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JAMA Intern Med. 2015 May;175(5):691-700.

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

Kutner JS, Blatchford PJ, Taylor DH Jr, et al

This multicentre, parallel-group, unblinded, pragmatic randomized trial evaluated the safety, clinical, and cost impact of discontinuing statin medications for patients in the palliative care setting. Patients had an advanced, life-limiting illness with a recent deterioration in functional status, were estimated to have a life expectancy of between 1 month and 1 year, been receiving a statin for 3 months or more for primary or secondary prevention of cardiovascular disease, and had no recent active cardiovascular disease. The primary end point of the study was the proportion of deaths within 60 days of trial enrolment. 1659 patients screened for eligibility, 662 were eligible and 381 patients enrolled; 189 of these were randomized to discontinue statins, and 192 to continue statins. Mean age was 74.1 years, 22% of the participants were cognitively impaired, and 49% had cancer. Median follow-up time was 18 weeks.

There was no difference in the primary outcome, death within 60 days. Survival was similar between the groups. There was no significant difference in time to first cardiovascular-related event, with 24 participants (6.3%) experienced a cardiovascular related event (13 in the discontinuation group vs 11 in the continuation group). Quality of life was better for the group discontinuing statin therapy, with significant differences in the support and wellbeing, but not in the psychological and physical domains. There was no effect on physical symptoms (including statin-specific symptoms) or performance status. The total number of non-statin medications was lower in the discontinuation group. The mean cost savings of statin discontinuation were US$3.37 per day and US$716 per patient (over the mean 213 days survival). This represents potential savings of US$603 million in the United States in 2014.

 

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