Today, results from AMADEO*, one of a series of studies comparing two angiotensin receptor blockers (ARBs) in hypertensive patients with diabetic nephropathy, were presented at the 17th annual European Meeting on Hypertension in Milan, Italy.

The randomized, double-blind, forced titration, parallel group, multicenter study included 860 hypertensive patients (>130/80mmHg) with type 2 diabetes and overt nephropathy from 124 centers in 10 countries. Patients were randomized to receive treatment with either Micardis (telmisartan) 80mg or losartan 100mg. To ensure blood pressure control in the two patient groups, other non-ARB treatments (hydrochlorothiazide or a calcium channel blocker) were added, if needed.

No significant difference in blood pressure control or number of adverse events was observed between the two treatment groups.(1)

After treatment of one year, 24 hour protein excretion measured by spot protein to creatinine ratio was reduced by 29% with Micardis (telmisartan) vs. 20% with losartan (p= 0.0284).(1)

At baseline proteinuria was similar for both groups. The change from baseline after 12 months (log transformed Urinary Protein creatinine ratio) was 0.71 for Micardis (telmisartan) vs. 0.80 for losartan (p=0.0284)(1) [Micardis (telmisartan) 0.71 (95% CI; 0.66, 0.77) vs. losartan 0.80 (95% CI; 0.74, 0.87)].(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 in proteinuria of >30% at six months are strongly linked to slowed progression to end-stage kidney disease and reduced cardiovascular events.(2)

AMADEO* concludes a series of studies which are part of an extensive ongoing trial program, with several clinical studies, as well as observational studies investigating the effects of Micardis (telmisartan) compared with other treatments, including other available ARBs, for hypertension. Note that these trials were investigational and were conducted to expand scientific knowledge of Micardis (telmisartan). These trials include treatment for conditions outside of the approved indications for Micardis (telmisartan).

*A prospective, randomised, double-blind, double-dummy, forced-titration, multicenter, parallel group, 1-year treatment trial to compare telMisartan 40 mg titrated to 80 mg versus losArtan 50 mg titrated to 100 mg, in hypertensive type 2 DiabEtic patients with Overt nephropathy.

  References

  (1) Burgess E et al. Efficacy of telmisartan compared with losartan in
      reducing proteinuria in hypertensive type 2 diabetic patients with
      overt nephropathy. Presented at the Annual Meeting of the European
      Society of Hypertension. June 2007, Milan, Italy.

  (2) Bakris G et al.  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.  Presented
      at the Annual Meeting of the American Society of Hypertension.  May
      2007, Chicago, USA

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