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

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 INTERVENTIONS:Statin therapy was withdrawn from eligible patients who were randomized to the discontinuation group.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

SUBMITTER: Kutner JS

PROVIDER: S-EPMC4618294 | biostudies-literature | 2015 May

REPOSITORIES: biostudies-literature

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

Kutner Jean S JS Blatchford Patrick J PJ Taylor Donald H DH Ritchie Christine S CS Bull Janet H JH Fairclough Diane L DL Hanson Laura C LC LeBlanc Thomas W TW Samsa Greg P GP Wolf Steven S Aziz Noreen M NM Currow David C DC Ferrell Betty B Wagner-Johnston Nina N Zafar S Yousuf SY Cleary James F JF Dev Sandesh S Goode Patricia S PS Kamal Arif H AH Kassner Cordt C Kvale Elizabeth A EA McCallum Janelle G JG Ogunseitan Adeboye B AB Pantilat Steven Z SZ Portenoy Russell K RK Prince-Paul Maryjo M Sloan Jeff A JA Swetz Keith M KM Von Gunten Charles F CF Abernethy Amy P AP

JAMA internal medicine 20150501 5

<h4>Importance</h4>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.<h4>Objective</h4>To evaluate the safety, clinical, and cost impact of discontinuing statin medications for patients in the palliative care setting.<h4>Design, setting, and participants</h4>This wa ...[more]

PMID: 25798575

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Project description:ObjectivesTo evaluate the prevalence and factors associated with statin pharmacotherapy in long-stay nursing home residents with life-limiting illness.DesignCross-sectional.SettingUS Medicare- and Medicaid-certified nursing home facilities.ParticipantsLong-stay nursing home resident Medicare fee-for-service beneficiaries aged 65 years or older with life-limiting illness (n = 424 212).MeasurementsPrevalent statin use was estimated as any low-moderate intensity (daily dose low-density lipoprotein-cholesterol [LDL-C] reduction <30%-50%) and high-intensity (daily dose LDL-C reduction >50%) use via Medicare Part D claims for a prescription supply on September 30, 2016, with a 90-day look-back period. Life-limiting illness was operationally defined to capture those near the end of life using evidence-based criteria to identify progressive terminal conditions or limited prognoses (<6 mo). Poisson models provided estimates of adjusted prevalence ratios and 95% confidence intervals for resident factors.ResultsA total of 34% of residents with life-limiting illness were prescribed statins (65-75 y = 44.0%, high intensity = 11.1%; >75 y = 31.1%, high intensity = 5.4%). Prevalence of statins varied by life-limiting illness definition. Of those with a prognosis of less than 6 months, 23% of the 65 to 75 and 12% of the older than 75 age groups were on statins. Factors positively associated with statin use included minority race or ethnicity, use of more than five concurrent medications, and atherosclerotic cardiovascular disease or risk factors.ConclusionDespite having a life-limiting illness, more than one-third of clinically compromised long-stay nursing home residents remain on statins. Although recent national guidelines have expanded indications for statins, the benefit of continued therapy in an advanced age population near the end of life is questionable. Efforts to deprescribe statins in the nursing home setting may be warranted. J Am Geriatr Soc 68:708-716, 2020.

Project description:ObjectivesTo estimate 30-day statin discontinuation among newly admitted nursing home residents overall and within categories of life-limiting illness.DesignRetrospective cohort using Minimum Data Set 3.0 nursing home admission assessments from 2015 to 2016 merged to Medicare administrative data files.SettingU.S. Medicare- and Medicaid-certified nursing home facilities (n = 13,092).ParticipantsMedicare fee-for-service beneficiaries, aged 65 years and older, newly admitted to nursing homes for non-skilled nursing facility stays on statin pharmacotherapy at the time of admission (n = 73,247).MeasurementsResidents were categorized using evidence-based criteria to identify progressive, terminal conditions or limited prognoses (<6 months). Discontinuation was defined as the absence of a new Medicare Part D claim for statin pharmacotherapy in the 30 days following nursing home admission.ResultsOverall, 19.9% discontinued statins within 30 days of nursing home admission, with rates that varied by life-limiting illness classification (no life-limiting illness: 20.5%; serious illness: 18.6%; receipt of palliative care consult: 34.5%; clinician designated as end-of-life: 45.0%). Relative to those with no life-limiting illness, risk of 30-day statin discontinuation increased with life-limiting illness severity (serious illness: adjusted risk ratio (aRR) = 1.06; 95% confidence interval (CI) = 1.02-1.10; palliative care index diagnosis: aRR = 1.15; 95% CI = 1.10-1.21; palliative care consultation: aRR = 1.58; 95% CI = 1.43-1.74; clinician designated as end of life: aRR = 1.59; 95% CI = 1.42-1.79). Nevertheless, most remained on statins after entering the nursing home regardless of life-limiting illness status.ConclusionStatin use continues in a large proportion of Medicare beneficiaries after admission to a nursing home. Additional deprescribing research, which identifies how to engage nursing home residents and healthcare providers in a process to safely and effectively discontinue medications with questionable benefits, is warranted.

Project description:BACKGROUND:Polypharmacy may be particularly burdensome near the end of life, as patients "accumulate" medications to treat and prevent multiple diseases. OBJECTIVE:To evaluate associations between polypharmacy, symptom burden, and quality of life (QOL) in patients with advanced, life-limiting illness (clinician-estimated, 1 month-1 year). DESIGN:Secondary analysis of baseline data from a trial of statin discontinuation. PARTICIPANTS:Adults with advanced, life-limiting illness. MAIN MEASURES:Polypharmacy was assessed by summing the number of non-statin medications taken regularly or as needed. Symptom burden was assessed using the Edmonton Symptom Assessment Scale (range 0-90; higher scores indicating greater symptom burden) and QOL was assessed using the McGill QOL Questionnaire (range 0-10; higher scores indicating better QOL). Linear regression models assessed associations between polypharmacy, symptom burden, and QOL. KEY RESULTS:Among 372 participants, 47% were age 75 or older and 35% were enrolled in hospice. The mean symptom score was 27.0 (standard deviation (SD) 16.1) and the mean QOL score was 7.0 (SD 1.3). The average number of non-statin medications was 11.6 (SD 5.0); one-third of participants took ≥ 14 medications. In adjusted models, higher polypharmacy was associated with higher symptom burden (coefficient 0.81; p < .001) and lower QOL (coefficient - .06; p = .001). Adjusting for symptom burden weakened the association between polypharmacy and QOL (coefficient - .03; p = .045) without a significant interaction, suggesting that worse quality of life associated with polypharmacy may be related to medication-associated symptoms. CONCLUSIONS:Among adults with advanced illness, taking more medications is associated with higher symptom burden and lower QOL. Attention to medication-related symptoms and shared decision-making regarding deprescribing are warranted in this setting. NIH TRIAL REGISTRY NUMBER:ClinicalTrials.gov Identifier for Parent Study - NCT01415934.

Project description:BackgroundRelative risk reduction with statin therapy has been consistent across nearly all subgroups studied to date. However, in analyses of 2 randomized controlled primary prevention trials (ASCOT [Anglo-Scandinavian Cardiac Outcomes Trial-Lipid-Lowering Arm] and JUPITER [Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin]), statin therapy led to a greater relative risk reduction among a subgroup at high genetic risk. Here, we aimed to confirm this observation in a third primary prevention randomized controlled trial. In addition, we assessed whether those at high genetic risk had a greater burden of subclinical coronary atherosclerosis.MethodsWe studied participants from a randomized controlled trial of primary prevention with statin therapy (WOSCOPS [West of Scotland Coronary Prevention Study]; n=4910) and 2 observational cohort studies (CARDIA [Coronary Artery Risk Development in Young Adults] and BioImage; n=1154 and 4392, respectively). For each participant, we calculated a polygenic risk score derived from up to 57 common DNA sequence variants previously associated with coronary heart disease. We compared the relative efficacy of statin therapy in those at high genetic risk (top quintile of polygenic risk score) versus all others (WOSCOPS), as well as the association between the polygenic risk score and coronary artery calcification (CARDIA) and carotid artery plaque burden (BioImage).ResultsAmong WOSCOPS trial participants at high genetic risk, statin therapy was associated with a relative risk reduction of 44% (95% confidence interval [CI], 22-60; P<0.001), whereas in all others, the relative risk reduction was 24% (95% CI, 8-37; P=0.004) despite similar low-density lipoprotein cholesterol lowering. In a study-level meta-analysis across the WOSCOPS, ASCOT, and JUPITER primary prevention, relative risk reduction in those at high genetic risk was 46% versus 26% in all others (P for heterogeneity=0.05). Across all 3 studies, the absolute risk reduction with statin therapy was 3.6% (95% CI, 2.0-5.1) among those in the high genetic risk group and 1.3% (95% CI, 0.6-1.9) in all others. Each 1-SD increase in the polygenic risk score was associated with 1.32-fold (95% CI, 1.04-1.68) greater likelihood of having coronary artery calcification and 9.7% higher (95% CI, 2.2-17.8) burden of carotid plaque.ConclusionsThose at high genetic risk have a greater burden of subclinical atherosclerosis and derive greater relative and absolute benefit from statin therapy to prevent a first coronary heart disease event.Clinical trial registrationURL: http://www.clinicaltrials.gov. Unique identifiers: NCT00738725 (BioImage) and NCT00005130 (CARDIA). WOSCOPS was carried out and completed before the requirement for clinical trial registration.

Project description:BackgroundWe sought to identify innovative navigation programs across Canadian jurisdictions that target their services to individuals affected by life-limiting illness and their families, and articulate the principal components of these programs that enable them to address the needs of their clients who are living in the community.MethodsThis realist evaluation used a two-phased approach. First, we conducted a horizon scan of innovative community-based navigation programs across Canadian jurisdictions to identify innovative community-based navigation programs that aim to address the needs of community-dwelling individuals affected by life-limiting illness. Second, we conducted semi-structured interviews with key informants from each of the selected programs. Informants included individuals responsible for managing and delivering the program and decision-makers with responsibility and/or oversight of the program. Analyses proceeded in an iterative manner, consistent with realist evaluation methods. This included iteratively developing and refining Context-Mechanism-Outcome (CMO) configurations, and developing the final program theory.ResultsTwenty-seven navigation programs were identified from the horizon scan. Using specific eligibility criteria, 11 programs were selected for subsequent interviews and in-depth examination. Twenty-three participants were interviewed from these programs, which operated in five Canadian provinces. The programs represented a mixture of community (non-profit or volunteer), research-initiated, and health system programs. The final program theory was articulated as: navigation programs can improve client outcomes if they have supported and empowered staff who have the time and flexibility to personalize care to the needs of their clients.ConclusionsThe findings highlight key principles (contexts and mechanisms) that enable navigation programs to develop client relationships, personalize care to client needs, and improve client outcomes. These principles include staff (or volunteer) knowledge and experience to coordinate health and social services, having a point of contact after hours, and providing staff (and volunteers) time and flexibility to develop relationships and respond to individualized client needs. These findings may be used by healthcare organizations - outside of navigation programs - to work towards more person-centred care.

Dataset Information

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

Publications

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

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