Fixed-dose combination of extended-release niacin plus simvastatin for lipid disorders

Expert Review of Cardiovascular Therapy

Volumn 6, Issue 10, 2008, Pages 1303-1310

  Vo, Anthony N ^a   Kashyap, Moti L ^a  

^a VA LONG BEACH HEALTHCARE SYSTEM   (United States)

Author keywords

Combination therapy; Dyslipidemia; Extended release niacin; Niacin; Simvastatin

Indexed keywords

APOLIPOPROTEIN A1; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; LOW DENSITY LIPOPROTEIN CHOLESTEROL; MEVINOLIN; NICOTINIC ACID; NICOTINIC ACID PLUS SIMVASTATIN; PLACEBO; SIMVASTATIN; TRIACYLGLYCEROL; VERY LOW DENSITY LIPOPROTEIN CHOLESTEROL; ANTILIPEMIC AGENT; CHOLESTEROL;

ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; ATHEROSCLEROSIS; BEDTIME DOSAGE; CHOLESTEROL BLOOD LEVEL; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CREATINE KINASE BLOOD LEVEL; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG DOSE COMPARISON; DRUG DOSE INCREASE; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG EXCRETION; DRUG MEGADOSE; DRUG METABOLISM; DRUG SAFETY; DRUG STRUCTURE; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSLIPIDEMIA; GLUCOSE BLOOD LEVEL; HOT FLUSH; HUMAN; ISCHEMIC HEART DISEASE; LIVER TOXICITY; MONOTHERAPY; MORBIDITY; MORTALITY; MUSCLE DISEASE; PHARMACOLOGICAL BLOCKING; SIDE EFFECT; SUSTAINED DRUG RELEASE; TRIACYLGLYCEROL BLOOD LEVEL; ANIMAL; BLOOD; CORONARY ARTERY DISEASE; DELAYED RELEASE FORMULATION; DRUG COMBINATION; PRACTICE GUIDELINE; REVIEW; RISK FACTOR;

ANIMALS; ANTILIPEMIC AGENTS; CHOLESTEROL; CLINICAL TRIALS AS TOPIC; CORONARY DISEASE; DELAYED-ACTION PREPARATIONS; DRUG COMBINATIONS; DYSLIPIDEMIAS; HUMANS; NIACIN; PRACTICE GUIDELINES AS TOPIC; RISK FACTORS; SIMVASTATIN; TRIGLYCERIDES;

EID: 59049102654     PISSN: 14779072     EISSN: 17448344     Source Type: Journal    
DOI: 10.1586/14779072.6.10.1303     Document Type: Article

References (58)

1. Rosamond W, Flegal K, Friday G et al. Heart disease and stroke statistics-2007 Update: a report from the American Heart Association Statistic Committee and Stroke Statistics Subcommittee. Circulation 115, e69-e171 (2007).
2. Wong ND, Kashyap M. Cholesterol and lipids chapters. In: Preventive Cardiology (2nd Edition). Wong ND, Black HR, Gardin JM (Eds). McGraw-Hill, NY, USA (2004).
3. Robins SJ, Collins D, Wittes JT et al.; VA-HIT Study Group. Veterans Affairs High-Density Lipoprotein Intervention Trial. Relation of gemfibrozil treatment and lipid levels with major coronary events: VA-HIT: a randomized controlled trial. JAMA 285(12), 1585-1591 (2001).
4. Expert Panel and Detection Evaluation and Treatment of High Blood Cholesterol in Adults. Executive summary of the third report of the National Cholesterol Educational Program (NCEP) expert panel and detection, evaluation, and treatment of high blood cholesterol in adults (Adult Treatment Panel III) final report. Circulation 106, 3143-3421 (2002).
5. LaRosa JC, He J, Vupputuri S. Effect of statins on risk of coronary disease: a meta-analysis of randomized-control trials. JAMA 282, 2340-2346 (1999).
6. Myers C D, Kamanna VS, Kashyap ML. Niacin therapy in atherosclerosis. Curr. Opin. Lipidol. 15, 659-665 (2004).
7. Carlson LA. Nicotinic acid: the broad-spectrum lipid drugs. A 50th anniversary review. J. Intern. Med. 258, 94-114 (2005).
8. Stein EA, Davison MH, Dujovne CA et al. Efficacy and tolerability of low-dose simvastatin and niacin, alone and in combination, in patients with combined hyperlipidemia: a prospective trial. J. Cardiovasc. Pharmacol. Ther. 1, 107-116 (1996).
9. Brown BG, Zhao XQ, Chait A et al. Simvastatin and niacin, antioxidant vitamins, or the combination for the prevention of coronary disease. N. Engl. J. Med. 345, 1582-1592 (2001).
10. Taylor AJ, Sullenberger LE, Lee HJ et al. Arterial Biology for the Investigation of the Treatment Effects of Reducing Cholesterol (ARBITER) 2. A double-blind, placebo-controlled study of extended-release niacin on atherosclerosis progression in secondary prevention patients treated with statin. Circulation 110, 3512-3517 (2004).
11. Altschuitz R, Hoffer A, Stephen JD. Influence of nicotinic acid on serum cholesterol in man. Arch. Biochem. Biophys. 54, 558-559 (1995).
12. Tavintharan S, Kashyap ML. The benefits of niacin in atherosclerosis. Curr. Atheroscler. Rep. 3, 74-82 (2001).
13. The Coronary Drug Project Research Group: clofibrate and niacin in coronary heart disease. JAMA 231, 360-381 (1975).
14. Canner PL, Berge KG, Wenger NK et al. Fifteen year mortality in Coronary Drug Project patients: long-term benefits with niacin. J. Am. Coll. Cardiol. 8, 1245-1255 (1986).
15. McKenney J. New prospective on the use of niacin in the treatment of lipid disorders. Arch. Intern. Med. 164(7), 697-705 (2004).
16. Cefali EA, Simmons PD, Stanek, EJ et al. Improved control of niacin-induced flushing using an optimized once-daily, extended-release niacin formulation. Int. J. Clin. Pharmacol. Ther. 44, 633-640 (2006).
17. Cefali EA, Simmons PD, Stanek EJ et al. Aspirin reduces cutaneous flushing after administration of an optimized extended-released niacin formulation. Int. J. Clin. Pharmacol. Ther. 45, 78-88 (2007).
18. Scandinavian Simvastatin Survival Study Group: Randomized trial of cholesterol lowering in 4444 patients with coronary heart disease: The Scandinavian Simvastatin Survival Study (4S). Lancet 344, 1383-1389 (1994).
19. Insull W, Mc Govern ME, Schrott H et al. Efficacy of extended-release niacin with lovastatin for hypercholesterolemia. Arch. Intern. Med. 164, 1121-1127 (2004).
20. Karas RH, Kashyap ML, Knopp R et al. Long-term safety and efficacy of a combination of extended-release niacin and simvastatin in patients with dyslipidemia: The OCEANS Study. Am. J. Cardiovasc. Drugs 8(2), 69-81 (2008).
21. 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. 101, 1428-1436 (2008).
22. Ballantyne CM, Davidson MH, McKenney J et al. Comparison of the efficacy and safety of a combination tablet of niacin extended-release and simvastatin with simvastatin 80mg monotherapy: the SEACOAST II (high dose) study. J. Clin. Lipidol. 2, 79-90 (2008).
23. The Merck Index. An Encyclopedia of Chemical, Drug and Biologicals. Niacin. Budavari S, O'Neil MJ, Smith A, Hecklelman PE (Eds). Merck & Co., Inc., NJ, USA (1989).
24. The Merck Index. An Encyclopedia Of Chemical, Drug And Biologicals. Simvastatin. Budavari S, O'Neil MJ, Smith A, Hecklelman PE (Eds). Merck & Co. Inc., NJ, USA (1989).
25. Knopp RH, Alagona P, Davidson M et al. Equivalent efficacy of a time-release form of niacin (Niaspan) given once-a-night versus plain niacin in the managment of hyperlipidemia. Metabolism 47 (9), 1097-1104 (1998).
26. Guyton JR, Goldberg AC, Kreisberg RA et al. Effectiveness of once-daily dosing of extended-release niacin alone or in combination for hypercholesterolemia. Am. J. Cardiol. 82(6), 737-743 (1998).
27. Capuzzi DM, Guyton JR, Morgan JM et al. Efficacy and safety of an extended-release niacin (Niaspan): a long-term study Am. J. Cardiol. 82, 74U-81U (1998).
28. Sakai T, Kanmanna VS, Kashyap ML. Niacin but not gemfibrozil increases LP-AI, a cardioprotective subfraction of HDL, in patients with low HDL-cholesterol. Arterioscler. Throm. Vasc. Biol. 21, 1783-1789 (2001).
29. Jin FY, Kamanna VS, Kashyap ML. Niacin decreases removal of high-density lipoprotein apolipoprotein A-I but not Cholesterol estes by Hep G2 Cells. Implication for reverse cholesterol transport. Artheroscler Thromb. Vasc. Biol. 17, 2020-2028 (1997).
30. Zhang L, Kamanna VS, Zhang MC, Kashyap ML. Niacin inhibits surface expression of ATP synthase β chain in HepG2 cells: implications for raising HDL. J. Lipid Res. 49, 1195-1201 (2008).
31. Carlson LA. Studies on the effects of nicotinic acid on catecholamide stimulated lipolysis in adipose tissue in vitro. Acta Med. Scand. 173, 719-722 (1963).
32. Jin FY, Kamanna VS, Kashyap ML. Niacin accelerates intracellular apo B degradation by inhibiting triacylglycerol synthesis in human hepatoblastoma (Hep G2) cells. Artherioscler. Thromb. Vasc. Biol. 19, 1051-1059 (1999).
33. Ganji SH, Tavintharan S, Zhu D et al. Niacin noncompetitively inhibits DGAT2 but not DGAT1 activity in HepG2 cells. J. Lipid Res. 45, 1835-1945 (2004).
34. Kamanna VS, Kashyap ML. Mechanism of action of niacin on lipoprotein metabolism. Curr. Atheroscl. Rep. 2, 36-46 (2002).
35. Kashyap ML. Mechanistic studies of high density lipoprotein. Am. J. Cardiol. 82, 42U-46U (1998).
36. Brinton EA, Jiang P, Thakkar R, Padley RJ. Extended-release niacin combined with simvastatin increases an antiatherogenic HDL subtraction. Arterioscler. Thromb. Vasc. Bio. 28 (Abstract e93) (2008).
37. Kamanna VS, Kashyap ML. Nicotinic acid (niacin) receptor agonists: will they be useful therapeutic agents Am. J. Cardiol. 100(11 A), S53-S61 (2007).
38. Mauro VF, MacDonald JL. Simvastatin: a review of its pharmacology and clinical use. Ann. Pharmacother. 25, 257-264. (1991).
39. Plosker GL, McTavish D. Simvastatin: a reappraisal of its pharmacology and therapeutic efficacy in hypercholesterolemia. Drugs 50, 334-363 (1995).
40. Meredith KG, Home BD, Pearson RR et al. Comparison of effects of high (80 mg) versus low (20 mg) dose of simvastatin on C-reactive protein and lipoproteins in patients with angiographic evidence of coronary arterial narrowing. Am. J. Cardiol. 99(2), 149-153 (2007).
41. Bays HE, Stein EA, Shah AK et al. Effects of simvastatin on C-reactive protein in mixed hyperlipidemic and hypertriglyceridemic patients. Am. J. Cardiol. 90(9), 942-946 (2002).
42. Albert MA, Danielson E, Rifai N et al. Effect of statin therapy on C-reactive protein levels: The Pravastatin Inflammation/CRP Evaluation (PRINCE): a randomized trial and cohort study. JAMA 286, 64-670 (2001).
43. Piepho RW. The pharmacokinetics and pharmacodynamics of agents proven to raise high-density lipoprotein cholesterol. Am. J. Cardiol. 86, 35L-40L (2000).
44. Benyo Z, Gille A, Kero J et al. GPR109A (PUMA-G/HM74A) mediates nicotinic acid-induced flushing. J. Clin. Invest. 115, 3634-3640 (2005).
45. Benyo Z, Gille A, Benett C et al. Nicotinic acid-induced flushing is mediated by activation of epidermal Langerhans cells. Mol. Pharm. 70, 1844-1849 (2006).
46. Stern RH, Freeman D, Spence JD. Differences in metabolism of time-release and unmodified nicotinic acid: explanation of the differences in hypolipidemic action? Metabolism 41, 879-881 (1992).
47. SIMCOR®, prescribing information. Abbott Laboratories, IL, USA (2008).
48. Downs JR, Clearfield M, Weis S et al. Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol level: results of AFCAPS/TexCAPS. JAMA 279, 1615-1622 (1998).
49. Canner PL, Berge KG, Wenger NK et al. Fifteen-years mortality in Coronary Drug Project patients: long-term benefit with niacin. J. Am. Coll. Cardiol. 8, 1245-1255 (1986).
50. Strandberg TE, Pyorala K, Cook TJ et al. Mortality and incidence of cancer during 10 years follow up of the Scandinavian Simvastatin Survival Study (4S). Lancet 364, 771-777 (2004).
51. Heart Protection Collaborative Group: MRC/BHF Heart Protection Study of cholesterol-lowering with simvastatin in 20,536 high risk individuals: a randomized placebo controlled trial. Lancet 360, 7-22 (2002).
52. Blankenhorn DH, Nessim SA, Johnson RL et al. Beneficial effects of combined colestipol-niacin therapy on coronary atherosclerosis and coronary venous bypass graft. JAMA 257, 3233-3240 (1987).
53. Brown BG, Albers JJ, Fisher LD. Regression of coronary disease as a result of intensive lipid-lowering therapy in men with high level of apolipoprotein B. N. Engl. J. Med. 323, 1289-1298 (1990).
54. Zhao XQ, Morse JS, Dowdy AA et al. Safety and tolerability of simvastatin plus niacin in patients with coronary artery disease and low high-density lipoprotein cholesterol (the HDL Atherosclerosis Treatment Study). Am. J. Cardiol. 93, 307-312 (2004).
55. Taylor AJ, Lee HJ, Sullenberger LE et al. The effect of 24 months of combination statin and extended-release niacin on carotid intima-media thickness: ARBITER 3. Curr. Med. Res. Opin. 22(11), 2243-2250 (2006).
56. Robinson JG, Davidson MH. Combination therapy with ezetimibe and simvastatin to achieve LDL reduction. Expert Rev. Cardiovasc. Ther. 4(4), 461-476 (2006).
57. Grundy SM, Vega GL, Yuan Z et al. Effectiveness and tolerability of simvastatin plus fenofibrate for combined hyperlipidemia (the SAFARI trial). Am. J. Cardiol. 95, 462-468 (2005).
58. Davidson MH, Stein EA, Bays HE et al. Efficacy and tolerability of adding prescription omega-3 fatty acid 4g/d to simvastatin 40 mg/d in hypertriglyceridemic patients: an 8-week, randomized, double blind, placebo-controlled study. Clin. Ther. 29, 1354-1367 (2007).