AMADEO, a randomized, double-blind, forced-titration,
parallel-group, multicentre study, included 860 hypertensive
patients ((greater than)130/80mmHg) with type 2 diabetes and
overt nephropathy from 124 centres in 10 countries. Patients
were randomized to receive treatment with either telmisartan
80mg or losartan 100mg. To ensure blood pressure control in
the two patient groups other non- ARB treatments
(hydrochlorothiazide or calcium channel blocker) were added,
if needed.
After one year's treatment, telmisartan was significantly more
effective than losartan in reducing the amount of protein
excreted in the urine. The primary end point of the study was
reduced by 29% with telmisartan vs. 20% with losartan;
p=0.0284(1). Telmisartan was superior to losartan on the
primary endpoint, a change from baseline after 12 months (log
transformed Urinary Protein creatinine ratio) of 0.71 (95%
CI; 0.66, 0.77) vs. 0.80 (95% CI; 0.74,0.87) for losartan;
p=0.0284.(1) No significant difference in blood pressure
control or number of adverse events was observed between the
two treatments groups(1). Proteinuria (high levels of protein
in the urine) is a very important signal for disease severity
in diabetic nephropathy and is also considered a relevant
cardiovascular risk factor. Renal outcomes trials have shown
that reductions of (greater than)30% at six months are
strongly linked to slowed progression to end-stage kidney
disease and reduced cardiovascular
events.(6)
AMADEO successfully concludes the series of PROTECTION studies
which are part of an extensive ongoing trial programme,
including clinical and observational studies, investigating
the outstanding effects of telmisartan compared with other
treatments for hypertension, including other available ARBs.
The trials established the effects of telmisartan in providing
powerful blood pressure reductions from morning to morning as
well as organ-protective
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