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document
Safety and benefit of discontinuing statin therapy in the setting of advanced , life-limiting illness : a randomized clinical trial . 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 INTERVENTIONS Statin therapy was withdrawn from eligible patients who were randomized to the discontinuation group .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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Intervention_Pharmacological
statin therapy
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Intervention_Pharmacological
statin
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Intervention_Physical
discontinue or continue
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Intervention_Pharmacological
statin therapy
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Intervention_Pharmacological
Statin therapy
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Intervention_Physical
receive
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Intervention_Pharmacological
statins
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Intervention_Pharmacological
statins
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Outcome_Mortality
death within 60 days ( primary outcome )
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Outcome_Mortality
survival ,
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Outcome_Adverse-effects
cardiovascular events
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Outcome_Other
quality of life ( QOL )
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Outcome_Physical
symptoms
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Outcome_Mental
number of nonstatin medications
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Outcome_Other
cost savings
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Outcome_Other
Total QOL
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Outcome_Adverse-effects
cardiovascular events
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Outcome_Other
Mean cost savings
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Outcome_Other
QOL
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Outcome_Mental
fewer nonstatin medications
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Outcome_Other
corresponding reduction in medication costs
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Participant_Condition
advanced , life-limiting illness :
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Participant_Condition
patients with limited prognosis
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Participant_Condition
patients with limited life expectancy
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Participant_Condition
patients in the palliative care setting
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Participant_Age
adults
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Participant_Condition
cardiovascular disease
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Participant_Condition
recent active cardiovascular disease
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Participant_Sample-size
381
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Participant_Age
Mean ( SD ) age was 74.1 ( 11.6 ) years