6/30/23, 12:52 AM 4-D Pathway Feedback Search Clinical Topics Home Studies 4 D 4 D Disease Disease Disease Chronic kidney disease Diabetes mellitus type 2 Diabeti Trial question What is the role of atorvastatin in patients with T2DM mellitus undergoing hemodialysis? Study design Multi-center Double blinded RCT Population Characteristics of study participants 46.0% female N = 1255 54.0% male 1255 patients (578 female, 677 male) Inclusion criteria: patients with T2DM mellitus undergoing hemodialysis Key exclusion criteria: hematopoietic disease or systemic disease unrelated to end-stage renal disease; vascular intervention, congestive HF, or myocardial infarction within the three months preceding the period of enrollment; unsuccessful kidney transplantation; and hypertension resistant to therapy Interventions N=619 atorvastatin (20 mg/day) N=636 placebo (matching placebo per day) Primary outcome Death from cardiac causes, nonfatal myocardial infarction, and stroke, at 3 years 31.9 % 31.9 30.5 23 9 % https://web.pathway.md/studies/receFcNM2rvqNPEGs 1/2 6/30/23, 12:52 AM 23.9 % 4-D Pathway 15.9 % 8.0 % No significant difference 0.0 % Atorvastatin Placebo No significant difference in death from cardiac causes, nonfatal myocardial infarction, and stroke, at 3 years (31.9% vs. 30.5%; RR 0.92, 95% CI 0.77 to 1.1) Secondary outcomes Significant increase in fatal stroke (4% vs. 2%; RR 2.03, 95% CI 1.05 to 3.93) Significant decrease in all cardiac events combined (33% vs. 39%; RR 0.82, 95% CI 0.68 to 0.99) No significant difference in death (48% vs. 50%; RR 0.93, 95% CI 0.79 to 1.08) Conclusion In patients with T2DM mellitus undergoing hemodialysis, atorvastatin was not superior to placebo with respect to death from cardiac causes, nonfatal myocardial infarction, and stroke, at 3 years. Reference Wanner C, Krane V, Marz W et al. Atorvastatin in patients with type 2 diabetes mellitus undergoing hemodialysis. N Engl J Med. 2005 Jul 21;353(3):238-48. Open reference URL https://web.pathway.md/studies/receFcNM2rvqNPEGs 2/2