CHICAGO, IL USA (Press Release) - May 30, 2014 - New findings from a federally funded randomized study indicate that it is safe to stop statin therapy in patients with a life expectancy of less than a year. Discontinuing statins did not shorten survival, and provided a number of important benefits, including reduced pill and symptom burden and improved overall quality of life.
“Many doctors argue that, near the end of life, it is not necessary to continue medications for chronic illnesses that are not life-threatening. But we have no guidance on what medicines to stop and when to do so,” said lead study author Amy P. Abernethy, MD, PhD, a medical oncologist and palliative care specialist at Duke University Medical Center in Durham, NC. “Our study provides the first evidence that stopping statins is safe and improves patient quality of life.”
The number of medications patients take doubles in the last year of life for those with terminal illnesses. This means patients are taking 10 or more different pills per day – a big burden for patients who frequently have difficulty swallowing and poor appetite. An additional problem is that the side effects of each medication accumulate, and new side effects can appear when multiple drugs are taken together. Furthermore, interactions between drugs can reduce the efficacy of individual treatments.
This study included 381 patients with life-limiting illness (49 percent had cancer) and a life expectancy of one month to one year, who had been taking a statin for at least three months. Statins are cholesterol-lowering drugs prescribed to reduce the risk of heart attacks and strokes. The most common side effects of statins are headache, difficulty sleeping, muscle aches, drowsiness, and dizziness. Patients were randomly assigned to either continue or discontinue statin therapy.
Researchers found that discontinuing statins was safe. Few patients in either group experienced cardiovascular complications (13 in the group that discontinued vs. 11 in the group that continued). The rate of death within 60 days was not significantly different between the two groups (20.3 percent vs. 23.8 percent), and the group that discontinued statins even had a longer median time-to-death (229 days vs. 190 days).
Patients who discontinued statins had a substantially better total quality of life (about a 10 percent improvement on a standard scale) and tended to have fewer symptoms. They also took fewer medications overall compared to patients who continued statins (10.1 vs. 10.8).
Researchers estimate $603 million would potentially be saved in the United States if all people with a life expectancy of a year or less, similar to the group involved in this study, were to discontinue statins. However, Dr. Abernethy noted, discontinuing statins is not appropriate for every patient, and the decision should be made on an individual patient basis.
This research was supported by the National Institute of Nursing Research, National Institutes of Health.
“Discontinuing chronically administered medications near the end of life has limited study. No one wants to ‘rock the boat’ at this stage of life, and continuing medications that have no benefit for prevention of future disease generally makes sense in this situation,” said Patricia Ganz, MD, FASCO, ASCO Expert. “However, 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.”
Relevant links from Cancer.Net, the oncologist-approved cancer information website from the American Society of Clinical Oncology:
- Advanced Cancer Care Planning
- Chronic Conditions: When Cancer Is Not Your Only Health Concern
- Hospice Care
Relevant links from CancerProgress.Net, the home of ASCO's 50th Anniversary and progress made against 18 of the most common cancers:
Title: Managing comorbidities in oncology: A multisite randomized controlled trial of continuing versus discontinuing statins in the setting of life-limiting illness.
Authors: Amy Pickar Abernethy, Jean Kutner, Patrick Jud Blatchford, Christine Ritchie, Diane Fairclough, Laura Hanson, Janet Bull, PCRC Investigators
Duke University Medical Center, Durham, NC; University of Colorado Denver, Denver, CO; University of California, San Francisco, San Francisco, CA; The University of North Carolina at Chapel Hill, Chapel Hill, NC; Four Seasons Hospice, Flat Rock, NC
Background: For patients with life-threatening illness such as advanced cancer, optimal management of longstanding medications prescribed for comorbid illness is uncertain. Risks may outweigh benefits; e.g., benefits from HMG Co-A reductase inhibitors (“statins”) may take years to accrue and may not be relevant for a person with limited prognosis. Is it safe to discontinue statins for the patient with less than a year to live?
Methods: This was a multicenter, unblinded pragmatic trial. At enrollment, participants were randomized (1:1) to discontinue or continue their statin medication. Eligible patients were adults with advanced life-limiting illness on a statin for ≥3 months for primary or secondary prevention, a life expectancy of greater than one month, and evidence of recent deterioration in performance status. Outcomes measured at baseline and at least monthly included survival, cardiovascular-related events, quality of life (QOL), symptoms, and polypharmacy. Rate of death within 60 days of randomization was the primary outcome.
Results: 381 patients were enrolled (189 discontinue statins; 192 continue statins). Mean age was 74 years (SD 12); 22% were cognitively impaired; 49% had cancer as the primary diagnosis; and, 69% had used statins for >5 years. Rate of death within 60 days was not statistically different between groups (discontinue vs. continue, 23.8% vs. 20.3%, 90% CI -3.5% to 10.5%, p=0.36). The group discontinuing statins had longer median time-to-death (229 days [90% CI 186–332] vs. 190 days [90% CI 170-257]; p=0.60). Total QOL was significantly better among the group discontinuing statins (McGill QOL: 7.11 vs. 6.85, p=0.037) and there were fewer symptoms in this group (Edmonton Symptom Assessment Scale: 25.2 vs. 27.4, p=0.128). People in the discontinue statins group took significantly fewer medications (10.1 vs. 10.8, p = 0.034). Few participants in either group experienced cardiovascular events (13 vs. 11).
Conclusions: 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; these patients may even benefit.
Disclosures: Nothing to disclose
Research Funding Source: NIH
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