Wall Street Journal - April 3, 2008

In a study published online in The Lancet medical journal, European researchers said that the antiretroviral abacavir, which is also known as Ziagen and is included as part of many anti-AIDS regimens world-wide, almost doubled patients' chances of heart problems.

The lesser-used drug didanosine also increased the heart-attack risk by about 50%. Didanosine, or Videx, is made by U.S.-based Bristol-Myers Squibb Co.

While experts said doctors should be aware of the increased heart-attack risk, they didn't recommend that patients abandon the drugs.

"These antiretrovirals are wonderful and lifesaving, but they do have toxicity problems," said Charlie Gilks, director of AIDS treatment and prevention at the World Health Organization, who wasn't connected with the study. "It may be that we can continue to use them, but we need to be aware of their long-term problems," Dr. Gilks said.

The European Medicines Agency said Wednesday that it would seek more information on abacavir, saying it wasn't able to draw firm conclusions about the drug's safety from the study published in the Lancet. Last week, also aware of the new study, the U.S. Food and Drug Administration said it would review abacavir and didanosine to see whether the drugs increase patients' risk of heart attacks.

In the study, Jens D. Lundgren of the University of Copenhagen and colleagues analyzed data from more than 33,000 people with HIV in Europe, the U.S. and Australia. Patients were enrolled in the study from 1999 to 2005. Researchers looked for any heart problems that occurred until February 2007.

In the 517 patients who had heart attacks, 124 had recently taken didanosine and 192 had taken abacavir. Patients on Ziagen had twice the chances of a heart attack compared with patients on other antiretrovirals. Those on Videx had a 50% higher chance. However, the risk disappeared six months after patients stopped taking the drugs.

Glaxo said its own analysis of its database of about 14,600 HIV patients didn't support the Lancet study's conclusions.

"We were unable to show any increased risk in heart attacks," said Gwenan White, a company spokeswoman. She called the Lancet study results "inconclusive."

Dr. Lundgren said patients already susceptible to heart problems, such as smokers and obese people, were most at risk.

In people with HIV, heart attacks don't appear to be more deadly than in the normal population, though some doctors suspect that once people with HIV have a heart attack, they are more likely than others to have another.

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