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JAMA Intern Med. 2015 May;175(5):691-700. doi: 10.1001/jamainternmed.2015.0289.

Safety and benefit of discontinuing statin therapy in the setting of advanced, life-limiting illness: a randomized clinical trial.

Author information

1
Department of Medicine, University of Colorado School of Medicine, Aurora.
2
Department of Biostatistics and Informatics, Colorado School of Public Health, Denver.
3
Sanford School of Public Policy, Duke University, Durham, North Carolina.
4
San Francisco Veterans Affairs Medical Center, Center for Research on Aging, Jewish Home of San Francisco, San Francisco, California5Division of Geriatrics, Department of Medicine, University of California, San Francisco.
5
Four Seasons Compassion for Life, Flat Rock, North Carolina.
6
Division of Geriatric Medicine, University of North Carolina, Chapel Hill.
7
Center for Learning Health Care, Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.
8
Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, North Carolina.
9
National Institute of Nursing Research, National Institutes of Health, Bethesda, Maryland.
10
Discipline, Palliative, and Supportive Services, Flinders University, Adelaide, Australia.
11
Department of Nursing Research, City of Hope Medical Center, City of Hope, California.
12
Department of Medicine, Washington University in St Louis, St Louis, Missouri.
13
Division of Hematology/Oncology, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison.
14
Department of Medicine, Phoenix Veterans Affairs Health Care System, Phoenix, Arizona.
15
Veterans Affairs Geriatric Research, Education, and Clinical Center, Birmingham Veterans Affairs Medical Center, Birmingham, Alabama17Division of Gerontology, Geriatrics, and Palliative Care, University of Alabama at Birmingham.
16
Hospice Analytics, Denver, Colorado.
17
The Denver Hospice, Denver, Colorado.
18
Department of Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
19
Department of Medicine, University of California, San Francisco.
20
Metropolitan Jewish Health System, Hospice and Palliative Care, New York, New York.
21
Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, Ohio.
22
Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota.
23
Department of Medicine, Mayo Clinic, Rochester, Minnesota.
24
Department of Hospice and Palliative Medicine, OhioHealth, Columbus.

Erratum in

Abstract

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.

PMID:
25798575
PMCID:
PMC4618294
DOI:
10.1001/jamainternmed.2015.0289
[Indexed for MEDLINE]
Free PMC Article

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