The SLIM study: Slo-Niacin® and Atorvastatin Treatment of Lipoproteins and Inflammatory Markers in Combined Hyperlipidemia

Journal of Clinical Lipidology

Volumn 3, Issue 3, 2009, Pages 167-178

  Knopp, Robert H ^a   Retzlaff, Barbara M ^a   Fish, Brian ^a   Dowdy, Alice ^a   Twaddell, Barbara ^a   Nguyen, Thuy ^a   Paramsothy, Pathmaja ^b  

^a UNIVERSITY OF WASHINGTON   (United States)

^b UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE   (United States)

Author keywords

Combined hyperlipidemia; Inflammation; Lipoproteins; Niacin; Statins

Indexed keywords

ALANINE AMINOTRANSFERASE; APOLIPOPROTEIN A1; APOLIPOPROTEIN B; ASPARTATE AMINOTRANSFERASE; ATORVASTATIN; C REACTIVE PROTEIN; GLUCOSE; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; INSULIN; INTERLEUKIN 6; LOW DENSITY LIPOPROTEIN CHOLESTEROL; NICOTINIC ACID; SLO NIACIN; TRIACYLGLYCEROL; TUMOR NECROSIS FACTOR ALPHA; UNCLASSIFIED DRUG;

ADULT; ANTIINFLAMMATORY ACTIVITY; ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED RELEASE FORMULATION; CONTROLLED STUDY; DIZZINESS; DRUG DOSE ESCALATION; DRUG DOSE INCREASE; DRUG DOSE REDUCTION; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FATIGUE; FEMALE; FLUSHING; HUMAN; HYPERLIPIDEMIA; LIVER TOXICITY; MALE; NAUSEA; PATIENT COMPLIANCE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT;

EID: 66949154654     PISSN: 19332874     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jacl.2009.04.052     Document Type: Article

References (42)

1. Knopp R., Paramsothy P., Atkinson B., and Dowdy A. Comprehensive lipid management vs. aggressive LDL lowering to reduce cardiovascular risk. Am J Cardiol 101 suppl (2008) 48B-57B
2. Clofibrate and niacin in coronary heart disease. Jama 231 (1975) 360-381
3. 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
4. Brown G., Albers J.J., Fisher L.D., 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 323 (1990) 1289-1298
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. Taylor A.J., Sullenberger L.E., Lee H.J., Lee J.K., and Grace K.A. 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 110 (2004) 3512-3517
7. Taylor A.J., Lee H.J., and Sullenberger L.E. The effect of 24 months of combination statin and extended-release niacin on carotid intima-media thickness: ARBITER 3. Curr Med Res Opin 22 (2006) 2243-2250
8. Brunzell J.D. Clinical practice. Hypertriglyceridemia. N Engl J Med 357 (2007) 1009-1017
9. Knopp R.H. Drug treatment of lipid disorders. N Engl J Med 341 (1999) 498-511
10. Goldstein J.L., Schrott H.G., Hazzard W.R., Bierman E.L., and Motulsky A.G. Hyperlipidemia in coronary heart disease. II. Genetic analysis of lipid levels in 176 families and delineation of a new inherited disorder, combined hyperlipidemia. J Clin Invest 52 (1973) 1544-1568
11. Genest Jr. J.J., Martin-Munley S.S., McNamara J.R., et al. Familial lipoprotein disorders in patients with premature coronary artery disease. Circulation 85 (1992) 2025-2033
12. 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
13. Vaccari C.S., Hammoud R.A., Nagamia S.H., Ramasamy K., Dollar A.L., and Khan B.V. Revisiting niacin: reviewing the evidence. J Clin Lipidol 1 (2007) 248-255
14. Davidson M.H. Niacin use and cutaneous flushing: mechanisms and strategies for prevention. Am J Cardiol 101 (2008) 14B-19B
15. Guyton J.R. Niacin in cardiovascular prevention: mechanisms, efficacy, and safety. Curr Opin Lipidol 18 (2007) 415-420
16. Ballantyne C.M., Davidson M.H., McKenney J., Keller L.H., Bajorunas D.R., and Karas R.H. Comparison of the safety and efficacy of a combination tablet of niacin extended release and simvastatin vs simvastatin monotherapy in patients with increased non-HDL cholesterol (from the SEACOAST I study). Am J Cardiol 101 (2008) 1428-1436
17. Karas R.H., Kashyap M.L., Knopp R.H., Keller L.H., Bajorunas D.R., and Davidson M.H. Long-term safety and efficacy of a combination of niacin extended release and simvastatin in patients with dyslipidemia: the OCEANS study. Am J Cardiovasc Drugs 8 (2008) 69-81
18. McKenney J.M., Jones P.H., Bays H.E., et al. Comparative effects on lipid levels of combination therapy with a statin and extended-release niacin or ezetimibe versus a statin alone (the COMPELL study). Atherosclerosis 192 (2007) 432-437
19. Brown B.G., Bardsley J., Poulin D., 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 80 (1997) 111-115
20. Lavie C.J., Mailander L., and Milani R.V. Marked benefit with sustained-release niacin therapy in patients with "isolated" very low levels of high-density lipoprotein cholesterol and coronary artery disease. Am J Cardiol 69 (1992) 1083-1085
21. Squires R.W., Allison T.G., Gau G.T., Miller T.D., and Kottke B.A. Low-dose, time-release nicotinic acid: effects in selected patients with low concentrations of high-density lipoprotein cholesterol. Mayo Clin Proc 67 (1992) 855-860
22. Warnick G.R. Enzymatic methods for quantification of lipoprotein lipids. In: Segrest J.P., and Albers J.J. (Eds). Methods in enzymology, part B: characterization, cell biology, and metabolism (1986), Academic Press, New York 101-123
23. Nakajima K., Saito T., Tamura A., et al. Cholesterol in remnant-like lipoproteins in human serum using monoclonal anti apo B-100 and anti apo A-I immunoaffinity mixed gels. Clin Chim Acta 223 (1993) 53-71
24. Physicians' desk reference (2006), Thompson PDR, Montvale, NJ 2495-2498
25. 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 285 (2001) 2486-2497
26. 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
27. Tabas I., Williams K.J., and Boren J. Subendothelial lipoprotein retention as the initiating process in atherosclerosis: update and therapeutic implications. Circulation 116 (2007) 1832-1844
28. Jafri H., Alsheikh A.A., Mooney P., Kimmelstiel C.D., Karas R.H., and Kuvin J.T. Extended-release niacin reduces LDL particle number without changing total LDL cholesterol in patients with stable CAD. J Clin Lipidol 3 (2009) 45-50
29. Williams P.T., Superko H.R., Haskell W.L., et al. Smallest LDL particles are most strongly related to coronary disease progression in men. Arterioscler Thromb Vasc Biol 23 (2003) 314-321
30. St-Pierre A.C., Cantin B., Dagenais G.R., et al. Low-density lipoprotein subfractions and the long-term risk of ischemic heart disease in men: 13-year follow-up data from the Quebec Cardiovascular Study. Arterioscler Thromb Vasc Biol 25 (2005) 553-559
31. Zambon A., Hokanson J.E., Brown B.G., and Brunzell J.D. Evidence for a new pathophysiological mechanism for coronary artery disease regression: hepatic lipase-mediated changes in LDL density. Circulation 99 (1999) 1959-1964
32. Vittone F., Chait A., Morse J.S., Fish B., Brown B.G., and Zhao X.Q. Niacin plus simvastatin reduces coronary stenosis progression among patients with metabolic syndrome despite a modest increase in insulin resistance: A Subgroup Analysis of the HDL-Atherosclerosis Treatment Study (HATS). J Clin Lipidol 1 (2007) 203-210
33. Poynten A.M., Gan S.K., Kriketos A.D., et al. Nicotinic acid-induced insulin resistance is related to increased circulating fatty acids and fat oxidation but not muscle lipid content. Metabolism 52 (2003) 699-704
34. Vaccari C.S., Nagamia S., Thoenes M., Oguchi A., Hammoud R., and Khan B.V. Efficacy of controlled-release niacin in treatment of metabolic syndrome: correlation to surrogate markers of atherosclerosis, vascular reactivity and inflammation. J Clin Lipidol 1 (2007) 605-613
35. Treasure C.B., Klein J.L., Weintraub W.S., et al. Beneficial effects of cholesterol-lowering therapy on the coronary endothelium in patients with coronary artery disease. N Engl J Med 332 (1995) 481-487
36. Haus J.M., Kashyap S.R., Kasumov T., et al. Plasma ceramides are elevated in obese subjects with type 2 diabetes and correlate with the severity of insulin resistance. Diabetes 58 (2009) 337-343
37. Nieto-Vazquez I., Fernandez-Veledo S., de Alvaro C., and Lorenzo M. Dual role of interleukin-6 in regulating insulin sensitivity in murine skeletal muscle. Diabetes 57 (2008) 3211-3221
38. McKenney J.M., Proctor J.D., Harris S., and Chinchili V.M. A comparison of the efficacy and toxic effects of sustained- vs immediate-release niacin in hypercholesterolemic patients. JAMA 271 (1994) 672-677
39. Keenan J.M., Fontaine P.L., Wenz J.B., Myers S., Huang Z.Q., and Ripsin C.M. Niacin revisited. A randomized, controlled trial of wax-matrix sustained-release niacin in hypercholesterolemia. Arch Intern Med 151 (1991) 1424-1432
40. Guyton J.R., and Simmons P.D. Flushing and other dermatologic adverse events associated with extended-release niacin therapy. J Clin Lipidol 3 (2009) 101-108
41. Steinbrook R. Health care and the American Recovery and Reinvestment Act. N Engl J Med 360 (2009) 1057-1060
42. Brown B.G., and Zhao X.Q. Nicotinic acid, alone and in combinations, for reduction of cardiovascular risk. Am J Cardiol 101 (2008) 58B-62B