Abacavir Use and Risk for Myocardial Infarction and Cardiovascular Events: Pooled Analysis of Data From Clinical Trials
BACKGROUND: Some observational studies and randomized controlled trials (RCTs) have suggested an association between abacavir (ABC) use and myocardial infarction (MI), whereas others have not. METHODS: This pooled analysis of 66 phase II–IV RCTs estimates exposure-adjusted incidence rates (IRs) and...
Autores principales: | , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Oxford University Press
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5946856/ https://www.ncbi.nlm.nih.gov/pubmed/29766019 http://dx.doi.org/10.1093/ofid/ofy086 |
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author | Nan, Cassandra Shaefer, Mark Urbaityte, Rimgaile Oyee, James Hopking, Judy Ragone, Leigh Perger, Teodora Win, Beta Vangerow, Harald McCoig, Cynthia Vannappagari, Vani |
author_facet | Nan, Cassandra Shaefer, Mark Urbaityte, Rimgaile Oyee, James Hopking, Judy Ragone, Leigh Perger, Teodora Win, Beta Vangerow, Harald McCoig, Cynthia Vannappagari, Vani |
author_sort | Nan, Cassandra |
collection | PubMed |
description | BACKGROUND: Some observational studies and randomized controlled trials (RCTs) have suggested an association between abacavir (ABC) use and myocardial infarction (MI), whereas others have not. METHODS: This pooled analysis of 66 phase II–IV RCTs estimates exposure-adjusted incidence rates (IRs) and relative rates (RRs) of MI and cardiovascular events (CVEs) in participants receiving ABC- and non-ABC-containing combination antiretroviral therapy (cART). The primary analysis of MI included ABC-randomized trials with ≥48-week follow-up. Sensitivity analyses of MI and CVEs included non-ABC-randomized and <48-week follow-up trials. RESULTS: In 66 clinical trials, 13 119 adults (75% male, aged 18–85 years) were on ABC-containing cART and 7350 were not. Exposure-adjusted IR for MI was 1.5 per 1000 person-years (PY; 95% confidence interval [CI], 0.67–3.34) in the ABC-exposed group and 2.18 per 1000 PY (95% CI, 1.09–4.40) in the unexposed group. The IR for CVEs was 2.9 per 1000 PY (95% CI, 2.09–4.02) in the exposed group and 4.69 per 1000 PY (95% CI, 3.40–6.47) in the unexposed group with studies of ≥48 weeks of follow-up, with an RR of 0.62 (95% CI, 0.39–0.98). The inclusion of nonrandomized and shorter-duration trials did not significantly change the RR for MI or coronary artery disease. CONCLUSIONS: This pooled analysis 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. Modifiable risk factors for MI and CVEs should be addressed when prescribing ART. |
format | Online Article Text |
id | pubmed-5946856 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | Oxford University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-59468562018-05-15 Abacavir Use and Risk for Myocardial Infarction and Cardiovascular Events: Pooled Analysis of Data From Clinical Trials Nan, Cassandra Shaefer, Mark Urbaityte, Rimgaile Oyee, James Hopking, Judy Ragone, Leigh Perger, Teodora Win, Beta Vangerow, Harald McCoig, Cynthia Vannappagari, Vani Open Forum Infect Dis Major Article BACKGROUND: Some observational studies and randomized controlled trials (RCTs) have suggested an association between abacavir (ABC) use and myocardial infarction (MI), whereas others have not. METHODS: This pooled analysis of 66 phase II–IV RCTs estimates exposure-adjusted incidence rates (IRs) and relative rates (RRs) of MI and cardiovascular events (CVEs) in participants receiving ABC- and non-ABC-containing combination antiretroviral therapy (cART). The primary analysis of MI included ABC-randomized trials with ≥48-week follow-up. Sensitivity analyses of MI and CVEs included non-ABC-randomized and <48-week follow-up trials. RESULTS: In 66 clinical trials, 13 119 adults (75% male, aged 18–85 years) were on ABC-containing cART and 7350 were not. Exposure-adjusted IR for MI was 1.5 per 1000 person-years (PY; 95% confidence interval [CI], 0.67–3.34) in the ABC-exposed group and 2.18 per 1000 PY (95% CI, 1.09–4.40) in the unexposed group. The IR for CVEs was 2.9 per 1000 PY (95% CI, 2.09–4.02) in the exposed group and 4.69 per 1000 PY (95% CI, 3.40–6.47) in the unexposed group with studies of ≥48 weeks of follow-up, with an RR of 0.62 (95% CI, 0.39–0.98). The inclusion of nonrandomized and shorter-duration trials did not significantly change the RR for MI or coronary artery disease. CONCLUSIONS: This pooled analysis 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. Modifiable risk factors for MI and CVEs should be addressed when prescribing ART. Oxford University Press 2018-04-20 /pmc/articles/PMC5946856/ /pubmed/29766019 http://dx.doi.org/10.1093/ofid/ofy086 Text en © The Author(s) 2018. Published by Oxford University Press on behalf of Infectious Diseases Society of America. http://creativecommons.org/licenses/by/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Major Article Nan, Cassandra Shaefer, Mark Urbaityte, Rimgaile Oyee, James Hopking, Judy Ragone, Leigh Perger, Teodora Win, Beta Vangerow, Harald McCoig, Cynthia Vannappagari, Vani Abacavir Use and Risk for Myocardial Infarction and Cardiovascular Events: Pooled Analysis of Data From Clinical Trials |
title | Abacavir Use and Risk for Myocardial Infarction and Cardiovascular Events: Pooled Analysis of Data From Clinical Trials |
title_full | Abacavir Use and Risk for Myocardial Infarction and Cardiovascular Events: Pooled Analysis of Data From Clinical Trials |
title_fullStr | Abacavir Use and Risk for Myocardial Infarction and Cardiovascular Events: Pooled Analysis of Data From Clinical Trials |
title_full_unstemmed | Abacavir Use and Risk for Myocardial Infarction and Cardiovascular Events: Pooled Analysis of Data From Clinical Trials |
title_short | Abacavir Use and Risk for Myocardial Infarction and Cardiovascular Events: Pooled Analysis of Data From Clinical Trials |
title_sort | abacavir use and risk for myocardial infarction and cardiovascular events: pooled analysis of data from clinical trials |
topic | Major Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5946856/ https://www.ncbi.nlm.nih.gov/pubmed/29766019 http://dx.doi.org/10.1093/ofid/ofy086 |
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