Prolonged-release nicotinic acid: A review of its use in the treatment of dyslipidaemia

Drugs

Volumn 65, Issue 18, 2005, Pages 2719-2740

  McCormack, Paul L ^a   Keating, Gillian M ^a  

^a ADIS INTERNATIONAL LIMITED   (New Zealand)

Author keywords

[No Author keywords available]

Indexed keywords

2,4 THIAZOLIDINEDIONE DERIVATIVE; ATORVASTATIN; COLESTYRAMINE; GEMFIBROZIL; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; LIPOPROTEIN A; LOW DENSITY LIPOPROTEIN CHOLESTEROL; MEVINOLIN; NICOTINIC ACID; PRAVASTATIN; ROSUVASTATIN; SIMVASTATIN; TRIACYLGLYCEROL; TROGLITAZONE;

ABDOMINAL PAIN; ASTHENIA; ATHEROSCLEROSIS; CLINICAL TRIAL; DIARRHEA; DISEASE ASSOCIATION; DISEASE COURSE; DOSE RESPONSE; DRUG COST; DRUG EFFECT; DRUG FORMULATION; DRUG TOLERABILITY; DRUG UPTAKE; DYSLIPIDEMIA; DYSPEPSIA; EDEMA; FLUSHING; GASTROINTESTINAL DISEASE; HEADACHE; HUMAN; HYPERTENSION; HYPESTHESIA; LIPID BLOOD LEVEL; LIPOPROTEIN BLOOD LEVEL; METABOLIC SYNDROME X; NAUSEA; NON INSULIN DEPENDENT DIABETES MELLITUS; PAIN; PRURITUS; RASH; REVIEW; RHINITIS; SKIN MANIFESTATION; STATISTICAL SIGNIFICANCE; TREATMENT OUTCOME; TREATMENT WITHDRAWAL; VOMITING;

ANTILIPEMIC AGENTS; DELAYED-ACTION PREPARATIONS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG THERAPY, COMBINATION; DYSLIPIDEMIAS; HUMANS; NIACIN; RANDOMIZED CONTROLLED TRIALS;

EID: 30144445801     PISSN: 00126667     EISSN: 00126667     Source Type: Journal    
DOI: 10.2165/00003495-200565180-00014     Document Type: Review

References (55)

1. Carlson LA. Niaspan, the prolonged release preparation of nicotinic acid (niacin), the broad-spectrum lipid drug. Int J Clin Pract 2004 Jul; 58 (7): 706-13
2. McKenney J. New perspectives on the use of niacin in the treatment of lipid disorders. Arch Intern Med 2004 Apr 12; 164 (7): 697-705
3. Crouse III JR. New developments in the use of niacin for treatment of hyperlipidemia: new considerations in the use of an old drug. Coron Artery Dis 1996 Apr; 7 (4): 321-6
4. Coronary Drug Project Research Group. Clofibrate and niacin in coronary heart disease. JAMA 1975 Jan 27; 231 (4): 360-81
5. Canner PL, Berge KG, Wenger NK, et al. Fifteen year mortality in Coronary Drug Project patients: long-term benefit with niacin. J Am Coll Cardiol 1986 Dec; 8 (6): 1245-55
6. 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 2001 Nov 29; 345 (22): 1583-92
7. Carlson LA, Rosenhamer G. Reduction of mortality in the Stockholm Ischaemic Heart Disease Secondary Prevention Study by combined treatment with clofibrate and nicotinic acid. Acta Med Scand 1988; 223 (5): 405-18
8. 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 Nov 8; 323 (19): 1289-98
9. Canner PL, Furberg CD, Terrin ML, et al. Benefits of niacin by glycemic status in patients with healed myocardial infarction (from the Coronary Drug Project). Am J Cardiol 2005 Jan 15; 95 (2): 254-7
10. Yim BT, Chong PH. Niacin-ER and lovastatin treatment of hypercholesterolemia and mixed dyslipidemia. Ann Pharmacother 2003 Jan; 37 (1): 106-15
11. Capuzzi DM, Morgan JM, Weiss RJ, et al. Beneficial effects of rosuvastatin alone and in combination with extended-release niacin in patients with a combined hyperlipidemia and low high-density lipoprotein cholesterol levels. Am J Cardiol 2003 Jun 1; 91 (11): 1304-10
12. National Cholesterol Education Program Expert Panel. 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) final report. Circulation 2002 Dec 17; 106 (25): 3143-421
13. Thompson GR. Management of dyslipidaemia. Heart 2004 Aug; 90 (8): 949-55
14. Pieper JA. Understanding niacin formulations. Am J Manag Care 2002 Sep; 8 (12 Suppl.): S308-14
15. Guyton JR, Capuzzi DM. Treatment of hyperlipidemia with combined niacin-statin regimens. Am J Cardiol 1998 Dec 17; 82 Suppl. 12A: 82U-4U
16. Knopp RH. Evaluating niacin in its various forms. Am J Cardiol 2000 Dec 21; 86 Suppl. 12A: 51L-6L
17. Pieper JA. Overview of niacin formulations: differences in pharmacokinetics, efficacy, and safety. Am J Health Syst Pharm 2003 Jul 1; 60 Suppl. 2: S9-14
18. McKenney J. Niacin for dyslipidemia: considerations in product selection. Am J Health Syst Pharm 2003 May 15; 60 (10): 995-1005
19. Superko HR, McGovern ME, Raul E, et al. Differential effect of two nicotinic acid preparations on low-density lipoprotein subclass distribution in patients classified as low-density lipoprotein pattern A, B, or I. Am J Cardiol 2004 Sep 1; 94 (5): 588-94
20. Morgan JM, Capuzzi DM, Baksh RI, et al. Effects of extendedrelease niacin on lipoprotein subclass distribution. Am J Cardiol 2003 Jun 15; 91 (12): 1432-6
21. Morgan JM, Capuzzi DM, Guyton JR, et al. Treatment effect of Niaspan, a controlled-release niacin, in patients with hypercholesterolemia: a placebo-controlled trial. J Cardiovasc Pharmacol Ther 1996 Jul; 1 (3): 195-202
22. Sakai T, Kamanna VS, Kashyap ML. Niacin, but not gemfibrozil, selectively increases LP-AI, a cardioprotective subfraction of HDL, in patients with low HDL cholesterol. Arterioscler Thromb Vasc Biol 2001 Nov; 21 (11): 1783-9
23. Guyton JR, Blazing MA, Hagar J, et al. Extended-release niacin vs gemfibrozil for the treatment of low levels of high-density lipoprotein cholesterol. Arch Intern Med 2000 Apr 24; 160: 1177-84
24. Morgan JM, Capuzzi DM, de la Llera-Moya M, et al. The effects of crystalline and extended-release niacin, Niaspan, on HDL lipoprotein-mediated cellular cholesterol efflux as compared to placebo [abstract no. 1075-78]. J Am Coll Cardiol 1999 Feb; 33 Suppl. A: 245A
25. Kuvin JT, Patel AR, Kimmelstiel CD, et al. Extended-release niacin improves endothelial function in patients with coronary artery disease and controlled low density lipoprotein levels [abstract no. 899]. Circulation 1999 Nov 2; 100 Suppl.: I-173
26. Cefali EA, Adams MH. Extended-release niacin pharmacokinetics following multiple-dose administration [abstract no. 125]. Pharmacotherapy 2003 Mar; 23 (3): 410
27. Kos Pharmaceuticals Inc. Niaspan® (niacin extended-release tablets): US prescribing information [online]. Available from URL: http://www.niaspan.com [Accessed 2005 Feb 11]
28. Merck KGaA. Niaspan (prolonged release tablets): summary of product characteristics [online]. Available from URL: http://emc.medicines.org.uk [Accessed 2005 Feb 2]
29. Goldberg A, Alagona Jr P, Capuzzi DM, et al. Multiple-dose efficacy and safety of an extended-release form of niacin in the management of hyperlipidemia. Am J Cardiol 2000 May 1; 85: 1100-5
30. 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 management of hyperlipidemia. Metabolism 1998 Sep; 47 (9): 1097-104
31. Insull Jr W, McGovern ME, Schrott H, et al. Efficacy of extended-release niacin with lovastatin for hypercholesterolemia: assessing all reasonable doses with innovative surface graph analysis. Arch Intern Med 2004 May 24; 164 (10): 1121-7
32. Hunninghake DB, McGovern ME, Koren M, et al. A dose-ranging study of a new, once-daily, dual-component drug product containing niacin extended-release and lovastatin. Clin Cardiol 2003 Mar; 26: 112-8
33. 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 statins. Circulation 2004 Dec 7; 110 (23): 3512-7
34. Grundy SM, Vega GL, McGovern ME, et al. Efficacy, safety, and tolerability of once-daily niacin for the treatment of dyslipidemia associated with type 2 diabetes: results of the Assessment of Diabetes Control and Evaluation of the Efficacy of Niaspan Trial. Diabetes Multicenter Research Group. Arch Intern Med 2002 Jul 22; 162: 1568-76
35. Capuzzi DM, Guyton JR, Morgan JM, et al. Efficacy and safety of an extended-release niacin (Niaspan): a long-term study. Am J Cardiol 1998 Dec 17; 82 Suppl. 12A: 74U-81U
36. Guyton JR, Goldberg AC, Kreisberg RA, et al. Effectiveness of once-nightly dosing of extended-release niacin alone and in combination for hypercholesterolaemia. Am J Cardiol 1998 Sep 15; 82: 737-43
37. Wolfe ML, Vartanian SF, Ross JL, et al. Safety and effectiveness of Niaspan when added sequentially to a statin for treatment of dyslipidemia. Am J Cardiol 2001 Feb 15; 87 (4): 476-9
38. Taylor AJ, Sullenberger LE, Lee HY. ARBITER 3: atherosclerosis regression during open-label continuation of extended-release niacin following ARBITER 2 [abstract no. 943]. Circulation 2005 Oct 25; 112 (17 Suppl.): II-179
39. Kreisberg RA. Diabetic dyslipidemia. Am J Cardiol 1998 Dec 17; 82 Suppl. 12A: 67U-73U; discussion 85U-86U
40. Berger W, Roze S, Valentine WJ, et al. Cost effectiveness of adding Niaspan to atorvastatin treatment in the secondary prevention of cardiovascular disease in patients with dys-ipidemia in the UK [abstract no. PCV11]. Value Health 2004 Nov; 7 (6): 688
41. Goldberg AC. A meta-analysis of randomized controlled studies on the effects of extended-release niacin in women. Am J Cardiol 2004 Jul 1; 94 (1): 121-4
42. Garg A, Grundy SM. Nicotinic acid as therapy for dyslipidaemia in non-insulin-dependent diabetes mellitus. JAMA 1990 Aug 8; 264 (6): 723-6
43. Kane MP, Hamilton RA, Addesse E, et al. Cholesterol and glycemic effects of niaspan in patients with type 2 diabetes. Pharmacotherapy 2001 Dec; 21 (12): 1473-8
44. Joint British recommendations on prevention of coronary heart disease in clinical practice: summary. British Cardiac Society, British Hyperlipidaemia Association, British Hypertension Society, British Diabetic Association. BMJ 2000 Mar 11; 320 (7236): 705-8
45. Gordon T, Castelli WP, Hjortland MC, et al. High density lipoprotein as a protective factor against coronary heart disease: the Framingham Study. Am J Med 1977 May; 62 (5): 707-14
46. Worz CR, Bottorff M. Treating dyslipidemic patients with lipid-modifying and combination therapies. Pharmacotherapy 2003 May; 23 (5): 625-37
47. Shepherd J, Cobbe SM, Ford I, et al. Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia. N Engl J Med 1995 Nov 16; 333 (20): 1301-7
48. Grundy SM, Cleeman JI, Merz CNB, et al. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III guidelines. Coordinating Committee of the National Cholesterol Education Program. Circulation 2004 Jul 13; 110 (2): 227-39
49. Kashyap ML, Tavintharan S, Kamanna VS. Optimal therapy of low levels of high density lipoprotein-cholesterol. Am J Cardiovasc Drugs 2003; 3 (1): 53-65
50. Rosenson RS. Antiatherothrombotic effects of nicotinic acid. Atherosclerosis 2003; 171: 87-96
51. 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 Jun 19; 257 (23): 3233-40
52. Cashin-Hemphill L, Mack WJ, Pogoda JM, et al. Beneficial effects of colestipol-niacin on coronary atherosclerosis: a 4-year follow-up. JAMA 1990 Dec 19; 264 (23): 3013-7
53. Sacks FM, Pasternak RC, Gibson CM, et al. Effect on coronary atherosclerosis of decrease in plasma cholesterol concentrations in normocholesterolaemic patients. Harvard Atherosclerosis Reversibility Project (HARP) Group. Lancet 1994 Oct 29; 344 (8931): 1182-6
54. Kos Pharmaceuticals Inc. Kos Pharmaceuticals announces commencement of landmark long-term coronary heart disease outcomes study: AIM-HIGH study will evaluate whether combination therapy with Niaspan® and simvastatin is superior to simvastatin alone in preventing cardiovascular events [media release]. 2005 Jul 6
55. Mosca L, Appel LJ, Benjamin EJ, et al. Evidence-based guide-lines for cardiovascular disease prevention in women. American Heart Association. Circulation 2004 Feb 10; 109 (5): 672-93