Jan. 13, 2008 University of Vermont cardiovascular physician-scientists Mary Cushman, M.D., and Matthew Watkins, M.D., are conducting cutting-edge research on the number-one killer of men and women in the United States -- cardiovascular disease.
Hormones and blood clot risk
In early December 2007, Cushman presented preliminary data from two Women’s Health Initiative trials that assessed factors that indicate increased risk of venous thromboembolism (VTE) with postmenopausal hormone therapy. VTE refers to a blood clot that forms in the veins, usually in the legs. These clots can become fatal if they travel through the veins to the lung. According to the American Heart Association, more than 200,000 cases of VTE occur each year and 30 percent of these people die within three days. It is known that postmenopausal hormone treatments can double the risk of developing VTE, and in recent years hormone prescriptions have declined, partly as a result of this.
“If these findings are confirmed, measurement of some of these factors might assist women with decision-making about whether or not to take estrogen or estrogen plus progestin for treatment of postmenopausal symptoms," said Cushman. "This becomes very important since hormones remain a very effective treatment for menopausal symptoms."
Women with angina better candidates for angiogenic therapy
A reported 8.9 million people in the United States, including 4.6 million women, live with chronic angina, the debilitating chest pain, squeezing or pressure experienced by people with coronary heart disease. However, women with heart disease have been largely underrepresented in cardiovascular clinical trials. A recent study article co-authored by Matthew Watkins, M.D., professor of medicine at the University of Vermont College of Medicine, indicates that an experimental treatment designed to promote blood vessel growth and improve cardiovascular blood flow in patients with angina may have a positive treatment effect in women as opposed to men.
The AGENT (Angiogenic Gene Therapy) studies (1 through 4) have to date involved 663 patients at more than one hundred U.S., European and other international medical centers. The experimental therapy under examination in the AGENT trials is Generx™ (alferminogene tadenovec, Ad5FGF-4), a gene product in a new class of cardiovascular biologics that when administered by intracoronary injection, promotes angiogenesis – the process of blood vessel growth in the heart. For their September 11, 2006 Journal of American College of Cardiology article, Watkins and his colleagues analyzed pooled original data from the AGENT -3 and -4 trials to determine treatment effects in two subgroups, gender and older patients with severe angina.
The study used exercise tolerance testing time to track any changes from baseline at 4 weeks, 12 weeks and 6 months among three groups – placebo, low-dose Ad5FGF-4 and high-dose Ad5FGF-4. At 12 weeks, there was significant improvement in women at both doses, but not in men.
Based on these findings, a Phase 3 clinical trial titled AWARE (Angiogenesis in Women with Angina pectoris who are not candidates for Revascularization) was launched in August 2007. UVM is one of more than two dozen centers in the country currently participating in this trial, which aims to enroll approximately 300 women with chronic angina who are not candidates for conventional bypass surgery or angioplasty in order to more closely examine the effects of angiogenic therapy on this population of patients.
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