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| |  Meta-analysis Shows Abacavir Has No Effect on Cardiovascular Adverse Events: Presented at AIDS 2010 By Evelyn Harvey VIENNA -- July 21, 2010 -- An effective component of HIV drug regimens, abacavir has been subject to controversy following its apparent association with cardiovascular adverse events in several observational studies and in 1 randomised controlled trial (RCT). However, other RCTs and aggregated safety data contradict this. A meta-analysis presented here on July 21 at the 18th International AIDS Conference 2010 potentially clarifies the situation -- no link between abacavir and cardiovascular risk was found using data from 29 RCTs. "Observational studies are prone to biases and should be interpreted with caution given the potential for confounding," said Mario Cruciani, MD, University of Padua, Padua, Italy. Therefore, Dr. Cruciani and colleagues selected 29 RCTs of which 19 were identified via systematic review of the literature, and 10 were unpublished trials conducted by the manufacturer of abacavir. Studies were selected where abacavir-containing regimens were compared with non- abacavir regimens, for a minimum of 24 weeks' exposure to abacavir. The researchers analysed rates of myocardial infarction (MI), death, and adverse events (both overall and requiring discontinuation), as well as the proportion of patients with viral loads below either 50 or 200 to 500 HIV RNA copies/mL at weeks 48 and 96. Data from 9,611 participants were included in the meta-analysis. In terms of virological outcomes, abacavir was similar to all control groups with 1 exception -- abacavir was favoured over tenofovir at 48 weeks in a subgroup of individuals with baseline viral loads >100,000 copies/mL. Examining adverse event data, the researchers found that abacavir use did not increase the occurrence of MI (P = .36) or the overall mortality (P = .17). The rate of adverse events requiring discontinuation was also unchanged between abacavir groups and controls (P = .19). The authors acknowledged that previous observational studies linking abacavir to cardiovascular risk followed patients for longer than the studies included in this meta-analysis. However, only recent (<6 months) use of abacavir was associated with risk in previous studies. The researchers also pointed to a failure to allow for the confounding factor of kidney disease, which may be linked to cardiovascular risk in patients with HIV. [Presentation title: Abacavir Use and Cardiovascular Disease Events: A Meta-Analysis of Published and Unpublished Data. Abstract WEPE0121]
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