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

Jean S. Kutner, Patrick J. Blatchford, Donald H. Taylor, Christine S. Ritchie, Janet H. Bull, Diane L. Fairclough, Laura C. Hanson, Thomas W. LeBlanc, Greg P. Samsa, Steven Wolf, Noreen M. Aziz, David C. Currow, Betty Ferrell, Nina Wagner-Johnston, S. Yousuf Zafar, James F. Cleary, Sandesh Dev, Patricia S. Goode, Arif H. Kamal, Cordt KassnerElizabeth A. Kvale, Janelle G. McCallum, Adeboye B. Ogunseitan, Steven Z. Pantilat, Russell K. Portenoy, Maryjo Prince-Paul, Jeff A Sloan, Keith M. Swetz, Charles F. Von Gunten, Amy P. Abernethy

Research output: Contribution to journalArticle

217 Citations (Scopus)

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 Thiswas 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, toMay 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 INTERVENTIONS Statin therapy was withdrawn from eligible patients who were randomized to the discontinuation group.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.

Original languageEnglish (US)
Pages (from-to)691-700
Number of pages10
JournalJAMA Internal Medicine
Volume175
Issue number5
DOIs
StatePublished - May 1 2015

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Hydroxymethylglutaryl-CoA Reductase Inhibitors
Randomized Controlled Trials
Safety
Quality of Life
Pragmatic Clinical Trials
Therapeutics
Cost Savings
Life Expectancy
Cardiovascular Diseases
Costs and Cost Analysis
Primary Prevention
Secondary Prevention
Palliative Care

ASJC Scopus subject areas

  • Internal Medicine

Cite this

Kutner, J. S., Blatchford, P. J., Taylor, D. H., Ritchie, C. S., Bull, J. H., Fairclough, D. L., ... Abernethy, A. P. (2015). Safety and benefit of discontinuing statin therapy in the setting of advanced, life-limiting illness a randomized clinical trial. JAMA Internal Medicine, 175(5), 691-700. https://doi.org/10.1001/jamainternmed.2015.0289

Safety and benefit of discontinuing statin therapy in the setting of advanced, life-limiting illness a randomized clinical trial. / Kutner, Jean S.; Blatchford, Patrick J.; Taylor, Donald H.; Ritchie, Christine S.; Bull, Janet H.; Fairclough, Diane L.; Hanson, Laura C.; LeBlanc, Thomas W.; Samsa, Greg P.; Wolf, Steven; Aziz, Noreen M.; Currow, David C.; Ferrell, Betty; Wagner-Johnston, Nina; Zafar, S. Yousuf; Cleary, James F.; Dev, Sandesh; Goode, Patricia S.; Kamal, Arif H.; Kassner, Cordt; Kvale, Elizabeth A.; McCallum, Janelle G.; Ogunseitan, Adeboye B.; Pantilat, Steven Z.; Portenoy, Russell K.; Prince-Paul, Maryjo; Sloan, Jeff A; Swetz, Keith M.; Von Gunten, Charles F.; Abernethy, Amy P.

In: JAMA Internal Medicine, Vol. 175, No. 5, 01.05.2015, p. 691-700.

Research output: Contribution to journalArticle

Kutner, JS, Blatchford, PJ, Taylor, DH, Ritchie, CS, Bull, JH, Fairclough, DL, Hanson, LC, LeBlanc, TW, Samsa, GP, Wolf, S, Aziz, NM, Currow, DC, Ferrell, B, Wagner-Johnston, N, Zafar, SY, Cleary, JF, Dev, S, Goode, PS, Kamal, AH, Kassner, C, Kvale, EA, McCallum, JG, Ogunseitan, AB, Pantilat, SZ, Portenoy, RK, Prince-Paul, M, Sloan, JA, Swetz, KM, Von Gunten, CF & Abernethy, AP 2015, 'Safety and benefit of discontinuing statin therapy in the setting of advanced, life-limiting illness a randomized clinical trial', JAMA Internal Medicine, vol. 175, no. 5, pp. 691-700. https://doi.org/10.1001/jamainternmed.2015.0289
Kutner, Jean S. ; Blatchford, Patrick J. ; Taylor, Donald H. ; Ritchie, Christine S. ; Bull, Janet H. ; Fairclough, Diane L. ; Hanson, Laura C. ; LeBlanc, Thomas W. ; Samsa, Greg P. ; Wolf, Steven ; Aziz, Noreen M. ; Currow, David C. ; Ferrell, Betty ; Wagner-Johnston, Nina ; Zafar, S. Yousuf ; Cleary, James F. ; Dev, Sandesh ; Goode, Patricia S. ; Kamal, Arif H. ; Kassner, Cordt ; Kvale, Elizabeth A. ; McCallum, Janelle G. ; Ogunseitan, Adeboye B. ; Pantilat, Steven Z. ; Portenoy, Russell K. ; Prince-Paul, Maryjo ; Sloan, Jeff A ; Swetz, Keith M. ; Von Gunten, Charles F. ; Abernethy, Amy P. / Safety and benefit of discontinuing statin therapy in the setting of advanced, life-limiting illness a randomized clinical trial. In: JAMA Internal Medicine. 2015 ; Vol. 175, No. 5. pp. 691-700.
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T1 - Safety and benefit of discontinuing statin therapy in the setting of advanced, life-limiting illness a randomized clinical trial

AU - Kutner, Jean S.

AU - Blatchford, Patrick J.

AU - Taylor, Donald H.

AU - Ritchie, Christine S.

AU - Bull, Janet H.

AU - Fairclough, Diane L.

AU - Hanson, Laura C.

AU - LeBlanc, Thomas W.

AU - Samsa, Greg P.

AU - Wolf, Steven

AU - Aziz, Noreen M.

AU - Currow, David C.

AU - Ferrell, Betty

AU - Wagner-Johnston, Nina

AU - Zafar, S. Yousuf

AU - Cleary, James F.

AU - Dev, Sandesh

AU - Goode, Patricia S.

AU - Kamal, Arif H.

AU - Kassner, Cordt

AU - Kvale, Elizabeth A.

AU - McCallum, Janelle G.

AU - Ogunseitan, Adeboye B.

AU - Pantilat, Steven Z.

AU - Portenoy, Russell K.

AU - Prince-Paul, Maryjo

AU - Sloan, Jeff A

AU - Swetz, Keith M.

AU - Von Gunten, Charles F.

AU - Abernethy, Amy P.

PY - 2015/5/1

Y1 - 2015/5/1

N2 - 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 Thiswas 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, toMay 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.

AB - 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 Thiswas 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, toMay 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.

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