Abacavir use and cardiovascular disease events: A meta-analysis of published and unpublished data

AIDS

Volumn 25, Issue 16, 2011, Pages 1993-2004

  Cruciani, Mario ^a   Zanichelli, Veronica ^b   Serpelloni, Giovanni ^a   Bosco, Oliviero ^a   Malena, Marina ^a   Mazzi, Romualdo ^a   Mengoli, Carlo ^b   Parisi, Saverio G ^b   Moyle, Graeme ^c  

^a ULSS 20 Verona   (Italy)

^b UNIVERSITY OF PADOVA   (Italy)

^c CHELSEA AND WESTMINSTER HOSPITAL   (United Kingdom)

Author keywords

abacavir; meta analysis; myocardial infarction; randomized controlled trials

Indexed keywords

ABACAVIR; LAMIVUDINE; ZIDOVUDINE;

ARTICLE; CARDIOVASCULAR DISEASE; CARDIOVASCULAR RISK; CONFIDENCE INTERVAL; CONTROLLED STUDY; HEART INFARCTION; HIGHLY ACTIVE ANTIRETROVIRAL THERAPY; HUMAN; MAJOR CLINICAL STUDY; MANTEL HAENSZEL TEST; META ANALYSIS (TOPIC); PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); TREATMENT OUTCOME;

ANTI-HIV AGENTS; CARDIOVASCULAR DISEASES; DIDEOXYNUCLEOSIDES; FEMALE; HIV INFECTIONS; HUMANS; MALE; MYOCARDIAL INFARCTION; ODDS RATIO; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RISK FACTORS;

EID: 80054973427     PISSN: 02699370     EISSN: 14735571     Source Type: Journal    
DOI: 10.1097/QAD.0b013e328349c6ee     Document Type: Article

References (53)

1. Department of Health and Human Services. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescent-GL.pdf. [1 December 2009]
2. European AIDS Clinical Society. Guidelines. Clinical management and treatment of HIV infected Adults in Europe. http://www. europeanaidsclinicalsociety.org/guidelines.asp.
3. The DAD Study Group. Class of antiretroviral drugs and the risk of myocardial infarction. N Engl J Med 2007; 356:1723-1735.
4. Sabin CA, Worm SW, Weber R, Reiss P, El-Sadr W, Dabis F, et al., D:A:D Study Group. Use of nucleoside reverse transcriptase inhibitors and risk of myocardial infarction in HIV-infected patients enrolled in the D:A:D study: a multicohort collaboration. Lancet 2008; 371:1417-1426.
5. Strategies for Management of Anti-Retroviral Therapy/INSIGHT; DAD Study Groups. Use of nucleoside reverse transcriptase inhibitors and risk of myocardial infarction in HIV-infected patients. AIDS 2008; 22:F17-F24.
6. Lang S, Mary-Krause M, Cotte L, Gilquin J, Partisani M, Simon A, et al., Clinical Epidemiology Group of the French Hospital Database on HIV. Impact of individual antiretroviral drugs on the risk of myocardial infarction in human immunodeficiency virus-infected patients: a case-control study nested within the French Hospital Database on HIV ANRS cohort CO4. Arch Intern Med 2010; 170:1228-1238.
7. Bedimo RJ, Westfall AO, Drechsler H, Vidiella G, Tebas P. Abacavir use and risk of acute myocardial infarction and cerebrovascular events in the highly active antiretroviral therapy era. Clin Infect Dis 2011; 53:84-91.
8. Aberg JA, Ribaudo H. Cardiac risk: not so simple. J Infect Dis 2010; 201:315-317.
9. George E, Lucas GM, Nadkarni GN, Fine DM, Moore R, Atta MG. Kidney function and the risk of cardiovascular events in HIV-1-infected patients. AIDS 2010; 24:387-394.
10. Worm SW, Sabin C, Weber R, Reiss P, El-Sadr W, Dabis F, et al. 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 2010; 201:318-330.
11. Brothers CH, Hernandez JE, Cutrell AG, Curtis L, Ait-Khaled M, Bowlin SJ, et al. Risk of myocardial infarction and abacavir therapy: no increased risk across 52 GlaxoSmithKlinesponsored clinical trials in adult subjects. J Acquir Immune Defic Syndr 2009; 51:20-28.
12. Ribaudo HJ, Benson CA, Zheng Y, Koletar SL, Collier AC, Lok JJ, et al., for the ACTG A5001/ALLRT Protocol Team. No risk of myocardial infarction associated with initial antiretroviral treatment containing abacavir: short and long-term results from ACTG A5001/ALLRT. Clin Infect Dis 2011; 52:929-940.
13. Deeks JJ, Dinnes J, D'Amico R, Sowden AJ, Sakarovitch C, Song F, et al. Evaluating nonrandomised intervention studies. Health Technol Assess 2003; 7.
14. Tebas P, Henry WK, Matining R, Weng-Cherng D, Schmitz J, Valdez H, et al. Metabolic and immune activation effects of treatment interruption in chronic HIV-1 infection: implications for cardiovascular risk. PLoS One 2008; 3:e2021.
15. Higgins JPT, Green S, editors. Cochrane handbook for systematic reviews of interventions. Version 5.0.2 [updated September 2009]. The Cochrane Collaboration, 2009. Available from www.cochrane-handbook.org
16. Higgins J, Thompson S, Deeks J, Altman DTI. Measuring inconsistency in meta-analyses. Br Med J 2003; 32:557-560. (Pubitemid 37088507)
17. Sterne J, Jüni P, Moher D. Investigating and dealing with bias in systematic reviews. In 16th Cochrane Colloquium. Evidence in the era of globalisation. Freiburg, Germany. 3-7 October, 2008.
18. Egger M, Davey Smith G, Schneider M, Minder CTI. Bias in meta-analysis detected by a simple, graphical test. Br Med J 1997; 315:629-634. (Pubitemid 27387172)
19. Clumeck N, Goebel F, Rozenbaum W, Gerstoft J, Staszewski S, Montaner J, et al. Simplification with abacavir-based triple nucleoside therapy versus continued protease inhibitor-based highly active antiretroviral therapy in HIV-1-infected patients with undetectable plasma HIV-1 RNA. AIDS 2001; 15:1517-1526. (Pubitemid 32744599)
20. Staszewski S, Keiser P, Montaner J, Raffi F, Gathe J, Brotas V, et al. Abacavir-lamivudine-zidovudine vs. indinavir-lamivudinezidovudine in antiretroviral-naive HIV-infected adults: a randomized equivalence trial. JAmMed Assoc 2001; 285:1155-1163. (Pubitemid 32198480)
21. Opravil M, Hirschel B, Lazzarin A, Furrer H, Chave JP, Yerly S, et al. A randomized trial of simplified maintenance therapy with abacavir, lamivudine, and zidovudine in human immunodeficiency virus infection. J Infect Dis 2002; 185:1251-1260. (Pubitemid 34439132)
22. Katlama C, Fenske S, Gazzard B, Lazzarin A, Clumeck N, Mallolas J, et al. TRIZAL study: switching from successful HAART to Trizivir (abacavir-lamivudine- zidovudine combination tablet): 48 weeks efficacy, safety and adherence results. HIV Med 2003; 4:79-86. (Pubitemid 36582289)
23. Maggiolo F, Ripamonti D, Ravasio L, Gregis G, Quinzan G, Callegaro A, et al. Outcome of 2 simplification strategies for the treatment of human immunodeficiency virus type 1 infection. Clin Infect Dis 2003; 37:41-49. (Pubitemid 36836643)
24. Mart́nez E, Arnaiz JA, Podzamczer D, Dalmau D, Ribera E, Domingo P, et al. Nevirapine, Efavirenz, and Abacavir (NEFA) Study Team. Substitution of nevirapine, efavirenz, or abacavir for protease inhibitors in patients with human immunodeficiency virus infection. N Engl J Med 2003; 349:1036-1046. (Pubitemid 37087618)
25. Matheron S, Descamps D, Boué F, Livrozet JM, Lafeuillade A, Aquilina C, et al. CNA3007 Study Group. Triple nucleoside combination zidovudine/lamivudine/abacavir versus zidovudine/lamivudine/nelfinavir as first-line therapy in HIV-1-infected adults: a randomized trial. Antivir Ther 2003; 8:163-171. (Pubitemid 36565897)
26. Vibhagool A, Cahn P, Schechter M, Smaill F, Soto-Ramirez L, Carosi G, et al. Triple nucleoside treatment with abacavir plus the lamivudine/zidovudine combination tablet (COM) compared to indinavir/COM in antiretroviral therapy-näve adults: results of a 48-week open-label, equivalence trial (CNA3014). Curr Med Res Opin 2004; 20:1103-1114. (Pubitemid 38954473)
27. Bonjoch A, Paredes R, Galvez J, Miralles C, Videla S, Mart́nez E, et al. Antiretroviral treatment simplification with 3 NRTIs or 2 NRTIs plus nevirapine in HIV-1-infected patients treated with successful first-line HAART. J Acquir Immune Defic Syndr 2005; 39:313-316. (Pubitemid 40923211)
28. Keiser PH, Sension MG, DeJesus E, Rodriguez A, Olliffe JF, Williams VC, et al. Substituting abacavir for hyperlipidemiaassociated protease inhibitors in HAART regimens improves fasting lipid profiles, maintains virologic suppression, and simplifies treatment. BMC Infect Dis 2005; 5:2.
29. Orkin C, Stebbing J, Nelson M, Bower M, Johnson M, Mandalia S, et al. A randomized study comparing a three-and fourdrug HAART regimen in first-line therapy (QUAD study). J Antimicrob Chemother 2005; 55:246-251. (Pubitemid 40331153)
30. Kumar PN, Rodriguez-French A, Thompson MA, Tashima KT, Averitt D, Wannamaker PG, et al. A prospective, 96-week study of the impact of Trizivir, Combivir/nelfinavir, and lamivudine/stavudine/nelfinavir on lipids, metabolic parameters and efficacy in antiretroviral-naive patients: effect of sex and ethnicity. HIV Med 2006; 7:85-98.
31. Moyle GJ, Sabin CA, Cartledge J, Johnson M, Wilkins E, Churchill D, et al. RAVE (Randomized Abacavir versus Viread Evaluation) Group UK. A randomized comparative trial of tenofovir DF or abacavir as replacement for a thymidine analogue in persons with lipoatrophy. AIDS 2006; 20:2043-2050. (Pubitemid 44611057)
32. Mart́nez E, Arnaiz JA, Podzamczer D, Dalmau D, Ribera E, Domingo P, et al. Three-year follow-up of protease inhibitorbased regimen simplification in HIV-infected patients. AIDS 2007; 21:367-369. (Pubitemid 46175050)
33. Kumar PN, Salvato P, Lamarca A, Dejesus E, Patel P, McClernon D, et al. A randomized, controlled trial of initial antiretroviral therapy with abacavir/lamivudine/zidovudine twice-daily compared to atazanavir once-daily with lamivudine/zidovudine twice-daily in HIV-infected patients over 48 weeks (ESS100327, the ACTION Study). AIDS Res Ther 2009; 6:3.
34. Martin A, Bloch M, Amin J, Baker D, Baker D, Cooper DA, et al. Simplification of antiretroviral therapy with tenofoviremtricitabine or abacavir-lamivudine: a randomized, 96-week trial. Clin Infect Dis 2009; 49:1591-1601.
35. Mart́nez E, Arranz JA, Podzamczer D, Loncá M, Sanz J, Barragán P, et al. A simplification trial switching from nucleoside reverse transcriptase inhibitors to once-daily fixed-dose abacavir/lamivudine or tenofovir/emtricitabine in HIV-1-infected patients with virological suppression. J Acquir Immune Defic Syndr 2009; 51:290-297.
36. Smith KY, Patel P, Fine D, Bellos N, Sloan L, Lackey P, et al. Randomized, double-blind, placebo-matched, multicenter trial of abacavir/lamivudine or tenofovir/emtricitabine with lopinavir/ritonavir for initial HIV treatment. AIDS 2009; 23:1547-1556.
37. Sax PE, Tierney C, Collier AC, Fischl MA, Mollan K, Peeples L, et al. AIDS Clinical Trials Group Study A5202 Team. Abacavirlamivudine versus tenofovir-emtricitabine for initial HIV-1 therapy. N Engl J Med 2009; 361:2230-2240.
38. Amin J, De Lazzari E, Emery S, Martin A, Mart́nez E, Carr A, et al. Simplification with fixed-dose tenofovir-emtricitabine or abacavir-lamivudine in treatment experienced, virologically suppressed adults with HIV infection: combined analysis of two randomised, non-inferiority trials bicombo and steal. J AIDS Clinic Res 1:103.
39. Daar E, Tierney C, Fischl M, CollierA, Mollan K, C Budhathoki C, et al. ACTG 5202: final results of ABC/3TC or TDF/FTC with either EFV or ATV/r in treatment-naive HIV infected patients [Abstract 59LB]. 17th Conference on Retroviruses and Opportunistic Infections. February 16-19, 2010; San Francisco, CA.
40. Post FA, Moyle GJ, Stellbrink HJ, Domingo P, Podzamczer D, Fisher M, et al. Randomized comparison of renal effects, efficacy, and safety with once-daily abacavir/lamivudine versus tenofovir/emtricitabine, administered with efavirenz, in antiretroviral-naive, HIV-1-infected adults: 48-week results from the ASSERT study. J Acquir Immune Defic Syndr 2010; 55:49-57.
41. GSK repository data on file.
42. Egger M, Schneider M, Davey Smith G. Spurious precision? Meta analysis of observational studies. BMJ 1998; 316:140-144.
43. Dagenais GR, Marchioli R, Yusuf S, Tognoni G. Beta-carotene, vitamin C, and vitamin E and cardiovascular diseases. Curr Cardiol Rep 2000; 2:293-299.
44. Golder S, Loke YK, Bland M. Meta-analyses of adverse effects data derived from randomised controlled trials as compared to observational studies: methodological overview. PLoS Med 2011; 8:e1001026.
45. Ding X, Andraca-Carrera E, Cooper C, Miele P, Kornegay C, Soukup M, et al. No Association of myocardial infarction with ABC use: an FDA meta-analysis. 18th Conference on Retroviruses & Opportunistic Infections (CROI 2011). February 27-March 2, 2011. Boston. Abstract 808.
46. Francisci D, Giannini S, Baldelli F, Leone M, Belfiori B, Guglielmini G, et al. HIV type 1 infection, and not short-term HAART, induces endothelial dysfunction. AIDS 2009; 23:589-596.
47. Hsue PY,Hunt PW,WuY, Schnell A,HoJE,HatanoH, et al. Association of abacavir and impaired endothelial function in treated and suppressed HIV-infected patients. AIDS 2009; 23:2021-2027.
48. Jong E, Meijers JC, van Gorp EC, Spek CA, Mulder JW. Markers of inflammation and coagulation indicate a prothrombotic state in HIV-infected patients with long-term use of antiretroviral therapy with or without abacavir. AIDS Res Ther 2010; 7:9.
49. Mart́nez E, Larrousse M, Podzamczer D, Pérez I, Gutiérrez F, Loncá M, et al., BICOMBO Study Team. Abacavir-based therapy does not affect biological mechanisms associated with cardiovascular dysfunction. AIDS 2010; 24:F1-9.
50. Martin A, Amin J, Cooper DA, Carr A, Kelleher AD, Bloch M, et al., STEAL study group. Abacavir does not affect circulating levels of inflammatory or coagulopathic biomarkers in suppressed HIV: a randomized clinical trial. AIDS 2010; 24:2657-2663.
51. Satchell CS, Cotter AG, O'Connor EF, Peace AJ, Tedesco AF, Clare A, et al. Platelet function and HIV: a case-control study. AIDS 2010; 24:649-657.
52. Francisci D, Falcinelli E, Belfiori B, Petito E, Mezzasoma M, Baldelli F, et al. Role of platelet activation in the cardiovascular complications associated with HIV infection: differential effect of abacavir versus tenofovir. 10th International Congress on Drug Therapy in HIV Infection, 7-11 Nov 2010, Glasgow. Abstract P062.
53. Palacios R, González-Correa JA, Ruiz J, Nuño E, Márquez M, de la Cruz JP, et al. Platelet activity in HIV-infected patients on abacavir-containing antiretroviral drugs. 10th International Congress on Drug Therapy in HIV Infection, 7-11 Nov 2010, Glasgow. Abstract P063.