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HIV Drugs Reviewed for Heart Attack Risk

Mar 29, 2008 | Parker Waichman LLP

According to the Food and Drug Administration (FDA), a recent study—The Data Collection on Adverse Events of Anti-HIV Drugs or, D:A:D, Study—indicates GlaxoSmithKline, PLC and Bristol-Myers Squibb Company HIV drugs lead to a higher heart attack risk as compared with other HIV medicines.  US health officials are reviewing the safety of AIDS drugs and the FDA is evaluating the data on Glaxo's Ziagen and Bristol-Myers' Videx.  The FDA said that the review "may result in the need to revise labeling for the products; however, until evaluation is complete, healthcare providers should evaluate the potential risks and benefits" of each HIV drug their patients are taking.  Researchers reviewed heart attack risk among patients taking certain medicines from the NRTI class—nucleoside reverse transcriptase inhibitor—of AIDS drugs.

The FDA notice was issued as part of an effort to notify the public about early signs of potential safety concerns before officials have reached a final conclusion.

Glaxo and Bristol-Myers said their own evaluations did not reveal any risk of increased heart attack linked to the study; however, according to the FDA, patients taking either Ziagen or Videx "had a greater chance of developing a heart attack than patients taking other medications."   The study was conducted with 33,347 HIV-1 infected patients living in North America, Europe, and Australia who were monitored to evaluate the short- and long-term adverse effects of treatment with anti-HIV drugs.

The FDA did say that the study indicated that the risk did not appear to increase over time and seemed reversible after drugs were stopped. "The effect was not seen six months after stopping the drugs," confirmed the FDA.  But, the FDA did say it believed analyses of the D:A:D study were not complete, adding that researchers had not evaluated heart-attack risk when patients were taking two other NRTIs:  Gilead Sciences Inc.'s Viread and Emtriva.  The study reviewed the relative risk of heart attack among cumulative use, recent use (currently or within the past six months), and past use (last use greater than six months ago).

Glaxo analyzed its own databases and "did not see any sign of an increased risk of heart attack" with Ziagen.  Ziagen—known generically as abacavir—is a component of Glaxo's Trizivir, Epzicom, and Kivexa AIDS drugs.  Also, Bristol-Myers spokeswoman Sonia Choi said "we haven't seen an increase of cardiovascular events in our studies of Videx or in our (company) safety database."  Videx is sold generically as didanosine.  The FDA said the results from Glaxo and Bristol-Myers analyses were inconclusive.  

Meanwhile, the study was able to confirm:  The excess risk of heart attack in patients taking at least some NRTIs appears to be greater in patients with other risk factors for heart disease.  Some of the analyses confirmed the risk of heart attack increased by 49% in patients taking didanosine and increased by 90% in patients taking abacavir.
  The study also reveled that the increased risk for heart attack remained stable over the course of treatment and the effect was not seen six months after stopping the drugs.



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