Safety, tolerance, and efficacy of extended-release niacin monotherapy for treating dyslipidemia risks in persons with chronic tetraplegia: A randomized multicenter controlled trial

Archives of Physical Medicine and Rehabilitation

Volumn 92, Issue 3, 2011, Pages 399-410

  Nash, Mark S ^a   Lewis, John E ^a   Dyson Hudson, Trevor A ^e,f   Szlachcic, Yaga ^b,c   Yee, Florence ^b,d   Mendez, Armando J ^a   Spungen, Ann M ^g   Bauman, William A ^g,h  

^a UNIVERSITY OF MIAMI MILLER SCHOOL OF MEDICINE   (United States)

^b Rancho Los Amigos National Research Center   (United States)

^c UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

^d UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

^e KESSLER FOUNDATION   (United States)

^f RUTGERS NEW JERSEY MEDICAL SCHOOL   (United States)

^g VETERANS AFFAIRS MEDICAL CENTER   (United States)

^h MOUNT SINAI SCHOOL OF MEDICINE   (United States)

Author keywords

Cardiovascular diseases; Cholesterol, HDL; Cholesterol, LDL; Niacin; Randomized controlled trial, publication type; Rehabilitation

Indexed keywords

ALANINE AMINOTRANSFERASE; ALKALINE PHOSPHATASE; ASCRIPTIN; ASPARTATE AMINOTRANSFERASE; BILIRUBIN; GLUCOSE; GLYCOSYLATED HEMOGLOBIN; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; LOW DENSITY LIPOPROTEIN CHOLESTEROL; NICOTINIC ACID; PLACEBO; URIC ACID;

ADULT; AGED; ARTICLE; BEDTIME DOSAGE; BILIRUBIN BLOOD LEVEL; CHOLESTEROL BLOOD LEVEL; DECUBITUS; DIARRHEA; DRUG EFFICACY; DRUG RELEASE; DRUG SAFETY; DRUG TOLERANCE; DRUG WITHDRAWAL; DYSLIPIDEMIA; FEMALE; FLUSHING; FRACTURE; GLUCOSE BLOOD LEVEL; HUMAN; HYPERURICEMIA; HYPOTENSION; INSOMNIA; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; MULTICENTER STUDY; PRESYNCOPE; QUADRIPLEGIA; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SINGLE BLIND PROCEDURE; SPINAL CORD INJURY;

ADOLESCENT; ADULT; AGED; CHOLESTEROL; CHRONIC DISEASE; DELAYED-ACTION PREPARATIONS; DOUBLE-BLIND METHOD; DYSLIPIDEMIAS; FEMALE; HUMANS; HYPOLIPIDEMIC AGENTS; MALE; MIDDLE AGED; NIACIN; QUADRIPLEGIA; TRIGLYCERIDES; YOUNG ADULT;

EID: 79952058313     PISSN: 00039993     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.apmr.2010.06.029     Document Type: Article

References (52)

1. W.A. Bauman, and A.M. Spungen Coronary heart disease in individuals with spinal cord injury: assessment of risk factors Spinal Cord 46 2008 466 476 (Pubitemid 351948237)
2. W.A. Bauman, and A.M. Spungen Risk assessment for coronary heart disease in a veteran population with spinal cord injury Top Spinal Cord Inj Rehabil 12 2007 35 53
3. J. Myers, M. Lee, and J. Kiratli Cardiovascular disease in spinal cord injury: an overview of prevalence, risk, evaluation, and management Am J Phys Med Rehabil 86 2007 142 152 (Pubitemid 46148688)
4. 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
5. S.L. Groah, M.S. Nash, and I.H. Ljungberg Nutrient intake and body habitus after spinal cord injury: an analysis by sex and level of injury J Spinal Cord Med 32 2009 25 33
6. A.S. Gorgey, and D.R. Gater Prevalence of obesity after spinal cord injury Top Spinal Cord Inj Rehabil 12 2007 1 7
7. A.M. Spungen, R.H. Adkins, and C.A. Stewart Factors influencing body composition in persons with spinal cord injury: a cross-sectional study J Appl Physiol 95 2003 2398 2407 (Pubitemid 37444985)
8. W.C. Duckworth, S.S. Solomon, P. Jallepalli, C. Heckemeyer, J. Finnern, and A. Powers Glucose intolerance due to insulin resistance in patients with spinal cord injuries Diabetes 29 1980 906 910 (Pubitemid 11022288)
9. W.C. Duckworth, P. Jallepalli, and S.S. Solomon Glucose intolerance in spinal cord injury Arch Phys Med Rehabil 64 1983 107 110 (Pubitemid 13162975)
10. G. Brenes, S. Dearwater, R. Shapera, R.E. LaPorte, and E. Collins High density lipoprotein cholesterol concentrations in physically active and sedentary spinal cord injured patients Arch Phys Med Rehabil 67 1986 445 450 (Pubitemid 16067702)
11. M.S. Nash, and A.J. Mendez A guideline-driven assessment of need for cardiovascular disease risk intervention in persons with chronic paraplegia Arch Phys Med Rehabil 88 2007 751 757 (Pubitemid 46805153)
12. W.A. Bauman, A.M. Spungen, and M. Raza Coronary artery disease: metabolic risk factors and latent disease in individuals with paraplegia Mt Sinai J Med 59 1992 163 168
13. L.M. Jones, M. Legge, and A. Goulding Factor analysis of the metabolic syndrome in spinal cord-injured men Metabolism 53 2004 1372 1377 (Pubitemid 39222102)
14. M.S. Nash, B.M. Johnson, and P.L. Jacobs Combined hyperlipidemia in a single subject with tetraplegia: ineffective risk reduction after atorvastatin monotherapy J Spinal Cord Med 27 2004 484 487
15. P.Y. Wong, Y.C. Wang, N.K. Chu, F.T. Tang, and M.K. Wong Body weight, serum uric acid and lipid profile one year after spinal cord injury Chang Gung Med J 24 2001 569 575
16. A.J. Dallmeijer, L.H. van der Woude, G.J. van Kamp, and A.P. Hollander Changes in lipid, lipoprotein and apolipoprotein profiles in persons with spinal cord injuries during the first 2 years post-injury Spinal Cord 37 1999 96 102 (Pubitemid 29082503)
17. A.G. Bostom, M.M. Toner, W.D. McArdle, T. Montelione, C.D. Brown, and R.A. Stein Lipid and lipoprotein profiles relate to peak aerobic power in spinal cord injured men Med Sci Sports Exerc 23 1991 409 414
18. H. Liang, M.C. Mojtahedi, D. Chen, and C.L. Braunschweig Elevated C-reactive protein associated with decreased high-density lipoprotein cholesterol in men with spinal cord injury Arch Phys Med Rehabil 89 2008 36 41 (Pubitemid 350298997)
19. W.A. Bauman, A.M. Spungen, Y.G. Zhong, J.L. Rothstein, C. Petry, and S.K. Gordon Depressed serum high density lipoprotein cholesterol levels in veterans with spinal cord injury Paraplegia 30 1992 697 703
20. R.E. LaPorte, G. Brenes, and S. Dearwater HDL cholesterol across a spectrum of physical activity from quadriplegia to marathon running Lancet 1 1983 1212 1213
21. R.A. Washburn, and S.F. Figoni High density lipoprotein cholesterol in individuals with spinal cord injury: the potential role of physical activity Spinal Cord 37 1999 685 695 (Pubitemid 29504882)
22. M.H. Frick, O. Elo, and K. Haapa 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 317 1987 1237 1245 (Pubitemid 17147964)
23. P.H. Bowen, and J.R. Guyton Nonpharmacologic and pharmacologic treatment of patients with low levels of high-density lipoprotein cholesterol Curr Atheroscler Rep 2 2000 58 63
24. P.C. Strike, and A. Steptoe Behavioral and emotional triggers of acute coronary syndromes: a systematic review and critique Psychosom Med 67 2005 179 186 (Pubitemid 40410951)
25. K.M. Ross, V.A. Milsom, and K.A. Rickel The contributions of weight loss and increased physical fitness to improvements in health-related quality of life Eat Behav 10 2009 84 88
26. M.S. Nash Exercise as a health-promoting activity following spinal cord injury J Neurol Phys Ther 29 2005 87 103
27. J. Remick, H. Weintraub, R. Setton, J. Offenbacher, E. Fisher, and A. Schwartzbard Fibrate therapy: an update Cardiol Rev 16 2008 129 141 (Pubitemid 351549675)
28. R.H. Knopp, J. Ginsberg, and J.J. Albers 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 (Pubitemid 15036921)
29. J.M. Morgan, D.M. Capuzzi, and J.R. Guyton A new extended-release niacin (Niaspan): efficacy, tolerability, and safety in hypercholesterolemic patients Am J Cardiol 82 1998 29U 34U (Pubitemid 29047613)
30. A.C. Goldberg Clinical trial experience with extended-release niacin (Niaspan): dose-escalation study Am J Cardiol 82 1998 35U 38U (Pubitemid 29047614)
31. A.J. Taylor, S.M. Kent, P.J. Flaherty, L.C. Coyle, T.T. Markwood, and M.N. Vernalis ARBITER: Arterial Biology for the Investigation of the Treatment Effects of Reducing Cholesterol: a randomized trial comparing the effects of atorvastatin and pravastatin on carotid intima medial thickness Circulation 106 2002 2055 2060 (Pubitemid 35192810)
32. D.H. Blankenhorn, S.A. Nessim, R.L. Johnson, M.E. Sanmarco, S.P. Azen, and L. Cashin-Hemphill Beneficial effects of combined colestipol-niacin therapy on coronary atherosclerosis and coronary venous bypass grafts JAMA 257 1987 3233 3240 (Pubitemid 17078320)
33. T.A. Dyson-Hudson, and M.S. Nash Guideline-driven assessment of cardiovascular disease and related risks after spinal cord injury Top Spinal Cord Inj Rehabil 14 2009 32 45
34. R.J. Marino, T. Barros, and F. Biering-Sorensen International standards for neurological classification of spinal cord injury J Spinal Cord Med 26 Suppl 1 2003 50 56
35. A.C. Goldberg A meta-analysis of randomized controlled studies on the effects of extended-release niacin in women Am J Cardiol 94 2004 121 124 (Pubitemid 38813467)
36. 2 receptor subtype 1 Clin Pharmacol Ther 81 2007 849 857 (Pubitemid 46788299)
37. S.M. Grundy, J.I. Cleeman, and C.N. Merz Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III Guidelines J Am Coll Cardiol 44 2004 720 732
38. S.M. Grundy Approach to lipoprotein management in 2001 National Cholesterol Guidelines Am J Cardiol 90 2002 11i 21i (Pubitemid 35284907)
39. D.M. Capuzzi, J.R. Guyton, and J.M. Morgan Efficacy and safety of an extended-release niacin (Niaspan): a long-term study Am J Cardiol 82 1998 74U 81U (Pubitemid 29044485)
40. D.M. Capuzzi, J.M. Morgan, O.A. Brusco, and C.M. Intenzo Niacin dosing: relationship to benefits and adverse effects Curr Atheroscler Rep 2 2000 64 71
41. A.M. Whelan, S.O. Price, S.F. Fowler, and B.L. Hainer The effect of aspirin on niacin-induced cutaneous reactions J Fam Pract 34 1992 165 168
42. P.W. Jungnickel, P.A. Maloley, E.L. Vander Tuin, T.E. Peddicord, and J.R. Campbell Effect of two aspirin pretreatment regimens on niacin-induced cutaneous reactions J Gen Intern Med 12 1997 591 596 (Pubitemid 27446611)
43. L.A. Carlson Niaspan, the prolonged release preparation of nicotinic acid (niacin), the broad-spectrum lipid drug Int J Clin Pract 58 2004 706 713 (Pubitemid 39144586)
44. V.S. Kamanna, and M.L. Kashyap Mechanism of action of niacin on lipoprotein metabolism Curr Atheroscler Rep 2 2000 36 46
45. R.E. Cowan, L.A. Malone, and M.S. Nash EXERCISE is Medicine©: exercise prescription after SCI to manage CVD risk factors Top Spinal Cord Inj Rehabil 14 2009 69 83
46. Y. Szlachcic, R.H. Adkins, T. Adal, F. Yee, W. Bauman, and R.L. Waters The effect of dietary intervention on lipid profiles in individuals with spinal cord injury J Spinal Cord Med 24 2001 26 29 (Pubitemid 37484224)
47. K.M. Anderson, P.W. Wilson, P.M. Odell, and W.B. Kannel An updated coronary risk profile A statement for health professionals Circulation 83 1991 356 362
48. M.J. Stampfer, F.M. Sacks, S. Salvini, W.C. Willett, and C.H. Hennekens A prospective study of cholesterol, apolipoproteins, and the risk of myocardial infarction N Engl J Med 325 1991 373 381
49. W.A. Bauman, N.N. Kahn, D.R. Grimm, and A.M. Spungen Risk factors for atherogenesis and cardiovascular autonomic function in persons with spinal cord injury Spinal Cord 37 1999 601 616 (Pubitemid 29430054)
50. P.L. Canner, K.G. Berge, and N.K. Wenger Fifteen year mortality in Coronary Drug Project patients: long-term benefit with niacin J Am Coll Cardiol 8 1986 1245 1255 (Pubitemid 17208898)
51. N.R. Matthan, A. Giovanni, E.J. Schaefer, B.G. Brown, and A.H. Lichtenstein Impact of simvastatin, niacin, and/or antioxidants on cholesterol metabolism in CAD patients with low HDL J Lipid Res 44 2003 800 806 (Pubitemid 37279682)
52. E. Rizos, and D.P. Mikhailidis Are high-density lipoprotein and triglyceride levels important in secondary prevention: impressions from the BIP and VA-HIT trials Int J Cardiol 82 2002 199 207 (Pubitemid 34241573)