Discontinuing Statins in Late-Stage Cancer Patients

Amy P. Abernethy, MD, PhD

Patients starting palliative care for advanced cancer are often already on repeat prescriptions of statins to lower cholesterol and reduce risk of a heart attack or stroke, and many of these patients continue on statin therapy until death. This may contribute additional burden to these patients, because side effects from statin use include muscle pain, liver damage, digestive problems, rash/flushing, increased blood sugar levels, and memory loss/confusion, and patients with late-stage cancer are at a greater risk for adverse reactions from statins.

Amy P. Abernethy, MD, PhD, medical oncologist and palliative medicine specialist at the Duke Clinical Research Institute, thinks it is important to carefully consider whether or not a patient, who may be in the final stages of his or her life, should be continued on statins.

“The number of pills in our pill cup doubles at the end of life,” said Abernethy during a briefing on palliative care at the 2014 ASCO Annual Meeting. “For people with life-threatening illness, optimal management of those medications, including which ones we can discontinue, is a critical question about which we are uncertain.”

On behalf of the Palliative Care Cooperative Group, Abernethy presented results from a multisite randomized controlled trial that studied the effects of continuing versus discontinuing statins in the setting of life-limiting illness. The trial was funded by the National Institute for Nursing Research. Abstract LBA9514

“The question at hand is,” said Abernethy “Is it safe to discontinue statins for the patient with less than a year to live?”

Participants in the study (n = 381) were randomized (1:1) to discontinue or continue their statin medication. Adult patients, with a mean age of 74 years and a life expectancy greater than 1 month, with decreased performance status, were included in the study. Patients needed to be on a statin for ≥3 months for the purposes of primary or secondary prevention to qualify for the study.

Outcomes, which were measured at baseline and at least monthly, included survival, cardiovascularrelated events, quality of life (QOL), symptoms, and number of medications. The primary outcome of the study was rate of death within 60 days of randomization. Cost was also a consideration in the study, according to Abernethy.

Almost half of the patients in the study had cancer as their primary diagnosis. Sixty-nine percent of them had used statins for more than 5 years.

Upon analysis, the rate of death within 60 days was similar between the group that continued on statins compared with the group that discontinued statin therapy.

The group discontinuing statins had longer median time-to-death (229 days [90% CI, 186-332] vs 190 days [90% CI, 170-257]; P = .60). The total QOL was significantly better among the group discontinuing statins, and patients in this group experienced fewer symptoms.

Patients who discontinued statins took significantly fewer medications (10.1 vs 10.8; P = .034) and experienced decreased symptoms. Interestingly, few participants in either group experienced cardiovascular events (13 vs 11).

The study authors concluded that in the setting of life-limiting illness such as advanced cancer, it is unlikely that harm will accrue when statins being used for primary or secondary prevention are discontinued. In fact, the authors continued, these patients may even benefit.

According to Abernethy, savings on average equaled $3.37 per patient/per day, which came to an average of $716 per patient. Using a 2014 population estimate, she equated this to about $630 million saved if the discontinuation of statins occurred during the last year of life for these patients, and by 2040, the savings would equate to approximately $1 billion.

Despite the overall benefits, Abernethy feels that the decision remains a personal one.

“We still think that this is a patient-centered decision where clinicians and patients together talk about what to do. However, as clinicians, we can now feel confident that we are not harming our patients by making this decision.”

Nurse Perspective

Kristin Barber, RN, MSN, APRN

Utah Cancer Specialists

Salt Lake City, UT

Although statins are a staple of modern-day medicine and have significantly reduced cardiovascular disease in the primary care setting, when we have an incurable oncology patient who has exhausted his or her therapies, there may be multiple medications that are no longer helping and may even be harming patients.

I completely agree that when initiating palliative care, it is important to take a look at the patient’s medications. Unfortunately, when you tell a patient they can stop their cholesterol medication, they think you are killing them. The study done by the National Institute for Nursing Research gives us the evidence to tell patients that not only are we not hastening their death, we may be improving quality of life, side effects, and out-of-pocket costs. All of this can be done while safely discontinuing the drug. The fact that the patient is also able to save approximately $716 offers another incentive.

Cancer is quite expensive for all patients, and to be able to confidently tell them there was no increased risk of death in the group that stopped their cholesterol medication is imperative. The article does conclude by stating that ultimately even with the new findings, that it is still the patients’ decision whether or not to take the medication. I think this is a fundamental principle in palliative care.