6/29/23, 11:57 PM Stopping Statins at the End of Life Pathway Feedback Search Clinical Topics Home Studies Stopping Statins at the End of Life Stopping Statins at the End of Life DiseaseDyslipidemia 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 N = 381 55.0% male 381 patients (171 female, 210 male) Inclusion criteria: adults 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, liver function test (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or other contraindications to continuing statin therapy Interventions N=189 discontinuation of statins (statin therapy withdrawn) N=192 continuation of statins (continued to receive statin therapy) Primary outcome Death at 60 days https://web.pathway.md/studies/recz1IzKpDVLg0S8t 1/2 6/29/23, 11:57 PM Stopping Statins at the End of Life Pathway 23.8 % 23.8 20.3 17.9 % 11.9 % Difference not exceeding nonferiority margin 6.0 % 0.0 % Discontinuation of statins Continuation of statins Difference not exceeding nonferiority 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 quality of life McGill QOL score (7.11 vs. 6.85; AD 0.26, 95% CI 0.02 to 0.5) No significant difference in cardiovascular 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 adults 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. Open reference URL https://web.pathway.md/studies/recz1IzKpDVLg0S8t 2/2