GSK says its trials do not link abacavir to increased risk of heart attack.

GSK has defended the safety record of its HIV drug abacavir following a report published in this week’s edition of The Lancet, which suggests use of the drug could increase the risk of heart attacks.
 
The study, conducted by the Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D), tested five drugs and concluded that whilst the majority were not linked with increased risk of heart attack, GSK’s product could almost double the risk.

In response, GSK said it had conducted trials with more than 9,600 patients and that “no increased risk of heart attack associated with abacavir was found.”

Didier Lapierre, Vice President of Clinical Development for Infectious Diseases at GSK, said: “It is important to note that although the relative risk of heart attack risk seen in the D:A:D study was increased in patients who had recently taken abacavir, the likelihood of an individual patient having a heart attack remains low in absolute terms.

“Abacavir remains an important treatment option for patients with HIV and patients should not discontinue treatment on their own.”

GSK also pointed out that, in March 2008, the US Federal Drugs Administration (FDA) revealed it currently believes the analyses conducted by the D:A:D to be “incomplete” and indicated that the results of the GSK analysis are inconclusive, but “did not show an increased risk.”

FDA has expressed caution at patients’ drugs being changed without individual assessment, whilst European drug regulator the EMEA is reviewing the D:A:D data and is expected to post its results in the next few days.

By Natasha Piscitelli