JEFFREY BROWN: Next, the latest findings about how cholesterol drugs do and do not work.
Margaret Warner has the story.
MARGARET WARNER: Millions of Americans take two kinds of cholesterol drugs to lower their risk of heart attack or stroke, statins to reduce so-called bad cholesterol, and another class to boost so-called good cholesterol, known as HDL.
But, yesterday, researchers at NIH announced they had stopped their study of a popular HDL-boosting drug based on niacin after results showed that patients taking it didn't suffer fewer heart attacks or strokes.
We look at this now with Dr. Steven Nissen, chief of cardiovascular medicine at Cleveland Clinic.
And, Dr. Nissen, thank you for joining us.
Expand on this study just a little bit for us. What did it show?
DR. STEVEN NISSEN, Cleveland Clinic: Well, we know that patients that have high levels of good cholesterol, HDL, have a lower instance of heart disease.
And so, it was believed -- and it has been believed for decades -- that if you could raise the good cholesterol, you would lower the risk of heart attack, stroke and death.
It turns out that the best drug we have available to raise good cholesterol is derived from niacin, a B vitamin. And this particular form is a slow-release form of the drug known as Niaspan.
Well, the NIH put a large study together, asked the question, does it actually reduce the risk of death, heart attack and stroke? The answer was it didn't. And in fact there was an excess of stroke, although we haven't seen the final data, so we don't know how statistically significant that difference was.
MARGARET WARNER: So, how significant a finding is this? How big a deal is this?
DR. STEVEN NISSEN: Well, this is a very big deal.
First of all, it was a shocker to the medical community. Many people would have bet on this drug working. It probably shouldn't have surprised us. We have seen over and over again that when drugs are approved or administered because they change some laboratory measure, that doesn't always translate into a clinical benefit.
And I think this is a wakeup call for the regulatory community that we really have to demand that drugs have improvements in clinical outcome, not just laboratory measures.
MARGARET WARNER: So, you're saying this drug did boost your level of HDL. So if you went into the doctor's office and had a blood test, you would -- he would say, "Oh, and your HDL level is nice and high," but that that was false reassurance, that basically it didn't change the health outcome at all?
DR. STEVEN NISSEN: It didn't. And we have seen this kind of problem occur over and over again after -- over the last decade, that drugs that make biochemical measures better don't always make people better. And we really have to demand a higher quality of evidence.
MARGARET WARNER: Now, does this cast any doubt on the underlying thesis that, in fact, at least if you have a naturally occurring high level of HDL, that that is some protection against heart attack and stroke?
DR. STEVEN NISSEN: Well, those patients that have naturally occurring high levels of HDL generally do, do better.
But HDL is very complicated. It's much more complicated than the bad cholesterol, LDL. HDL comes in different forms, some of which may be good, some which may be actually harmful. And so, we're not as smart as we thought we were. We don't understand HDL well enough. We don't know the best way to raise it. And we have had a whole series of setbacks now that have really set the medical community back in terms of understanding how to make HDL go up and how to make that benefit patients.
MARGARET WARNER: Now, why wouldn't a study like this -- you said this has been used for decades -- or niacin-based drugs have -- have been done much, much, much earlier?
DR. STEVEN NISSEN: Well, we have had a problem with the regulatory policy here.
The regulators have made the assumption, based upon the effects of the popular statin drugs, that if you can change cholesterol levels in a favorable way that you will change outcomes. But that paradigm worked only for the statin drugs.
Statins were introduced in 1987, and we have not had a successful new cholesterol-lowering drug class in 25 years. Every time we have tried since then, it's turned out that the biochemical measures didn't actually predict the clinical benefit.
MARGARET WARNER: So, bottom line, as a patient what should you do? If you're taking one of these drugs, niacin-based HDL-boosting drugs, what should you do?
DR. STEVEN NISSEN: Well, patients should never stop taking a drug because they hear a news report.
We haven't seen the final publication yet. We need to go over this in great detail, study the results and try to advise patients. For now talk to your doctor. It's important, however, when any patient sees their doctor for a cholesterol-altering medication, to ask, what is the evidence that it will actually reduce my risk of heart attack, stroke or death?
And physicians really have to provide patients with that information because changing a laboratory parameter doesn't necessarily make patients live longer or feel better.
MARGARET WARNER: Words to the wise.
Dr. Steven Nissen of the Cleveland Clinic, thank you so much.
DR. STEVEN NISSEN: Thank you.