WEDNESDAY, April 2 (HealthDay News) -- Two well-known HIV drugs,
abacavir and didanosine, appear to increase the risk of heart
attacks, European researchers reported Wednesday.
Based on that data, the U.S. Food and Drug Administration is now
conducting a safety review of the potential risks of both
drugs.
Many people with HIV take a combination of antiretroviral drugs,
which include a protease inhibitor and a nucleoside reverse
transcriptase inhibitor such as abacavir or didanosine. Concerns
have been raised about the cardiovascular effects of long-term use
of these drugs.
"We have investigated a number of drugs used to treat HIV
patients for whether they are associated with an altered risk of
having a heart attack," said lead researcher Dr. Jens D. Lundgren,
from the University of Copenhagen in Denmark. "We have identified
[that] two of those drugs were indeed associated with an increased
risk of a heart attack."
The actual risk of having a heart attack when using these drugs
varies with whether a patient already has underlying risk for heart
attack, Lundgren added. For example, a patient who is at risk for
having a heart attack will increase his or her risk by 38 percent
by using either abacavir or didanosine, he said.
"However, if you have a very small underlying risk of heart
attack, the risk will only be slightly increased," Lundgren
said.
The report was published Wednesday in the online edition of
The Lancet.
In the study, Lundgren's team collected data on 33,347 HIV
patients who participated in the Data Collection on Adverse Events
of Anti-HIV Drugs study (D:A:D). Specifically, the researchers
looked for a connection between HIV medications and heart
attack.
For commonly used drugs called nucleoside reverse transcriptase
inhibitors such as zidovudine, stavudine or lamivudine, the
researchers found no association with an increased risk for heart
attack.
However, the nucleoside reverse transcriptase inhibitors
abacavir and didanosine were associated with an increased rate of
heart attack, the researchers found. For patients taking abacavir,
there was a twofold increased risk for heart attack. For those
taking didanosine, the increased risk was about 50 percent.
For patients who stopped using these drugs, their risk for heart
attack decreased within six months, Lundgren's group found.
"For those patients who have an increased underlying
cardiovascular risk, then our suggestion is that these patients
should consider whether there are other safer alternatives to these
drugs," Lundgren said. "If there are safer alternatives, then
patients should consider switching to those."
In a letter published in the same journal issue,
GlaxoSmithKline, the maker of abacavir, said that their own
analysis of 54 studies found no increase in the risk of heart
attack from the drug.
GlaxoSmithKline spokesman Dr. Didier Lapierre wrote, "We did not
find a result consistent with that of D:A:D... GSK takes the D:A:D
finding seriously and is committed to understanding these data more
fully and to communicating openly with treating physicians and
regulatory agencies globally."
Didanosine is manufactured by Bristol-Myers Squibb.
Based on the data from D:A:D, the FDA said last week that it was
conducting a safety review of both drugs.
"FDA continues to evaluate the overall risks and benefits of
abacavir and didanosine. This evaluation may result in the need to
revise labeling for the products. Until this evaluation is
complete, health-care providers should evaluate the potential risks
and benefits of each HIV-1 antiretroviral drug their patients are
taking, including abacavir and didanosine," the agency said in a
statement.
One expert thinks it's more important for patients to have their
HIV under control; then they can worry about potential
cardiovascular side effects.
"This is a surprising and provocative finding," said Dr. James
Sosman, an associate professor of medicine at the University of
Wisconsin School of Medicine. "We have not seen cardiovascular
problems associated with abacavir."
Sosman noted that the use of antiretroviral drugs has replaced
concerns about serious opportunistic infections in HIV patients
with concerns about less serious risks like cardiovascular disease
and diabetes.
"The most important thing for HIV patient is to control their
HIV," Sosman said. "If they have excellent control with abacavir or
didanosine, then you look for options to limit other risk factors.
Patients not on HIV therapy have a higher risk of developing heart
disease than people on HIV therapy," he said.
More information
For more on HIV, visit the
U.S. National Institute of Allergy and Infectious
Diseases.