JIM LEHRER: Prescription drugs report number one: New findings on cholesterol and heart disease. Gwen Ifill has that story.
GWEN IFILL: The findings come from a major study showing aggressive use of cholesterol-lowering drugs can save lives and reduce suffering in patients with cardiac disease.
The study, released yesterday at the annual meeting of the American College of Cardiology looked at more than 4,100 people recovering from heart attacks or severe chest pain. Comparing differing doses of two statin drugs, Lipitor and Pravachol, the study found that patients who took higher doses of Lipitor were 16 percent less likely to die, suffer another heart attack, or become sicker. Their overall death rate was 30 percent lower. More than 1 million Americans die of heart disease each year.
For more, we turn to Dr. Peter Libby, the chief of cardiovascular medicine at Brigham and Women's Hospital in Boston. Dr. Libby, welcome.
DR. PETER LIBBY: Good evening.
GWEN IFILL: These were widely held as fairly significant results today from this study. Why is that?
DR. PETER LIBBY: Well, our current national guidelines say that individuals who have had a heart attack or a near heart attack, which for the patients that were studied in this large trial, should have a goal of lowering their bad cholesterol to under 100. Now, the patients that were in the milder treatment group in this study had achieved a goal that met with the national guidelines. It was about 95 was their cholesterol number for the bad cholesterol.
GWEN IFILL: The national guidelines are what? We get confused about that a lot.
DR. PETER LIBBY: Under a 100 for that category of patient.
GWEN IFILL: Okay.
DR. PETER LIBBY: So the mild treatment group already met the national guidelines, and the news here is that the more aggressive treatment of the cholesterol actually yielded a better benefit in terms of recurrent heart troubles in this category of patients.
GWEN IFILL: So when you say "this category of patients," these findings apply specifically and only to people who have had previous heart problems?
DR. PETER LIBBY: This study enrolled people who had had a recent heart attack or were hospitalized with chest pains that required urgent kind of hospitalization. However, we have a growing database that suggests that this kind of aggressive approach to cholesterol might have a broader benefit in different categories of patients.
GWEN IFILL: Well, when you talk about broader benefits you get right to the little light bulb that went off in my head as you were talking, if you are worried that maybe you might be -- that everyone else in your family had heart disease, should you rush out to the store, rush to your doctor and get a prescription for Lipitor and start taking as much of it as you can?
DR. PETER LIBBY: I don't think so. I think the first thing is not to reach for a prescription pad or a pill. The cornerstone of cardiovascular prevention is lifestyle. And I'm sorry to tell you that we're losing the lifestyle war. I think we'll hear more about it in this program.
It's diet and exercise and stopping smoking. That's the cornerstone, not a prescription pad. Unfortunately in many of our population, those measures are not enough to bring their risk of cardiovascular events down as low as we'd like to see it. And that's why this is very encouraging news for people who are sufferers of heart disease or at high risk, because it means that more aggressive treatment of their cholesterol may accrue additional benefits, more than we'd ever expected.
GWEN IFILL: If you are at risk but you haven't suffered a heart event, any kind of negative effect, a heart attack, and you are among the walking well, would this apply to you? Is this something that you should be watching as well?
DR. PETER LIBBY: I think that it means that everyone should know their cholesterol number and stay tuned for other studies which are going to be coming out in the next year or two which I think will cause a reevaluation of our national guidelines and probably justify us taking a more aggressive stance in treating broader people, broader categories of people not only those who have already had declared heart trouble but those who have high risk. We can gauge the high risk better and better these days including with some simple blood tests.
GWEN IFILL: If you are among the people who are either at high risk or have already suffered from this attack and you begin -- from an attack and you begin to take these increased dosages, is there a risk of any kind of negative side effect that this study revealed?
DR. PETER LIBBY: No, this study showed the drugs to be safe which is our general experience.
The statin category of drugs is really remarkable in their benefit versus their risk in terms of side effects. It is a very safe category of drugs.
There are rare patients who will have some abnormalities of their muscles, which sometimes can be very serious. Those individuals we can usually pick out because they have risk factors such as being very old, taking large doses for their body weight, elderly women are particularly susceptible, and also combinations with other medications which cause interactions. This is a very small category of the broad swath of our population who can benefit from more aggressive statin treatment.
GWEN IFILL: How costly would this new treatment be for an average patient whose doctor decided that this was a good way to avoid future setbacks? Is it an expensive new treatment?
DR. PETER LIBBY: You raise a very good point because we're all concerned about health care costs. And certainly the kinds of medications that were used in this study do have a cumulative cost which can be hundreds of dollars a year or even more if the patient is paying themselves. I think again there is some hope on the horizon because a number of medications in this class are going to be coming available as generic medications in the next few years and while the aggressive kind of goals which were found to be helpful in this study in very high-risk patients require some of the newer statins to achieve that kind of goal, I think that many of our patients who could benefit from statin therapy could do so with the generic forms or the forms that will be becoming generic over the next few years.
GWEN IFILL: Dr. Libby, I know that you have acted as a consultant for big drug companies -- in this case Bristol-Myers Squibb is the manufacturer of the Pravachol, is that correct?
DR. PETER LIBBY: That's right.
GWEN IFILL: And Pfizer is the manufacturer of Lipitor, the other cholesterol drug. How unusual is it, as has happened in this case, that one company Bristol-Myers pays for a study to prove a point which it turns out it has disproved. In other words, Bristol-Myers came out on the short end of the stick. How unusual is that?
DR. PETER LIBBY: Right. It is unusual but I think that this points to an actual strength of our pharmaceutical industry is that it's able to sponsor large clinical trials which are very difficult to fund in any other way which answer new scientific questions.
I don't think that any of the investigators or the sponsor thought that the answer was going to come out this way but you don't know until you test it. Testing it requires enormous resources. I think it's to Bristol-Myers Squibb credit that they had the courage to go forward and put their dollar down to expand our scientific knowledge of how best to treat people who have had a heart attack and who are at very high risk for recurrent events.
GWEN IFILL: You say there are other studies on the way. So the average person who is dealing with heart issues and who looks at this as a ray of sunlight, when can they expect to be able to benefit from these findings?
DR. PETER LIBBY: Well, they can benefit today by lifestyle changes. I think that all of us can do a better job of the diet and exercise and there's no excuse for smoking. I think that there are very important reasons why everyone should know their blood pressure, should know their cholesterol number and compute with their doctor their risk, and there are some individuals who need help beyond just the lifestyle measures and for them very often medication, including medications in the statin category are helpful and would improve their outcomes in the long run.
GWEN IFILL: Dr. Peter Libby, thank you very much.
DR. PETER LIBBY: Thank you. It's wonderful to be here.