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Clinical Trials Need Your Help

Tremendous advances over the past two decades have improved the survival rate and quality of life of heart attack victims. But continued advancement among older people is uncertain because in many research trials they are underrepresented, and we lack information about how they respond to new treatments.

Why the low participation rate? Older people may choose not to join clinical trials, or physicians may not make patients aware of them. Whatever the reason, the lack of knowledge is a chronic problem in treating older people. From 1991 to 2000, for example, only 9 percent of patients in trials of treatments for acute heart conditions were over 75, even though 40 percent of heart attack patients are in this age group, according to a study in the Journal of the American Medical Association.

Learning how older people respond to certain drugs and procedures becomes more important as the 60-plus segment of the population grows. President Bill Clinton tried to address this in 2000 when he directed Medicare to encourage beneficiaries to sign up for clinical trials and to begin reimbursing routine care costs of trial participants.

More specifically, low participation can adversely affect care for the older heart attack survivor. A case in point: Beta-blockers are universally recommended because doctors know they improve survival rates. But even though we believe the drugs may be even more effective for older people, they are not prescribed as frequently. That’s because beta-blockers may slow the heart rate—a condition common even in older people who haven’t had a heart attack—to a dangerous level.

A new clinical trial—the PACEmaker and Beta-blocker Therapy After Myocardial Infarction (PACE-MI) trial, sponsored by the National Institutes of Health—involves implanting a pacemaker to prevent the potentially dangerous slowing of the heart rate. It may demonstrate that the benefits of beta-blocker therapy will outweigh the small risks related to having a pacemaker. The survival of patients getting the new treatment will be compared to the survival of a standard treatment group. (To learn more about the trial or to enlist, go to www.pace-mi.org. For general information, go to NIH’s website www.clinicaltrials.gov.)

One of the greatest benefits of clinical trials is that the knowledge gained can be applied to perhaps millions of patients—in this case, the 1.2 million Americans who have heart attacks each year. While the ability to contribute to this new knowledge may be appealing, many older people who don’t see the benefit to them of participating simply won’t. While there are no guarantees about the outcomes of research studies, there is at least one potential benefit for participants: They are monitored and evaluated more frequently, typically by experts in the field of investigation, which could lead to better medical attention.

Ultimately, the decision to participate in a clinical trial is a personal one. Because the safety of individuals who choose to do so is of prime importance to everyone involved in the research, an independent group of physicians is appointed to oversee safety issues. Working together, patient volunteers, their physicians, investigators and the oversight agencies can continue to identify new ways to help older people who have had a heart attack.

Jeffrey Goldberger, M.D., is professor of medicine at Northwestern University’s Feinberg School of Medicine.

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