01-25-2008, 10:37 AM
i just heard from my friend in europe that drs. are talkign about an increase in MI for abacavir. does anyone know about this???? has this been disclosed? if so, why not?! is this abacavir specific - or other?
01-25-2008, 02:54 PM
It's the HIV/AIDS that will kill you...not the drug!
01-31-2008, 12:52 PM
Drs. are pulling HIV patients off abacavir @ Chelsea and Westminster Hospital in London. What gives with that?
Does GSK have anything to say about this?
02-01-2008, 02:37 PM
Here's an announcement of the upcoming study that's being released this weekend in Boston at the CROI. Not pretty.
02-04-2008, 03:37 PM
Glaxo's HIV Drug Ziagen Linked to Heart Attacks, Study Finds
February 4, 2008
By John Lauerman
Feb. 4 (Bloomberg) -- GlaxoSmithKline Plc's drug Ziagen, a widely prescribed treatment for HIV, may raise the risk of heart attacks, doctors said today at a medical meeting in Boston.
Used in combination with other medications to keep blood levels of the AIDS virus low, the drug almost doubled the risk of heart attack in people who had used it recently, said Jens Lundgren, a researcher at the University of Copenhagen. Another medication, called didanosine or DDI, increased the risk by 49 percent, he said.
Potent HIV drugs called protease inhibitors have also been linked to heart disease. Finding that Ziagen and DDI, from a class of drugs called nucleoside reverse transcriptase inhibitors, were linked to heart attacks was a surprise, Lundgren said at the Conference on Retroviruses and Opportunistic Infections.
“What the biological mechanism of this is, we don't know,'' he said in an interview. “We're trying to formulate how people should react to this information.''
Glaxo fell 6 pence, or less than 1 percent, to 1,178 pence in London trading, and has declined 7.9 percent in the past 12 months.
Researchers had suspected that another type of AIDS drugs called thymidine analogues might increase heart risk because they've been linked to diabetes and high cholesterol, said Lundgren, who led the study performed by the Data Collection on Adverse Events of Anti-HIV Drugs (DAD) Study Group. The link to Ziagen, known as well by the generic name of abacavir, also surprised researchers at Glaxo, said Lynn Marks, a senior vice president of infectious diseases at the company's Medicine Development Center.
Not Seen Before
“We haven't seen it before, and we don't find it when looking across our data sets,'' he said in an interview at the conference. “Historically, abacavir regimens have been chosen for their favorable risk profile.''
Patients should talk to their doctors before changing treatments, Lundgren said. Stopping any HIV treatment can allow the virus to grow or develop resistance to remaining drugs in a person's system. Doctors can help patients determine whether they should seek alternatives, he said.
“Maybe the first thing to discuss is the patient's underlying risk,'' he said. “Number two would be, what treatment options does the patient have?''
About 250,000 HIV patients, most of them in rich countries, take Ziagen, Lundgren estimated. The medicine is also available as part of a combination sold in the U.S. as Epzicom.
Patients who were already vulnerable to heart disease because of cigarette smoking, family history of the disease, diabetes, obesity and high levels of cholesterol were at highest risk when taking Ziagen or DDI, Lundgren said. Patients' risks returned to previous levels when they stopped taking the medicines, he said.
Since improved treatment has helped many HIV patients live longer, doctors have begun turning their attention to the long- term side effects of antiviral drugs. Studies have shown that interrupting drug doses puts patients at increased risk of disease and death. Once they've begun, doctors advise HIV patients to continue taking their medications for the rest of their lives, Lundgren said.
A number of drugs, including Merck & Co.'s Vioxx for pain and Glaxo's diabetes drug Avandia, have been linked to heightened heart risk in recent years. While pain and diabetes patients may be able to switch therapies, those with HIV often develop resistance to certain treatments, and might have limited options, Lundgren said.
Lundgren and his colleagues used a database with information on more than 33,000 patients to study the link between drugs and heart risk. After linking protease inhibitors to heart disease in a study published in the New England Journal of Medicine, they began looking for harmful side effects in other medications that HIV patients take for years.
Ziagen and DDI themselves may not be fully responsible for the higher heart risk, Lundgren said. For example, if doctors have considered the drugs safer than other alternatives, they may be used preferentially in people with heart risk.
“There may be a so-called ‘channeling bias,” said Glaxo's Marks. “That would seem to us to be important to understand in this data set.”
Glaxo has studied about 9,600 people taking Ziagen in 54 studies, Marks said. The company will continue to monitor patients and stay in touch with Lundgren's group and regulatory authorities as more information becomes available, he said.
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