Tampa is only site on Florida’s west coast for the large-scale, NIH-funded clinical trial

Tampa, FL (June 9, 2014) — A new clinical trial at USF Health is evaluating the ability of a common antibiotic, doxycycline, to slow the growth of small abdominal aortic aneurysms, possibly preventing or delaying the need for surgery.

USF Health is one of only two sites in Florida, and 16 nationwide, participating in the $12.2-million study sponsored by the National Institutes of Health.  The other Florida site is Baptist Health Medical Center in Miami.

“The intent is to test if doxycycline — which is widely available, relatively inexpensive, and has minimal side effects — can reduce inflammation in the abdominal aorta and prevent small aneurysms from becoming larger,” said local principal investigator Murray Shames, MD, a vascular surgeon at USF Health Morsani College of Medicine and Tampa General Hospital.

“If drug treatment can do that, we could potentially improve care and reduce the costs of surveillance and operations needed to fix large aneurysms.”

USF Health/TGH vascular surgeon Dr. Murray Shames leads the local NIH-sponsored trial testing the effects of the common antibiotic doxycycline on the growth of abdominal aortic aneurysms.

An abdominal aortic aneurysm is a ballooning or bulge in the lower part of the aorta, a major blood vessel running from the heart through the center of the chest and abdomen. Since the aorta is the body’s main supplier of blood, a ruptured abdominal aortic aneurysm can cause life-threatening bleeding.  If an aortic aneurysm bursts, it is fatal more than half the time.

When aortic aneurysms are small and low risk, less than 5 cm. or about the size of a plum, doctors closely monitor with ultrasound any changes in the aneurysm’s size and rate of growth.  Surgery is performed to fix the aneurysm only when it reaches a size at which the risk of rupture outweighs the risk of surgery.

USF expects to enroll 25 patients, ages 55 and older who have been diagnosed with small abdominal aortic aneurysms, in the local trial.  Nationwide, 248 men and women will be enrolled.

Abdominal aortic aneurysms typically grow slowly, no more than a half-centimeter each year, and predicting which ones will enlarge rapidly is difficult, Dr. Shames said. “Right now we watch and wait until the aneurysm gets bigger to intervene, because there’s nothing else to do. That waiting can create a lot of anxiety for patients.”

Bernard Remas, 82, of Fort Myers, was one of the first patients enrolled in the randomized, double-blind, placebo-controlled trial at USF Health.  Remas’s abdominal aortic aneurysm was diagnosed about two years ago.  Like many people, he experienced no symptoms and his aneurysm was diagnosed by doctors when he underwent an imaging test for another reason.

Patients are randomized to receive either two doses of doxycycline a day, or a placebo. They will be followed for two years, getting their blood drawn and CT scans every six months.

Remas doesn’t know if he’s taking the tested drug or a placebo, but he says “the study seemed like a good thing to do…it’s pretty easy and painless.” If taking a medication could safely help him avoid an operation to repair an aneurysm, that would be preferable, he said.

USF Health’s Dr. Shames was involved in some earlier rat studies showing that doxycycline and similar anti-inflammatory drugs helped block the enzymes that weaken aortic walls.  Now, he’s part of a comprehensive trial that will determine whether the promising data gained from years of animal studies for slowing aneurysm growth can be replicated in humans.

“If treatment with this medication proves effective, it could become the gold standard for treating small abdominal aortic aneurysms,” he said.

Adominal aortic aneurysm is more common in men and those age 65 or older. Risk factors include family history, smoking, high blood pressure, high cholesterol and atherosclerosis (hardening of arteries).  The U.S. Preventive Services Task Force recommends ultrasound screening for abdominal aortic aneurysms for men ages 65 to 75 who have ever smoked, even if they have no symptoms.

For more information about the Non-Invasive Treatment of Abdominal Aortic Aneurysm Clinical Trial at USF Health, please contact Stephenie Yapchanyk, vascular surgery research coordinator at (813) 259-0683, or Syapchan@health.usf.edu

  -USF Health-
USF Health’s mission is to envision and implement the future of health. It is the partnership of the USF Health Morsani College of Medicine, the College of Nursing, the College of Public Health, the College of Pharmacy, the School of Biomedical Sciences and the School of Physical Therapy and Rehabilitation Sciences; and the USF Physician’s Group. The University of South Florida is a Top 50 research university in total research expenditures among both public and private institutions nationwide, according to the National Science Foundation. For more information, visit www.health.usf.edu

-Tampa General Hospital-
Tampa General is a 1018-bed academic medical center on the west coast of Florida that serves as the region’s only center for Level l trauma, comprehensive burn care, and adult solid organ transplants. It is the primary teaching hospital for the USF Health Morsani College of Medicine. TGH is a comprehensive stroke center and a state-certified spinal cord and brain injury rehabilitation center.

Media contacts:
Anne DeLotto Baier, USF Health Communications, (813) 974-3303, or abaier@health.usf.edu
Ellen Fiss, Tampa General Hospital, (813) 844-6397, or efiss@tgh.org

Photo by Eric Younghans, USF Health Communications