title: Safety and benefit of discontinuing statin therapy in the setting of advanced, life-limiting illness: a randomized clinical trial.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  Statin therapy was withdrawn from eligible patients who were randomized to the discontinuation group. Patients in the continuation group continued to receive statins.
  
  
  METHODS
  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
  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.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT01415934.
authors: Department of Medicine, University of Colorado School of Medicine, Aurora.
authors: Jean S
authors: JS
authors: Kutner
authors: Department of Biostatistics and Informatics, Colorado School of Public Health, Denver.
authors: Patrick J
authors: PJ
authors: Blatchford
authors: Sanford School of Public Policy, Duke University, Durham, North Carolina.
authors: Donald H
authors: DH
authors: Taylor
authors: 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.
authors: Christine S
authors: CS
authors: Ritchie
authors: Four Seasons Compassion for Life, Flat Rock, North Carolina.
authors: Janet H
authors: JH
authors: Bull
authors: Department of Biostatistics and Informatics, Colorado School of Public Health, Denver.
authors: Diane L
authors: DL
authors: Fairclough
authors: Division of Geriatric Medicine, University of North Carolina, Chapel Hill.
authors: Laura C
authors: LC
authors: Hanson
authors: Center for Learning Health Care, Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.
authors: Thomas W
authors: TW
authors: LeBlanc
authors: Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, North Carolina.
authors: Greg P
authors: GP
authors: Samsa
authors: Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, North Carolina.
authors: Steven
authors: S
authors: Wolf
authors: National Institute of Nursing Research, National Institutes of Health, Bethesda, Maryland.
authors: Noreen M
authors: NM
authors: Aziz
authors: Discipline, Palliative, and Supportive Services, Flinders University, Adelaide, Australia.
authors: David C
authors: DC
authors: Currow
authors: Department of Nursing Research, City of Hope Medical Center, City of Hope, California.
authors: Betty
authors: B
authors: Ferrell
authors: Department of Medicine, Washington University in St Louis, St Louis, Missouri.
authors: Nina
authors: N
authors: Wagner-Johnston
authors: Center for Learning Health Care, Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.
authors: S Yousuf
authors: SY
authors: Zafar
authors: Division of Hematology/Oncology, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison.
authors: James F
authors: JF
authors: Cleary
authors: Department of Medicine, Phoenix Veterans Affairs Health Care System, Phoenix, Arizona.
authors: Sandesh
authors: S
authors: Dev
authors: 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.
authors: Patricia S
authors: PS
authors: Goode
authors: Center for Learning Health Care, Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.
authors: Arif H
authors: AH
authors: Kamal
authors: Hospice Analytics, Denver, Colorado.
authors: Cordt
authors: C
authors: Kassner
authors: 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.
authors: Elizabeth A
authors: EA
authors: Kvale
authors: The Denver Hospice, Denver, Colorado.
authors: Janelle G
authors: JG
authors: McCallum
authors: Department of Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
authors: Adeboye B
authors: AB
authors: Ogunseitan
authors: Department of Medicine, University of California, San Francisco.
authors: Steven Z
authors: SZ
authors: Pantilat
authors: Metropolitan Jewish Health System, Hospice and Palliative Care, New York, New York.
authors: Russell K
authors: RK
authors: Portenoy
authors: Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, Ohio.
authors: Maryjo
authors: M
authors: Prince-Paul
authors: Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota.
authors: Jeff A
authors: JA
authors: Sloan
authors: Department of Medicine, Mayo Clinic, Rochester, Minnesota.
authors: Keith M
authors: KM
authors: Swetz
authors: Department of Hospice and Palliative Medicine, OhioHealth, Columbus.
authors: Charles F
authors: CF
authors: Von Gunten
authors: Center for Learning Health Care, Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.
authors: Amy P
authors: AP
authors: Abernethy
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002318:Cardiovascular Diseases / Q000150:complications / Q000503:physiopathology / Q000517:prevention & control; D003072:Cognition Disorders / Q000150:complications / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage*; D008017:Life Expectancy; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy; D010166:Palliative Care / Q000379:methods*; D062072:Patient Acuity; D011379:Prognosis; D018570:Risk Assessment; D016896:Treatment Outcome; D028761:Withholding Treatment
chemical_list: D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors