Considering the Discontinuation of 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.¹This 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, and memory loss/confusion,²and patients with late-stage cancer are at a greater risk for adverse reactions from statins.¹

Amy P. Abernethy, MD, PhD, medical oncologist and palliative medicine specialist, 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 press briefing on palliative care that kicked off the 50^thAnnual Meeting of the American Society of Clinical Oncology. “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 trial³that 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.

“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, cardiovascular-related 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 (discontinue vs continue, 23.8% vs 20.3%, 90% CI:3.5%-10.5%,P= .36).

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 (McGill QOL Scale: 7.11 vs 6.85,P=.037), and patients in this group experienced fewer symptoms (Edmonton Symptom Assessment Scale: 25.2 vs 27.4,P=.128).

Patients that 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 patient/day, which came to an average of $716 per patient. Using a 2014 population estimate, she equated this to about 630 million dollars 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 a billion dollars.

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.”

References

1. Ballantyne CM, Corsini A, Davidson MH, et al. Risk for myopathy with statin therapy in high-risk patient. Arch Intern Med. 2003;163(5):553-564.
2. Mayo Clinic. Diseases and Conditions: High Cholesterol. Statin side effects: weight the benefit and risks.http://www.mayoclinic.org/diseases-conditions/high-blood-cholesterol/in-depth/statin-side-effects/art-20046013?pg=1. Accessed May 30, 2014.
3. Abernethy AP, Kutner J, Blatchford PJ, et al; Palliative Care Cooperative Group Investigators. A randomized study evaluating how discontinuing statins affects quality of life and other outcomes in patients with terminal cancer, and other illnesses. Presented at the Annual Meeting of the American Society of Clinical Oncology, May 30, 2014. Abstract LBA9514.

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