No Association of Abacavir Use With Myocardial Infarction: Findings of an FDA Meta-Analysis

  title={No Association of Abacavir Use With Myocardial Infarction: Findings of an FDA Meta-Analysis},
  author={Xiao Ding and Eugenio Andraca-Carrera and Charles K. Cooper and Peter S Miele and Cynthia J. Kornegay and Mat Soukup and Kendall A Marcus},
  journal={JAIDS Journal of Acquired Immune Deficiency Syndromes},
Background:Several studies have reported an association between abacavir (ABC) exposure and increased risk of myocardial infarction (MI) among HIV-infected individuals. Randomized controlled trials (RCTs) and a pooled analysis by GlaxoSmithKline, however, do not support this association. To better estimate the effect of ABC use on risk of MI, the US Food and Drug Administration (FDA) conducted a trial-level meta-analysis of RCTs in which ABC use was randomized as part of a combined… 

Abacavir Use and Risk for Myocardial Infarction and Cardiovascular Events: Pooled Analysis of Data From Clinical Trials

A pooled analysis of 66 phase II–IV RCTs found comparable IRs for MI and CVEs among ABC-exposed and -unexposed participants, suggesting no increased risk for MI or CVEs following ABC exposure in a clinical trial population.

Is there continued evidence for an association between abacavir usage and myocardial infarction risk in individuals with HIV? A cohort collaboration

Despite a reduction in the channelling of ABC for patients at higher CVD risk since 2008, an association between ABC use and MI risk is observed, and confounding cannot be fully ruled out.

Abacavir and cardiovascular disease: A critical look at the data.

Effects of Combination Antiretroviral Therapies on the Risk of Myocardial Infarction Among HIV Patients

An increased rate of MI among patients initiating abacavir compared with tenofovir, although the association was decreased after confounding adjustment, and a much larger observational study of patients initiating cART would be needed to better define this apparent association.

Risk of Cardiovascular Disease from Antiretroviral Therapy for HIV: A Systematic Review

The findings that implicate specific ARTs in the observational setting provide sufficient evidence to warrant further investigation of this relationship in studies designed for that purpose.

Abacavir use and risk of recurrent myocardial infarction: the D: A: D study

There was no evidence for an association between use of ABC post-MI and an elevated risk of a recurrent MI among HIV-positive people with a prior MI.

Recent Abacavir Use Increases Risk of Type 1 and Type 2 Myocardial Infarctions Among Adults With HIV

Recent ABC use was associated with MI after adjustment for known risk factors and for FRS, however, screening for T1MI risks may not identify all or even most persons at risk of ABC use-associated MIs.

Abacavir use and risk of recurrent myocardial infarction

There was no evidence for an association between use of ABC post-MI and an elevated risk of a recurrent MI among HIV-positive people with a prior MI.

Cardiovascular toxicity of abacavir: a clinical controversy in need of a pharmacological explanation

The present review aims to shed light on this complex subject by summarizing and critically evaluating all the available clinical data regarding a relationship between ABC and cardiovascular disease, and to put forward potential pharmacological explanations compatible with both the clinical scenario and experimental findings.

Virological efficacy of abacavir: systematic review and meta-analysis

The cumulative, cross-sectional data suggest a similar virological efficacy of abacavir/lamivudine and tenofovir/emtricitabine regardless of the baseline VL, as well as differences in the occurrence of adverse events requiring discontinuation of treatment.



Risk of Myocardial Infarction and Abacavir Therapy: No Increased Risk Across 52 GlaxoSmithKline-Sponsored Clinical Trials in Adult Subjects

In this pooled summary, few MI events overall and no excess risk of MI with ABC therapy are observed and it is unclear why results from this data set seem discrepant to the Data collection of Adverse events of Anti-HIV Drugs data set, particularly, as the non-ABC MI event rate is similar.

No risk of myocardial infarction associated with initial antiretroviral treatment containing abacavir: short and long-term results from ACTG A5001/ALLRT.

  • H. RibaudoC. Benson J. Schouten
  • Medicine
    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
  • 2011
Although the risk of MI decreased over time, there was no evidence to suggest a time-dependent abacavir effect, and Classic cardiovascular disease (CVD) risk factors were the strongest predictors of MI.

Combination antiretroviral therapy and the risk of myocardial infarction.

Combination antiretroviral therapy was independently associated with a 26 percent relative increase in the rate of myocardial infarction per year of exposure during the first four to six years of use, however, the absolute risk of my Cardiac Infarction was low and must be balanced against the marked benefits from antireTroviral treatment.

Class of antiretroviral drugs and the risk of myocardial infarction.

Investigation of the association of cumulative exposure to protease inhibitors and nonnucleoside reverse-transcriptase inhibitors with the risk of myocardial infarction found no evidence of such an association for nonn nucleosidereverse-transcriptionase inhibitors; however, the number of person-years of observation for exposure to this class of drug was less than that for Exposure to prote enzyme inhibitors.

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.

The risk of MI was increased by cumulative exposure to all the studied PIs except saquinavir and particularly to amprenavir/fosamprenavIR with or without ritonavir, and lopinavir with ritonvir, whereas the association with abacavir cannot be considered causal.

Cardiovascular disease risk factors in HIV patients – association with antiretroviral therapy. Results from the DAD study

Of specific concern is the fact that use of the NNRTI and PI drug classes (alone and especially in combination), particularly among older subjects with normalized CD4 cell counts and suppressed HIV replication, was associated with a lipid profile known to increase the risk of coronary heart disease.

A randomized comparative trial of tenofovir DF or abacavir as replacement for a thymidine analogue in persons with lipoatrophy

Switching from a thymidine nucleoside analogue to either tenofovir disoproxil fumarate (DF) or abacavir leads to significant improvement in limb fat mass over 48 weeks, and ten ofovir DF may have modest advantages over abacvir for changes in lipids.

Less Lipoatrophy and Better Lipid Profile With Abacavir as Compared to Stavudine: 96-Week Results of a Randomized Study

This study shows a notably weaker association of abacavir with lipoatrophy than stavudine, and the lipid changes that occurred were more favorable in patients receiving abacvir.

Short communication: benefits in the lipid profile after substitution of abacavir for Stavudine: a 48-week prospective study.

In a prospective and randomized study, the substitution of ABC for d4T was found to be safe and provided a reduction in both LDL cholesterol and the total cholesterol (TC)/HDLc ratio, which might impact favorably on cardiovascular risk.