March 30th, 2011

Many Elderly Patients Excluded from Heart Failure Trials

Despite the large and growing burden of heart failure in the elderly population, older people are often excluded from heart failure clinical trials. In a paper in the Archives of Internal Medicine, Antonio Cherubini and colleagues  examined 251 heart failure trials and found that a quarter of the trials excluded patients by an arbitrary upper age limit, while 43% included poorly justified exclusion criteria that might have reduced the number of older subjects.

The authors write that “the discrepancy between the patients evaluated in most” clinical trials and the real world patient population “is particularly marked in the field of HF, a condition common in older age.” They observe that only a relatively small number of elderly hospitalized HF patients would have been eligible for the landmark clinical trials that established the current standard of care for these patients.

In an accompanying commentary, Jerry Gurwitz and Robert Goldberg propose several initial steps to improve the evidence base of care for older heart patients:

  1. “Eliminate arbitrary age-based exclusions in cardiovascular clinical trials;
  2. “Require strong justification for exclusion criteria that could adversely affect the inclusion of older individuals, including those criteria relating to comorbidity, medication use, and functional and cognitive impairment;
  3. “Encourage the design and conduct of RCTs specific to older individuals through targeted funding; and
  4. “Report and publicize trends in the inclusion of elderly patients in cardiovascular clinical trials to assess progress in improving the generalizability of research findings to this high-risk population.”

2 Responses to “Many Elderly Patients Excluded from Heart Failure Trials”

  1. Robin Motz, M.D., Ph.D. says:

    The problem with including older individuals in clinical trials, is that we prefer our case patients to be pharmacologically naive, and the older a patient is, the more drugs they have been prescribed. This complicates setting up treatment vs. control panels. If the study is a 2 year study, there is an almost 50% chance that another drug will be added to an individual patient’s regimen, and this makes it even more difficult to keep the two groups evenly matched.

  2. I apologize for disagreeing but the patients that you and I find in daily practice are different from the ones I and you would like to have to include in the research paper that we are planning. Here is an example of a group of the usual patients that were described while investigating what happened to the treatment prescribed for their Atrial Fibrillation. From a post by Mr. Ed Susman from, in an article on the subject of AF Rx…”What we found was that, in general, the patients who were treated with amiodarone were sicker than those who were treated with sotalol,” (Dr.) Lin (paper’ author) said. “Their conditions might also have played a role in treatment cessation”. “The patients on amiodarone tended to discontinue treatment earlier and more frequently than those on sotalol,” he added.

    (Dr.) Lin said the research could not explain whether discontinuation was related to side effects or lack of efficacy or other considerations.

    “What this study shows,” said Nanette Wenger, MD, professor of medicine at Emory University in Atlanta, “is that real world patients are very different than what is seen in clinical trials.

    “These patients are older and sicker than the ones reported in trials. These studies are important because they give us an idea of what is really happening in the community setting,” Wenger told MedPage Today.

    “The FDA likes to have clean outcomes in trials, but they really should be doing more studies with patients that doctors are likely to see in the community,” she said.

    Posted today in page. Primary source: American College of Cardiology meeting
    Source reference:
    Kim M, et al “Amiodarone and sotalol in atrial fibrillation: Treatment persistence and occurrence of adverse events in the real-world setting pathway” ACC 2011; Abstract 1134-148.

    Competing interests pertaining specifically to this post, comment, or both: