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| |  DG DISPATCH - ACC: Exercise Tolerance Increased With Angiogenesis Drugs In Angina And Peripheral Artery Disease Patients By Ed Susman Special to DG News
ORLANDO, FL -- March 20, 2001 -- Researchers report that patients with intermittent claudication and those with angina can extend treadmill exercise times significantly with treatment that stimulates angiogenesis. The studies presented at the 50th annual scientific session of the American College of Cardiology Monday (March 19) differed from previous procedures in that they appeared to show success-and they were placebo-controlled, double-blind trials. Doctors at Duke University in Durham, North Carolina and University of Michigan in Ann Arbor, Michigan, both in the United States, injected the recombinant protein, fibroblast growth factor (FGF-2), in the leg arteries of patients with peripheral artery disease. In a second study, doctors at William Beaumont Hospital in Royal Oak, Michigan, injected a genetically-engineered virus, constructed to induce production of FGF, into coronaries of angina patients. The patients who received the active agent showed improved treadmill function that was significantly better than did patients who were given placebo injections. "These studies are important," said Dr. Valentin Fuster, director of the Cardiovascular Institute at Mt. Sinai Medical Center in New York, New York, "because they represent the first controlled studies that show a positive benefit of these attempts at angiogenesis." The new studies, Dr. Fuster said, "are first steps that show promise of these treatments. But these are only first steps. There is a lot of work that needs to be done before these treatments will be available to patients." In one study, Dr. Robert Lederman, formerly at the University of Michigan and now director of cardiovascular interventions at the National Heart, Lung and Blood Institute in Bethesda, Maryland, reported that he and colleagues enrolled 190 patients with intermittent claudication. About one-third of patients received sham injections, while the rest received either one or two doses of FGF. After 90 days, the placebo patients achieved a 14 percent improvement in the time they could walk on a treadmill before being stopped by pain, compared with a 34 percent improvement seen in patients getting the single dose of FGF. The patients getting two doses of FGF had a 20 percent improvement that did not reach statistical significance. "This is the first large, randomized, placebo-controlled, therapeutic angiogenesis study to show benefit in its primary efficacy measure," Dr. Lederman said. He said that one of the findings that will be taken further in new trials is that in these cases two injections of the drug were not better than one. At William Beaumont Hospital in Royal Oak, Michigan, Dr. Cindy Grines, director of cardiac catheterisation laboratories, reported similar findings in her gene therapy procedure. "The trial marks the first scientifically well-controlled clinical study of cardiovascular gene therapy," she said. "A one-time administration during cardiac catheterisations has the potential to be an important addition to current treatment options." Her study involved 79 patients who received either placebo or two doses of the genetically-modified virus-its ability to multiply was deleted from the viral genome preventing it from becoming an infectious threat. Patients who received that larger doses of the virus showed a 50 percent improvement in treadmill exercise times at four weeks and a 45 percent improvement at 12 weeks. Placebo patients achieved a 16 percent improvement at four weeks and 21 percent improvement at 12 weeks.
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