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by Jennifer Kowalewski
OU-COM’s role in
a six-year study on postponing or preventing hypertension was
cited in the April 20 article, “Feasibility of Treating
Prehypertension with an Angiotensin-Receptor Blocker,”
published in the prestigious New England Journal of Medicine.
The pioneering research study, Trial of Preventing Hypertension
or TROPHY, has shown the drug candesartan cilexetil, sold
as Atacand® by AstraZeneca, reduced the risk of
developing hypertension. OU-COM was one of 71 sites
participating in the nationwide clinical trial.
“The TROPHY study
is groundbreaking because it’s the first study to examine the
potential to change the natural history of hypertension through
early pharmacological intervention in patients diagnosed with
prehypertension,” says principal investigator Stevo Julius,
M.D., professor of internal medicine and physiology at the
University of Michigan, Ann Arbor.
Prehypertension,
according to the National Institutes of Health, National Heart,
Lung and Blood Institute, is defined as blood pressure between
120/80 and 139/89 mmHg.
Persons with
prehypertension are at greater risk of advancing to
hypertension. Hypertension or high blood pressure raises the
risk for heart disease and stroke, leading causes of death in
this country. About one in three adults in this country have
hypertension.
Patients in the
TROPHY study had blood pressures of 130–139 (systolic) and 89 or
lower (diastolic); or 139 (systolic) and 85–89 (diastolic).
Untreated patients, age 30 to 65, were enrolled in a four-year,
multicenter, randomized study.
The study
demonstrated that beneficial anatomic or physiologic changes
were occurring in patients taking candesartan that lasted even
after the medication was discontinued, says OU-COM Dean Jack
Brose, D.O.
“Because of this
study, I think we have shown we can compete with larger sites in
terms of the number of patients we recruit and how well we
follow the research protocols,” Brose says. Then assistant dean
for clinical research, Brose served as principal investigator at
OU-COM. Other participating physicians were Jay Shubrook,
D.O. (’94); Robert Gotfried, D.O.; and Chris Simpson,
D.O.
OU-COM managed
its trial and made day-to-day decisions about patient health and
participation, as did each of the other 70 sites. However,
OU-COM so successfully recruited patients that Julius flew Brose
and research nurse Lori Arnott to Michigan to meet with
researchers from a select few other top recruitment sites. They
discussed the ways they had recruited patients, which was shared
with the other participating sites.
The college
enrolled 25 patients in the study and retained 23 throughout the
four-year process. Patients reported “excellent” satisfaction
with their participation in the clinical trial. The reason for
this, says Brose, was the first-rate care that the college’s
research nurse staff — Arnott; Cammie Starner; Lynn Petrik,
R.N.; and Rosemary Vance — provided.
The research
nurses also administered routine blood pressure checks and
educated patients on healthy living. Patients were evaluated
every three months.
“Most loved being
involved with the study,” says Starner. “We did a great job of
following up on them. Any suspected adverse events were dealt
with quickly.”
Prehypertension
patients were identified with the help of local physicians.
During the study, about half the patients received a placebo
while the others received candesartan. After two years, those on
candesartan were switched to a placebo.
In March, Brose
and Starner flew to Atlanta to share in the unveiling of the
results at the American College of Cardiology’s 55th
annual Scientific Session.
The study showed
that after two years, patients who had received candesartan were
almost 67 percent less likely to develop hypertension. After
four years, when all patients had been on placebo for two years,
patients who had been on candesartan were almost 16 percent less
likely to develop hypertension. Brose says the study not only
showed candesartan helped prevent hypertension, it showed that
patients who went off the experimental drug after two years were
still less likely to develop the potentially fatal condition.
“I’m very pleased
that we helped contribute to this landmark study,” says Brose.
“We rank right up there with the best clinical research sites in
America.”
Currently, OU-COM
is involved in other clinical trials, including several diabetes
trials, a dyslipidemia trial and a prevention trial.
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