Guess what... some news just came out this AM
STONY BROOK, N.Y.--(BW HealthWire)--May 2, 1997--May 1st
marked the completion of patient enrollment in the Multicenter Study
of Enhanced External Counterpulsation (MUST-EECP), the recruitment
target of 120 patients with coronary artery disease having been
exceeded.
Patients were entered in a double-blinded trial in which one
group received EECP(R) and a similar "control" group received
"inactive" treatment.
"This study is unique in that it is the first randomized
controlled clinical trial ever conducted of external
counterpulsation," said William W. Parmley, M.D., Professor of
Medicine at the University of California San Francisco. "There are
inherent difficulties in carrying out a study such as this
especially since participants were required to make a commitment to
undergo 35 one-hour long sessions spanning a seven-week period with
the understanding that there was a good possibility that they might
be randomized to placebo treatment."
EECP(R), which received market clearance from the FDA in 1995,
is presently the only clinically tested non-invasive outpatient
procedure to relieve angina pectoris by improving perfusion of
insufficiently supplied areas of the heart.
Angina pectoris, affecting more than seven million people in the
United States, strikes when obstructed coronary arteries deprive the
heart muscle of oxygen adequate to its needs.
MUST-EECP was designed to confirm effectiveness, to quantify
benefits, and to determine further which patients will benefit most
from EECP(R). Several previous studies demonstrated that most
patients with angina experienced relief from pain, decreased need
for medication, and increased exercise tolerance after receiving
EECP(R). Recent abstracts presented at Biomedicine '97, an
important scientific meeting, provided additional confirmation of
the long-term benefits of EECP(R).
Speaking on behalf of the MUST-EECP investigators, Professor of
Medicine and Chief of Cardiology at the State University of New York
at Stony Brook, Peter Cohn, M.D. remarked, "The completion of
patient enrollment is a noteworthy accomplishment and an important
milestone in the history of external counterpulsation. Now that
patient enrollment is completed, we look forward to the unblinding
and publication of the findings in a widely read peer-reviewed
medical journal soon after presentation of study results at a
major medical meeting."
Criteria for study entry included: a confirmed diagnosis of
coronary artery disease, ability to undergo exercise testing on a
treadmill, and willingness to commit to a course of treatment
comprising 35 hour-long sessions. Study endpoints were time to
exercise-induced cardiac ischemia, exercise duration,
patient-reported anginal attacks, and nitroglycerin usage.
Carl Pepine, M.D., University of Florida, headed the safety and
data monitoring committee. Study data are being submitted to a
core laboratory at the State University of New York at Stony Brook
Health Sciences Center.
Long-term patient outcomes including quality-of-life and
cost-effectiveness factors such as use of medication, physician office
visits and medical resource utilization are being measured using the
SF36(TM) (Medical Outcomes Trust) and angina-specific Quality of
Life Index 3 (Ferrans and Powers). This parallel study is being
conducted by The Lash Group, a specialized healthcare consultancy
located in Washington, D.C.
Institutions participating in MUST-EECP are: University of
California San Francisco, Columbia University College of Physicians
& Surgeons at the Columbia-Presbyterian Medical Center in New York,
Beth Israel - Deaconess Hospital, a teaching affiliate of Harvard
Medical School, Yale University School of Medicine, Grant/Riverside
Methodist Hospitals in Columbus, Ohio, University of Pittsburgh
Medical Center, and Loyola University Medical Center in Chicago.
Vasomedical Inc., Westbury, N.Y., (NASDAQ:VASO), developer and
marketer of EECP(R), sponsored the study.
People suffering with angina pectoris may receive EECP(R) at
hospitals and clinics throughout the country. Vasomedical, Inc.
provides equipment, staff training, and treatment guidelines.
CONTACT: Scientific:
Peter Cohn, M.D.
516/444-1060
or
Media:
Jeanette Hutter
215/233-5086
or
Investment:
Natalie Karp
516/625-9483
KEYWORD: NEW YORK
INDUSTRY KEYWORD: MEDICINE PHARMACEUTICAL |
