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6/11/04 - 10/11/04, New Orleans, LA
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Scientific Sessions, the largest cardiovascular meeting
in the world, is being held in New Orleans Nov. 6–10.
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 related discussion |
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Many heart disease patients who are already
receiving state-of-the-art therapy do not benefit from
additional treatment with angiotensin converting enzyme (ACE)
inhibitors, according to results of a new study funded by the
National Heart, Lung, and Blood Institute (NHLBI), part of the
National Institutes of Health.
The study provides the most definitive evidence to
date of the effect of the drug in stable heart disease patients
whose heart function was shown to be at normal or near-normal
levels, and whose heart disease was already well managed.
Researchers found that ACE inhibitors do not lower the risk of
cardiovascular death, heart attack, or the need for coronary
revascularization (bypass surgery or angioplasty to restore
blood flow to clogged arteries) in these patients.
Results of the Prevention of Events with
Angiotensin Converting Enzyme Inhibition (PEACE) are being
presented November 7 at the American Heart Association
Scientific Sessions in New Orleans. They will also be published
online concurrently by the New England Journal of Medicine and
in the journal's November 11 printed issue.
The American Heart Association currently recommends ACE
inhibitors for all patients who have had a heart attack and
others with coronary or other vascular disease. ACE inhibitors
are a type of drug called vasodilators, meaning they cause blood
vessel walls to widen or relax, thereby lowering blood pressure;
they are one of several classes of drugs that are recommended
for treating high blood pressure. Clinical studies have also
found that ACE inhibitors improve survival and reduce the risk
of heart attack among patients with heart failure, a condition
in which the heart muscle is no longer pumping enough blood
throughout the body. In addition, the drug has been shown to
help prevent heart failure in some patients with moderate to
severe ventricular dysfunction, or abnormalities in the lower
chambers of the heart.
"Although ACE inhibitors have been proven to help patients
with heart failure, until now it wasn't clear whether all
patients with coronary heart disease benefit from this class of
drugs," said NHLBI Acting Director Barbara Alving, M.D. "These
results could significantly change clinical care of perhaps
millions of Americans with heart disease."
"This study indicates that many patients with coronary heart
disease whose heart muscle is in good shape and who receive
intense treatment including revascularization and lipid-lowering
drugs do not gain extra cardiovascular protection from ACE
inhibitors," added Eugene Braunwald, M.D., who co-chaired the
study with colleague Marc Pfeffer, M.D. Both are in the
Cardiovascular Division of Brigham and Women's Hospital in
Boston.
"These lower-risk patients can avoid side effects and the
added expense of ACE inhibitors without putting themselves at
additional risk for cardiovascular complications," Dr. Braunwald
said. The drug's side effects include cough, fainting spells,
and a rare but serious allergic reaction known as angioedema.
Heart disease is the single leading cause of death in the
United States. More than 13 million adults have coronary heart
disease, putting them at increased risk for heart attack, sudden
death, angina, heart failure, and stroke. Most patients with
coronary heart disease, including heart attack survivors,
however, do not have heart failure or ventricular dysfunction.
PEACE was designed to test whether ACE inhibitors provide added
benefits to this group of heart disease patients with relatively
good heart function.
The PEACE trial involved nearly 8300 participants who did not
have heart failure, and who had normal or near normal left
ventricular function, as evidenced by left ventricular ejection
fraction of greater than 40 percent. (The ejection fraction is
an indication of the amount of blood that is pumped out of a
filled ventricle; a normal rate is 50 percent or more.) The
average age of participants when they started the trial was 64
years. The study was conducted at 180 clinical sites in the
United States, Canada, Puerto Rico, and Italy.
All of the participants followed recommended treatments for
heart disease as warranted. For example, 70 percent were on
lipid-lowering medications (drugs to lower the level of LDL or
"bad" cholesterol in the blood) and 72 percent had previously
had coronary revascularization when they enrolled in the trial.
Participants were then randomized to either take the standard
dosage (4 mg/day) of the ACE inhibitor trandolapril (Mavik), or
an inactive placebo. The drug was provided by Abbott Labs/Knoll.
After an average follow-up of 4.8 years, the same proportion
(about 22 percent) of participants in each group died from
cardiovascular disease (CVD), had a heart attack, or needed
revascularization. The results did not differ when the
researchers adjusted for the participants' age, gender, or
history of heart attack, transient ischemic attack, diabetes, or
high blood cholesterol. Similarly, there were no differences
based on which heart disease therapies participants followed
during the study. Although trandolapril lowered systolic blood
pressure (the top number in a blood pressure reading) by an
average of 4.4 mm Hg, the reduction did not have a significant
effect on the patients' outcomes.
"PEACE tells us that patients with coronary disease and
normal or only mildly reduced heart function do not benefit from
ACE inhibitors unless the drug is being used to treat another
condition, such as high blood pressure," noted Michael Domanski,
M.D., head of the NHLBI Clinical Trials Scientific Research
Group, and a project officer of the study. "The entry criteria
in PEACE can be used to help physicians decide which patients do
not need ACE inhibitors." PEACE was the final in a series of
three large clinical trials worldwide to test whether ACE
inhibitors benefit heart disease patients who do not have heart
failure. The participants in the PEACE trial were at lower risk
both at baseline and after treatment compared to participants in
the two earlier studies. Furthermore, although all three trials
enrolled only patients who had no known heart failure or
ventricular dysfunction, only PEACE used an ejection fraction
found to be normal or slightly below normal using standard
imaging tests as a key criterion for enrollment. The two earlier
trials did not document the participants' ejection fractions;
thus, these participants could have had moderate to severe
ventricular dysfunction.
"While the results from the PEACE study demonstrate that many
patients with heart disease who are already receiving
state-of-the-art therapy may not also need ACE inhibitors, it is
important to remember that these drugs continue to be
recommended for patients with heart failure or ventricular
dysfunction,' said Yves Rosenberg, M.D. of NHLBI. Dr. Rosenberg
is co-project officer of PEACE.
Approximately 5 million Americans have heart failure. Common
causes of heart failure include coronary heart disease and high
blood pressure. Based on the NHLBI's Framingham Heart Study,
approximately 22 percent of men and 46 percent of women who
survive a heart attack will be disabled by heart failure within
six years.
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American Heart Association - scientific sessions - 6/11/04 - 10/11/04, New Orleans, LA Legal Disclaimer
The materials presented here were prepared by independent authors
under the editorial supervision of The Doctors Lounge, and do not represent a
publication of the American Heart Association. These
materials and the related activity are not sanctioned by the American
Heart Association or the commercial supporter of the
conference, and do not constitute an official part of that conference.
The material presented here does not reflect the views of The Doctors
Lounge or
the companies providing unrestricted educational grants. These materials
may discuss uses and dosages for therapeutic products that have not been
approved by the United States Food and Drug Administration. A qualified
health care professional should be consulted before using any
therapeutic product discussed. All readers or continuing education
participants should verify all information and data before treating
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Copyright © 2004 The Doctors Lounge.
| Article reviewed by: |
Dr. Tamer Fouad, M.D.
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