial function and inflammatory markers in patients with the metabolic syndrome. Int J Clin Pract 2007 Nov; 61 (11): 1942-8
24. Sorrentino SA, Besler C, Bahlmann FH, et al. Extended-release niacin improves endothelial function, restores re-endothelialization capacity of endothelial progenitor cells and augments vasoprotective properties of HDL in patients with metabolic syndrome [abstract no. 189]. Circulation 2007 Oct 17; 116 (16): 16
25. Kuvin JT, Dave DM, Sliney KA, et al. Effects of extended-release niacin on lipoprotein particle size, distribution, and inflammatory markers in patients with coronary artery disease. Am J Cardiol 2006 Sep 15; 98 (6): 743-5
26. Vega GL, Cater NB, Meguro S, et al. Influence of extended-release nicotinic acid on nonesterified fatty acid flux in the metabolic syndrome with atherogenic dyslipidemia. Am J Cardiol 2005 Jun 1; 95 (11): 1309-13
27. Merck and Co. Inc. Zocor®: prescribing information [online]. Available from URL: http://www.merck.com/product/usa/pi_circulars/z/zocor/ zocor_pi.pdf [Accessed 2008 Jul 7]
28. Abbott. Niaspan®: prescribing information [online]. Available from URL: http://www.fda.gov/cder/foi/label/2007/020381s034lbl.pdf [Accessed 2008 Jul 2]
29. Menon RM, Adams MH, Gonzáles MA, et al. Plasma and urine pharmacokinetics of niacin and its metabolites from an extended-release niacin formulation. Int J Clin Pharmacol Ther 2007; 45 (8): 448-54
30. US FDA Center for Drug Evaluation and Research. Simcor® summary review [online]. Available from URL: http://www.fda.gov/cder/foi/nda/2008/ 022078s000_SumR.pdf [Accessed 2008 Sep 16]
31. Ballantyne CM, Davidson MH, McKenney J, et al. Comparison of the safety and efficacy of a combination tablet of niacin extended release and simvastatin vs simvastatin monotherapy in patients with increased non-HDL cholesterol (from the SEACOAST I Study). Am J Cardiol 2008 May 15; 101 (10): 1428-36
32. Ballantyne CM, Davidson MH, McKenney JM, et al. Comparison of the efficacy and safety of a combination tablet of niacin extended-release and simvastatin with simvastatin 80 mg monotherapy: the SEACOAST II (high-dose) study. J Clin Lipidol 2008 Apr; 2 (2): 79-90
33. Karas RH, Kashyap ML, Knopp RH, et al. Long-term safety and efficacy of a combination of niacin extended release and simvastatin in patients with dyslipidemia. Am J Cardiovasc Drug 2008; 8 (2): 69-81
34. Karas RH, Bajorunus DR, Davidson MH, et al. The combination of niacin extended-release with simvastatin improves lipid levels in treatment-naive patients [abstract no. 219]. J Clin Lipidol 2008; 2 (3): 221-2. Plus poster presented at the National Lipid Association 2008 Annual Scientific Sessions; 2008 May 29-Jun 1; Seattle (WA)
35. Bays H. Safety of niacin and simvastatin combination therapy. Am J Cardiol 2008 Apr 17; 101 (8A): 3-8B
36. Thompson PD, Clarkson P, Karas RH. Statin-associated myopathy. JAMA 2003 Apr 2; 289 (13): 1681-90