New Study Shows That Telmisartan Has Greater Renoprotective Potential Than Losartan in Hypertensive Patients with Type 2 Diabetes

New Study Shows That Telmisartan Has Greater Renoprotective Potential Than Losartan in Hypertensive Patients with Type 2 Diabetes

June 18, 2007

    MILAN, Italy, June 18 /Xinhua-PRNewswire/ -- 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
losartan.(1)

    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 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
effects.

    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.

    Boehringer Ingelheim
 
    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
http://www.boehringer-ingelheim.com .

    Please be advised

    This release is from the Corporate Headquarters of
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    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. 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.


    For more information, please contact: 

     Dr. Reinhard Malin
     Corporate Division Communications
     Boehringer Ingelheim
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