Researchers at the University of Rochester Medical Center are testing whether different doses of an established blood pressure medication can provide the same benefits as a standard dose in people with mild hypertension, possibly with fewer side effects and at a lower cost. The newly launched clinical trial, funded with a $1.9 million grant from the National Heart Lung and Blood Institute, is the first of its kind in the United States.
The study drug, carvedilol (brand name Coreg®), is FDA approved and widely used for the treatment of high blood pressure. What researchers hope to learn is how varying amounts of the medication, including doses lower than typically prescribed, affect patients with mild or stage 1 hypertension – a systolic pressure (top number) ranging from 140 to 160 mm Hg.
According to hypertension expert and study investigator John D. Bisognano, M.D., Ph.D., people with this early form of the disease are often advised to try lifestyle changes, such as eating a healthier diet and exercising, for six months to a year before initiating drug therapy. For individuals implementing lifestyle modifications who are also considering medical treatment, the trial provides an opportunity to try a safe and effective drug that, even at varying doses, may help bring their blood pressure back to healthy levels.
"It is so ingrained in everyone's mind that we have to have a constant level of medication, but it is possible that if the drug level goes down, the brain may be able to make up for that," said Bisognano, director of Cardiology Outpatient Services who will run the trial with Francisco A. Tausk, M.D., professor in the Departments of Dermatology and Psychiatry and Jan A. Moynihan, Ph.D., Engel Professor in Psychosocial Medicine also in the Department of Psychiatry at the Medical Center. "We may be able to meet the medical need with less medication in this low-risk population and potentially decrease side effects in the process."
Such an outcome would be a huge step forward for the millions of Americans with mild hypertension who are limited in the amount or number of medications that they can take because of adverse side effects. It may also appeal to the growing number of Americans who are skeptical of or want to avoid standard pharmaceuticals, a culture change that Bisognano and other physicians have witnessed in their practices over the past few years.
According to the Centers for Disease Control and Prevention, nearly a third of the nation's adults struggle with high blood pressure, which increases the risk of heart disease and stroke and represents a significant economic burden to society, with $54 billion spent on the condition in 2001 alone.
People with mild hypertension who pass a medical exam may be eligible for the study. Once enrolled, individuals will receive different daily amounts of the study drug for at least three and up to eight weeks. In addition to brief weekly visits, participants will be asked to: monitor their blood pressure every morning and evening; record their results and any side effects in a blood pressure diary; and fill out weekly questionnaires regarding how they feel and any noteworthy events or changes that took place.
Individuals who complete study weeks one through three will be paid $100, and those who go on to complete weeks four through eight will be paid another $100. All travel expenses for appointments will also be reimbursed.
Anyone interested in participating in the study should call 585-341-7739.
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