THE HEART OF THE MATTER
a special program of the National Emergency Medicine Association (NEMA) 

Week: 557.7 Guest: Stephen Soumerai, Sci.D., Harvard Medical School Topic: Old beta blockers shown best for heart attack victims Producer/Host: Steve Girard

HEART OF THE MATTER 24:00 PUBLIC AFFAIRS PROGRAM ( 2 segments 12:00 each)

NEMA: Welcome back to The Heart of the Matter. One quarter of all Americans over 65 suffer a heart attack, and in an article in a recent Journal of the American Medical Association, new statistics show these people might be better equipped for survival if more physicians take the old stand-by, Beta blockers, out of mothballs, and prescribe them...sometimes in place of the newer calcium channel blocker therapy. We're happy to have with us today Stephen Soumerai, a Doctor of Science in health policy, Associate Professor of ambulatory care and prevention at Harvard Medical School and Harvard Pilgrim Health Care...and who also directs the drug policy research group at both institutions. Dr. Soumerai, Beta blockers have been around for many years, but please give me a quick primer on the drugs....what they are and how they're put to use for people who have had a heart attack...

SOUMERAI: Well, there are quite a few beta blockers now that have been around for many years..and they're drugs that reduce the heart rate, reduce the blood pressure, and reduce the demand of the heart for oxygen, and therefore, really give the heart a break, in a way. They reduce potentially dangerous types of arrhythmias, and in the long term have been shown to reduce cardiac deaths and particularly sudden deaths, in younger people up until age 75, in the randomized control trials. But they have not been studied in terms of their effects on mortality and morbidity in older people, over age 75.

NEMA: Before we get into the structure and results of the study on beta blockers, it seems there has been some misinformation and concerns...many apparently without sufficient proof...that implicated beta blockers in causing complications...and has caused a lot of confusion. Tell me about that....

SOUMERAI: Starting particularly in the mid 80's, when the calcium channel blockers began to be promoted, physicians and perhaps the marketers of the alternative drugs began to question whether beta blocker therapy might produce side effects that could be prevented by prescribing another drug. And in fact, many physicians abandoned beta blocker therapy due to these concerns about side effects. I'm talking about things like fatigue, impotence, and actually, depression. However, the studies documenting these effects were often not very good in terms of their control for other variables. So, for example, in the mid to late 80's, several studies were published suggesting that beta blocker therapy would produce outright depression. These studies were based on one-time analyses, no analysis of exposure before and then a bad outcome after. So they were very crude studies, and yet, this kind of thinking filtered out into the physician community such that many physicians today, and even geriatric physicians, have a sort of knee jerk reaction that beta blocker therapy produces fatigue and depression, and don't even try the therapy on patients whose lives could be saved after a heart attack. What we know now is that, when we look at the randomized control trial evidence, and subsequent studies of depression, for example, that use much better research designs. We now know that these concerns were grossly exaggerated, in fact, earlier data suggesting that beta blocker therapy might increase the risk of depression two fold...when they were done correctly, there was absolutely no increase in risk of depression. That's not to say that beta blockers don't have some side effects... particularly if they're prescribed at too high a dose for older people. And what we now know, especially among cardiologists who use these drugs routinely, is if you use the lowest effective dose in the elderly, and you choose a beta selective agent, it's very unlikely that the side effects will be significant enough to interfere with treatment...and so that these people can actually benefit from the 40% reduction in risk of death or 22% reduction in the risk of a follow-up hospitalization for cardiovascular illness that we found in our study.

NEMA: Let's talk about the study specifically...how was it set up...and what was the actual reduction in risk for elderly people who've had a heart attack?

SOUMERAI: This was an unusual opportunity ...this study...in that we were able to link large databases on drug use on the elderly in New Jersey with the Medicare data on their hospitalization events for one year prior to their M.I....or their heart attack, and two years following their heart attack. And so we had a whole record of drug use, hospitalization, experience, diagnoses, procedures, etc... And it gave us a very rich experience to tap, for understanding the effects of these drugs in a population, particularly those over age 75, that had not been studied in the randomized trial. So, it was a great opportunity to look at this previously unstudied population, but important one. And what we found was that, surprisingly, despite the strong evidence in literature that beta blockers were life saving and reduced illness in all sorts of cardiac problems, only 21% of the elderly who survived a heart attack received even a trial ...one prescription of a beta blocker drug in the 3 months following their heart attack. And moreover, we found that those patients who received beta blockers were 43% less likely to die and had had 22% fewer cardiac hospitalizations over two years, than patients not receiving this therapy. Looking at the practical effect of this reduction of mortality in our population, we found that of 2,952 patients who did not receive beta blocker therapy, 886 died. Based on our estimates of lowering of risk due to beta blocker therapy, meant that 381 out of 886 of these deaths could have been prevented if they had received this treatment. And looking at this on a national basis translates to something on the order of 7 thousand to 10 thousand lives that could be saved each year....if these elderly patients were put on beta blockers soon after their heart attacks. The patients and their M.I.'s occurred in the late 80's and early 90's and we followed them through 1992. At that time, we found that patients often received newer calcium channel blockers instead of beta blockers...and that this doubled their risk of death. This was not because of a finding that calcium channel blockers were intrinsically dangerous...and that has been suggested in other studies that some types of calcium channel blockers may not be safe....that was not the goal of our study. What we found was that putting the patient on calcium channel blockers, they were 35% less likely to get a beta blocker, and this doubled their risk of death.

NEMA: With this information, it appears likely that many physicians may rethink their position on prescribing beta blockers....

SOUMERAI: Yes, in fact, the positive message here is that physicians are beginning to take a second look at these drugs, and if you start to look at the gross utilization statistics for beta blockers, since the early 90's, we're starting to see an upward creep in their utilization...although there's still a great amount of room to move in terms of preventing unnecessary morbidity and mortality. One very positive thing that has occurred recently, and as a result of this study, is that the national Hedis standards for reporting the quality of health care in managed organizations, are being changed. These are the so called report cards on quality for HMO's and other managed care organizations, that are being used to monitor quality in over 300 HMO's around the country...and now, as a result of seeing these data, they will measure whether heart attack survivors aged 75 and over, in addition to younger patients, receive beta blocker therapy. This is a major advance, I believe, and I think these organizations will have a huge incentive to increase beta blocker therapy and to set up the kinds of supports that physicians need to remind them that these old drugs are better than the new ones in terms of treating patients after a heart attack.

NEMA: Another benefit of beta blockers over calcium channel blockers seems to be that they're a lot less expensive...

SOUMERAI: That's right...in fact, at the Harvard Pilgrim Health Care HMO, the cost of beta blocker therapy for a month is sometimes as low as 2 dollars...and one has to compare that with the cost of the new calcium channel blockers that are between 30 to 50 dollars a month therapy...so we're talking about huge savings if the right drug is given to patients after a heart attack.

NEMA: They're effective, the claims of big side effects have been disproved, and they are very inexpensive. According to this new study, beta blockers...once relegated to the back of the shelf among the measures aimed at preventing recurring heart attacks and cardiac complications...seem now to be heading back to the front lines...to save lives. Our thanks to Stephen Soumerai, of Harvard Medical School and Harvard Pilgrim Health Care in Massachusetts.

And for more information, call 800-332-6362. I'm Steve Girard for The Heart of the Matter!