Indinavir did not further increase mean triglyceride levels in HIV-infected patients treated with nucleoside reverse transcriptase inhibitors: An analysis of three randomized clinical trials

Pharmacoepidemiology and Drug Safety

Volumn 12, Issue 5, 2003, Pages 361-369

  Rojas, Carlos ^a   Coplan, Paul M ^b   Rhodes, Thomas ^b   Robertson, Michael N ^b   DiNubile, Mark J ^b   Guess, Harry A ^a,b  

^a UNIVERSITY OF NORTH CAROLINA   (United States)

^b MERCK RESEARCH LABORATORIES   (United States)

Author keywords

Cardiovascular disease; Indinavir; Lipodystrophy; Protease inhibitor; Triglycerides

Indexed keywords

ANTIRETROVIRUS AGENT; IMMUNOSUPPRESSIVE AGENT; INDINAVIR; LAMIVUDINE; PROTEINASE INHIBITOR; RNA DIRECTED DNA POLYMERASE INHIBITOR; STAVUDINE; TRIACYLGLYCEROL; ZIDOVUDINE;

ARTICLE; CARDIOVASCULAR DISEASE; CONTROLLED STUDY; DISEASE ASSOCIATION; DRUG EFFECT; DRUG EFFICACY; DRUG POTENTIATION; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; HIGHLY ACTIVE ANTIRETROVIRAL THERAPY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; HYPERLIPIDEMIA; HYPERTRIGLYCERIDEMIA; LIPODYSTROPHY; MAJOR CLINICAL STUDY; MALE; METABOLIC DISORDER; MODEL; MONOTHERAPY; PRIORITY JOURNAL; RETROSPECTIVE STUDY; RISK FACTOR; TRIACYLGLYCEROL BLOOD LEVEL;

ANTIRETROVIRAL THERAPY, HIGHLY ACTIVE; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; HUMANS; IMMUNOCOMPROMISED HOST; INDINAVIR; MALE; RETROSPECTIVE STUDIES; REVERSE TRANSCRIPTASE INHIBITORS; RISK FACTORS; TIME FACTORS; TRIGLYCERIDES; ZIDOVUDINE;

EID: 0041524901     PISSN: 10538569     EISSN: None     Source Type: Journal    
DOI: 10.1002/pds.808     Document Type: Article

References (47)

1. Carr A, Samaras K, Burton S, et al. A syndrome of peripheral lipodystrophy, hyperlipidemia, and insulin resistance in patients receiving HIV protease inhibitors. AIDS 1998; 12: F51-F58.
2. Carr A, Samaras K, Thorisdottir A, Kauffmann G, Cooper D. Diagnosis, prediction, and natural course of HIV-1 protease-inhibitor-associated lipodystrophy, hyperlipidemia, and diabetes mellitus: A cohort study. Lancet 1999; 353: 2093-2099.
3. Safrin S, Grunfeld C. Fat distribution and metabolic changes in patients with HIV infection. AIDS 1999; 13: 2943-3005.
4. Dube M. Disorders of glucose metabolism in patients infected with human immunodeficiency virus. Clin Infect Dis 2000; 31: 1467-1475.
5. Graham N. Metabolic disorders among HIV-infected patients treated with protease inhibitors: A review. J AIDS 2000; 25: S4-S11.
6. Mulligan K, Grunfeld C, Tai VW, et al. Hyperlipidemia and insulin resistance are induced by protease inhibitors independent of changes in body composition in patients with HIV infection. J AIDS 2000; 25: 35-43.
7. Yanovski JA, Miller KD, Kino T, et al. Endocrine and metabolic evaluation of human immunodeficiency virus-infected patients with evidence of protease inhibitor-associated lipodystrophy. J Clin Endocrinol Metab 1999; 84: 1925-1931.
8. Thiebaut R, Daucort V, Mercie P, et al. Lipodystrophy, metabolic disorders, and human immunodeficiency virus infection: Aquitaine cohort, France, 1999. Clin Infect Dis 2000; 31: 1482-1487.
9. Nguyen A, Gagnon A, Angel J, Sorisky A. Ritonavir increases the level of active ADD-1/SREBP-1 protein during adipogenesis. AIDS 2000; 14: 2467-2473.
10. Hadigan C, Corcoran C, Stanley T, Piecuch S, Klibanski A, Grinspoon S. Fasting hyperinsulinemia in HIV-infected men: Relationship to body composition, gonadal function and protease-inhibitor use. J Clin Endocrinol Metab 2000; 85: 35-41.
11. Hadigan C, Corcoran C, Basgoz NP, Davis B, Sax P, Grinspoon S. Metformin in the treatment of HIV lipodystrophy syndrome. JAMA 2000; 284: 472-477.
12. Mynarcik D, McNurlan M, Steigbigel R, Fuhrer J, Gelato M. Association of severe insulin resistance with both loss of limb fat and elevated serum tumor necrosis factor receptor levels in HIV lipodystrophy. J AIDS 2000; 25: 312-321.
13. Saint-Marc T, Partisani M, Poizot-Martin I, et al. A syndrome of peripheral fat wasting (lipodystrophy) in patients receiving long-term nucleoside analogue therapy. AIDS 1999; 13: 1659-1667.
14. Polo R, Verdejo J, Gonzalez-Munoz M, et al. Switch to AZT + 3TC improves lipodystrophy signs in the presence of protease inhibitors. [Abstract]. Presented at the: International Conference on Antimicrobial Agents and Chemotherapy 1999.
15. Brinkman K, Smeitink JA, Romijn JA, Reiss P. Mitochondrial toxicity induced by nucleoside-analogue reverse-transcriptase inhibitors is a key factor in the pathogenesis of antiretroviral-therapy-related lipodystrophy. Lancet 1999; 354: 1112-1115.
16. Grunfeld C, Kotler DO, Hamadeh R, et al. Hypertriglyceridemia in the acquired immunodeficiency syndrome. Am J Med 1989; 86: 27-31.
17. Hellerstein MK, Grunfeld C, Wu K, et al. Increased de novohepatic lipogenesis in human immunodeficiency virus infection. J Clin Endocrinol Metab 1993; 76: 559-565.
18. Grunfeld C, Pang M, Doerrler W, et al. Lipids, lipoproteins, triglyceride clearance, and cytokines in human immunodeficiency virus infection and the acquired immunodeficiency syndrome. J Clin Endocrinol Metab 1992; 74: 1045-1052.
19. Thiebaut R, Daucort V, Mercie P, et al. Lipodystrophy, metabolic disorders, and human immunodeficiency virus infection: aquitaine cohort, France, 1999. Clin Infect Dis 2000; 31: 1482-1487.
20. Noor MA, Lo JC, Mulligan K, et al. Metabolic effects of indinavir in healthy HIV-seronegative men. AIDS 2001; 15: F11-F18.
21. Purnell JQ, Zambon A, Knopp RH, et al. Effect of ritonavir on lipids and post-heparin lipase activities in normal subjects. AIDS 2000; 14: 51-57.
22. Sharrett AR, Sorlie PD, Chambless LE, et al. Relative importance of various risk factors for asymptomatic carotid atherosclerosis versus coronary heart disease incidence. Am J Epidemiol 1999; 149: 843-852
23. Stampfer MJ, Krauss RM, Ma J, et al. A prospective study of triglyceride level, low-density lipoprotein particle diameter, and risk of myocardial infarction. JAMA 1996; 276: 882-888.
24. Criqui M, Heiss G, Cohn R, et al. Plasma triglyceride level and mortality from coronary heart disease. New Engl J Med 1993; 328: 1220-1225.
25. Jeppesen J, Hein HO, Suadicani P, Gyntelberg F. Low triglycerides-high high-density lipoprotein cholesterol and risk of ischemic heart disease. Arch Intern Med 2001; 161: 361-366.
26. Jeppesen J, Hein HO, Suadicani P, Gyntelberg F. Triglyceride concentration and ischemic heart disease. Circulation 1998; 97: 1029-1036.
27. West of Scotland Coronary Prevention Group. Identification of high-risk groups and comparison with other cardiovascular intervention trials. Lancet 1996; 348: 1339-1342.
28. Despres JP, Lamache B, Mauriege P, et al. Hyperinsulinemia as an independent risk factor for ischaemic heart disease. N Engl J Med 1996; 334: 952-957.
29. Turner RC, Millns H, Neil HAW, et al. Risk factors for coronary artery disease in non-insulin dependent diabetes mellitus: United Kingdom Prospective Diabetes Study (UKPDS:23). BMJ 1998; 316: 823-828.
30. Wayne HHS, Shieh SM, Fuh MMT, et al. Insulin resistance, glucose intolerance, and hyperinsulinemia: Hypertriglyceridemia versus hypercholesterolemia. Arterioscler Thromb 1993; 13: 367-370.
31. Coplan P, Nikas A, Leavitt RY, et al. Indinavir did not increase the short-term risk of adverse cardiovascular events relative to nucleoside reverse transcriptase inhibitor therapy in four phase III clinical trials. AIDS 2001; 15: 1584-1586.
32. Coplan P, Cormier K, Japour A, et al. Myocardial infarction incidence in clinical trials of 4 protease inhibitors. Presented at the 7th Conference on Retroviruses and Opportunistic Infections [Abstract 34]. San Francisco, 30 January-2 February 2000.
33. Klein D, Hurley L, Sidney S. Do protease inhibitors increase the risk for coronary heart disease among HIV-positive patients? Additional follow up. Presented at the: 7th Conference on Retroviruses and Opportunistic Infections [Abstract 33]. San Francisco, 30 January-2 February 2000.
34. Maggi P, Serio G, Efifani G, et al. Premature lesions of the carotid vessels in HIV-1-infected patients treated with protease inhibitors. AIDS 2001; 14: F123-F128.
35. Hadigan C, Meigs J, Corcoran C, et al. Metabolic abnormalities and cardiovascular disease risk factors in adults with human immunodeficiency virus infection and lipodystrophy. Clin Infect Dis 2001; 32: 130-139.
36. Periard D, Telenti A, Sudre P, et al. Atherogenic dyslipidemia in HIV-infected individuals treated with protease inhibitors. Circulation 1999; 100: 700-705.
37. Henry K, Melroe H, Huebsch J, et al. Severe premature coronary artery disease with protease inbitors [letter]. Lancet 1998; 351: 1328.
38. Akaike H. A new look at the statistical model identification. IEEE Transaction on Automatic Control 1974; AC-19, 716-723.
39. Littell RC, Milliken GA, Stroup WW, Wolfinger RD. SAS(c) System for Mixed Models, Cary, NC: SAS Institute Inc., 1996.
40. Dong KL, Bausserman LL, Flynn MM, et al. Changes in body habitus and serum lipid abnormalities in HIV-positive women on highly active antiretroviral therapy (HAART). J AIDS 1999; 21: 107-113.
41. Sanit-Marc T, Touraine JL. The effects of discontinuing stavudine therapy on clinical and metabolic abnormalities in patients suffering from lipodystrophy. AIDS 1999; 13: 2188-2189.
42. Midvan D, Machado SG, Wilets I, Grossberg SE. Endogenos interferon and triglyceride concentrations to assess response to zidovudine in AIDS and advanced AIDS-related complex. Lancet 1992; 339: 453-456.
43. Robertson MN, Nessly M, Aversa D, Rawlins S, Leavitt RY. Changes in serum triglyceride and cholesterol levels in patients treated with Crixivan® or NRTIs. Presented at the 6th Conference of Retroviruses and Opportunistic Infections, Chicago, IL. 1999.
44. Staszewski S, Keiser P, Montaner J, et al. Abacavir-lamivudine-zidovudine vs indinavir-lamivudine-zidovudine in antiretroviral-naïve HIV-infected adults. JAMA 2001; 285: 1155-1163.
45. Segerer S, Bogner JR, Burton S, et al. Hyperlipidemia under treatment with protease inhibitors. Infection 1999; 27: 77-81.
46. Schimitz M, Michl GM, Walli R, et al. Alterations of apolipoprotein B metabolism in HIV-infected patients with antiretroviral combination therapy. J AIDS 2001; 26: 225-235.
47. Panel on Clinical Practices for the Treatment of HIV Infection convened by the Department of Health and Human Services and the Henry J. Kaiser Family Foundation. Guidelines for the use of antiretroviral agents in HIV-infected adults and adolescents. Available at: http//hivatis.org/trtgdlns.html. 2 July 2001.