Safety of extended-release niacin/laropiprant in patients with dyslipidemia

Journal of Clinical Lipidology

Volumn 4, Issue 2, 2010, Pages

  McKenney, James ^a   Bays, Harold ^b   Koren, Michael ^c   Ballantyne, Christie M ^d   Paolini, John F ^e   Mitchel, Yale ^e   Betteridge, Abigaile ^e   Kuznetsova, Olga ^e   Sapre, Aditi ^e   Sisk, Christine McCrary ^e   Maccubbin, Darbie ^e  

^a National Clinical Research Inc   (United States)

^b LOUISVILLE METABOLIC AND ATHEROSCLEROSIS RESEARCH CENTER   (United States)

^c Jacksonville Center for Clinical Research   (United States)

^d BAYLOR COLLEGE OF MEDICINE   (United States)

^e MERCK RESEARCH LABORATORIES   (United States)

Author keywords

Extended release niacin; Laropiprant; Safety

Indexed keywords

ANTILIPEMIC AGENT; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; LAROPIPRANT PLUS NIACIN; NICOTINIC ACID; PLACEBO; SIMVASTATIN; UNCLASSIFIED DRUG;

ADULT; ARTICLE; CARDIOVASCULAR DISEASE; CHOLECYSTITIS; CHOLELITHIASIS; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DRUG ERUPTION; DRUG RELEASE; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSLIPIDEMIA; ERYTHEMA; FEMALE; FLUSHING; GASTROINTESTINAL DISEASE; GLUCOSE BLOOD LEVEL; HEPATITIS; HOT FLUSH; HUMAN; HYPERSENSITIVITY REACTION; MAJOR CLINICAL STUDY; MALE; MYOPATHY; NAUSEA; NON INSULIN DEPENDENT DIABETES MELLITUS; OUTCOME ASSESSMENT; PARESTHESIA; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; PRESYNCOPE; PRIORITY JOURNAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RHABDOMYOLYSIS; SIDE EFFECT; SPONTANEOUS ABORTION; THROMBOCYTE COUNT; UNSTABLE ANGINA PECTORIS; URIC ACID BLOOD LEVEL; VERTIGO;

EID: 77949822116     PISSN: 19332874     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jacl.2010.02.002     Document Type: Article

References (31)

1. Gotto A.M. High-density lipoprotein cholesterol and triglycerides as therapeutic targets for preventing and treating coronary artery disease. Am Heart J 144 6 Suppl (2002) S33-S42
2. Shah P.K., Kaul S., Nilsson J., and Cercek B. Exploiting the vascular protective effects of high-density lipoprotein and its apolipoproteins-an idea whose time for testing is coming, Part I. Circulation 104 (2001) 2376-2383
3. 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 106 (2002) 3143-3421
4. Anon. The coronary drug project. JAMA 221 (1972) 918
5. Brown B.G., 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 345 (2001) 1583-1592
6. Brown B.G., Hillger L., Zhao X.Q., Poulin D., and Albers J.J. Types of change in coronary stenosis severity and their relative importance in overall progression and regression in coronary disease. Observations from the FATS trial. Familial Atherosclerosis Treatment study. Ann NY Acad Sci 748 (1995) 407-417
7. Brown B.G., Bardsley J., Poulin D., et al. Moderate dose, 3-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 80 (1997) 111-115
8. The Coronary Drug Project Research Group. Clofibrate and niacin in coronary heart disease. JAMA 231 (1975) 360-381
9. Canner P.L., Berge K.G., Wenger N.K., et al. Fifteen year mortality in Coronary Drug Project patients: long-term benefit with niacin. J Am Coll Cardiol 8 (1986) 1245-1255
10. Guyton J.R., and Bays H.E. Safety considerations with niacin therapy. Am J Cardiol 99 (2007) 22C-31C
11. Knopp R.H., Ginsberg J., Albers J.J., et al. Contrasting effects of unmodified and time-release forms of niacin on lipoproteins in hyperlipidemic subjects: clues to mechanism of action of niacin. Metabolism 34 (1985) 642-650
12. Birjmohun R.S., Hutten B.A., Kastelein J.J., and Stroes E.S. Increasing HDL cholesterol with extended-release nicotinic acid: from promise to practice. Neth J Med 62 (2004) 229-234
13. Illingworth D.R., Stein E.A., Mitchel Y.B., et al. Comparative effects of lovastatin and niacin in primary hypercholesterolemia: a prospective trial. Arch Intern Med 154 (1994) 1586-1595
14. Mills E., Prousky J., Raskin G., et al. The safety of over-the-counter niacin. A randomized placebo-controlled trial. BMC Clin Pharmacol 3 (2003) 4-11
15. Kamal-Bahl S.J., Burke T., Watson D., and Wentworth C. Discontinuation of lipid modifying drugs among commercially insured United States patients in recent clinical practice. Am J Cardiol 99 (2007) 530-534
16. Kamal-Bahl, Burke T., and Watson D. Dosage, titration, and gaps in treatment with extended release niacin in clinical practice. Curr Med Res Opin 24 (2008) 1817-1821
17. 2 receptor 1 suppresses nicotinic acid-induced vasodilation in mice and humans. Proc Natl Acad Sci U S A 103 (2006) 6682-6687
18. Kaijser L., Eklund B., Olsson A.G., and Carlson L.A. Dissociation of the effects of nicotinic acid on vasodilatation and lipolysis by a prostaglandin synthesis inhibitor, indomethacin, in man. Med Biol 57 (1979) 114-117
19. Negishi M., Sugimoto Y., and Ichikawa A. Prostanoid receptors and their biological actions. Prog Lipid Res 32 (1993) 417-434
20. Sturino C.F., O'Neill G., Lachance N., et al. Discovery of a potent and selective prostaglandin D(2) receptor antagonist, [(3R)-4-(4-Chloro-benzyl)-7-fluoro-5-(methylsulfonyl)-1,2,3,4-tetrahydrocyclopenta[b]indol-3-yl]-acetic Acid (MK-0524). J Med Chem 50 (2007) 794-806
21. Maccubbin D., Bays H.E., Olsson A.G., et al. Lipid-modifying efficacy and tolerability of extended-release niacin/laropiprant in patients with primary hypercholesteroaemia or mixed dyslipidaemia. Int J Clin Pract 62 (2008) 1959-1970
22. Paolini J.F., Mitchel Y.B., Reyes R., et al. Effects of laropiprant on nicotinic acid-induced flushing in patients with dyslipidemia. Am J Cardiol 101 (2008) 625-630
23. 2-induced nasal airway obstruction in healthy volunteers. Eur J Pharmacol 63 (2007) 135-141
24. 2 receptor antagonist. Clin Pharacol Ther 83 (2008) 840-847
25. Gleim G., Ballantyne C.M., Liu N., et al. Efficacy and safety profile of co-administered ER niacin/laropiprant and simvastatin in dyslipidaemia. Br J Cardiol 16 (2009) 90-97
26. Koren M.J., Maccubbin D., Davidson M., et al. Flushing profile of extended release niacin/laropiprant versus gradually titrated Niaspan™ in patients with dyslipidemia. [abstract]. J Am Coll Cardiol 51 Suppl 1 (2008) A324
27. Tatò F., Vega G.L., and Grundy S.M. Effects of crystalline nicotinic acid-induced hepatic dysfunction of serum low-density lipoprotein cholesterol and lecithin cholesteryl acyl transferase. Am J Cardiol 81 (1998) 805-807
28. Rader J.I., Calvert R.J., and Hathcock J.N. Hepatic toxicity of unmodified and time-release preparations of niacin. Am J Med 92 (1992) 77-81
29. Grundy S.M., Vega G.L., McGovern M.E., et al., Diabetes Multicenter Research Group. Efficacy, safety, and tolerability of once-daily niacin for the treatment of dysplipidemia associated with type 2 diabetes-results of the assessment of diabetes control and evaluation of the efficacy of niaspan trial. Arch Intern Med 162 (2002) 1568-1576
30. Elam M.B., Hunninghake D.B., Davis K.B., et al. Effect of niacin on lipid and lipoprotein levels and glycemic control in patients with diabetes and peripheral arterial disease. JAMA 284 (2000) 1263-1270
31. Knopp R.H., 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 47 (1998) 1097-1104