DO - Ohio University College of Osteopathic Medicine

OU-COM Participates in First-of-a-kind
Prehypertension Drug Study
A pioneering six-year study on postponing or preventing
hypertension has shown that a new drug, if introduced
while a patient is prehypertensive, can reduce that patient’s
risk of developing hypertension. OU-COM was one of 71
sites participating in the nationwide clinical trial.
The Trial of Preventing Hypertension, or TROPHY, study
is groundbreaking. “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,” principal investigator
Stevo Julius, M.D., professor of internal medicine and
physiology at the University of Michigan, Ann Arbor, says.
Prehypertension, according to the Centers for Disease
Control and Prevention, is defined as a systolic blood
pressure of 120-139 mmHg or a diastolic blood pressure
of 80-89 mmHg.
Persons with prehypertension are at greater risk to advance
to hypertension. Hypertension or high blood pressure
raises the risk for heart disease and stroke, both leading
causes of death in this country. About one in three adults
in this country has 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.
–Jennifer Kowalewski
summer 2006 27