New EASD/ADA Consensus Recommends Metformin (Glucophage(R)) at Diagnosis of Type 2 Diabetes

New EASD/ADA Consensus Recommends Metformin (Glucophage(R)) at Diagnosis of Type 2 Diabetes

September 13, 2006

    COPENHAGEN, Denmark, Sept. 13 /Xinhua-PRNewswire/ --
Newly diagnosed patients with diabetes should be treated
with metformin (Glucophage(R)) in conjunction with
lifestyle modification (unless metformin is
contraindicated).  Initiation of metformin should no longer
be delayed until lifestyle modification (weight loss and
increased activity) fails to adequately control glycaemia. 
This is the recommendation of a new consensus statement from
the American Diabetes Association (ADA) and the European
Association for the Study of Diabetes (EASD)(1).

    Traditionally, guidelines have recommended lifestyle
modification as the first step in intervention to reduce
glycaemia.  Oral antidiabetic treatment should be initiated
with metformin, according to guidelines published by the
International Diabetes Federation (IDF) in 2005.  These
guidelines stated that: "Standard care should begin
with metformin unless there is evidence or risk of renal
impairment."(2)

    Now, however, the ADA/EASD expert panel has recognised
that lifestyle modification alone often fails to achieve or
maintain metabolic goals. Therefore, most patients will also
require effective treatment with metformin (Glucophage). 
Thus, the added benefits of metformin (Glucophage) should
not be delayed after diagnosis. 

    Dr Clifford Bailey, Professor of Clinical Science at
Aston University, Birmingham, UK, and a member of the EASD
committee that reviewed the new treatment algorithm, said:
"Metformin is widely available and efficacious in
long-term glycaemic control.  The recommendation of
metformin at diagnosis of type 2 diabetes is not a major
variation from many other treatment algorithms, but is
noteworthy in that it appears for the first time in an
international consensus guideline."

    Metformin (Glucophage) is recommended because it has
demonstrated:

    -- Typical lowering of HbA1c by 1.5-2.0% according to
dosage

    -- Absence of weight gain and hypoglycaemia

    -- Generally low level of side effects

    -- High level of acceptance by patients

    -- Relatively low cost

    Additionally, the landmark United Kingdom Prospective
Diabetes Study (UKPDS) demonstrated that metformin
significantly reduced the risk of fatal and non-fatal
cardiovascular events in patients with type 2 diabetes(3). 
The study showed a 36% reduction in all-cause mortality, a
42% reduction in diabetes-related mortality and a 32%
reduction in diabetes-related endpoints.

    Following initiation of treatment, the expert group
recommends that metformin (Glucophage) should be titrated
to the maximum effective and tolerated dose over one to two
months. Only after this is achieved should another agent be
added if required to achieve glycaemic goals.

    References

    1. Nathan DM, Buse JB, Davidson MB et al. Management of
hyperglycaemia in 
       type 2 diabetes: a consensus algorithm for the
initiation and 
       adjustment of therapy. A consensus statement from
the American Diabetes 
       Association and the European Association for the
Study of Diabetes. 
       Diabetologia 2006; 49: 1711-1721 and Diabetes Care
2006; 29: 1963-1972.

    2. International Diabetes Federation 2005. Clinical
Guidelines Task Force. 
       Global guideline for type 2 diabetes. Available from
http://www.idf.org 

    3. UKPDS Group. Effect of intensive blood glucose
control with metformin 
       on complication in overweight patients with type 2
diabetes (UKPDS 34). 
       Lancet 1998; 352: 854-65.

    Note to Editors

    -- This is the first international treatment algorithm
of hyperglycaemia in type 2 diabetes to recommend
simultaneous initiation of pharmaceutical therapy and
lifestyle intervention in newly diagnosed patients.

    -- The recommendations were reviewed and approved by
the Professional Practice Committee of the American
Diabetes Association and by an ad hoc committee of the
European Association for the Study of Diabetes (U Smith,
Gothenburg, Sweden; S Del Prato, Pisa, Italy; C Bailey,
Birmingham, UK; and, B Charbonnel, Nantes, France).

    About Merck CardioMetabolic Care

    Merck's commitment to cardiometabolic care stretches
back for more than four decades, since the introduction of
Glucophage(R)(x) into clinical practice. Merck is the
global market leader in oral diabetes medications. Most
patients with type 2 diabetes in over 100 countries around
the globe currently benefit from various products based on
metformin. In addition, Merck is offering the
lipid-modifying drug Niaspan(R) (prolonged release
nicotinic acid) with a particularly strong HDL-raising
effect that is intended to be used in patients with
dyslipidaemia; the Concor(R) product family which offers
treatment for hypertension, coronary artery disease and
chronic heart failure and other cardiovascular products
available in various countries.

    (x) Glucophage(R) is also marketed under the following
brand names: Diabex(R), Dabex(R), Dianben(R), Glifage(R),
Glisulin(R), Merckformin(R) and Risidon(R)

    Merck is a global pharmaceutical and chemical company
with sales of EUR 5.9 billion in 2005, a history that began
in 1668, and a future shaped by 29,958 employees in 55
countries. Its success is characterized by innovations from
entrepreneurial employees. Merck's operating activities come
under the umbrella of Merck KGaA, in which the Merck family
holds a 73% interest and free shareholders own the
remaining 27%. In 1917 the U.S. subsidiary Merck & Co.
was expropriated and has been an independent company ever
since.

    For more information, please contact:

     Harry Howlett 
     PhD FRCP
     International Medical Adviser
     Tel:  [phone]

     Jean-Christophe Valluy
     International Marketing Manager
     Tel:  [phone]

     Isabella Schmele
     Tel:  [phone]

SOURCE  Merck KGaA