Efficacy and safety of extended-release niacin/laropiprant plus statin vs. doubling the dose of statin in patients with primary hypercholesterolaemia or mixed dyslipidaemia

International Journal of Clinical Practice

Volumn 64, Issue 6, 2010, Pages 727-738

  Shah, S ^a   Ceska, R ^b   Gil Extremera, B ^c   Paolini, J F ^d   Giezek, H ^e   Vandormael, K ^e   Mao, A ^a   McCrary Sisk, C ^a   MacCubbin, D ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

^b CHARLES UNIVERSITY   (Czech Republic)

^c HOSPITAL UNIVERSITARIO SAN CECILIO   (Spain)

^d Bayer HealthCare Pharmaceuticals Inc   (United States)

^e Merck Sharp and Dohme   (Belgium)

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ANTILIPEMIC AGENT; APOLIPOPROTEIN A1; APOLIPOPROTEIN B; ASPARTATE AMINOTRANSFERASE; ATORVASTATIN; C REACTIVE PROTEIN; CHOLESTEROL; CREATINE KINASE; HEMOGLOBIN A1C; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; LAROPIPRANT PLUS NICOTINIC ACID; LIPOPROTEIN; LOW DENSITY LIPOPROTEIN CHOLESTEROL; SIMVASTATIN; TRIACYLGLYCEROL; UNCLASSIFIED DRUG;

ABDOMINAL PAIN; ADULT; AGED; ARTICLE; BEDTIME DOSAGE; CARDIOVASCULAR DISEASE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED DRUG RELEASE; CONTROLLED STUDY; CREATINE KINASE BLOOD LEVEL; DIABETES MELLITUS; DIARRHEA; DISEASE SEVERITY; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG DOSE INCREASE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSLIPIDEMIA; ERYTHEMA; EVENING DOSAGE; FEMALE; FLUSHING; GASTROINTESTINAL SYMPTOM; GLUCOSE BLOOD LEVEL; HEADACHE; HEMOGLOBIN BLOOD LEVEL; HOT FLUSH; HUMAN; HYPERCHOLESTEROLEMIA; HYPERTRANSAMINASEMIA; INSULIN RESISTANCE; LIPID ANALYSIS; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MYALGIA; MYOPATHY; NAUSEA; PARESTHESIA; PRIORITY JOURNAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RASH; RHABDOMYOLYSIS; SIDE EFFECT; TABLET; TOXIC HEPATITIS; TREATMENT DURATION;

ADULT; AGED; AGED, 80 AND OVER; CHOLESTEROL, HDL; CHOLESTEROL, LDL; DELAYED-ACTION PREPARATIONS; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG COMBINATIONS; DYSLIPIDEMIAS; FEMALE; HUMANS; HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITORS; HYPERCHOLESTEROLEMIA; HYPOLIPIDEMIC AGENTS; INDOLES; MALE; MIDDLE AGED; NIACIN; PROSTAGLANDIN D2; TREATMENT OUTCOME; YOUNG ADULT;

EID: 77950641140     PISSN: 13685031     EISSN: 17421241     Source Type: Journal    
DOI: 10.1111/j.1742-1241.2010.02370.x     Document Type: Article

References (33)

1. Grundy SM, Cleeman JI, Merz CN et al. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III guidelines. J Am Coll Cardiol 2004 44 : 720 732.
2. Phatak H, Wentworth C, Sazonov Kocevar V, Burke TA. Prevalence and predictors of lipid abnormalities in patients treated with statins in the UK general. Atheresclerosis 2009 202 : 225 233.
3. Rajagopalan S, Alemao E, Finch L, Yin D. Impact of new Joint British Societies' (JBS 2) guidelines on prevention of cardiovascular disease: evaluation of serum total cholesterol goal achievement in UK clinical practice. Curr Med Res Opin 2007 23 : 2027 2034. (Pubitemid 47300402)
4. Van Ganse E, Laforest L, Burke T, Phatak H, Souchet T. Mixed dyslipidemia among patients using lipid lowering therapy in French general practice: an observational study. Clin Ther 2007 29 : 1671 1681. (Pubitemid 47500127)
5. National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). 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 106 : 3143 3421.
6. Guyton JR, Goldber AC, Kreisberg RA, Sprecher DL, Superko R, O'Connor CM. Effectiveness of once-nightly dosing of extended-release niacin alone and in combination for hypercholesterolemia. Am J Cardiol 1998 82 : 737 743. (Pubitemid 28439633)
7. Danesh J, Collins R, Peto R. Lipoprotein(a) and coronary artery disease. Meta-analysis of prospective studies. Circulation 2000 102 : 1082 1085.
8. Kamal-Bahl S, Burke T, Watson D, Wentworth C. Discontinuation of Lipid Modifying Drugs Among Commercially Insured United States Patients in Recent Clinical Practice. Am J Cardiol 2007 99 : 530 534. (Pubitemid 46215558)
9. Alsheikh-Ali AA, Lin JL, Abourjaily P, Ahearn D, Kuvin JT, Karas RH. Prevalence of low high-density lipoprotein cholesterol in patients with documented coronary heart disease or risk equivalent and controlled low-density lipoprotein cholesterol. Am J Cardiol 2007 100 : 1499 1501. (Pubitemid 350050854)
10. Sarawate CA, Cziraky MJ, Stanek EJ, Willey VJ, Corbelli JC, Charland SL. Achievement of Optimal Combined Lipid Values in a Managed Care Setting: is a New Treatment Paradigm Needed? Clin Ther 2007 29 : 196 209.
11. Dorais M, Chirovsky D, Ambegaonkar BM et al. Utilization patterns of extended-release niacin in Canada: analysis of an administrative claims database. Can J Cardiol in press.
12. Marentette M, Cadieux P, Chan P, Sazonov V. Mixed dyslipidemia among Canadian patients using lipid-lowering therapy. Quality of Care and Outcomes Research in Cardiovascular Disease and Stroke Conference, 9-11 May 2007, vol. 200, p. 15(P68).
13. Böhler S, Scharnagl H, Freisinger F et al. Unmet needs in the diagnosis and treatment of dyslipidemia in the primary care setting in Germany. Atherosclerosis 2007 190 : 397 407. (Pubitemid 46074031)
14. Knopp RH, Ginsberg J, Albers JJ 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 1985 34 : 642 650.
15. Birjmohun RS, Hutten BA, Kastelein JJ, Stroes ES. Increasing HDL cholesterol with extended-release nicotinic acid: from promise to practice. Neth J Med 2004 62 : 229 234.
16. Illingworth DR, Stein EA, Mitchel YB et al. Comparative effects of lovastatin and niacin in primary hypercholesterolemia: a prospective trial. Arch Intern Med 1994 154 : 1586 1595.
17. Mills E, Prousky J, Raskin G et al. The safety of over-the-counter niacin. A randomized placebo-controlled trial. BMC Clin Pharmacol 2003 3 : 4 11.
18. Cheng K, Wu TJ, Wu KK et al. Antagonism of the prostaglandin D2 receptor 1 suppresses nicotinic acid-induced vasodilation in mice and humans. Proc Natl Acad Sci USA 2006 103 : 6682 6687.
19. Sturino CF, 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 2007 50 : 794 806.
20. Paolini JF, Mitchel YB, Reyes R et al. Effects of laropiprant on nicotinic acid-induced flushing in dyslipidemic patients. Am J Cardiol 2008 101 : 625 630.
21. Maccubbin D, Bays HE, Olsson AG et al. Lipid-modifying efficacy and tolerability of extended release niacin/laropiprant in patients with primary hypercholesterolaemia or mixed dyslipidaemia. Int J Clin Pract 2008 62 : 1959 1970.
22. The coronary drug project. JAMA 1972 221 : 918.
23. 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 345 : 1583 1592.
24. Brown BG, Hillger L, Zhao XQ, Poulin D, Albers JJ. 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 1995 748 : 407 417.
25. The Coronary Drug Project Research Group. Clofibrate and niacin in coronary heart disease. JAMA 1975 231 : 360 381.
26. 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 1255.
27. Maccubbin D, Koren MJ, Davidson M et al. Flushing profile of extended release niacin/laropiprant versus gradually titrated niacin extended release in patients with dyslipidemia with and without ischemic cardiovascular disease. Am J Cardiol 2009 104 : 74 81.
28. Ariyo AA, Thach C, Tracy R, the Cardiovascular Health Study Investigators. Lp(a) lipoprotein, vascular disease, and mortality in the elderly. N Engl J Med 2003 349 : 2108 2115.
29. Guyton JR, Bays HE. Safety considerations with niacin therapy. Am J Cardiol 2007 99 (Suppl. 22C 31C.
30. Tatò F, Vega GL, Grundy SM. Effects of crystalline nicotinic acid-induced hepatic dysfunction of serum low-density lipoprotein cholesterol and lecithin cholesteryl acyl transferase. Am J Cardiol 1998 81 : 805 807.
31. Rader JI, Calvert RJ, Hathcock JN. Hepatic toxicity of unmodified and time-release preparations of niacin. Am J Med 1992 92 : 77 81.
32. Grundy SM, Vega GL, McGovern ME et al. 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 2002 162 : 1568 1576.
33. Elam MB, Hunninghake DB, Davis KB et al. Effect of niacin on lipid and lipoprotein levels and glycemic control in patients with diabetes and peripheral arterial disease. JAMA 2000 284 : 1263 1270.