Stopping statins may benefit terminally ill patients

May 30, 2014

CHICAGO - People in the late stages of cancer and other terminal illnesses are not only unharmed by discontinuing statins for cholesterol management, they may benefit, according to a study presented Friday by researchers at Duke Medicine representing a national research network.

The finding addresses a thorny question in treating people with life-limiting illnesses: When, if ever, is it appropriate to discontinue medications prescribed for other conditions that will likely not lead to their death?

In an analysis presented at the American Society of Clinical Oncology annual meeting in Chicago, the researchers reported that discontinuing statins in patients with advanced illnesses resulted in improved overall quality of life, lower costs and no increased deaths. In fact, the patients who stopped taking statins appeared to live slightly longer.

"When you look at the number of medications people take when they are dying, it doubles in the last year of life," said lead author Amy Abernethy, M.D., Ph.D., director of the Center for Learning Health Care at the Duke Clinical Research Institute and a member of the Duke Cancer Institute. Abernethy represented the Palliative Care Research Cooperative Group, a national research network focused on improving care for people with serious illnesses.

"Cancer patients, for example, take medications for pain, nausea and other problems associated with advanced disease," Abernethy said. "Many don't have an appetite, and simply swallowing medications can be a problem. So the issue is whether some longstanding medications such as cholesterol-lowering drugs might be safely discontinued, but there has been little research to help guide clinicians in making that recommendation."

Abernethy said the researchers identified statins as a good candidate to explore the issue, because the drug is widely prescribed and benefits can take years to accrue. Other drugs the researchers could eventually study include medications for blood pressure and blood clots.

In their study of statins, Abernethy and colleagues enrolled 381 patients who faced the likelihood of dying within a year. All patients had been taking statins for at least three months; roughly half were randomized to continue taking the drug, the other half to discontinuing it.

The researchers followed the patients for up to a year to monitor survival, cardiovascular events and changes in quality of life.

Among the 192 study patients who continued statins, the median survival was 190 days; the 192 participants who stopped taking the drugs had a median survival of 229 days.

Those who discontinued the drugs reported a better overall quality of life, particularly in their psychological wellbeing, and saved money: $716 per person over the course of the trial for name-brand drugs, and $629 for generics.

Using U.S. population estimates, the researchers reported that as much as $603 million a year could be saved if patients in the late stages of fatal illnesses were to cut out statins.

"This is a decision that needs to be discussed between patients and their doctors; it's not something that should be done independently or in a one-size-fits-all manner," Abernethy said. "But our study found that patients who discontinued statins reported improvements in quality of life. This runs counter to the idea that discontinuing a treatment would cause people to somehow feel as if they were getting less care or inadequate care."

Abernethy is a leading advocate for extending palliative care -- extra support from care teams to relieve both pain and improve quality of life -- to patients facing life-limiting illnesses. She said findings from this study should force new discussions.

"These are conversations that need to be had," she said. "This brings us to a new era of asking how to right-size care, and how to bring evidence to that issue. There is an important message here that taking things away isn't always bad."
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In addition to Abernethy, study authors include Don Taylor at Duke, along with Jean Kutner, Diane Fairclough and Patrick J. Blatchford at the University of Colorado; Laura Hanson at the University of North Carolina; Christine Ritchie at the University of California, San Francisco; and Janet Bull, Four Seasons.

The National Institute of Nursing Research provided funding for the study (UC4-NR012584, U24-NR014637).

Duke University Medical Center

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