4-D
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
54.0% male
N = 1255
1255 patients (578 female, 677 male).
Inclusion criteria: patients with T2DM mellitus undergoing hemodialysis.
Key exclusion criteria: hematopoietic disease or systemic disease unrelated to ESRD; vascular intervention, congestive HF, or MI 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 MI, and stroke, at 3 years
31.9%
30.5%
31.9 %
23.9 %
15.9 %
8.0 %
0.0 %
Atorvastatin
Placebo
No significant
difference ↔
No significant difference in death from cardiac causes, nonfatal MI, 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 MI, 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.
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