* Astra/BMS and Takeda drugs do not raise heart attack risks
* Studies also clear Onglyza and Nesina on pancreatic safety
* But more heart failure hospitalisations seen with Onglyza
By Ben Hirschler
AMSTERDAM, Sept 2 Diabetes pills known as DPP-4
therapies got a mixed safety report on Monday as studies showed
they did not raise the risk of heart attacks but might be linked
to heart failure, where the heart fails to pump blood
Reassuringly, the medicines were not associated with
increased rates of either inflammation of the pancreas or cancer
- something that has been a worry in the past.
However, in the case of AstraZeneca and
Bristol-Myers Squibb's approved drug Onglyza, there was
a small increase in hospitalisations for heart failure.
"It is a little bit concerning," said Dr. Christopher
Grainger of Duke University Medical Center, who was not involved
in the research. "I'm sure the FDA (U.S. Food and Drug
Administration) will want to know more about it."
Doctors and regulators are wary of the cardiovascular safety
profile of diabetes drugs following past problems, including
with GlaxoSmithKline's Avandia pill, since patients with
diabetes are at increased risk of heart troubles.
Researchers from Brigham and Women's Hospital in Boston, who
studied Onglyza over two years in 16,492 patients, said the
heart failure finding was unexpected and deserved further
AstraZeneca and Bristol had already given headline results
from the study in June showing that Onglyza did not increase
heart attack risk - although it did not reduce it either, as the
companies had initially hoped.
Detailed results of the Onglyza study were presented at the
European Society Cardiology (ESC) congress in Amsterdam,
alongside a 5,380-patient study of Takeda's Nesina,
which showed no increase in overall cardiovascular risks.
Both studies were also published in the New England Journal
Dr. Heinz Drexel, a heart doctor at Feldkirch Hospital in
Austria and an ESC spokesman, said DPP-4s offered several
advantages, including a lack of weight gain seen with some other
antidiabetics, which would offset the heart failure worries.
Dr. Anthony DeMaria, editor-in-chief of the Journal of the
American College of Cardiology, said the absence of severe
adverse events was reassuring but it might be that DPP-4s were
best avoided for certain patients at high risk of heart failure.
Drugs like Onglyza and Nesina work by inhibiting dipeptidyl
peptidase-4, or DPP-4, to enhance the body's ability to lower
elevated levels of blood sugar.
The DPP-4 market is dominated by Merck's Januvia,
which has annual sales of around $5 billion, including a related
combination treatment called Janumet. But growth of the class
has slowed this year, partly on concerns over pancreatic safety.
Onglyza, which had sales of $709 million in 2012, is a
crucial product for AstraZeneca, which is banking on diabetes to
help revive falling group sales due to patent expiries on
several of its biggest-selling drugs.
Briggs Morrison, AstraZeneca's head of global medicines
development, said the overall results of the latest trial were
reassuring and the small increase in heart failure
hospitalisations did not change the risk profile of the drug.
A similar heart study of Merck's Januvia in more than 14,000
patients is being conducted with results expected next year.