VIVALDI
Background/Rationale:
- Proteinuria is a key indicator of renal and cardiovascular health.
- Reducing proteinuria is key to preventing renal and cardiovascular disease progression in patients with type 2 diabetes and nephropathy.
- The renin–angiotensin system plays a central role in the pathophysiology of renal disease in patients with diabetes.
- Pritor®/Kinzalmono® is an ARB with a 24-hour plasma half-life that has demonstrated efficacy in slowing glomerular filtration rate (GFR) decline in type 2 diabetes (DETAIL).
Objective: The objective of the VIVALDI study was to prove the renoprotective equivalence of Pritor®/Kinzalmono® with the gold standard valsartan in hypertensive patients with type 2 diabetes and overt nephropathy.
Study Design: The VIVALDI study was a 1-year prospective, multicenter, randomised, double-blind, double-dummy, parallel group, non-inferiority trial in 800 hypertensive patients with type 2 diabetes and overt nephropathy.
Galle Jet al. - Poster 1046 - EASD 2006.
Study Endpoints:
- Primary endpoint: change from baseline in 24-hour proteinuria after 1 year of treatment
Results:
- Pritor®/Kinzalmono® provides similar reductions in proteinuria to valsartan in hypertensive patients with type 2 diabetes and overt nephropathy.
- Pritor®/Kinzalmono® provides greater oxidative stress reductions than valsartan in hypertensive patients with type 2 diabetes and overt nephropathy.
Galle Jet al. - Poster 1046 - EASD 2006.
Conclusion:
- In hypertensive patients with type 2 diabetes and overt nephropathy, Pritor®/Kinzalmono® provides:
- Similar reductions in proteinuria to the gold standard valsartan
- Greater oxidative stress reductions than the gold standard valsartan
- Pritor®/Kinzalmono® may reduce the progression of diabetic nephropathy in hypertensive patients with type 2 diabetes and overt nephropathy.
