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New Data Presented On Micardis(R) (Telmisartan) Tablets In Hypertensive Patients With Type 2 Diabetes
06/21/07
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. About Micardis(R) (telmisartan) tablets MICARDIS is an angiotensin II receptor blocker (ARB) indicated for the treatment of hypertension and may be used alone or in combination with other antihypertensive agents. In the clinical trial programs PROTECTION, ONTARGET and PRoFESS, over 58,000 patients have been enrolled to investigate the cardiovascular protective effects of MICARDIS. For more information and full prescribing information, please visit

(Author: http://www.MICARDIS.com)

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