1. Goodwin, Peter

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CHICAGO-Patients with advanced cancer and a life expectancy between a month and a year lived just as long, had better quality of life, and needed less medications overall when statin therapy was discontinued, compared with patients who continued statins, according to a study reported here at the American Society of Clinical Oncology Annual Meeting (Abstract #LBA9514).

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Amy P. Abernethy, MD, PhD, a palliative care specialist and Professor of Medicine at Duke University Medical Center, explained that she and her co-researchers decided to conduct the study because the risks of continuing with any medication might theoretically outweigh the benefits and that in the case of HMG Co-A reductase inhibitors (statins), the benefits might take years to accrue and not be relevant for someone with a limited prognosis.


Additionally she noted that despite the common belief that near the end of life it is not necessary to continue medications for chronic illnesses that are not life-threatening, there has been no guidance: "And for people who have less than a year to live one of the critical questions is: Which medicines can we discontinue-and do so safely?" she said.


The study included 381 patients with life-limiting illness (49 percent of whom had cancer) who had been taking statins for primary or secondary cardioprevention for at least three months. Patients were randomized to either discontinue (189 patients) or continue (192 patients) the lipid-lowering therapy.


Sixty-day mortality was not statistically different between the two groups: 20.3 percent died in the group taken off statins versus 23.8 percent in the control group. And patients who stopped statins lived longer-a median of 229 days versus 190 days.


Abernethy said that quality of life was 10 percent better on average-with fewer symptoms-among patients who discontinued statins. Additionally there was a statistically significant reduction in the total overall number of medicines-beyond just statins-to an average of 10.1 per patient in those no longer taking statins compared with 10.8 different medicines per patient in those who continued. Abernethy described these differences in secondary outcome measures as: "very important."


Few Cardiovascular Complications

The study found few cardiovascular complications in either group-13 in the patients who discontinued statins compared with 11 in the patients who continued. Another key finding was an estimate that end-of-life statin withdrawal could theoretically reduce treatment costs in the United States by about $600 million a year.


Abernethy said the team had previously surveyed some 5,000 palliative care doctors in the United States, and found that certain other long-term medications could also be candidates for possible discontinuation, such as bisphosphonates and anticoagulants. "This study sets up a platform where we can now ask sequential questions about discontinuing other medicines," she said.


"For doctors, one of the important guidelines is to stop and look and have the conversation with patients about any accumulation of drugs." Since these patients were often losing weight, were less able to swallow, and had metabolic changes, having conversations with primary care doctors and other specialists was important: "Doctors and patients together can now feel more confident about making a decision to discontinue statins in the end-of-life setting."


In summary, she said, "for people who have a prognosis of a year or less and are taking statins for primary or secondary prevention, there is not any increased harm to discontinuing statins-and in fact there may be improved quality of life."


Gregory A. Masters MD, a member of ASCO's Clinical Practice Committee and a designated ASCO expert, commented: "We don't want to be giving long-term medications that may have toxic effects. This study provides scientific evidence that statins can be withdrawn safely: A patient may not need to be on statins in the last year of life-certainly not in the last few months of life."


He agreed that other drugs were also candidates for discontinuation: "Any drugs that are aimed at long-term outcomes-beyond a year, certainly beyond five years-probably can be scaled back near the end of life."

AMY P. ABERNETHY, MD... - Click to enlarge in new windowAMY P. ABERNETHY, MD, PHD. AMY P. ABERNETHY, MD, PHD: "This study sets up a platform where we can now ask sequential questions about the possibility of discontinuing other long-term medicines."

Also commenting, Patricia Ganz, MD, FASCO, and Director of Cancer Prevention and Control Research at UCLA's Jonsson Comprehensive Cancer Center, said that prior to this study there had actually not been much research that looked into discontinuing chronically administered medications near the end of life and that while no one wanted to "rock the boat," this situation had now changed: "Now we have evidence that discontinuing certain medications is safe-specifically in the case of the widely prescribed statin drugs-and can improve quality of life for patients," she said.