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| | | ![]() Abacavir Linked to Heart Disease in Patients With HIV: Presented at AIDS 2008 By Ed Susman MEXICO CITY -- August 8, 2008 -- New data indicate that patients infected with human immunodeficiency virus (HIV) who also have underlying heart disease may experience an increased risk of suffering a heart attack if they are prescribed the nucleoside reverse transcriptase inhibitor abacavir, researchers noted at the 17th International AIDS Conference (AIDS 2008). "This adverse event appears to be only clinically relevant … in patients with elevated cardiovascular risk," noted Jens Lundgren, MD, University of Copenhagen, speaking at a late-breaker presentation here on August 7. In his analysis of the Strategies for Management of Anti-Retroviral Therapy (SMART) trial -- a study designed to examine the safety of structured treatment interruption among patients on HIV antiretroviral combination therapy -- Dr. Lundgren and colleagues found that patients with HIV infection and heart disease who were taking abacavir appeared to have a 4-fold risk of myocardial infarction as well as higher risks of other adverse cardiovascular events. The study was undertaken to confirm results of another trial that indicated a heart-disease association with abacavir. That other trial (Data Collection on Adverse Events of Anti-HIV Drugs [DAD]) study, found a 90% increase in the risk of myocardial infarction associated with abacavir. Dr. Lundgren and colleagues studied 2,752 patients from the continuous-treatment arm of the SMART trial, examining 3 categories: clinical myocardial infarction; major cardiovascular disease (including heart attacks, stroke, surgery for coronary artery disease, and cardiovascular death); and expanded cardiovascular disease (congestive heart failure, peripheral vascular disease, coronary artery disease requiring drug treatment, and unwitnessed deaths). Compared with other drugs in the nucleoside reverse transcriptase inhibitor class, abacavir was associated with a relative risk of myocardial infarction that was 4.3 times greater than that of the other drugs. The risk of suffering a major cardiovascular disease was 1.8 times greater. Finally, the risk of suffering an event in the expanded definition of cardiovascular disease was 1.9 times greater than that of other drugs in the class. Dr. Lundgren noted, however, that the risk of these heart events was concentrated among participants in the study who had 5 or more risk factors. The risk was not significantly increased for patients with fewer than 5 risk factors. Further attention was paid to the subject of abacavir and cardiovascular risk in an oral abstract session here on August 6. Jaime Hernandez, MD, GlaxoSmithKline, Research Triangle Park, North Carolina, described a pooled analysis of 54 of the company's clinical trials. The pooled analysis demonstrated no increase in coronary artery disorders or myocardial infarctions among 9,639 HIV-infected volunteers who received abacavir-containing treatment and among 5,044 who received regimens without the drug. The analysis found that the incidence rate per 1,000 patient years, comparing abacavir regimens to others, was 0.593 for coronary artery disorders and 0.863 for myocardial infarction. Funding for the SMART study was provided by the US National Institutes of Health. [Presentation titles: Use of Nucleoside Reverse Transcriptase Inhibitors and Risk of Myocardial Infarction in HIV-Infected Patients Enrolled in the SMART Study. Abstract THAB0305 and Is Abacavir (ABC)-Containing Combination Antiretroviral Therapy (CART) Associated With Myocardial Infarction (MI)? No Association Identified in Pooled Summary of 54 Clinical Trials. Abstract WEAB0106]
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