| July
27, 2007
Two Diabetes Drugs Double Heart Failure Risk:
Study
By Steven Reinberg
HealthDay Reporter
FRIDAY, July 27 (HealthDay News) -- Patients taking either of
the diabetes drugs Avandia or Actos face twice the risk of developing
heart failure compared to people not on the popular medications,
a new study finds.
This means for every 50 patients with type 2 diabetes taking
these drugs, one patient will develop heart failure within 26
months, according to the report released Friday and published
in the August issue of Diabetes Care.
"Both Avandia and Actos double the risk of heart failure,"
concluded the lead author of the first study, Dr. Sonal Singh,
an assistant professor of internal medicine at Wake Forest University
School of Medicine. "We know these drugs increase the risk,
but we found the risk is more substantial than suspected. This
occurs at even the lowest dose and among young patients."
The report follows a U.S. government review released Thursday
that found Avandia's heart risks are far higher than Actos'. That
report sets the stage for an advisory panel hearing Monday that
will examine whether Avandia's cardiovascular risks warrant a
stronger warning label.
Avandia (rosiglitazone) and Actos (pioglitazone) are from the
same family of diabetes drugs and used by more than 3 million
diabetic patients across the United States.
The current product label warns against using these drugs in
patients with more severe cases of heart failure. The label also
warns that there is an increased risk of heart failure if the
drugs are used in combination with insulin.
Singh's group, however, found that the risk wasn't limited to
patients on insulin, and it was present even among patients without
any risk factors for heart failure.
The government study, by a medical and safety review team at
the Food and Drug Administration, found that patients are at much
higher risk of heart problems if they take Avandia, compared to
patients taking Actos. Avandia is especially hazardous to patients
who are already on insulin, the report found, whereas Actos users
can take insulin as well without fearing cardiac side effects,
the New York Times reported.
That data could help decide whether or not Avandia remains on
drug store shelves, experts said.
"A critical question to be resolved in determining appropriate
regulatory action is whether the anticipated therapeutic benefit
of rosiglitazone outweighs the demonstrated cardiovascular risk,"
one FDA reviewer concluded according to the Times report.
In the Diabetes Care study, Singh's team collected data on more
than 78,000 patients taking either of the drugs. These patients
were included in previously published studies and in case reports.
Not only did the drugs double the risk of heart failure, but
the increased risk was seen with both high and low doses, the
team found.
Heart failure developed in some patients taking lower doses than
are commonly prescribed. The average time for heart failure to
develop was 24 weeks after starting the drugs, the researchers
found.
Heart failure wasn't confined to older patients. Twenty-five
percent of the patients who developed heart failure were under
60. In addition, both men and women developed heart failure while
taking the drugs, Singh noted.
Singh's group suspect that Avandia and Actos may boost heart
failure risk by encouraging fluid retention.
Current guidelines allow the use of these drugs in patients with
early-stage heart failure. "Based on our information, that
may have to change," Singh said.
Singh noted that there are alternative drugs available. "Doctors
should be aware of the risk," he said. "Patients who
are on these drugs and start developing symptoms of heart failure
should see their doctor immediately, and patients not on these
drugs should look at alternatives."
One expert believes that patients taking Avandia and Actos face
not only an increased risk of heart failure, but Avandia users
also face a 43 percent increased risk of heart attack.
"This hazard of heart failure is pretty well known for these
drugs," said Dr. Steven E. Nissen, chairman of the department
of cardiovascular medicine at the Cleveland Clinic. He noted that,
in May, the FDA said it was going to mandate a "black box"
warning about heart failure risk on the labels of these drugs.
That same month, Nissen published a paper in the New England
Journal of Medicine that found that Avandia increased the risk
of heart attack.
Since then, the controversy has continued, with both sides weighing
in.
On Thursday, Mary Anne Rhyne, a spokeswoman for GlaxoSmithKline,
which makes Avandia, responded to the new government review by
saying the company continued to believe Avandia was safe, the
Times reported.
"Across the extensive data we have, the science shows no
increase in cardiovascular death, and does not support a difference
in heart attack rates between Avandia and the other most commonly
prescribed oral antidiabetics," Rhyne told the Times.
On Friday, the company's director of clinical development, Dr.
Andy Zambanini, told HealthDay that Glaxo was "still in negotiation
with the FDA about a new warning label on heart failure, and we
expect to release that information soon."
Nissen believes that patients who are considering taking Avandia
should discuss the decision with their doctor. "It is important
that the totality of information be out there," he said.
"But no patient should stop taking a medication [only] because
they read a news report."
Another expert contends that the two drugs are safe if prescribed
correctly.
"The risk for heart failure with these drugs may be one
in 50, but if you can correctly identify who that person [at risk]
is, you can safely treat the other 49 and not hurt anybody,"
said Dr. Larry Deeb, president for medicine and science at the
American Diabetes Association.
Deeb believes the same holds true for the risk of heart attack.
The boost in risk of heart failure and heart attack does not
warrant taking these drugs off the market, he added.
"They fit into the armamentarium of diabetes drugs if used
properly," Deeb said.
SOURCES: Sonal Singh, M.D., assistant professor, internal medicine,
Wake Forest University School of Medicine, Winston-Salem, N.C.;
Steven E. Nissen, M.D., chairman, department of cardiovascular
medicine, Cleveland Clinic; Larry Deeb, M.D., president, medicine
and science, American Diabetes Association; Andy Zambanini, M.D.,
director of clinical development, GlaxoSmithKline; August 2007
Diabetes Care; July 26, 2007, New York Times
Source: www.medicinenet.com
Comments:
This is another event where experts are debating the safety
of certain medications or their combination with other drugs.
This study clearly indicates that the combination of Avandia
and Actos is more dangerous then either alone, even in smaller
than recommended doses, and in younger than expected patients.
The authors of this study, Dr. Singh and Dr. Steven Nissen,
first indicated the risks associated with Avandia in May
’07, and have repeatedly urged FDA and the manufacturer
either to put a strong black box warning or, better yet,
to pull the drug off the market. Yet GlaxoSmithKline, the
manufacturer, maintains the position that Avandia is safe
when used properly. Current labeling on the drug warns that
it should not be used in severe cases of heart failure,
and not in combination with insulin. However, there are
many people taking the combination medications who are un-necessarily
being put at a significantly elevated risk of heart failure
and fatal heart attacks.
This is yet another example of pharmaceutical companies
doing business with people’s lives to make more profit.
Over a decade ago, Dr. Rath started unveiling the dark side
of pharmaceutical companies. His research has also proved
that diabetes stems from the deficiency of specific nutrients
at the cellular level, and that diabetic complications can
be prevented by the intake of specific combinations of natural
cellular nutrients. You can read more about the research
in diabetes and the pharma business with diseases at: www.drrathresearch.org. |
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