Niacin-ER and lovastatin treatment of hypercholesterolemia and mixed dyslipidemia

Annals of Pharmacotherapy

Volumn 37, Issue 1, 2003, Pages 106-115

  Yim, Barbara T ^a,b,c   Chong, Pang H ^a,b,c  

^a UNIVERSITY OF ILLINOIS AT CHICAGO   (United States)

^b MIDWESTERN UNIVERSITY   (United States)

^c Jr Hospital of Cook County   (United States)

Author keywords

Extended release niacin; Lovastatin

Indexed keywords

AMINOTRANSFERASE; ANTIFUNGAL AGENT; CREATINE KINASE; CYCLOSPORIN; FLUINDOSTATIN; GLUCOSE; HIGH DENSITY LIPOPROTEIN; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; LOVASTATIN PLUS NICOTINIC ACID; LOW DENSITY LIPOPROTEIN; MACROLIDE; MEVINOLIN; NICOTINIC ACID; PRAVASTATIN; PROTEINASE INHIBITOR; SIMVASTATIN; TRIACYLGLYCEROL; URIC ACID; VERY LOW DENSITY LIPOPROTEIN;

AMINOTRANSFERASE BLOOD LEVEL; ARTICLE; CARDIOVASCULAR RISK; CLINICAL TRIAL; CONTROLLED DRUG RELEASE; CREATINE KINASE BLOOD LEVEL; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG EFFECT; DRUG EFFICACY; DRUG ELIMINATION; DRUG FORMULATION; DRUG METABOLISM; DRUG RELEASE; DRUG SAFETY; DRUG SYNTHESIS; DRUG TOLERABILITY; DRUG URINE LEVEL; DYSLIPIDEMIA; FLUSHING; FOOD AND DRUG ADMINISTRATION; GLUCOSE BLOOD LEVEL; HEAT; HUMAN; HYPERCHOLESTEROLEMIA; LIPOPROTEIN BLOOD LEVEL; LIVER TOXICITY; MONOTHERAPY; MYALGIA; MYOPATHY; PRIORITY JOURNAL; PRURITUS; SIDE EFFECT; SKIN TINGLING; TRIACYLGLYCEROL BLOOD LEVEL;

EID: 0037226704     PISSN: 10600280     EISSN: None     Source Type: Journal    
DOI: 10.1345/aph.1C161     Document Type: Article

References (56)

1. Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: The Scandinavian Simvastatin Survival Study (4S). Lancet 1994;344:1383-9.
2. Prevention of cardiovascular events and death with pravastatin in patients with coronary heart disease and a broad range of initial cholesterol levels. The Long-Term Intervention with Pravastatin in Ischemic Disease (LIPID) Study Group. N Engl J Med 1998;339:1349-57.
3. Downs JR, Clearfield M, Weis S, Whitney E, Shapiro DR, Beere PA, et al. Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels: Results of AFCAPS/Tex-CAPS. Air Force/Texas Coronary Atherosclerosis Prevention Study. JAMA 1998;279:1615-22.
4. Shepherd J, Cobbe SM, Ford I, Isles CG, Lorimer AR, MacFarlane PW, et al. Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia. West of Scotland Coronary Prevention Study Group. N Engl J Med 1995;333:1301-7.
5. Sacks FM, Pfeffer MA, Moye LA, Rouleau JL, Rutherford JD, Cole TG, et al. The effect of pravastatin on coronary events after myocardial infarction in patients with average cholesterol levels. N Engl J Med 1996;335:1001-9.
6. Amarenco P. Hypercholesterolemia, lipid-lowering agents, and the risk for brain infarction. Neurology 2001;57(suppl 2):S35-44.
7. Harper CR, Jacobson TA. New perspectives on the management of low levels of high-density lipoprotein cholesterol, Arch Intern Med 1999;159:1049-57.
8. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20,536 high-risk individuals: A randomised placebo-controlled trial. Heart Protection Study Collaborative Group. Lancet 2002;360:7-22.
9. Jones PJ. Lipid-lowering treatment in coronary artery disease. Drugs 2000;59:1127-35.
10. Serruys PW, de Feyter P, Macaya C, Kokott N, Puel J, Vrolix M, et al. Fluvastatin for prevention of cardiac events following successful first percutaneous coronary intervention: A randomized controlled trial. JAMA 2002;287:3215-22.
11. Gordon DJ, Rifkind BM. High-density lipoproteins - The clinical implications of recent studies. N Engl J Med 1989;321:1311-6.
12. Assmann G, Schulte H. Modelling the Helsinki Heart Study by means of risk equations obtained from the PROCAM Study and the Framingham Heart Study. Drugs 1990;40(suppl 1):13-8.
13. Austin MA, Hokanson JE, Edwards KL. Hypercholesterolemia as a cardiovascular risk factor. Am J Cardiol 1998:81(4A):7B-12B.
14. Jeppesen J, Hein HO, Suadicani R, Gyntelberg F. Triglyceride concentration and ischemic heart disease: An eight-year follow-up in the Copenhagen Male Study. Circulation 1998;97:1029-36.
15. 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 2001:285:2486-97.
16. Tonkin A. High-density lipoprotein cholesterol and treatment guidelines. Am J Cardiol 2001;88(12A):41N-4N.
17. Rubins HB, Robins SJ, Collins D, Fye CL, Anderson JW, Elam MB, 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.
18. Guyton JR, Blazing MA, Hagar J, Kashyap ML, Knopp RH, McKenney JM, et al. Extended-release niacin vs gemfibrozil for the treatment of low levels of high-density lipoprotein cholesterol. Arch Intern Med 2000;160:1177-84.
19. McKenney JM, Proctor JD, Harris S, Chinchili VM. A comparison of the efficacy and toxic effects of sustained- vs. immediate-release niacin in hypercholesterolemic patients. JAMA 1994;271:672-7.
20. Luria MH. Effect of low-dose niacin on high-density lipoprotein cholesterol and total cholesterol/high-density lipoprotein cholesterol ratio. Arch Intern Med 1988;148:2493-5.
21. Clofibrate and niacin in coronary heart disease. The Coronary Drug Project Research Group. JAMA 1975;231:360-81.
22. Canner PL, Berge KG, Wenger NK, Stambler J, Friedman L, Prineas RJ, et al. Fifteen-year mortality in Coronary Drug Project patients: Long-term benefit with niacin. J Am Coll Cardiol 1986;8:1245-55.
23. Product Information. Advicor (Niacin Extended-Release and Lovastatin Tablets). Miami, FL: Kos Pharmaceuticals, November 2001.
24. Brown MD, Goldstein JL. A receptor-mediated pathway for cholesterol homeostasis. Science 1986;232:34-47.
25. Von Eckardstein A, Nofer J, Assmann G. High density lipoproteins and arteriosclerosis. Role of cholesterol efflux and reverse cholesterol transport. Arterioscler Thromb Vasc Biol 2001;21:13-27.
26. Schaefer JR, Schweer H, Ikewaki K, Stracke H, Seyberth HJ, Kaffarnik H, et al. Metabolic basis of high density lipoproteins and apolipoprotein A-I increase by HMG-CoA reductase inhibition in healthy subjects and a patient with coronary artery disease. Atherosclerosis 1999;144:177-84.
27. Knopp RH, Alagona P, Davidson M, Goldberg AC, Kafonek SD, Kashyap 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.
28. Kashyap ML. Mechanistic studies of high-density lipoproteins. Am J Cardiol 1998;82:42U-8U.
29. Superko HR, Krauss RM. Differential effects of nicotinic acid in subjects with different LDL subclass patterns. Atherosclerosis 1992;95:69-76.
30. Gupta EK, Ito MK. Lovastatin and extended-release niacin combination product: The first drug combination for the management of hyperlipidemia. Heart Dis 2002;4:124-37.
31. Piepho RW. The pharmacokinetics and pharmacodynamics of agent proven to raise high-density lipoprotein cholesterol. Am J Cardiol 2000;86(12A):35L-40L.
32. Capuzzi DM, Guyton JR, Morgan JM, Goldberg AC, Kreisberg RA, Brusco OA, et al. Efficacy and safety of an extended-release niacin (Niaspan): A long-term study. Am J Cardiol 1998;82(12A):74U-81U.
33. Goldberg A, Alagona P, Capuzzi DM, Guyton J, Morgan JM, Rodgers J, et al. Multiple-dose efficacy and safety of an extended-release form of niacin in the management of hyperlipidemia. Am J Cardiol 2000:85: 1100-5.
34. Goldberg AC. Clinical trial experience with extended-release niacin (Niaspan): Dose-escalation study. Am J Cardiol 1998;82(12A):35U-8U.
35. Illingworth DR, Bacon S. Treatment of heterozygous familial hypercholesterolemia with lipid-lowering drugs. Arteriosclerosis 1989;9(suppl 1):1-121-34.
36. Reaven P, Witztum JL. Lovastatin, nicotinic acid, and rhabdomyolysis. Ann Intern Med 1988;109:597-8.
37. Norman DJ, Illingworth DR, Munson J, Hosenpud J. Myolysis and acute renal failure in a heart-transplant recipient receiving lovastatin (letter). N Engl J Med 1988;318:46-7.
38. Davignon J, Roederer G, Montigny M, Hayden MR, Tan MH, Connelly PW, et al. Comparative efficacy and safety of pravastatin, nicotinic acid and the two combined in patients with hypercholesterolemia. Am J Cardiol 1994;73:339-45.
39. Jacobson TA, Chin MM, Fromell GJ, Jokubaitis LA, Amorosa LF. Fluvastatin with and without niacin for hypercholesterolemia. Am J Cardiol 1994;74:149-54.
40. Tsalamandris C, Panagiotopoulos S, Sinha A, Cooper ME, Jerums G. Complementary effects of pravastatin and nicotinic acid in the treatment of combined hyperlipidemia in diabetic and non-diabetic patients. J Cardiovasc Risk 1994;1:231-9.
41. Vacek JL, Dittmeier G, Chiarelli T, White J, Bell HH. Comparison of lovastatin (20 mg) and nicotinic acid (1.2 g) with either drug alone for type II hyperlipoproteinemia. Am J Cardiol 1995;76:182-4.
42. O'Keefe JH Jr, Harris WS, Nelson J, Windsor SL. Effects of pravastatin with niacin or magnesium on lipid levels and postprandial lipemia. Am J Cardiol 1995:76:480-4.
43. Gardner SF, Schneider EF, Granberry MC, Carter IR. Combination therapy with low-dose lovastatin and niacin is as effective as higher-dose lovastatin. Pharmacotherapy 1996;16:419-23.
44. Pasternak RC, Brown LE, Stone PH, Silverman DI, Gibson CM, Sacks FM. Effect of combination therapy with lipid-reducing drugs in patients with coronary heart disease and "normal" cholesterol levels. A randomized, placebo-controlled trial. Harvard Atherosclerosis Reversibility Project (HARP) Study Group. Ann Intern Med 1996;125:529-40.
45. Gardner SF, Marx MA, White LM, Granberry MC, Skelton DR, Fonseca VA. Combination of low-dose niacin and pravastatin improves the lipid profile in diabetic patients without compromising glycemic control. Ann Pharmacother 1997;31:677-82.
46. Brown BG, Bardsley J, Poulin D, Hillger LA, Dowdy A, Maher VM, et al. Moderate dose, three-drug therapy with niacin, lovastatin, and colestipol to reduce low-density lipoprotein cholesterol <100 mg/dL in patients with hyperlipidemia and coronary artery disease. Am J Cardiol 1997;80:111-5.
47. Brown BG, Zhao XQ, Chait A, Fisher LD, Cheung MC, Morse JS, et al. Simvastatin and niacin, antioxidant vitamins, or the combination for the prevention of coronary disease. N Engl J Med 2001;345:1583-92.
48. Morgan JM, Capuzzi DM, Guyton JR, Centor RM, Goldberg R, Robbins DC, 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.
49. Morgan JM, Capuzzi DM, Guyton JR. A new extended-release niacin (Niaspan): Efficacy, tolerability, and safety in hypercholesterolemic patients. Ann J Cardiol 1998:82(12A):29U-34U.
50. Guyton JR, Goldberg AC, Kreisberg RA, Sprecher DL, Superko HR, O'Connor CM. Effectiveness of once-nightly dosing of extended-release niacin alone and in combination for hypercholesterolemia. Am J Cardiol 1998;82:737-43.
51. Kashyap ML, McGovern ME, Berra K, Guyton JR, Kwiterovich PO, Harper WL, et al. Long-term safety and efficacy of a once-daily niacin/lovastatin formulation for patients with dyslipidemia. Am J Cardiol 2002;89:672-8.
52. Furberg CD, Pitt B. Withdrawal of cerivastatin from the world market (commentary). Curr Control Trials Cardiovasc Med 2001;2:205-7.
53. Zocor Package Insert. Zocor (Simvastatin). Whitehouse Station, NJ: Merck Research Laboratories, 2002.
54. Grundy SM, Vega GL, McGovern ME, Tulloch BR, Kendall DM, Fitz-Patrick D, 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.
55. Wolfe ML, Vartanian SF, Ross JL, Bansavich LL, Mohler ER 3rd, Meagher E, et al. Safety and effectiveness of Niaspan when added sequentially to a statin for treatment of dyslipidemia. Am J Cardiol 2001;87:476-9A7.
56. Drug Topics Red Book Update. Montvale, NJ: Medical Economics, April 2002.