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Bristol-Myers Squibb Corp. and Sanofi-Aventis SA blood
pressure drug Avapro failed in a large study to show a benefit among patients
with a common and difficult to treat form of heart failure.
Avapro, known generically as irbesartan, is a member of a
class of blood-pressure drugs called angiotensin-receptor blockers or ARBs. It
was thought that Avapro could improve patients with preserved ejection fraction
heart failure who tend to have high blood pressure, but the study showed no
such benefit.
“We were particularly disappointed because we still have
large numbers of patients that still don’t have a good treatment” said Dr.
Barry Massie, who presented the data at the American Heart Association
scientific meeting on Tuesday.
Preserved ejection fraction heart failure, in which the
heart has a reduced ability to pump blood, appears to affect women and the
elderly. About 50 percent of the 5.3 million US citizens with heart failure have
it.
The 4-1/2 year-study involved 4,128
patients in 25 countries. The participants were given either their usual
medicines and Avapro, or a placebo on top of their other treatments, such as
hypertension drugs like ace inhibitors and beta blockers. After the follow-up
period ended, there was no statistically significant difference between the
composites rates of heart attack, heart failure or stroke in each group.
Some 742 patients in the Avapro group, or 36 percent, experienced these
events, versus 763, or 37 percent, in the placebo group, the study showed.
Also, there were similar rates of serious adverse events between the treatment
groups, such as low blood pressure and kidney failure.
The findings were published online by The New England Journal of Medicine.
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