MONDAY, Sept. 2 (HealthDay News) -- The new diabetes drug
Onglyza has no effect, good or bad, on a patient's risk for heart
attacks, a new study finds. However, the researchers from Brigham
and Women's Hospital in Boston did find a surprising rise in
hospitalizations for heart failure among those who took the
medication compared to those who did not.
The findings should "guide physicians and improve their ability
to prescribe different diabetes drugs in a more evidence-based and
data-driven way," study co-principal investigator Dr. Deepak Bhatt,
of Brigham and Women's and Harvard Medical School, said in a
hospital news release.
The study was funded by the drug's makers, AstraZeneca and
Bristol-Myers Squibb, and is published online Sept. 2 in the
New England Journal of Medicine, to coincide with its
presentation at the annual meeting of the European Society of
Cardiology in Amsterdam.
Issues around the safety profiles of newer diabetes drugs gained
prominence recently after one blockbuster medication, Avandia, was
all but pulled from the market in 2010 due to safety concerns. In a
journal editorial accompanying the new study, experts noted that
after Avandia gained U.S. Food and Drug Administration approval in
1999, "a highly publicized meta-analysis in 2007 reported a 43
percent increase in [heart attacks] and a 64 percent increase in
death from cardiovascular causes" tied to use of the drug.
The editorialists say the Avandia experience led the FDA to be
highly cautious in its oversight of new diabetes medications, and
in 2008 the agency issued a new Guidance for Industry mandating
that "preapproval and postapproval studies for all new antidiabetic
drugs rule out excess cardiovascular risk."
The new trial into the safety of Onglyza (saxagliptin) is in
keeping with the new guidelines. The large, international study
involved nearly 16,500 patients with type 2 diabetes from 26
The participants, who also had risk factors for heart disease,
were given either saxagliptin at 5 milligrams per day (or 2.5 mg
daily in patients with reduced kidney function), or a dummy pill
with no active ingredients. The patients did not know if they were
taking the medication or the placebo pill.
Over the course of more than two years, the researchers found
the patients who took the diabetes drug were at no greater risk for
a heart attack than those who took the dummy pill.
The study showed that cardiovascular death, heart attack,
stroke, or hospitalization for unstable angina, coronary
revascularization (angioplasty), or heart failure occurred in about
12.8 percent of patients who took the drug, compared to 12.4
percent of those in the placebo group -- not a significant
However, "our data also show an increase in hospitalization for
heart failure in patients who received saxagliptin, which was not
expected and deserves further study," the study chairman, Dr.
Eugene Braunwald of the TIMI Study Group, cardiovascular division
at Brigham and Women's and Harvard Medical School, said in the
hospital news release.
But the drug had real benefits, as well. "Patients who received
saxagliptin also had better control of blood sugar levels and a
reduced need for insulin therapy," noted the study's co-principal
investigator, Dr. Itamar Raz, of Hadassah Medical Center,
Raz added that the diabetes drug also prevented the progression
of microalbuminuria, a condition that occurs when a type of protein
called albumin is spilling into the urine due to kidney damage.
Two diabetes experts unconnected to the study said the findings
should help ease the minds of patients and physicians.
"The treatment of patients with diabetes has been challenging in recent years," said Dr. Sripal Bangalore, director of research in the cardiac catheterization laboratory at NYU Langone Medical Center, New York City. "It is reassuring to see a mega trial . . . re-assuring the cardiovascular safety of saxagliptin given for a median of two years," he added.
"The pessimistic way of looking at this is that the drug was no better than placebo [in reducing heart risks] and had higher risk of heart failure and hypoglycemic events," Bangalore said. "Hopefully, the investigators will publish more data from the trial showing improvement in microvascular events."
Dr. Tara Narula is associate director of the cardiac care unit
at Lenox Hill Hospital in New York City. She agreed that "there
currently exists a tremendous amount of confusion regarding which
diabetes drugs are safe to use in patients at risk for or with
established cardiovascular disease."
She said the new trial has it upside and downside. "The results
are truly noteworthy in that patients taking saxagliptin had
significantly improved rates of blood sugar control, less
microalbuminuria and no evidence of increased or decreased rates of
ischemic [vessel blockage] events," Narula said. "However, the
study median duration was only two years and a longer time of drug
therapy or longer follow-up may be required to reveal any real
signal of improvement or exacerbation of cardiovascular
Another study, also presented Monday at the European heart
meeting and published in the
New England Journal of Medicine, looked at the safety
profile of Nesina (alogliptin), another newly FDA-approved diabetes
The study, which was funded by the drug's maker, Takeda,
involved nearly 5,400 patients with type 2 diabetes and a history
of heart events (heart attack or angina requiring hospitalization).
Patients received either Nesina or a placebo and were followed for
an average of 18 months.
The researchers, led by Dr. William White of the University of
Connecticut School of Medicine, said they found no increase in
cardiovascular events for those using Nesina compared to those on a
The American Diabetes Association provides more information on
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