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Cited by 502Palliative Care and End-of-Life IssuesLipoproteins and Cardiovascular HealthPharmaceutical Practices and Patient Outcomes

Safety and Benefit of Discontinuing Statin Therapy in the Setting of Advanced, Life-Limiting Illness: A Randomized Clinical Trial

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Kutner, Jean S., Blatchford, Patrick J., Taylor, Donald H., Ritchie, Christine S., Bull, Janet H., Fairclough, Diane L., Hanson, Laura C., LeBlanc, Thomas W. +22 more·2015·JAMA Internal Medicine
DOI 10.1001/jamainternmed.2015.0289PMC PMC4618294
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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 INTERVENTIONS: Statin therapy was withdrawn from eligible patients who were randomized to the discontinuation group.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.

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  • In a multicenter trial, withdrawal of statins among people with diabetes in palliative care was found to improve quality of life.

    “In a multicenter trial, withdrawal of statins among people with diabetes in palliative care was found to improve quality of life (131-133).”

    From 13. Older Adults: <i>Standards of Care in Diabetes—2024</i> (2024) · cites this paper as [131]

    The Abstract Results report better total quality of life in the statin-discontinuation group (McGill score 7.11 vs 6.85; P = .04), and Methods > Patients describes enrollment across 15 palliative-care sites. The trial enrolled people with advanced, life-limiting illnesses, not specifically people with diabetes; the cited results do not establish a quality-of-life benefit for that subgroup. (LLM, conf=0.88)

    Experimental — accuracy not yet measured

  • In a multicenter trial, withdrawal of statins among people with diabetes in palliative care was found to improve quality of life.

    “In a multicenter trial, withdrawal of statins among people with diabetes in palliative care was found to improve quality of life (150-152).”

    From 13. Older Adults: Standards of Care in Diabetes—2025 (2025) · cites this paper as [150]

    The Results (page not provided) report better total quality of life in the statin-discontinuation group, and the Methods describe enrollment across 15 palliative-care sites. The finding is for the trial population as a whole; the paper does not report a quality-of-life result specifically for people with diabetes. (LLM, conf=0.88)

    Experimental — accuracy not yet measured

  • In a multicenter trial, withdrawal of statins among people with diabetes in palliative care was found to improve quality of life.

    “In a multicenter trial, withdrawal of statins among people with diabetes in palliative care was found to improve quality of life (171–173).”

    From 13. Older Adults: Standards of Care in Diabetes—2026 (2026) · cites this paper as [171]

    The Methods (Design and Patients; page unavailable) describe a multicenter trial of adults with advanced, life-limiting illness, without limiting eligibility to people with diabetes. The Results (page unavailable) report better total quality of life in the statin-discontinuation group, but do not establish that benefit specifically among participants with diabetes. (LLM, conf=0.90)

    Experimental — accuracy not yet measured

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Research works printed but not linked: 36

  1. [1]Currow DC Stevenson JP Abernethy AP Plummer J Shelby-James TM Prescribing in palliative care as death approaches J Am Geriatr Soc 2007 55 4 590 595 17397439
  2. [2]Stevenson J Abernethy AP Miller C Currow DC Managing comorbidities in patients at the end of life BMJ 2004 329 7471 909 912 15485977 PMC523125
  3. [3]Holmes HM Hayley DC Alexander GC Sachs GA Reconsidering medication appropriateness for patients late in life Arch Intern Med 2006 166 6 605 609 16567597
  4. [5]Vollrath AM Sinclair C Hallenbeck J Discontinuing cardiovascular medications at the end of life: lipid-lowering agents J Palliat Med 2005 8 4 876 881 16128666
  5. [6]Holmes HM Min LC Yee M Rationalizing prescribing for older patients with multimorbidity: considering time to benefit Drugs Aging 2013 30 9 655 666 23749475 PMC3755031
  6. [7]Russell BJ Rowett D Abernethy AP Currow DC Prescribing for comorbid disease in a palliative population: focus on the use of lipid-lowering medications Intern Med J 2014 44 2 177 184 24341863
  7. [8]Garfinkel D Mangin D Feasibility study of a systematic approach for discontinuation of multiple medications in older adults: addressing polypharmacy Arch Intern Med 2010 170 18 1648 1654 20937924
  8. [10]LaRosa JC He J Vupputuri S Effect of statins on risk of coronary disease: a meta-analysis of randomized controlled trials JAMA 1999 282 24 2340 2346 10612322
  9. [11]Thavendiranathan P Bagai A Brookhart MA Choudhry NK Primary prevention of cardiovascular diseases with statin therapy: a meta-analysis of randomized controlled trials Arch Intern Med 2006 166 21 2307 2313 17130382
  10. [12]Spencer FA Allegrone J Goldberg RJ GRACE Investigators Association of statin therapy with outcomes of acute coronary syndromes: the GRACE study Ann Intern Med 2004 140 11 857 866 15172899
  11. [13]Armitage J The safety of statins in clinical practice Lancet 2007 370 9601 1781 1790 17559928
  12. [14]Mansi I Frei CR Pugh MJ Makris U Mortensen EM Statins and musculoskeletal conditions, arthropathies, and injuries JAMA Intern Med 2013 173 14 1 10 23877079
  13. [15]Silveira MJ Kazanis AS Shevrin MP Statins in the last six months of life: a recognizable, life-limiting condition does not decrease their use J Palliat Med 2008 11 5 685 693 18588398
  14. [17]Moroni M Zocchi D Bolognesi D SUQ-P Group The “surprise question” question in advanced cancer patients: a prospective study among general practitioners Palliat Med 2014 28 7 959 964 24662237
  15. [18]Murray S Boyd K Using the “surprise question” can identify people with advanced heart failure and COPD who would benefit from a palliative care approach Palliat Med 2011 25 4 382 21610113
  16. [19]Abernethy AP Shelby-James T Fazekas BS Woods D Currow DC The Australia-Modified Karnofsky Performance Status (AKPS) scale: a revised scale for contemporary palliative care clinical practice [ISRCTN81117481] BMC Palliat Care 2005 4 7 16283937 PMC1308820
  17. [20]Pfeiffer E A short portable mental status questionnaire for the assessment of organic brain deficit in elderly patients J Am Geriatr Soc 1975 23 10 433 441 1159263
  18. [22]O’Brien PC Fleming TR A multiple testing procedure for clinical trials Biometrics 1979 35 3 549 556 497341
  19. [23]D’Hoore W Sicotte C Tilquin C Risk adjustment in outcome assessment: the Charlson Comorbidity Index Methods Inf Med 1993 32 5 382 387 8295545
  20. [24]Cohen SR Mount BM Bruera E Provost M Rowe J Tong K Validity of the McGill Quality of Life Questionnaire in the palliative care setting: a multi-centre Canadian study demonstrating the importance of the existential domain Palliat Med 1997 11 1 3 20 9068681
  21. [25]Cohen SR Mount BM Strobel MG Bui F The McGill Quality of Life Questionnaire: a measure of quality of life appropriate for people with advanced disease: a preliminary study of validity and acceptability Palliat Med 1995 9 3 207 219 7582177
  22. [26]Bruera E Kuehn N Miller MJ Selmser P Macmillan K The Edmonton Symptom Assessment System (ESAS): a simple method for the assessment of palliative care patients J Palliat Care 1991 7 2 6 9 1714502
  23. [28]Stone NJ Robinson JG Lichtenstein AH American College of Cardiology/American Heart Association Task Force on Practice Guidelines 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines J Am Coll Cardiol 2014 63 25 pt B 2889 2934 24239923
  24. [30]Pencina MJ Navar-Boggan AM D’Agostino RB Sr Application of new cholesterol guidelines to a population-based sample N Engl J Med 2014 370 15 1422 1431 24645848
  25. [31]Ko D Kutner J Blatchford P Abernethy A Management of medications for co-morbidities: a survey of current practice in hospice and palliative care using statins as a test case Paper presented at: National Institute of Nursing Research State of the Science Conference August 11, 2011 Bethesda, MD.
  26. [32]Ridker PM Wilson PW A trial-based approach to statin guidelines JAMA 2013 310 11 1123 1124 23942579
  27. [34]Wanner C Krane V März W German Diabetes and Dialysis Study Investigators Atorvastatin in patients with type 2 diabetes mellitus undergoing hemodialysis N Engl J Med 2005 353 3 238 248 16034009
  28. [35]Thompson PD Clarkson PM Rosenson RS National Lipid Association Statin Safety Task Force Muscle Safety Expert Panel An assessment of statin safety by muscle experts Am J Cardiol 2006 97 8A 69C 76C 16581332
  29. [37]Golomb BA Evans MA Dimsdale JE White HL Effects of statins on energy and fatigue with exertion: results from a randomized controlled trial Arch Intern Med 2012 172 15 1180 1182 22688574 PMC4285455
  30. [38]Krishnan GM Thompson PD The effects of statins on skeletal muscle strength and exercise performance Curr Opin Lipidol 2010 21 4 324 328 20581676
  31. [39]Gomez Sandoval YH Braganza MV Daskalopoulou SS Statin discontinuation in high-risk patients: a systematic review of the evidence Curr Pharm Des 2011 17 33 3669 3689 22074437
  32. [40]Taylor F Huffman MD Macedo AF Statins for the primary prevention of cardiovascular disease Cochrane Database Syst Rev 2013 1 CD004816 23440795 PMC6481400
  33. [42]Katz SJ Hawley S The value of sharing treatment decision making with patients: expecting too much? JAMA 2013 310 15 1559 1560 24061082
  34. [43]Bakitas M Kryworuchko J Matlock DD Volandes AE Palliative medicine and decision science: the critical need for a shared agenda to foster informed patient choice in serious illness J Palliat Med 2011 14 10 1109 1116 21895453 PMC3236099
  35. [44]Hoffman RM McNaughton-Collins M The superiority of patient engagement and shared decision-making in noninferiority trials J Gen Intern Med 2014 29 1 16 17 23979687 PMC3889944
  36. [45]Oshima Lee E Emanuel EJ Shared decision making to improve care and reduce costs N Engl J Med 2013 368 1 6 8 23281971

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Authors
Kutner, J. S., Blatchford, P. J., Taylor, D. H., Ritchie, C. S., Bull, J. H., Fairclough, D. L., Hanson, L. C., LeBlanc, T. W., Samsa, G. P., Wolf, S., Aziz, N. M., Currow, D. C., Ferrell, B., Wagner-Johnston, N., Zafar, S. Y., Cleary, J. F., Dev, S., Goode, P. S., Kamal, A. H., Kassner, C., Kvale, E. A., McCallum, J. G., Ogunseitan, A. B., Pantilat, S. Z., Portenoy, R. K., Prince-Paul, M., Sloan, J. A., Swetz, K. M., Von Gunten, C. F., & Abernethy, A. P.
Affiliations
  • University of Colorado Anschutz (US)
  • Colorado School of Public Health (US)
  • Duke University (US)
  • San Francisco VA Medical Center (US)
  • Four Seasons (US)
  • University of North Carolina at Chapel Hill (US)
  • Duke Medical Center (US)
  • National Institutes of Health (US)
  • Flinders University (AU)
  • City Of Hope National Medical Center (US)
  • Department of Medicine, Washington University in St Louis, St Louis, Missouri
  • University of Wisconsin–Madison (US)
  • Phoenix VA Health Care System (US)
  • University of Alabama at Birmingham (US)
  • Hospice Analytics, Denver, Colorado
  • Denver Hospice (US)
  • Northwestern University (US)
  • University of California, San Francisco (US)
  • Metropolitan Jewish Health System (US)
  • Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, Ohio
  • Mayo Clinic (US)
  • Department of Hospice and Palliative Medicine, OhioHealth, Columbus
Corresponding author
Abernethy, Amy P.
ORCID
Venue
JAMA Internal Medicine
Publisher
American Medical Association (AMA)
Published
2015-05-01
Volume
175
Issue
5
Pages
691
ISSN
2168-6106 (ISSN-L)
DOI
10.1001/jamainternmed.2015.0289
PMC
PMC4618294
OpenAlex
W2171541729
Cited by
502
References
6
Citations by year
2026: 34 · 2025: 34 · 2024: 49 · 2023: 28 · 2022: 37 · 2021: 48 · 2020: 36 · 2019: 56 · 2018: 50 · 2017: 50 · 2016: 55 · 2015: 25
FWCI
64.35
Type
journal article
Language
en
Open access
Locations
  • JAMA Internal Medicine (publishedVersion)
  • PubMed (publishedVersion)
  • Europe PMC (PubMed Central) (acceptedVersion)
  • PubMed Central (acceptedVersion)
  • eScholarship (California Digital Library) (submittedVersion)
Funders
  • National Cancer Institute (P30CA046934)
  • National Institute of Nursing Research (UC4NR012584, U2CNR014637, U24NR014637)
Topics
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Palliative Care and End-of-Life Issues
  • Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
  • Health Sciences › Medicine › Geriatrics and Gerontology › Pharmaceutical Practices and Patient Outcomes
Keywords
statin discontinuation, palliative care, life-limiting illness, advanced disease, drug withdrawal, quality of life, survival, cardiovascular events, cost reduction, medication burden, non-inferiority, end-of-life care, functional status, cancer patients, cognitive impairment, frailty, symptom burden
MeSH terms
Aged, Aged, 80 and over, Cardiovascular Diseases, Cognition Disorders, Female, Humans, Life Expectancy, Male, Middle Aged, Neoplasms, Palliative Care, Prognosis, Treatment Outcome, Risk Assessment, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Withholding Treatment, Patient Acuity

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