UI researchers are trying to increase the level of a certain type of cholesterol according to
lead researcher, Gregory Doelle, MD, endocrinologist with University of Iowa Hospitals and Clinics. He offers these comments:
Are trying to increase the level of a certain type of cholesterol?
What we're trying to do in this particular trial is to look at a population of individuals who have established vascular disease and have controlled LDL cholesterol levels. In other words, their LDL cholesterol has already been reduced, usually with medications. We're looking at people who have low HDL cholesterol and we're trying to intervene with a different medicine to see if raising HDL levels will further reduce heart disease risks.
What medications are being used in this clinical trial?
All individuals in this trial will receive very commonly used medicine called statins, which are the standard in terms of LDL lowering therapy. Individuals receiving statins will be randomized at this trial to receive either placebo or an extended-release niacin. Niacin has been an agent that's been around for a long time and is an effective agent in raising HDL cholesterol levels.
Who is eligible to participate in the study?
We're looking for individuals who are 45 years of age or older and who have established vascular disease, first of all. They need to have known coronary artery disease, cerebral vascular disease, or peripheral vascular disease. In addition, we're looking at individuals, then, who have controlled LDL cholesterol levels but who have low HDL cholesterol levels.
What else makes this project unique at this time?
Right now there is very convincing and compelling evidence that using statins as single agents will reduce heart disease risk and that's been established in a number of trials. But what's seen in those trials is that while statins reduce risk, they don't reduce risk back to baseline. In other words, individuals on statins, while being at reduced risk for heart disease, are still at increased risk overall. The question that we're proposing is that raising HDL cholesterol levels will further reduce this risk. There is some very preliminary evidence to suggest, in small groups of patients, that this might be effective therapy, but this really has not been examined in any large-scale clinical trial.
What do you see as the potential benefits of this approach to addressing cholesterol concerns?
We're looking at individuals with low HDL cholesterol, which is a very common lipid abnormality, and we don't have very effective therapies for raising HDL cholesterol levels. Nicotinic acid or niacin, which has been around for a very long time, is moderately effective in doing so. We know that statins can reduce risk, but we'd like to think that we can reduce risks further with combined lipid-lowering therapy.
How can our listeners learn more about this research trial?
Listeners can call Diabetes Clinical Research and Programs at The University of Iowa. The number there is 356-4879 and they can talk to study coordinators there to learn more about the trial and then to see if they might qualify for participation. |