Dr. Don Chomsky, assistant professor of Medicine and director of Cardiac Transplantation, is enrolling patients in a drug study to take a closer look at the drug combination now thought to have little use in standard therapy. (photo by Dana Johnson)
Heart study examines ethnicity factors to treat disease
It’s been nearly 20 years since a study showed Ace-Inhibitors were more effective in the treatment of heart failure than the standard drug combination of hydrazaline and nitrates.
Since that time the drug combination has rarely been used. But a cardiologist at Vanderbilt University Medical Center thinks that will change.
Dr. Don Chomsky, assistant professor of Medicine and director of Cardiac Transplantation, is enrolling patients in a drug study to take a closer look at the drug combination now thought to have little use in standard therapy.
The original study, VHeFT II, a cooperative study of Veteran’s Administration hospitals, explored the use of hydrazaline and nitrates versus Ace-Inhibitors for use as standard therapy. The patient population for that study consisted mostly of Caucasian males. Based on the results, Ace-Inhibitors proved to be the superior treatment option. It soon replaced the drug combination in the therapeutic protocol.
But a recent review of this study led physicians to reconsider the drug combination’s role in standard therapy.
“What is becoming clearer and clearer is that not all medications work the same way in all ethnic groups,” said Chomsky. “For example, we see this in some blood pressure medications. When researchers reevaluated the VHeFT II study, they found that African Americans enrolled in the study did better on the combination therapy than when treated with a placebo or Ace-Inhibitor.
“But the results of the study were based on the overall outcome, which was based on a patient population made up mostly of Caucasians,” Chomsky said.
Under the new multi-center study AHeFT (African American Heart Failure Trial), Vanderbilt will enroll at least 15 patients with moderate to severe chronic congestive heart failure. The study will be a comparison between standard therapy, which consists of Ace-Inhibitors, digoxin, beta blockers and diuretics and a placebo versus standard therapy along with a drug combination of hydrazaline and nitroglycerine, now called Bidil. More than 600 patients are expected to be enrolled in the nationwide study.
Bidil would act as a vasodilator to decrease resistance to flow in blood vessels and thereby decrease stress on, and increase performance of, the heart. The objective of the study is to demonstrate the efficacy and safety of Bidil when combined with standard therapy.
Chomsky said studies like this not only work to identify the best drug therapies for patients in specific ethnic groups, they will also help in the design of future clinical studies.
“Identifying the most appropriate regimen for African Americans with heart failure also raises greater issues about our decision-making about medical therapies based on studies often using populations that are not representative of the population most affected by a disease,” Chomsky said.
African Americans are diagnosed with heart failure at a higher rate due to the higher prevalence of hypertension, diabetes and coronary disease. The death rate from cardiovascular disease including heart failure in the 1990s was 353 per 100,000 for blacks and 244 per 100,000 for whites.
“Heart failure is an increasingly common condition in our population,” Chomsky said. “In the African-American segment of our population it carries an extremely high mortality rate. Any increments we can achieve in survival rates would be a significant advance.
“Hopefully this will give us insight to study these populations or at least have a well-represented number from these groups in future studies. More attention needs to be paid to genetic and ethnic differences and how these populations respond to various therapies.”
Vanderbilt is currently enrolling African American heart failure patients for the next six months. Patients will be followed for two years. For more information about this trial contact the Vanderbilt Heart Failure Program at 343-3735.