The First heart failure drug geared specifically to blacks not only improves
survival and reduces hospitalization rates among patients, but also results in
cost savings.
survival and reduces hospitalization rates among patients, but also results in
cost savings.
“Doctors should probably give BiDil to blacks with grade III heart failure,
and they should probably do it even if these patients are relatively
well-managed on existing medications,” said Dr. Derek C. Angus, lead author of a
study in the Dec. 13 issue of Circulation.
“The data is important,” added Dr. Hector Ventura, head of the cardiomyopathy
and heart transplantation center at the Ochsner Clinic Foundation in New
Orleans. “Whether or not other medicines work, at least we’re focusing on the
population that needs it.”
Heart failure, a condition in which the heart loses its ability to pump,
affects about 5 million Americans, including an estimated 750,000 blacks. And
blacks aged 45 to 64 are two-and-a-half times more likely to die from heart
failure than whites of similar age.
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The discovery of BiDil as an effective heart failure therapy for blacks was
an accident. It is actually a combination of two older drugs — hydralazine, an
anti-hypertensive agent that relaxes the arteries, and isosorbide dinitrate, an
anti-anginal agent that relaxes the veins and arteries. Neither drug was
approved for heart failure before clinical trials began, and it is still unclear
how the two work together.
In an earlier trial, BiDil did not have much effect in white patients but did
do well among black patients.
That trial was the impetus for the African-American Heart Failure Trial
(A-HeFT), designed to look specifically at the effects of BiDil in more than
1,000 black heart patients.
A-HeFT found a 43 percent reduced risk of death (6.2 percent vs. 10.2
percent), 39 percent reduced risk of first hospitalization and improved quality
of life among participants taking BiDil plus standard heart failure therapies
when compared to those taking only standard therapies. Indeed, the results were
so encouraging that the trial was halted early, in July 2004.
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The current study is based on A-HeFT data, this time focusing on resource
use, costs of care and cost-effectiveness within the same trial population. The
study was funded by NitroMed Inc., which makes BiDil.
Individuals treated with BiDil had 30 percent fewer hospitalizations and
shorter hospital stays (one day shorter) compared with the placebo group. This
resulted in a 41 percent reduction in the number of days spent in the hospital
for heart failure.
In the BiDil group, heart failure-related costs averaged $5,997 — 34 percent
lower than the $9,144 seen in the placebo group.
Total health-care costs averaged $15,384 in the BiDil group, which was 22
percent lower than the average of $19,728 in the placebo group.
The authors projected that, by using BiDil, heart failure-related costs would
be $16,000 a year at two years after starting the drug.
With an average daily cost of $6.38, BiDil has been the subject of some
controversy. If the two drugs were taken separately, the cost would be only
pennies per day. This particular combination, however, has been patented and
likely results in better patient compliance because it is one pill, not two.
According to this study, that extra cost is being more than made up for in
reduced overall health-care costs.
“Regardless of what you think of the pricing policy, it’s actually a cost
savings, at least over the duration of the study period,” said Angus, professor
of critical care medicine and health policy and management at the University of
Pittsburgh School of Medicine. “Six dollars a day is keeping the doctor away.
It’s decreasing the likelihood of acute hospitalization. One might think it’s
more than 60 cents, but it’s a lot less than being hospitalized.”
More information
The National Minority Health Month has more on
heart failure in blacks.
SOURCES: Derek C. Angus, M.D., professor, critical care medicine and
health policy and management, University of Pittsburgh School of Medicine;
Hector Ventura, M.D., head, cardiomyopathy and heart transplantation center,
Ochsner Clinic Foundation, New Orleans; Dec. 13, 2005, Circulation
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