-- HealthDay staff
WEDNESDAY, July 10 (HealthDay News) -- The development of what
might have become a significant diabetes drug has been halted by
its maker amid concerns that the medication raises the risk for
fractures, kidney problems and heart failure in those taking
Roche reported Wednesday that it would shut down a late-stage
clinical trial of the drug aleglitazar after a monitoring committee
found signs of troubling side effects and a lack of effectiveness
in patients with type 2 diabetes who had heart problems. The Swiss
pharmaceutical giant also closed all other studies of the drug.
"We are disappointed by this outcome as we hoped that aleglitazar would provide significant benefit for patients with type 2 diabetes who are at risk of cardiovascular disease," Dr. Hal Barron, chief medical officer at Roche, said in a company statement.
The drug was being tested to see if it could prevent heart
attacks and strokes, in addition to lowering blood sugar
The failure of aleglitazar might color any decision the U.S.
Food and Drug Administration may soon make about the troubled
diabetes drug Avandia, which is similar to aleglitazar,
The New York Timesreported.
In 2010, Avandia's use was severely restricted in the United
States because evidence suggested it raised the chances of heart
attacks and stroke.
An FDA advisory committee recommended in June, however, that the
restrictions on Avandia be eased. Thirteen members of the 26-person
panel voted to ease the controls, while seven voted to lift them
altogether. No decision on that recommendation has been made yet by
the agency, although it often follows the advice of its expert
Meanwhile, critics of Avandia argue that the entire class of
drugs is dangerous and Avandia's use should remain tightly
Roche noted in its statement, however, that aleglitazar did not
increase the risk of heart attacks or strokes, which may bolster
the argument that Avandia also does not raise cardiovascular risks,
the newspaper added.
In the aleglitazar study, more than 7,000 people with diabetes
who had also suffered a recent heart attack or the onset or
worsening of cardiac pain were involved. The study was supposed to
last five years, until the beginning of 2015.
For more on thiazolidinediones, the class of drugs to which
Avandia belongs, visit the
U.S. National Institute of Diabetes and Digestive ...
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