TREATING HEART FAILURE

July 20, 1999
		A world-wide study conducted by the University of Michigan Medical Center has found that a long-known drug is extremely effective in treating severe heart failure. Jim Lehrer talks to Dr. Bertram Pitt, the study's lead author. The Health Unit is a partnership with the Henry J. Kaiser Family Foundation.

Jim Lehrer describes his heart attack in a 1985 special "My Heart, Your Heart." May 27, 1999: Seeking hospitals for heart care. Nov. 11, 1998: Gains in the fight against Heart Disease. April 13, 1998: Smoking and Heart Disease. June 19, 1997: Estrogen and Heart Disease. April 3, 1997: Heart disease risks. Browse the NewsHour's coverage of Health     New England Journal of Medicine Report on effects of Aldactone NEMA Editorial on effects of Aldactone	JIM LEHRER: First, a new hope for those with severe heart failure. It comes from a study with results so dramatic they were published early on the Internet by the New England Journal of Medicine. The study showed a long-established drug, Aldactone, can cut death rates by 30 percent over a two-year period. Dr. Bertram Pitt is lead author of that study. He is a cardiologist at the University of Michigan Medical Center. Dr. Pitt, welcome. DR. BERTRAM PITT, University of Michigan Medical Center: Good evening.
	What is heart failure?
	JIM LEHRER: First, let's begin with some basics here. Tell us what heart failure is in the simplest terms. DR. BERTRAM PITT: Heart failure is an inability of the heart to pump blood or meet the needs of the body. And often when that heart can't do that, fluid builds up in the heart and goes out into the lungs and the patient suffers from shortness of breath and may often have swelling of the legs and their exercise is very limited. JIM LEHRER: And is heart failure considered a disease with a specific cause? DR. BERTRAM PITT: There are many causes. It may be an old heart attack; it may be high blood pressure; it may be a virus or a valvular disease, or sometimes we just don't have the answer. JIM LEHRER: Heart failure then is more of an end result than it is a disease in and of itself, is that correct? DR. BERTRAM PITT: Exactly right. JIM LEHRER: Okay. Now, does it affect people of all ages or only the elderly or what can you tell us about that? DR. BERTRAM PITT: It affects people of all ages but particularly the elderly because they've often had high blood pressure or suffered heart attacks. So, as we have an increasingly elderly population, we're going to see more and more people suffer from heart failure.
	The standard treatments
	JIM LEHRER: Well, now, as we speak now, what is the standard treatment for heart failure? DR. BERTRAM PITT: Over the last decade the standard treatment has been the use of a drug called an ace inhibitor and then a diuretic and very old drug -- digoxen. JIM LEHRER: What has been their success rate? DR. BERTRAM PITT: Well, the ace inhibitors have been very successful in reducing mortality but even with the standard therapy, the ace inhibitors, the diuretics, and digoxen, people with severe heart failure still have a very high death rate. For instance, in our study, patients with severe heart failure, 20 percent of them died each year. So that's worse than many cancers. So this a very serious and often a very debilitating disease. JIM LEHRER: All right. So, then you all started your study with Aldactone. First, tell us what Aldactone is. DR. BERTRAM PITT: Aldactone is a drug that blocks one of the hormones in the body called aldosterone. JIM LEHRER: And that is important for what reason? DR. BERTRAM PITT: Well, aldosterone is a hormone that normally is present to preserve fluid in the body and to repair the body. But in heart failure it causes a lot of very bad things that sort of lead to more shortness of breath, it causes more fluid retention, it stiffens the heart and the great vessels. It damages the vessels and it predisposes to sudden death. JIM LEHRER: Okay. Now, Aldactone has been around a while, right? DR. BERTRAM PITT: It's been around for over 30 years. JIM LEHRER: And it's been used to treat what, cirrhosis of the liver and things like that, right?
	Aldactone's other uses
	DR. BERTRAM PITT: It has been used for cirrhosis of the liver, and it was used for heart failure many years ago but over the last decade, most doctors felt that when they used this new class of drug, ace inhibitors, they didn't really need Aldactone because they felt that the ace inhibitors also blocked this hormone, aldosterone. But that turns out not to be true. The ace inhibitors do it for a short period of time but after several months, the aldosterone levels rise way above normal and begin to exert all their bad effects. JIM LEHRER: Okay. So, when did you start your new study with Aldactone, and why did you start it? What caused you I think, my goodness, hey, let's go back to Aldactone and try it on heart failure patients? DR. BERTRAM PITT: Well, there were observations many years ago by an investigator in Belgium actually in patients with heart failure who was using one of the ace inhibitors in patients and found that despite the fact they gave very good doses of the ace inhibitor, that the aldosterone levels were rising. And they didn't get rid of aldosterone. And that was a clue to us that we needed to do something else. We had done a lot of the studies with ace inhibitors and we saw that although we had good benefits, still people were dying, still people had recurrent heart failure and were hospitalized. JIM LEHRER: All right. Now, how many people were involved in your study? DR. BERTRAM PITT: We had a little over 1,600 patients with severe heart failure studied in many countries around the world. JIM LEHRER: And what are the results? DR. BERTRAM PITT: Well, the results are pretty dramatic. On top of standard therapy, the patients who got this drug, Aldactone, had an improvement in survival by 30 percent, and they had a reduction in their incidence of hospitalization for heart failure of 36 percent. And they said they felt better and less people said they felt worse. So this was a pretty dramatic and pretty uniform finding. JIM LEHRER: Over what period of time did you run this study? DR. BERTRAM PITT: The mean follow-up of these patients was about two years. Actually, we had planned to go further almost about another year and a half, but last August the trial was prematurely stopped because the patients were felt to be at great risk by continuing them on standard therapy.
	Early definitive results
	JIM LEHRER: So you decided we've got the results that are so good so let's stop it and get on with it? DR. BERTRAM PITT: Yes. There was an independent group of physicians who were monitoring the study who were unblinded to the results. I was blinded at the time. JIM LEHRER: What does that mean? DR. BERTRAM PITT: I couldn't tell who was getting the drug and who was getting a placebo. But there was a group of people around the world who were watching, and they knew exactly what was happening. And they felt that it would be unethical to go on and expose patients to great risk without receiving this drug. JIM LEHRER: You mean the people who were taking the placebo were the ones who were going to be at risk because you'd go ahead and give them the medicine now - DR. BERTRAM PITT: Absolutely. They felt we shouldn't keep using the standard therapy. We should add Aldactone to the standard therapy. JIM LEHRER: All right. Now, is this something that can this be done tomorrow by any doctor in the world? DR. BERTRAM PITT: Absolutely, because this drug has been around, it's available, and it's very inexpensive throughout the world. JIM LEHRER: Like what? DR. BERTRAM PITT: Well, it costs pennies a day. It varies obviously. It's made by Searle Pharmaceuticals but there are many copies around the world, and I think it costs probably about a dime a day or something like that.
	Exciting development for doctors
	JIM LEHRER: This must be awfully exciting for you? DR. BERTRAM PITT: It is. It's been very exciting because most of our colleagues really didn't believe that this would be effective. And if you look at most of the studies of heart failure, maybe about 1 percent of patients were really receiving this drug. So this is going to have a major impact around the world. And you probably know that in the elderly at least, that heart failure is the most common form of hospitalization and the most expensive. So the ability to reduce hospitalization should have a major impact on health care expenditures throughout the world. JIM LEHRER: Give as you feel for how many people we're talking about here in the United States. DR. BERTRAM PITT: Well, there are probably about four to five million people who have heart failure in the United States. And, of those, I would say probably about a quarter have severe heart failure. So that's the group that we're particularly focused on with this study. JIM LEHRER: And if this study holds true with the practical application for all these people, that means that 30 percent of them are going to live a lot longer. DR. BERTRAM PITT: Exactly right. JIM LEHRER: How many people were in your team who did all of this? DR. BERTRAM PITT: Well, there are several hundred investigators around the world who cooperated and it was in Europe, the United States, South America, Japan. So this was really a worldwide study. JIM LEHRER: Well, Dr. Pitt, congratulations to you and to all of them. DR. BERTRAM PITT: Thank you very much. JIM LEHRER: Thank you for being with us.