Completion of an advance care planning (ACP) process and/or an advance directive should result in patients receiving the care they desire at the end of life. However, three decades of research have shown that is just not the case. ACP has been a front runner in developing the science within palliative care. Some positive outcomes such as lowering levels of surrogate grief may be associated with ACP. Yet, it does not appear that further ACP research will ensure that seriously ill patients will get goal-concordant care. An unfortunate consequence of palliative care research and advocacy so far is the misguided notion of many hospital systems trying to solve their palliative care problems by only implementing an ACP initiative. At best, ACP is but one tool in the collective palliative care toolbox. New tools are needed. Given that we have finite resources, future research should focus more on tools to improve symptom management, better models of care, and systems that will ensure goal-concordant care that meet the needs of the population that the health care system is designed to meet.

Importance

For patients with limited prognosis, some medication risks may outweigh the benefits, particularly when benefits take years to accrue; statins are one example. Data are lacking regarding the risks and benefits of discontinuing statin therapy for patients with limited life expectancy.

Objective

To evaluate the safety, clinical, and cost impact of discontinuing statin medications for patients in the palliative care setting.

Design, setting, and participants

This was 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. The study was conducted from June 3, 2011, to May 2, 2013. All analyses were performed using an intent-to-treat approach.

Interventions

Statin therapy was withdrawn from eligible patients who were randomized to the discontinuation group. Patients in the continuation group continued to receive statins.

Main outcomes and measures

Outcomes included death within 60 days (primary outcome), survival, cardiovascular events, performance status, quality of life (QOL), symptoms, number of nonstatin medications, and cost savings.

Results

A total of 381 patients were enrolled; 189 of these were randomized to discontinue statins, and 192 were randomized to continue therapy. Mean (SD) age was 74.1 (11.6) years, 22.0% of the participants were cognitively impaired, and 48.8% had cancer. The proportion of participants in the discontinuation vs 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 noninferiority 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.

Conclusions and relevance

This pragmatic trial suggests that stopping statin medication therapy is safe and may be associated with benefits including improved QOL, use of fewer nonstatin medications, and a corresponding reduction in medication costs. Thoughtful patient-provider discussions regarding the uncertain benefit and potential decrement in QOL associated with statin continuation in this setting are warranted.

Trial registration

clinicaltrials.gov Identifier: NCT01415934.