1. Amongst a population of patients enrolled in palliative care secondary to advanced life-limiting illness, discontinuing their statin therapy did not lead to an increased proportion of deaths within the first two months, or time to first cardiovascular-related event.
2. While there was a trend towards improved quality of life amongst those who discontinued statin therapy, there were no significant differences observed between the two groups in other patient-centered outcomes.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Modern, evidence based medicine does well with determining when to start a variety of medications for different comorbidities. However, there is not as much guidance on when to potentially stop these medications, especially for those with advanced life-limiting illness. At these later stages, polypharmacy often places a higher burden compared to the potential benefit of the individual medications. Statin medications, which are used for primary and secondary prevention of cardiovascular disease, are one group of medications thought to be unnecessary in these late stages of life. This study, which was a randomized study amongst a palliative care population, showed that continuing versus discontinuing statin therapy did not affect the proportion of deaths in the first two months, or the time to first cardiovascular event during the study period. While there was a trend towards improved quality of life amongst those who discontinued statin therapy, there were no significant differences observed between the two groups in other patient-centered outcomes.
The strength of the study was in its design, which included randomization and multicenter involvement. The weakness includes the fact that investigators changed the primary outcomes midway through the study because of the limited number of patients reaching that initial end point. Also, including only palliative care patients, many of whom were hospice-enrolled, limits the generalizability of the results.
In-Depth [randomized controlled trial]: Patients for this study were chosen from 15 Palliative Care Research Cooperative Group member sites in the United States. The study was conducted from 2011 to 2013. There were a total of 381 patients enrolled in the study, with 189 discontinuing statin therapy and 192 continuing therapy. Inclusion criteria were adults who had been on statin therapy for at least three months prior to starting the study, who had a life-expectancy of between one month and one year as determined by their physician, and a recent deterioration in their functional status. Exclusion criteria included a recent cardiovascular event or intolerance to statin therapy. The primary endpoint was proportion of deaths within 60 days of study enrollment. Secondary endpoints included overall survival, time to first cardiovascular event, and a number of patient-centered outcomes.
The mortality rates in the first 60 days in the discontinuation and continuation groups were not significantly different (23.8% vs. 20.3%; 95%CI -3.5 to 10.5%; p = 0.36). There was also no significant difference in time to first cardiovascular-related event (p = 0.64). In the patient-centered outcomes, there was a higher Total McGill Quality of Life (QOL) amongst the discontinuation group (7.11 vs. 6.85; p = 0.04), but there was no difference in the single question assessment overall QOL (6.53 vs. 6.35; p = 0.44). There was also no difference in physical symptoms or performance status between the groups.
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