Statins: Discontinue in terminal illnesses

Discontinuing statin use in patients with late-stage cancer and other terminal illnesses may help improve patients’ quality of life without causing other adverse health effects, according to a study published in JAMA Internal Medicine.

Led by researchers at the University of Colorado Anschutz Medical Campus and Duke University and funded by the National Institute of Nursing Research (NINR), the study showed that care for patients with advanced illness can be improved by discontinuing some therapies that are primarily preventive for other health concerns.

Jean Kutner, MD, MSPH, professor of medicine at the University of Colorado School of Medicine, and colleagues conducted a multicenter, parallel-group, unblinded, pragmatic clinical trial. Eligibility included adults with an estimated life expectancy of between 1 month and 1 year, statin therapy for 3 months or more for primary or secondary prevention of cardiovascular disease, recent deterioration in functional status, and no recent active cardiovascular disease. Participants were randomized to either discontinue or continue statin therapy and were monitored monthly for up to 1 year.

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The proportion of participants in the discontinuation versus continuation groups who died within 60 days was not significantly different (23.8% vs 20.3%; 90%CI, −3.5% to 10.5%; P=.36) and did not meet the non-inferiority end point. Total QOL was better for the group discontinuing statin therapy (mean McGill QOL score, 7.11 vs 6.85; P=.04). Few participants experienced cardiovascular events (13 in the discontinuation group vs 11 in the continuation group). Mean cost savings were $3.37 per day and $716 per patient.  This pragmatic trial suggests that stopping statin medication therapy is safe and may be associated with benefits including improved QOL, use of fewer non-statin medications, and a corresponding reduction in medication costs.

Dr Kutner

“Thoughtful patient-provider discussions regarding the uncertain benefit and potential decrement in QOL associated with statin continuation in this setting are warranted,” said Dr Kutner.

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This study provides evidence that suggests that survival is not affected when statins prescribed for primary or secondary prevention of cardiovascular disease are discontinued in this population, she said.

“Although the cost savings identified were modest, the data suggest that statin therapy discontinuation in selected patients may improve quality of life at reduced aggregate healthcare cost,” Dr Kutner said. “Given the value and symbolism that patients may ascribe to preventive chronic medications and the importance of prognosis in timing this decision, the choice to continue or stop therapy with statin medications merits patient-centered decision making between the physician and the patient. Additional research exploring the use of other medications [eg, anticoagulants, anti-hypertensives, or oral hypoglycemic] in populations with limited life expectancies is needed.”

The findings should be used to inform shared decision making between clinicians and patients, according to Dr Kutner.

“Managed care and hospital decision makers should take an active role in disseminating study findings and facilitating shared decision making. Managed care and hospital decision makers can also take advantage of clinical and administrative databases to both track impact of the findings on clinical practice and on real-world patient outcomes.

“In addition, given the dearth of evidence to inform clinical decision making regarding use of other chronic preventive medications in the setting of limited life expectancy, managed care and hospital decision makers can contribute to the evidence through sharing of clinical and administrative data with investigators to inform future studies,” Dr Kutner added.

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