MILAN, Italy, June 15 /CNW/ - Today AMADEO, one of the first studies to
compare the protective potential of two angiotensin receptor blockers in
hypertensive patients with diabetic nephropathy, was presented at the European
Society of Hypertension, Milan. The results from this study show that
telmisartan reduces proteinuria to a significantly greater extent than
Commenting on the results, Prof. Ellen Burgess, Foothills Hospital in
Calgary, Canada said "The AMADEO results are encouraging for an increasing
number of patients with type 2 diabetes because they suggest that telmisartan
could improve renoprotection. It is particularly interesting that the observed
effect was seen despite the study being controlled for blood pressure." She
continued, "telmisartan has already shown superior blood pressure lowering
compared to losartan and, in AMADEO, patients were allowed to take other
medication, if needed, to ensure similar blood pressure in both treatment
groups. This suggests that the protective benefits seen with telmisartan here
are an additional attribute beyond its established blood pressure lowering
Diabetic nephropathy is a kidney disease that occurs in approximately one
third of patients with diabetes mellitus(2). These study results could,
therefore, have a positive impact on millions of type 2 diabetes patients as
well as healthcare systems worldwide. The prevalence of diabetes is projected
to increase at an alarming rate from 171 million in 2000 to 366 million by
2030(3), with the upsurge in obesity closely linked to increased type 2
diabetes. Over time, diabetic nephropathy can lead to end-stage renal disease,
a serious condition that needs dialysis and increased medical care and
resources. End-stage renal disease has tripled in prevalence over the past two
decades(4) and has huge associated healthcare costs, predicted to be
US$28 billion by 2010 in the US alone(5).
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;
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
Telmisartan has a longer duration of action than all other members of the
ARB class; it takes approximately 24 hours for half the dose of telmisartan to
be eliminated from the body compared to five to 15 hours for other ARBs.(7,8)
Telmisartan is 99.5% bound to serum protein and is excreted almost entirely
via non-renal pathways.
Clinical trials have shown that telmisartan provides powerful and
consistent blood pressure reduction over a full 24 hour period.(7-10)
About Telmisartan (Micardis(R)/Kinzal(R)/Pritor(R))
Telmisartan is a member of the angiotensin II receptor blocker (ARB)
class and is being investigated in the most ambitious and far-reaching
research programme ever conducted with an ARB. In the clinical trial
programmes PROTECTION, ONTARGET and PRoFESS, over 58,000 patients have been
enrolled to investigate the cardiovascular protective effects of Telmisartan.
Telmisartan was discovered and developed by Boehringer Ingelheim. Under
the trademarks Micardis(R) and MicardisPlus(R) (combination with HCTZ) the
company markets Telmisartan in 84 countries around the world, including the
USA, Japan and European countries. Telmisartan is marketed in cooperation with
Astellas Pharma Inc. in Japan, Bayer HealthCare in Europe and GlaxoSmithKline
in selected markets. Bayer HealthCare promotes Telmisartan under the brand
names Kinzalmono(R), Kinzalkomb(R) (combination with HCTZ), and Pritor(R) and
PritorPlus(R) in markets across Europe. Pritor(R) and PritorPlus(R) is also
marketed by GlaxoSmithKline in selected markets.
The Boehringer Ingelheim group is one of the world's 20 leading
pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates
globally with 137 affiliates in 47 countries and almost 38,400 employees.
Since it was founded in 1885, the family-owned company has been committed to
researching, developing, manufacturing and marketing novel products of high
therapeutic value for human and veterinary medicine.
In 2006, Boehringer Ingelheim posted net sales of 10.6 billion euro while
spending one fifth of net sales in its largest business segment Prescription
Medicines on research and development.
For more information please visit www.boehringer-ingelheim.com
Please be advised
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and is intended for all international markets. This being the case, please be
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referring to the material.
(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) Hossain P et al. Obesity and Diabetes in the Developing World - a
Growing Challenge. NEJM 2007; 356(3):213-215.
(3) Wild S et al. Global prevalence of diabetes: estimates for the
year 2000 and projections for 2030. Diabetes Care 2004; 27:1047-
(4) US Renal Data System. USRDS 2006 Annual Data Report: Atlas of End-
Stage Renal Disease in the United States. Available at:
http://www.usrds.org/atlas.htm. Accessed 06-2007.
(5) Yue JL et al. Forecast of the number of patients with end-stage
renal disease in the United States to the year 2010. J Am Soc
Nephrol. 2001; 12:2735-8.
(6) 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
(7) Burnier M, Brunner HR. Lancet 2000;355:637-45.
(8) Brunner HR. J Hum Hypertens 2002;16(suppl 2):S13-S16.
(9) Neutel JM, Smith HG. J Clin Hypertens 2003;5(1):58-63.
(10) Millar-Craig MW et al. Lancet 1978;1:795-97.
For further information:
For further information: Dr. Reinhard Malin, Corporate Division
Communications, Boehringer Ingelheim GmbH, 55216 Ingelheim/Germany, Phone:
+49-6132 -77-90815, Fax: +49-6132-72-6601, E-mail: