Roanoke Times
Copyright (c) 1995, Landmark Communications, Inc.
DATE: FRIDAY, February 26, 1993 TAG: 9302260351
SECTION: VIRGINIA PAGE: B1 EDITION: METRO
SOURCE: CAROLYN CLICK STAFF WRITER
DATELINE: LENGTH: Medium
DOCTOR STUDYING DRUG'S CORONARY EFFECTS
Picture two bloodstream gunslingers battling it out for control of the passageways to the heart.One, called high-density lipoprotein cholesterol, or HDL, wears a white hat and fights to clear out the "bad" cholesterol, known as low-density lipoprotein cholesterol or LDL, that clogs the arteries.
When there is not enough HDL, there is an increased risk of the black hats gaining control of the arteries and leading to heart attacks.
Doctors have known for some time that patients with high levels of "bad" cholesterol and low levels of "good" cholesterol are candidates for heart trouble.
Now, two doctors at the Salem Veterans Affairs Medical Center are joining researchers at 19 other VA hospitals to determine if increasing the "good" cholesterol level in patients with a pre-existing heart condition can reduce the risk of further coronary disease.
About 7 million Americans suffer from some form of coronary artery disease, and it is responsible for about a half million deaths annually.
To complete the research, Dr. Ali Iranmanesh, chief of endocrinology and coordinator of research at the VA hospital, needs patients who suffer from coronary heart disease to participate in a study that will last an average of six years.
He and Dr. Douglas Russell, the VA hospital's chief of cardiology, are the primary investigators.
Participants would undergo therapy to determine if the drug gemfibrozil, manufactured by Parke-Davis under the brand name Lopid, would raise the level of "good" cholesterol and lower incidences of heart attacks.
Lopid already is approved by the Food and Drug Administration for use in lowering the level of triglycerides, one of the fat components that circulate in the blood.
Other research, including the Helsinki Heart Study, already has shown that raising HDL cholesterol can reduce coronary disease. But Iranmanesh said there never has been as large a study specifically designed to examine subjects who have low HDL combined with normal triglycerides and normal levels of LDL, or bad cholesterol.
"For the most part, the LDL has been the one incriminated," said Iranmanesh.
Doctors believe that gemfibrozil may increase production of HDL by the liver and aid in breaking down fat particles in the blood. The drug also is believed to help in the elimination of cholesterol from the body.
The study, which began in August 1991, eventually will look at 2,500 men at VA centers across the country. Already, study coordinator Cindy Stephens has registered 79 men for the Virginia study, but she needs to have 125 registered by December.
"We know that raising HDL is good," said Stephens. "In this group everything is normal, except the HDL is low. There has never been a study of that group."
Iranmanesh and Russell have sent letters to physicians around the state in hopes they can identify patients who would be eligible to participate in the research.
Potential study participants will undergo a screening process to determine if their "lipid profile" shows they are good candidates for the study. Once they are determined to be eligible and consent to participate, they undergo a physical examination, electrocardiogram and other tests to determine their "baseline lipid status." They must be younger than 73 and have no history of other serious illnesses.
For the trials, patients will receive either Lopid or a placebo. To prevent bias, the study is double-blinded, meaning neither the researchers nor the patients know whether they are receiving the drug or the placebo.
The subjects will undergo check-ups every three months for several years. Blood is monitored every six months for lipid levels and the patient undergoes a physical examination and electrocardiogram once a year. Patients are not charged for the medical care they receive in the study.
"Even if they drop out, they are checked to see how they are doing," said Iranmanesh. The drug does have some minor side effects, including constipation, which has prompted a few to withdraw, said Stephens.
Although women also are subject to risk of coronary disease because of low levels of HDL, they are not included in this study, Iranmanesh said. Officials decided that the predominantly male population served by the Department of Veterans Affairs medical centers would likely mean only 25 of the 2,500 participants would be women.
Iranmanesh has high hopes for the research.
"There is the potential that this would be approved by the FDA for this particular indication," Iranmanesh said.
He also hopes to alter some of the bad dietary and exercise habits of the participants with regular counseling.
"There are a couple of things short of drugs that can increase HDL," he said.