Landmark study results
reported by researchers showed that the beta blocking agent Coreg®
(carvedilol) decreased mortality rates by 35 percent in patients with the most
advanced stage of heart failure who were already taking standard therapy.
Coreg is the first beta blocking agent to show a significant survival benefit
in this patient population. These results were presented today at the
European Society of Cardiologists (ESC) 22nd Annual Congress in Amsterdam.
COPERNICUS (CarvedilOl ProspEctive RaNdomIzed CUmulative Survival Trial)
-- the first major international study of the use of an agent with beta
blockade in advanced heart failure -- was halted earlier this year by its
Steering Committee due to the significant survival benefit seen with the drug.
This action was taken upon the unanimous recommendation of the study's Data
and Safety Monitoring Board (DSMB), an international committee whose purpose
is to oversee the study and ensure patient safety. Based on the size and
consistency of the mortality benefit, the committee believed that it would be
inappropriate for physicians to further withhold treatment with Coreg.
"Until recently, most of the trials that had been conducted with beta
blockers were in patients who had mild to moderate disease. There was a lot
of fear that these drugs would not work in patients with advanced disease,"
said Milton Packer, M.D., Director, Heart Failure Center and Professor of
Medicine, Columbia University College of Physicians and Surgeons in New York,
NY and Chairman of the Steering Committee. "The COPERNICUS trial is so
important because the results tell us that carvedilol can reduce the risk of
death in a much broader range of patients than we previously thought possible
for agents with beta blocking activity."
Study Results Demonstrate Survival Benefit in Advanced Heart Failure
This study involving Coreg was conducted in over 300 medical centers in
21 countries and enrolled over 2,200 patients with advanced heart failure who
had symptoms at rest or on minimal exertion, but not requiring intensive care
unit care or intravenous treatments to support their heart's function. Half
of the patients received Coreg and half received a placebo (sugar pill), which
were both added to the heart failure medications the patients were already
taking (ACE inhibitors, diuretics, and commonly digoxin). Patients were
evaluated for up to 29 months. Patients treated with Coreg showed a
significantly lower mortality rate compared to those treated with placebo
(11.4 percent vs. 18.5 percent, respectively). Additionally, serious adverse
effects were more common in the placebo group.
Coreg, approved in May 1997, is the only drug with beta blocking
properties approved in the U.S. for heart failure. It is presently indicated
for the treatment of mild or moderate heart failure. The COPERNICUS data will
be filed with the FDA for their review and approval. SmithKline Beecham and
Roche Pharmaceuticals are seeking to broaden Coreg's current indication to
include patients with advanced heart failure.
Heart Failure Is a Growing Epidemic
Heart failure develops when the heart is weakened and unable to pump blood
efficiently through the body. It commonly results from damage to the heart
after a heart attack, high blood pressure, or diabetes. Heart failure
currently affects nearly 5 million Americans, and is the only major
cardiovascular disorder on the rise. An estimated 400,000 to 700,000 new
cases of heart failure are diagnosed each year and the number of deaths in the
U.S. from this condition has more than doubled since 1979, averaging
The impact of heart failure has grown despite the use of digitalis,
diuretics and ACE inhibitors. Despite compelling evidence about their
benefits from previous studies, beta blocking agents are dramatically
under-utilized in the treatment of heart failure. It is estimated that less
than 15 percent of patients with heart failure in the U.S. are receiving beta
Some common side effects associated with Coreg (carvedilol) include
shortness of breath, a slow heartbeat, weight gain, fatigue, dizziness or
faintness. People taking Coreg who have any of these symptoms should call
their doctor. Additionally, if patients experience fatigue or dizziness, they
should sit or lie down and avoid driving or hazardous tasks. As with any
medicine, there are some people who should not take Coreg. The people who
should not take Coreg include those with severe heart failure who are
hospitalized in the intensive care unit. Also, people who require certain
intravenous medications that help support their circulation (inotropic
medications) should not receive Coreg. Other people who should not take Coreg
are those with asthma or other breathing problems, those with a very slow
heartbeat or heart that skips a beat (irregular heartbeat), those with liver
disease and those who are allergic to Coreg. People with diabetes should
report any changes in blood sugar levels to their physician. Contact lens
wearers may produce less tears or have dry eyes. As with any medicine,
patients taking Coreg should also first tell their doctor what other
medications they are taking.