Source: DGNews  |  Posted 4 years ago

By Jill Stein

CHICAGO, IL -- May 28, 2007 -- Telmisartan is associated with a larger reduction in proteinuria than losartan in hypertensive patients with type 2 diabetes and overt nephropathy, even though the 2 agents reduce blood pressure to a comparable extent, researchers reported here at the 22[^]nd[] Annual Meeting of the American Society of Hypertension (ASH).

Losartan is approved by the U.S. Food and Drug Administration for treatment of patients with diabetic nephropathy.

George Bakris, MD, director, hypertension center, the University of Chicago Hospitals, Chicago, Illinois, United States, and associates randomised 860 patients to 2 weeks of treatment with either telmisartan 40 mg or losartan 50 mg after a 4-week run-in period, then titrated to telmisartan 80 mg or losartan 100 mg for 50 weeks.

Dr. Bakris noted that several renal outcome trials have demonstrated that blocking the renin angiotensin system (RAS) to control blood pressure is essential for decreasing renal disease progression in diabetes. In these trials, a proteinuria reduction larger than 30% at 6 months to 1 year strongly correlated with slowed progression of diabetic nephropathy and decreased cardiovascular events.

The AMADEO trial was conducted to determine whether pharmacological differences between telmisartan and losartan would translate into larger and more durable reductions in urinary protein excretion over time in hypertensive patients with type 2 diabetes and overt nephropathy.

The primary outcome measure was the change from baseline in morning spot urinary protein:creatinine.

Results in the 687 patients who completed the trial showed that the mean final urinary protein:creatinine ratio after 1 year was 0.71 in the telmisartan group and 0.80 in the losartan group ([]P []=.028), for a reduction from baseline of 29% and 20% for the 2 groups, respectively.

Mean blood pressure reduction from baseline was similar in the 2 groups (-4.8 / -3.2 mm Hg and -2.7 / -2.9 mm Hg, respectively).

No significant differences were detected between the 2 treatment groups in urinary sodium:creatinine, glomerular filtration rate, serum aldosterone, and high-sensitivity C-reactive protein.

Telmisartan prolonged the time to a first cardiovascular event.

The data also indicated that a larger percentage of patients had sustained antiproteinuric effect 2 months after telmisartan had been stopped.

Dr. Bakris said that the larger antiproteinuric effect of telmisartan cannot be attributed to differences in blood pressure control since blood pressure reductions were comparable in the 2 groups. The differences in ARBs may relate to pharmacological differences such as lipophilicity, magnitude of receptor binding, and duration of action.

"Our findings suggest that at similar levels of blood pressure control, telmisartan may confer greater protection against progression to end-stage renal disease" Dr. Bakris commented. "This hypothesis must be prospectively tested, however."

The study was sponsored by BI Pharma in Ridgefield, Connecticut.

[[]Presentation title: Comparative Long Term Effects of Two AT1 Receptor Blockers on Proteinuria in Patients With Type-2 Diabetes and Overt Nephropathy and Hypertension: Results of the AMADEO Trial. Abstract P-65[]]