Stopping statins at the end of life
Trial question
What is the role of discontinuation of statin therapy in patients with limited life expectancy?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
45.0% female
55.0% male
N = 381
381 patients (171 female, 210 male).
Inclusion criteria: adult patients with an estimated life expectancy of 1 month to 1 year, statin therapy for ≥ 3 months for primary or secondary prevention of CVD.
Key exclusion criteria: active CVD, symptoms of myositis, LFT (AST, ALT, or ALP) or CK levels > 2.5 times the ULN, or other contraindications to continuing statin therapy.
Interventions
N=189 discontinuation of statins (statin therapy withdrawn).
N=192 continuation of statins (continued to receive statin therapy).
Primary outcome
Death at 60 days
23.8%
20.3%
23.8 %
17.9 %
11.9 %
6.0 %
0.0 %
Discontinuation of
statins
Continuation of
statins
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in death at 60 days (23.8% vs. 20.3%; RR 1.17, 90% CI -3.5 to 10.5).
Secondary outcomes
Significant increase in total QoL McGill QOL score (7.11 points vs. 6.85 points; AD 0.26 points, 95% CI 0.02 to 0.5).
No significant difference in CV events (6.9 vs. 5.7; RR 1.21, 95% CI -3.67 to 6.09).
No significant difference in median time to death (229 days vs. 190 days; MD 39, 95% CI -102.05 to 180.05).
Conclusion
In adult patients with an estimated life expectancy of 1 month to 1 year, statin therapy for ≥ 3 months for primary or secondary prevention of CVD, discontinuation of statins were noninferior to continuation of statins with respect to death at 60 days.
Reference
Kutner JS, Blatchford PJ, Taylor DH Jr et al. Safety and benefit of discontinuing statin therapy in the setting of advanced, life-limiting illness: a randomized clinical trial. JAMA Intern Med. 2015 May;175(5):691-700.
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