Safety and Benefit of Discontinuing Statin Therapy in the Setting of Advanced, Life-Limiting Illness

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Abstract

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.

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The safety of statins in clinical practice.

Jane Armitage (2007)

Statins are effective cholesterol-lowering drugs that reduce the risk of cardiovascular disease events (heart attacks, strokes, and the need for arterial revascularisation). Adverse effects from some statins on muscle, such as myopathy and rhabdomyolysis, are rare at standard doses, and on the liver, in increasing levels of transaminases, are unusual. Myopathy--muscle pain or weakness with blood creatine kinase levels more than ten times the upper limit of the normal range--typically occurs in fewer than one in 10,000 patients on standard statin doses. However, this risk varies between statins, and increases with use of higher doses and interacting drugs. Rhabdomyolysis is a rarer and more severe form of myopathy, with myoglobin release into the circulation and risk of renal failure. Stopping statin use reverses these side-effects, usually leading to a full recovery. Asymptomatic increases in concentrations of liver transaminases are recorded with all statins, but are not clearly associated with an increased risk of liver disease. For most people, statins are safe and well-tolerated, and their widespread use has the potential to have a major effect on the global burden of cardiovascular disease.

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Feasibility study of a systematic approach for discontinuation of multiple medications in older adults: addressing polypharmacy.

Doron Garfinkel, Derelie Mangin (2010)

Polypharmacy and inappropriate medication use is a problem in elderly patients, who are more likely to experience adverse effects from multiple treatments and less likely to obtain the same therapeutic benefit as younger populations. The Good Palliative-Geriatric Practice algorithm for drug discontinuation has been shown to be effective in reducing polypharmacy and improving mortality and morbidity in nursing home inpatients. This study reports the feasibility of this approach in community-dwelling older patients. The Good Palliative-Geriatric Practice algorithm was applied to a cohort of 70 community-dwelling older patients to recommend drug discontinuations. Success rates of discontinuation, morbidity, mortality, and changes in health status were recorded. The mean (SD) age of the 70 patients was 82.8 (6.9) years. Forty-three patients (61%) had 3 or more and 26% had 5 or more comorbidities. The mean follow-up was 19 months. Participants used a mean (SD) of 7.7 (3.7) medications. Protocol indicated that discontinuation was recommended for 311 medications in 64 patients (58% of drugs; mean [SD], 4.4 [2.5] drugs per patient overall, 4.9 per patient who had discontinuation). Of the discontinued drug therapies, 2% were restarted because of recurrence of the original indication. Taking nonconsent and failures together, successful discontinuation was achieved in 81%. Ten elderly patients (14%) died after a mean follow-up of 13 months, with the mean age at death of 89 years. No significant adverse events or deaths were attributable to discontinuation, and 88% of patients reported global improvement in health. It is feasible to decrease medication burden in community-dwelling elderly patients. This tool would be suitable for larger randomized controlled trials in different clinical settings.

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The Australia-modified Karnofsky Performance Status (AKPS) scale: a revised scale for contemporary palliative care clinical practice [ISRCTN81117481]

Amy Abernethy, Tania Shelby-James, Belinda S Fazekas … (2005)

Background The Karnofsky Performance Status (KPS) is a gold standard scale. The Thorne-modified KPS (TKPS) focuses on community-based care and has been shown to be more relevant to palliative care settings than the original KPS. The Australia-modified KPS (AKPS) blends KPS and TKPS to accommodate any setting of care. Methods Performance status was measured using all three scales for palliative care patients enrolled in a randomized controlled trial in South Australia. Care occurred in a range of settings. Survival was defined from enrollment to death. Results Ratings were collected at 1600 timepoints for 306 participants. The median score on all scales was 60. KPS and AKPS agreed in 87% of ratings; 79% of disagreements occurred within 1 level on the 11-level scales. KPS and TKPS agreed in 76% of ratings; 85% of disagreements occurred within one level. AKPS and TKPS agreed in 85% of ratings; 87% of disagreements were within one level. Strongest agreement occurred at the highest levels (70–90), with greatest disagreement at lower levels (≤40). Kappa coefficients for agreement were KPS-TKPS 0.71, KPS-AKPS 0.84, and AKPS-TKPS 0.82 (all p < 0.001). Spearman correlations with survival were KPS 0.26, TKPS 0.27 and AKPS 0.26 (all p < 0.001). AKPS was most predictive of survival at the lower range of the scale. All had longitudinal test-retest validity. Face validity was greatest for the AKPS. Conclusion The AKPS is a useful modification of the KPS that is more appropriate for clinical settings that include multiple venues of care such as palliative care.

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Author and article information

Journal

Title: JAMA Internal Medicine

Abbreviated Title: JAMA Intern Med

Publisher: American Medical Association (AMA)

ISSN (Print): 2168-6106

Publication date Created: May 01 2015

Publication date (Print): May 01 2015

Volume: 175

Issue: 5

Page: 691

Affiliations

[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, California

[5 ]Division of Geriatrics, Department of Medicine, University of California, San Francisco

[6 ]Four Seasons Compassion for Life, Flat Rock, North Carolina

[7 ]Division of Geriatric Medicine, University of North Carolina, Chapel Hill

[8 ]Center for Learning Health Care, Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina

[9 ]Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, North Carolina

[10 ]National Institute of Nursing Research, National Institutes of Health, Bethesda, Maryland

[11 ]Discipline, Palliative, and Supportive Services, Flinders University, Adelaide, Australia

[12 ]Department of Nursing Research, City of Hope Medical Center, City of Hope, California

[13 ]Department of Medicine, Washington University in St Louis, St Louis, Missouri

[14 ]Division of Hematology/Oncology, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison

[15 ]Department of Medicine, Phoenix Veterans Affairs Health Care System, Phoenix, Arizona

[16 ]Veterans Affairs Geriatric Research, Education, and Clinical Center, Birmingham Veterans Affairs Medical Center, Birmingham, Alabama

[17 ]Division of Gerontology, Geriatrics, and Palliative Care, University of Alabama at Birmingham

[18 ]Hospice Analytics, Denver, Colorado

[19 ]The Denver Hospice, Denver, Colorado

[20 ]Department of Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois

[21 ]Department of Medicine, University of California, San Francisco

[22 ]Metropolitan Jewish Health System, Hospice and Palliative Care, New York, New York

[23 ]Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, Ohio

[24 ]Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota

[25 ]Department of Medicine, Mayo Clinic, Rochester, Minnesota

[26 ]Department of Hospice and Palliative Medicine, OhioHealth, Columbus

Article

DOI: 10.1001/jamainternmed.2015.0289

PubMed ID: 25798575

SO-VID: 4f114689-f122-4747-b5d3-d0190be92c0b

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

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Most cited references 25

The safety of statins in clinical practice.

Feasibility study of a systematic approach for discontinuation of multiple medications in older adults: addressing polypharmacy.

The Australia-modified Karnofsky Performance Status (AKPS) scale: a revised scale for contemporary palliative care clinical practice [ISRCTN81117481]

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