Correction of low HDL cholesterol to reduce cardiovascular risk: Practical considerations relating to the therapeutic use of prolonged-release nicotinic acid (Niaspan®)

International Journal of Clinical Practice

Volumn 61, Issue 11, 2007, Pages 1914-1921

  Vogt, A ^a   Kassner, U ^a   Hostalek, U ^b   Steinhagen Thiessen, E ^a  

^a CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^b MERCK KGAA   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; GEMFIBROZIL; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; NICOTINIC ACID; PLACEBO; SIMVASTATIN;

ATHEROSCLEROSIS; BLURRED VISION; CARDIOVASCULAR DISEASE; CARDIOVASCULAR RISK; CHOLESTEROL BLOOD LEVEL; CLINICAL TRIAL; DELAYED RELEASE FORMULATION; DIET RESTRICTION; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG SAFETY; DYSLIPIDEMIA; EUROPE; FLUSHING; HEART PROTECTION; HUMAN; HYPERCHOLESTEROLEMIA; HYPERGLYCEMIA; HYPERURICEMIA; LIVER TOXICITY; LONG TERM EXPOSURE; MUSCLE DISEASE; PEPTIC ULCER; PRIORITY JOURNAL; RETINA MACULA CYSTOID EDEMA; REVIEW; RHABDOMYOLYSIS; RISK REDUCTION; SIDE EFFECT;

ANTILIPEMIC AGENTS; CARDIOVASCULAR DISEASES; CHOLESTEROL, HDL; DELAYED-ACTION PREPARATIONS; DYSLIPIDEMIAS; FLUSHING; HUMANS; NIACIN; TREATMENT OUTCOME;

EID: 35348915303     PISSN: 13685031     EISSN: 17421241     Source Type: Journal    
DOI: 10.1111/j.1742-1241.2007.01514.x     Document Type: Review

References (66)

1. National Cholesterol Education Program. Third Report of the Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). National Institutes of Health/National Heart Lung and Blood Institute. http://www.nhlbi.nih.gov/guidelines/cholesterol (accessed February 10, 2007).
2. Baigent C, Keech A, Kearney PM et al. Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90,056 participants in 14 randomised trials of statins. Lancet 2005 366 : 1267 78 JJP. The realities of dyslipidaemia: what do the studies tell us?. Eur Heart J Suppl 2005 7 : F27 33.
3. American Diabetes Association. Standards of medical care in diabetes - 2007. Diabetes Care 2007 30 (Suppl. 1 S4 S41.
4. Task Force on Diabetes and Cardiovascular Diseases of the European Society of Cardiology (ESC) and of the European Association for the Study of Diabetes (EASD). Guidelines on Diabetes, Pre-diabetes and Cardiovascular Diseases: Full Text. http://www.escardio.org (accessed April 2007).
5. Clinical Guidelines Task Force of the International Diabetes Federation. Global Guideline for Type 2 Diabetes (2005). http://www.idf.org (accessed February 10, 2007).
6. Colhoun HM, Betteridge DJ, Durrington PN et al. Primary prevention of cardiovascular disease with atorvastatin in type 2 diabetes in the Collaborative Atorvastatin Diabetes Study (CARDS): multicentre randomised placebo-controlled trial. Lancet 2004 364 : 685 96.
7. Ahmed S, Cannon CP, Murphy SA, Braunwald E. Acute coronary syndromes and diabetes: Is intensive lipid lowering beneficial? Results of the PROVE IT-TIMI 22 trial. Eur Heart J 2006 27 : 2323 9.
8. Pedersen TR, Faergeman O, Kastelein JJ et al. High-dose atorvastatin vs. usual-dose simvastatin for secondary prevention after myocardial infarction: the IDEAL study: a randomized controlled trial. JAMA 2005 294 : 2437 45.
9. LaRosa JC, Grundy SM, Waters DD et al. Intensive lipid lowering with atorvastatin in patients with stable coronary disease. N Engl J Med 2005 352 : 1425 35.
10. 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 62 : 707 14.
11. Gordon DJ, Probstfield JL, Garrison RJ. High-density lipoprotein cholesterol and cardiovascular disease. Four prospective American studies. Circulation 1989 79 : 8 15.
12. Yusuf S, Hawken S, Ounpuu S et al. Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the Interheart study): case-control study. Lancet 2004 364 : 937 52.
13. Wilson PW, Abbott RD, Castelli WP. High density lipoprotein cholesterol and mortality. The Framingham Heart Study. Arteriosclerosis 1988 8 : 737 41.
14. Castelli WP, Garrison RJ, Wilson PW et al. Incidence of coronary heart disease and lipoprotein cholesterol levels. The Framingham Study. JAMA 1986 256 : 2835 8.
15. Goldbourt U, Yaari S, Medalie JH. Isolated low HDL cholesterol as a risk factor for coronary heart disease mortality. A 21-year follow-up of 8000 men. Arterioscler Thromb Vasc Biol 1997 17 : 107 13.
16. Assmann G, Schulte H, von Eckardstein A et al. High-density lipoprotein cholesterol as a predictor of coronary heart disease risk. The PROCAM experience and pathophysiological implications for reverse cholesterol transport. Atherosclerosis 1996 124 (Suppl. S11 20.
17. Turner RC, Millns H, Neil HA et al. Risk factors for coronary artery disease in non-insulin dependent diabetes mellitus: United Kingdom Prospective Diabetes Study (UKPDS: 23). BMJ 1998 316 : 823 8.
18. Coronary Drug Project Research Group. Clofibrate and niacin in coronary heart disease. JAMA 1975 231 : 360 81.
19. 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 8 : 1245 55.
20. Brown BG, 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 345 : 1583 92.
21. 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 323 : 1289 98.
22. Whitney EJ, Krasuski RA, Personius BE et al. A randomized trial of a strategy for increasing high-density lipoprotein cholesterol levels: effects on progression of coronary heart disease and clinical events. Ann Intern Med 2005 142 : 95 104.
23. Kane JP, Malloy MJ, Ports TA et al. Regression of coronary atherosclerosis during treatment of familial hypercholesterolemia with combined drug regimens. JAMA 1990 264 : 3007 12.
24. Rubins HB, Robins SJ, Collins D et al. Gemfibrozil for the secondary prevention of coronary heart disease in men with low levels of high-density lipoprotein cholesterol. Veterans Affairs High-Density Lipoprotein Cholesterol Intervention Trial Study Group. N Engl J Med 1999 341 : 410 8.
25. Cashin-Hemphill L, Mack WJ, Pogoda JM et al. Beneficial effects of colestipol-niacin on coronary atherosclerosis. A 4-year follow-up. JAMA 1990 264 : 3013 17.
26. Frick MH, Elo O, Haapa K, Heinonen OP et al. Helsinki Heart Study: primary-prevention trial with gemfibrozil in middle-aged men with dyslipidemia. Safety of treatment, changes in risk factors, and incidence of coronary heart disease. N Engl J Med 1987 317 : 1237 45.
27. Bruckert E, Baccara-Dinet M, McCoy F et al. High prevalence of low HDL-cholesterol in a pan-European survey of 8545 dyslipidaemic patients. Curr Med Res Opin 2005 21 : 1927 34.
28. Chapman MJ, Assmann G, Fruchart JC et al. Raising high-density lipoprotein cholesterol with reduction of cardiovascular risk: the role of nicotinic acid - a position paper developed by the European Consensus Panel on HDL-C. Curr Med Res Opin 2004 20 : 1253 68.
29. Gotto AM Jr., Brinton EA. Assessing low levels of high-density lipoprotein cholesterol as a risk factor in coronary heart disease: a working group report and update. J Am Coll Cardiol 2004 43 : 717 24.
30. Knopp RH, Alagona P, Davidson M et al. Equivalent efficacy of a time-release form of niacin (Niaspan) given once-a-night vs. plain niacin in the management of hyperlipidemia. Metabolism 1998 47 : 1097 104.
31. Goldberg A, Alagona P Jr., 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 1 : 1100 5.
32. 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 1 : 195 202.
33. Knopp RH. Clinical profiles of plain versus sustained-release niacin (Niaspan) and the physiologic rationale for nighttime dosing. Am J Cardiol 1998 82 : 24U 8U.
34. Reasner CA. Achieving the therapeutic benefits of Niaspan in daily practice. Eur Heart J 2006 8 F68 73.
35. Vogt A, Kassner U, Hostalek U et al. Evaluation of the safety and tolerability of prolonged-release nicotinic acid in a usual care setting: the NAUTILUS study. Curr Med Res Opin 2006 22 : 417 25.
36. Vogt A, Kassner U, Hostalek U et al. Safety and tolerability of prolonged-release nicotinic acid in patients aged ≥ 65 years enrolled in NAUTILUS. Br J Cardiol 2006 13 : 278 82.
37. Vogt A, Kassner U, Hostalek U et al. Safety and tolerability of prolonged-release nicotinic acid combined with a statin in NAUTILUS. Br J Cardiol 2006 13 : 273 7.
38. Vogt A, Kassner U, Hostalek U et al. NAUTILUS (safety and tolerability of Niaspan®): a subgroup analysis of patients with diabetes. Br J Diabetes Vasc Dis 2006 6 : 127 33.
39. 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. Arch Intern Med 2002 162 : 1568 76.
40. Grundy SM, Vega GL, McGovern ME et al. Comparative effects on lipids and glycemic control of niacin extended-release/lovastatin or fenofibrate in patients with diabetic dyslipidemia. Abstract 29-LB, Presented at the 64th Scientific Sessions of the American Diabetes Association, 4-8 June 2004, Orlando, FL, USA.
41. McGovern ME, Malott CM, Simmons PD, Stanek EJ. Once-daily niacin-extended-release/lovastatin combination is effective and safe for treatment of dyslipidaemia associated with metabolic syndrome. Abstract 820-5, 2004 Scientific Session of the American College of Cardiology.
42. Anuurad E, Boffa MB, Koschinsky ML, Berglund L. Lipoprotein(a): a unique risk factor for cardiovascular disease. Clin Lab Med 2006 26 : 751 72.
43. Morgan JM, Capuzzi DM, Baksh RI et al. Effects of extended-release niacin on lipoprotein subclass distribution. Am J Cardiol 2003 91 : 1432 6.
44. Bays HE, McGovern ME. Once-daily niacin extended release/lovastatin combination tablet has more favorable effects on lipoprotein particle size and subclass distribution than atorvastatin and simvastatin. Prev Cardiol 2003 6 : 179 88.
45. Van JT, Pan J, Wasty T et al. Comparison of extended-release niacin and atorvastatin monotherapies and combination treatment of the atherogenic lipid profile in diabetes mellitus. Am J Cardiol 2002 89 : 1306 8.
46. Insull 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 164 : 1121 7.
47. 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 26 : 112 8.
48. Bays HE, Dujovne CA, McGovern ME et al. Comparison of once-daily, niacin extended-release/lovastatin with standard doses of atorvastatin and simvastatin (the ADvicor vs. Other Cholesterol-Modulating Agents Trial Evaluation [ADVOCATE]). Am J Cardiol 2003 91 : 667 72.
49. 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 87 : 476 9.
50. 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 82 : 74U 81U.
51. Guyton JR, Capuzzi DM. Treatment of hyperlipidemia with combined niacin-statin regimens. Am J Cardiol 1998 82 : 82U 4U.
52. 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 110 : 3512 7.
53. Taylor AJ, Lee HJ, Sullenberger LE. The effect of 24 months of combination statin and extended-release niacin on carotid intima-media thickness: ARBITER 3. Curr Med Res Opin 2006 22 : 2243 50.
54. AIM-HIGH trial. http://www.clinicaltrials.gov identifier NCT00120289 (accessed February 10, 2007).
55. Vega GL, Cater NB, Meguro S, Grundy SM. Influence of extended-release nicotinic acid on nonesterified fatty acid flux in the metabolic syndrome with atherogenic dyslipidemia. Am J Cardiol 2005 95 : 1309 13.
56. Canner PL, Furberg CD, Terrin ML, McGovern ME. Benefits of niacin by glycemic status in patients with healed myocardial infarction (from the Coronary Drug Project). Am J Cardiol 2005 95 : 254 7.
57. Psaty BM, Furberg CD, Ray WA, Weiss NS. Potential for conflict of interest in the evaluation of suspected adverse drug reactions: use of cerivastatin and risk of rhabdomyolysis. JAMA 2004 292 : 2622 31.
58. Thompson PD, Clarkson P, Karas RH. Statin-associated myopathy. JAMA 2003 289 : 1681 90.
59. Kashani A, Phillips CO, Foody JM et al. Risks associated with statin therapy: a systematic overview of randomized clinical trials. Circulation 2006 114 : 2788 97.
60. Al-Sheikh AA, Karas RH. Relative safety of lipid altering drugs in the general population. Abstract 3707 at the 2005 American Heart Association Scientific Sessions, Dallas, TX, USA, 13-16 November 2005.
61. Coppola A, Brady PG, Nord HJ. Niacin-induced hepatotoxicity: unusual presentations. South Med J 1994 87 : 30 2.
62. Dalton TA, Berry RS. Hepatotoxicity associated with sustained-release niacin. Am J Med 1992 93 : 102 4.
63. Pieper JA. Understanding niacin formulations. Am J Manag Care 2002 8 : S308 14.
64. Lahoti S, Lee WM. Hepatotoxicity of anticholesterol, cardiovascular, and endocrine drugs and hormonal agents. Gastroenterol Clin North Am 1995 24 : 907 22.
65. Jungnickel PW, Maloley PA, Vander Tuin EL et al. Effect of two aspirin pretreatment regimens on niacin-induced cutaneous reactions. J Gen Intern Med 1997 12 : 591 6.
66. Guyton JR, Bays HE. Safety considerations with niacin therapy. Am J Cardiol 2007 99 : S22 31.