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OBJECTIVE	For patients with limited prognosis , some medication risks may outweigh the benefits , particularly when benefits take years to accrue ; statins are one example .
OBJECTIVE	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 .
METHODS	This was a multicenter , parallel-group , unblinded , pragmatic clinical trial .
METHODS	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 .
METHODS	Participants were randomized to either discontinue or continue statin therapy and were monitored monthly for up to 1 year .
METHODS	The study was conducted from June 3 , 2011 , to May 2 , 2013 .
METHODS	All analyses were performed using an intent-to-treat approach .
METHODS	Statin therapy was withdrawn from eligible patients who were randomized to the discontinuation group .
METHODS	Patients in the continuation group continued to receive statins .
METHODS	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 .
RESULTS	Mean ( SD ) age was 74.1 ( 11.6 ) years , 22.0 % of the participants were cognitively impaired , and 48.8 % had cancer .
RESULTS	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 .
RESULTS	Total QOL was better for the group discontinuing statin therapy ( mean McGill QOL score , 7.11 vs 6.85 ; P = .04 ) .
RESULTS	Few participants experienced cardiovascular events ( 13 in the discontinuation group vs 11 in the continuation group ) .
RESULTS	Mean cost savings were $ 3.37 per day and $ 716 per patient .
CONCLUSIONS	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 .
CONCLUSIONS	Thoughtful patient-provider discussions regarding the uncertain benefit and potential decrement in QOL associated with statin continuation in this setting are warranted .
BACKGROUND	clinicaltrials.gov Identifier : NCT01415934 .

