Randomized placebo controlled double blind trial of patients on hemodialysis or to start hemodialysis in the next 6 months with a new AVG.
Primary outcome was loss of primary unassisted graft patency. thrombosis, 50% stenosis. Patients underwent regular site monitoring and referred for angiography if qB was less than 600 or less than 1000 and a greater than 25% reduction of qB.
Power analysis required 1054 patients.
results: 321 randomized to Aggrenox
328 assigned to placebo
No difference in bleeding or cardiovascular events.
Take home message: modest benefit from expensive drug in underpowered but well designed and executed study.
Brunelli et al. Thiazolidinedione use is associated with better survival in hemodialysis patients with non-insulin dependent diabetes. Kidney Int (2009) vol. 75 (9) pp. 961-8 (pdf)
Thiazolidinediones (TZDs)
- bind peroxisome proliferator-activated receptor gamma
- increase insulin sensitivity in peripheral tissues
- increase HDL
- decrease triglycerides
- decrease visceral fat
- improve endothelial function
ArMORR is a cohort of incident dialysis patients at FMC units. The total cohort includes 10,044 patients.
This analysis restricted to patients with diabetes surviving at least 30 days on dialysis.
Patients on pioglitazone (Actos) or rosiglitazone (Avandia) were placed in the TZD group. Primary outcome was time to death from any cause. Maximum follow-up was one year.
Results: 5,290 patientss were eligible for inclusion.
9.6% were treated with a TZD
Improved survival was seen among patients on TZDs, especially patients not also on insulin. Interestingly the survival benefit came from a reduction of non-CV end-points.