Milan, Italy (ots/PRNewswire) -
- For non-US Healthcare Media
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
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 effects."
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$28billion by 2010 in the US alone(5).
AMADEO, a randomized, double-blind, forced-titration,
parallel-group, multicentre study, included 860 hypertensive patients
(>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 >30% at six months are strongly
linked to slowed progression to end-stage kidney disease and reduced
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
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
This release is from the Corporate Headquarters of Boehringer
Ingelheim and is intended for all international markets. This being
the case, please be aware that there may be some differences between
countries regarding specific medical information including licensed
uses. Please take account of this when 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; 27:1047-53.
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.
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