Diabetes is the major cause of end-stage organ damage in the industrialized world. Hypertension also causes end-organ damage, with a consistent relationship between BP and fatal or non-fatal stroke, cardiovascular disease, and renal failure.
One of the first signs of renal disease is endothelial dysfunction characterized by a diminished response to the vasodilator nitric oxide (NO) and increased production of vasoconstrictors, including angiotensin II. These changes are accompanied by an increase in oxidative stress and prothrombotic effects that contribute to atherosclerosis.
Renal endothelial dysfunction provokes albuminuria and decreased renal function, both excellent predictors of nephropathy and cardiovascular morbidity and mortality.
Several randomised clinical trials have suggested that RAS blockade reduces the risk of new type 2 diabetes mellitus in patients with hypertension or congestive heart failure. It is well known that treatment with ARBs also delays progression to nephropathy in patients with type 2 diabetes.
The second half of the PROTECTION® Trial Programme assessed the renoprotective effects of telmisartan in patients at different stages of renal disease. The five studies were designed to assess the effect of telmisartan on renal protection in patients with an increased risk of renal, cardiac, and vascular damage:
- TRENDY compared telmisartan with ramipril on renal endothelial function in hypertensive patients with type 2 diabetes, glomerular filtration rate >80 ml/min, and normo to microalbuminuria
- DETAIL tested whether the renoprotective effect of telmisartan was similar to that of enalapril in the glomerular filtration rate in hypertensive patients with type 2 diabetes and albuminuria over a 5-year period
- INNOVATION investigated prevention of overt diabetic nephropathy by ARB treatment in normotensive and hypertensive Japanese patients with type 2 diabetes
- AMADEO assessed the effects of telmisartan and the ARB losartan (which is indicated to slow diabetic nephropathy progression) on proteinuria in hypertensive patients with type 2 diabetes and overt nephropathy. The study examined whether these effects translate into a greater and more persistent reduction in proteinuria over time
- VIVALDI compared the renoprotective properties of telmisartan with the gold standard valsartan in hypertensive patients with type 2 diabetes and overt nephropathy
