AMADEO

A trial to compare telMisartan 40 mg titrated to 80 mg versus losArtan 100 mg in hypertensive Type 2 DiabEtic patients with Overt nephropathy

AMADEO compared the effects of MICARDIS^® and losartan in protecting diabetic patients with hypertension by slowing down the effect of proteinuria on end-stage renal disease

Why conduct this study?

End-stage renal disease (ESRD) is a common and the most prevalent consequence of diabetic nephropathy, and a high percentage (80%) of patients with diabetes who develop ESRD also have a history of hypertension.^1,2

Angiotensin II receptor blockers (ARBs) have demonstrated renoprotective effects.^1,3-6  The RENAAL (Reduction of Endpoints in non-insulin dependent diabetes mellitus with the Angiotensin II Antagonist (Losartan) study evaluated the ARB losartan in patients with diabetic nephropathy.³ Losartan was associated with a significant improvement in renal outcomes, as demonstrated by fewer losartan-treated patients doubling their serum creatinine levels compared with placebo-treated patients.

ARBs are recommended as first-line treatments for patients with type 2 diabetes and nephropathy. However, head-to-head comparisons between ARBs in patients with diabetes are limited.

The aim of the AMADEO study was to compare, for the first time, the effect of MICARDIS^® and losartan on proteinuria – one of the most important disease-severity markers in diabetic nephropathy – in patients with type 2 diabetes and hypertension.⁷ Losartan has been approved for the treatment of renal disease in patients with diabetic nephropathy.

The study results were presented at the ESH 2007 (Milan, Italy) by Professor Ellen Burgess (Canada), who stated: “It is particularly interesting that the observed effect was seen despite the fact that the study design controlled for blood pressure reduction resulting in similar blood pressure at the start and end of the study in both treatment groups. This suggests that the protective benefits seen with MICARDIS^® are an additional attribute beyond the earlier established superior blood pressure lowering effect.”

References