Combination of niacin and fenofibrate with lifestyle changes improves dyslipidemia and hypoadiponectinemia in HIV patients on antiretroviral therapy: Results of "Heart Positive," a randomized, controlled trial

Journal of Clinical Endocrinology and Metabolism

Volumn 96, Issue 7, 2011, Pages 2236-2247

  Balasubramanyam, Ashok ^a   Coraza, Ivonne ^a   Smith, E O'Brian ^a   Scott, Lynne W ^a   Patel, Payal ^a   Iyer, Dinakar ^a   Taylor, Addison A ^a   Giordano, Thomas P ^a   Sekhar, Rajagopal V ^a   Clark, Pamela ^a   Cuevas Sanchez, Edith ^a   Kamble, Swarna ^a   Ballantyne, Christie M ^a   Pownall, Henry J ^a  

^a BAYLOR COLLEGE OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADIPONECTIN; ANTIRETROVIRUS AGENT; C REACTIVE PROTEIN; CHOLESTEROL; FENOFIBRATE; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; INSULIN; NICOTINIC ACID; NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR; PLACEBO; PROTEINASE INHIBITOR; RNA DIRECTED DNA POLYMERASE INHIBITOR; TRIACYLGLYCEROL;

ABDOMINAL PAIN; ADULT; AGED; ANGINA PECTORIS; ANOREXIA; ARTICLE; BACKACHE; BODY COMPOSITION; CONTROLLED STUDY; DIARRHEA; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG ERUPTION; DRUG INDUCED HEADACHE; DYSLIPIDEMIA; ENERGY EXPENDITURE; EXERCISE; FATIGUE; FEMALE; FLUSHING; GLUCOSE BLOOD LEVEL; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; HYPERTRIGLYCERIDEMIA; HYPOADIPONECTINEMIA; INSULIN SENSITIVITY; LEG CRAMP; LIFESTYLE MODIFICATION; LOW FAT DIET; MALE; METABOLIC DISORDER; MYALGIA; NAUSEA AND VOMITING; POLYURIA; PRIORITY JOURNAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; THORAX PAIN;

ADIPONECTIN; ADULT; AGED; ANTI-RETROVIRAL AGENTS; DOUBLE-BLIND METHOD; DYSLIPIDEMIAS; EXERCISE; FEMALE; FENOFIBRATE; HIV SEROPOSITIVITY; HUMANS; HYPOLIPIDEMIC AGENTS; LIFE STYLE; MALE; MIDDLE AGED; NIACIN; RISK REDUCTION BEHAVIOR; TREATMENT OUTCOME; TRIGLYCERIDES;

EID: 79960088422     PISSN: 0021972X     EISSN: 19457197     Source Type: Journal    
DOI: 10.1210/jc.2010-3067     Document Type: Article

References (46)

1. Carr A, Samaras K, Burton S, Law M, Freund J, Chisholm DJ, Cooper DA 1998 A syndrome of peripheral lipodystrophy, hyperlipidaemia and insulin resistance in patients receiving HIV protease inhibitors. AIDS 12:F51-F58 (Pubitemid 28190689)
2. Worm SW, Sabin C, Weber R, Reiss P, El-Sadr W, Dabis F, De Wit S, Law M, Monforte AD, Friis-Møller N, Kirk O, Fontas E, Weller I, Phillips A, Lundgren J 2010 Risk of myocardial infarction in patients with HIV infection exposed to specific individual antiretroviral drugs from the 3 major drug classes: the data collection on adverse events of anti-HIV drugs (D:A:D) study. J Infect Dis 201:318-330
3. d'Arminio A, Sabin CA, Phillips AN, Reiss P, Weber R, Kirk O, El-Sadr W, De Wit S, Mateu S, Petoumenos K, Dabis F, Pradier C, Morfeldt L, Lundgren JD, Friis-Moller N, Writing Committee of the D:A:D Study Group 2004 Cardio- and cerebrovascular events in HIV-infected persons. AIDS 18:1811-1817
4. Flynn TE, Bricker LA 1999 Myocardial infarction in HIV-infected men receiving protease inhibitors. Ann Intern Med 131:548 (Pubitemid 29482406)
5. Friis-Møller N, Weber R, Reiss P, Thiebaut R, Kirk O, d'Arminio Monforte A, Pradier C, Morfeldt L, Mateu S, Law M, El-Sadr W, De Wit S, Sabin CA, Phillips AN, Lundgren JD 2003 Cardiovascular disease risk factors in HIV patients-association with antiretroviral therapy. Results from the DAD study. AIDS 17:1179-1193 (Pubitemid 36667761)
6. Varriale P, Saravi G, Hernandez E, Carbon F 2004 Acute myocardial infarction in patients infected with human immunodeficiency virus. Am Heart J 147:55-59 (Pubitemid 38037397)
7. Samaras K, Wand H, Law M, Emery S, Cooper D, Carr A 2007 Prevalence of metabolic syndrome in HIV-infected patients receiving highly active antiretroviral therapy using International Diabetes Foundation and Adult Treatment Panel III criteria: associations with insulin resistance, disturbed body fat compartmentalization, elevated C-reactive protein, and [corrected] hypoadiponectinemia. Diabetes Care 30:113-119 (Pubitemid 46052508)
8. Rose H, Hoy J, Woolley I, Tchoua U, Bukrinsky M, Dart A, Sviridov D 2008 HIV infection and high density lipoprotein metabolism. Atherosclerosis 199:79-86 (Pubitemid 351842701)
9. Tsiodras S, Mantzoros C, Hammer S, Samore M 2000 Effects of protease inhibitors on hyperglycemia, hyperlipidemia, and lipodystrophy: a 5-year cohort study. Arch Intern Med 160:2050-2056 (Pubitemid 30437589)
10. Sekhar RV, Jahoor F, White AC, Pownall HJ, Visnegarwala F, Rodriguez-Barradas MC, Sharma M, Reeds PJ, Balasubramanyam A 2002 Metabolic basis of HIV-lipodystrophy syndrome. Am J Physiol Endocrinol Metab 283:E332-E337 (Pubitemid 34827449)
11. Hadigan C, Borgonha S, Rabe J, Young V, Grinspoon S 2002 Increased rates of lipolysis among human immunodeficiency virusinfected men receiving highly active antiretroviral therapy. Metabolism 51:1143-1147
12. Reeds DN, Mittendorfer B, Patterson BW, Powderly WG, Yarasheski KE, Klein S 2003 Alterations in lipid kinetics in men with HIV-dyslipidemia. Am J Physiol Endocrinol Metab 285:E490-E497 (Pubitemid 37010825)
13. Sekhar RV, Jahoor F, Pownall HJ, Rehman K, Gaubatz J, Iyer D, Balasubramanyam A 2005 Severely dysregulated disposal of post-prandial triacylglycerols exacerbates hypertriacylglycerolemia in HIV lipodystrophy syndrome. Am J Clin Nutr 81:1405-1410 (Pubitemid 41710245)
14. Ware LJ, Wootton SA, Morlese JM, Gazzard BG, Jackson AA 2002 The paradox of improved antiretroviral therapy in HIV: potential for nutritional modulation? Proc Nutr Soc 61:131-136
15. Mujawar Z, Rose H, Morrow MP, Pushkarsky T, Dubrovsky L, Mukhamedova N, Fu Y, Dart A, Orenstein JM, Bobryshev YV, Bukrinsky M, Sviridov D 2006 Human immunodeficiency virus impairs reverse cholesterol transport from macrophages. PLoS Biol 4:e365
16. Tong Q, Sankale JL, Hadigan CM, Tan G, Rosenberg ES, Kanki PJ, Grinspoon SK, Hotamisligil GS 2003 Regulation of adiponectin in human immunodeficiency virus-infected patients: relationship to body composition and metabolic indices. J Clin Endocrinol Metab 88:1559-1564 (Pubitemid 36623370)
17. Vigouroux C, Maachi M, Nguyên TH, Coussieu C, Gharakhanian S, Funahashi T, Matsuzawa Y, Shimomura I, Rozenbaum W, Capeau J, Bastard JP 2003 Serum adipocytokines are related to lipodystrophy and metabolic disorders in HIV-infected men under antiretroviral therapy. AIDS 17:1503-1511 (Pubitemid 36900551)
18. Dube MP, Stein JH, Aberg JA, Fichtenbaum CJ, Gerber JG, Tashima KT, Henry WK, Currier JS, Sprecher D, Glesby MJ 2003 Guidelines for the evaluation and management of dyslipidemia in human immunodeficiency virus (HIV)-infected adults receiving antiretroviral therapy: recommendations of the HIV Medical Association of the Infectious Disease Society of America and the Adult AIDS Clinical Trials Group. Clin Infect Dis 37:613-627 (Pubitemid 37100800)
19. Hulgan T, Sterling TR, Daugherty J, Arbogast PG, Raffanti S, Ray W2005 Prescribing of contraindicated protease inhibitor and statin combinations among HIV-infected persons. J Acquir Immune Defic Syndr 38:277-282
20. Samson SL, Pownall HJ, Scott LW, Ballantyne CM, Smith EO, Sekhar RV, Balasubramanyam A 2006 Heart Positive: design of a randomized controlled clinical trial of intensive lifestyle intervention, niacin and fenofibrate for HIV lipodystrophy/dyslipidemia. Contemp Clin Trials 27:518-530 (Pubitemid 44635337)
21. Brown BG, Zhao XQ, Chait A, Fisher LD, Cheung MC, Morse JS, Dowdy AA, Marino EK, Bolson EL, Alaupovic P, Frohlich J, Albers JJ 2001 Simvastatin and niacin, antioxidant vitamins, or the combination for the prevention of coronary disease. N Engl J Med 345:1583-1592 (Pubitemid 33126837)
22. 1987 Atherosclerosis risk in communities (ARIC) study. Operations manual. Bethesda, MD: National Heart Lung and Blood Institute
23. Siddiqui O, Hung HM, O'Neill R 2009MMRMvs. LOCF: a comprehensive comparison based on simulation study and 25 NDA datasets. J Biopharm Stat 19:227-246
24. Ingelsson E, Schaefer EJ, Contois JH, McNamara JR, Sullivan L, Keyes MJ, Pencina MJ, Schoonmaker C, Wilson PW, D'Agostino RB, Vasan RS 2007 Clinical utility of different lipid measures for prediction of coronary heart disease in men and women. JAMA 298:776-785 (Pubitemid 47263160)
25. Dube MP, Wu JW, Aberg JA, Deeg MA, Alston-Smith BL, McGovern ME, Lee D, Shriver SL, Martinez AI, Greenwald M, Stein JH 2006 Safety and efficacy of extended-release niacin for the treatment of dyslipidaemia in patients with HIV infection: AIDS Clinical Trials Group Study A5148. Antivir Ther 11:1081-1089 (Pubitemid 44955184)
26. Calza L, Manfredi R, Chiodo F 2003 Statins and fibrates for the treatment of hyperlipidaemia in HIV-infected patients receiving HAART. AIDS 17:851-859 (Pubitemid 36547657)
27. Aberg JA, Zackin RA, Brobst SW, Evans SR, Alston BL, Henry WK, Glesby MJ, Torriani FJ, Yang Y, Owens SI, Fichtenbaum CJ;ACTG 5087 Study Team 2005Arandomized trial of the efficacy and safety of fenofibrate versus pravastatin in HIV-infected subjects with lipid abnormalities: AIDS Clinical Trials Group Study 5087. AIDS Res Hum Retroviruses 21:757-767
28. Badiou S, Merle De Boever C, Dupuy AM, Baillat V, Cristol JP, Reynes J 2004 Fenofibrate improves the atherogenic lipid profile and enhances LDL resistance to oxidation in HIV-positive adults. Atherosclerosis 172:273-279 (Pubitemid 38167538)
29. Miller J, Brown D, Amin J, Kent-Hughes J, Law M, Kaldor J, Cooper DA, Carr A 2002 A randomized, double-blind study of gemfibrozil for the treatment of protease inhibitor-associated hypertriglyceridaemia. AIDS 16:2195-2200 (Pubitemid 35387274)
30. Silverberg MJ, Leyden W, Hurley L, Go AS, Quesenberry Jr CP, Klein D, Horberg MA 2009 Response to newly prescribed lipid-lowering therapy in patients with and without HIV infection. Ann Intern Med 150:301-313
31. 2002 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 106:3143-3421
32. Taylor AJ, Sullenberger LE, Lee HJ, Lee JK, Grace KA 2004 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 110:3512-3517 (Pubitemid 39612564)
33. Manninen V, Elo MO, Frick MH, Haapa K, Heinonen OP, Heinsalmi P, Helo P, Huttunen JK, Kaitaniemi P, Koskinen P 1988 Lipid alterations and decline in the incidence of coronary heart disease in the Helsinki Heart Study. JAMA 260:641-651
34. Rubins HB, Robins SJ, Collins D, Fye CL, Anderson JW, Elam MB, Faas FH, Linares E, Schaefer EJ, Schectman G, Wilt TJ, Wittes J 1999 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 341:410-418 (Pubitemid 29362514)
35. Di Angelantonio E, Sarwar N, Perry P, Kaptoge S, Ray KK, Thompson A, Wood AM, Lewington S, Sattar N, Packard CJ, Collins R, Thompson SG, Danesh J 2009 Major lipids, apolipoproteins, and risk of vascular disease. JAMA 302:1993-2000
36. Keech A, Simes RJ, Barter P, Best J, Scott R, Taskinen MR, Forder P, Pillai A, Davis T, Glasziou P, Drury P, Kesäniemi YA, Sullivan D, Hunt D, Colman P, d'Emden M, Whiting M, Ehnholm C, Laakso M; FIELD study investigators 2005 Effects of long-term fenofibrate therapy on cardiovascular events in 9795 people with type 2 diabetes mellitus (the FIELD study): randomised controlled trial. Lancet 366:1849-1861
37. Ginsberg HN, Elam MB, Lovato LC, Crouse 3rd JR, Leiter LA, Linz P, Friedewald WT, Buse JB, Gerstein HC, Probstfield J, Grimm RH, Ismail-Beigi F, Bigger JT, Goff Jr DC, Cushman WC, Simons-Morton DG, Byington RP 2010 Effects of combination lipid therapy in type 2 diabetes mellitus. N Engl J Med 362:1563-1574
38. Lindegaard B, Keller P, Bruunsgaard H, Gerstoft J, Pedersen BK 2004 Low plasma level of adiponectin is associated with stavudine treatment and lipodystrophy in HIV-infected patients. Clin Exp Immunol 135:273-279 (Pubitemid 38177967)
39. Falasca K, Manigrasso MR, Racciatti D, Zingariello P, Dalessandro M, Ucciferri C, Mancino P, Marinopiccoli M, Petrarca C, Conti P, Pizzigallo E, Guagnano MT, Vecchiet J 2006 Associations between hypertriglyceridemia and serum ghrelin, adiponectin, and IL-18 levels in HIV-infected patients. Ann Clin Lab Sci 36:59-66 (Pubitemid 43805880)
40. Hadigan C, Yawetz S, Thomas A, Havers F, Sax PE, Grinspoon S 2004 Metabolic effects of rosiglitazone in HIV lipodystrophy: a randomized, controlled trial. Ann Intern Med 140:786-794
41. Plaisance EP, Lukasova M, Offermanns S, Zhang Y, Cao G, Judd RL 2009 Niacin stimulates adiponectin secretion through the GPR109A receptor. Am J Physiol Endocrinol Metab 296:E549-E558
42. Westphal S, Borucki K, Taneva E, Makarova R, Luley C 2007 Extended- release niacin raises adiponectin and leptin. Atherosclerosis 193:361-365 (Pubitemid 47058098)
43. Plaisance EP, Grandjean PW, Brunson BL, Judd RL 2008 Increased total and high-molecular weight adiponectin after extended-release niacin. Metabolism 57:404-409 (Pubitemid 351178732)
44. Shahmanesh M, Das S, Stolinski M, Shojaee-Moradie F, Jackson NC, Jefferson W, Cramb R, Nightingale P, Umpleby AM 2005 Antiretroviral treatment reduces very-low-density lipoprotein and intermediate- density lipoprotein apolipoprotein B fractional catabolic rate in human immunodeficiency virus-infected patients with mild dyslipidemia. J Clin Endocrinol Metab 90:755-760 (Pubitemid 40279192)
45. Fitch KV, Anderson EJ, Hubbard JL, Carpenter SJ, Waddell WR, Caliendo AM, Grinspoon SK 2006 Effects of a lifestyle modification program in HIV-infected patients with the metabolic syndrome. AIDS 20:1843-1850 (Pubitemid 44358902)
46. Parhofer KG 2009 Review of extended-release niacin/laropiprant fixed combination in the treatment of mixed dyslipidemia and primary hypercholesterolemia. Vasc Health Risk Manag 5:901-908