Filed at 4:05 p.m. ET
CHICAGO (AP) -- A drug commonly used for short-term treatment of
worsening heart failure in hospitalized patients may cause dangerously low
blood pressure and abnormal heart rhythms, researchers found.
The findings suggest that the drug, milrinone, should be reserved for
patients who do not respond to other medication, said Dr. Mihai Gheorghiade
of Northwestern University.
The study is one of the few to compare a placebo with a drug for
worsening heart failure, a condition that sends about 1 million Americans to
the hospital each year. Despite the poor results, it shows that such studies
can and should be done on similar drugs, Gheorghiade said.
``We should not take things for granted just because they have been
approved, to assume they are useful,'' said Gheorghiade, who led the study,
published in Wednesday's Journal of the American Medical Association.
An accompanying editorial says the use of other drugs commonly used in
worsening heart failure, dopamine and dobutamine, should be reconsidered
given the milrinone findings, since all three drugs work similarly to
strengthen the heartbeat. Milrinone, sold as Primacor, was approved in 1987.
Heart failure, in which the heart gradually loses its ability to pump
blood efficiently, affects nearly 5 million Americans. The condition may be
chronic, but patients can develop severe attacks of breathing difficulty
that require hospitalization.
Dr. Ann Bolger, an American Heart Association spokeswoman, said patients
studied were generally less sick than those who typically would be given
milrinone. The study shows ``there really isn't any advantage'' to giving
milrinone to patients who are not acutely ill, Bolger said.
Sanofi-Synthelabo Inc., which markets milrinone in the United States,
funded the study. The company's Web site warns that the drug may cause
irregular heartbeats, and says milrinone should be stopped if blood pressure
falls too low. It also says that the drug may not be safe or effective when
given for longer than 48 hours, and that long-term oral treatment has been
linked with an increased risk of hospitalization and death.
Another JAMA study shows favorable results for a newer drug called
Natrecor, approved last year for worsening heart failure. Known chemically
as nesiritide, the drug improved breathing and blood flow, and appeared to
work more quickly than intravenous nitroglycerin.
Dr. Michael Cuffe, a Duke University cardiologist who helped lead the
milrinone study, said the research looked at how patients fared over the
longer term, unlike the research that led to government approval of the
drug.
The study involved 949 patients given either a dummy drug or a 48-hour
milrinone infusion.
Dangerously low blood pressure occurred much more frequently in milrinone
patients, 10.7 percent compared with 3.2 percent of the placebo patients; as
did irregular heartbeats, 4.6 percent versus 1.5 percent.
The average length of hospitalization did not differ significantly -- six
days for milrinone and seven days for placebo. Sixty-day death rates -- 10.3
percent in milrinone patients and 8.9 percent in placebo patients -- also
did not differ significantly.
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On the Net:
JAMA:
http://jama.ama-assn.org
Sanofi-Synthelabo:
http://www.sanofi-synthelabous.com