New High-Resolution Computer Tomography Data Demonstrates EVISTA(R)’s Effect on Bone Quality in Osteoporotic Patients

June 28, 2010

MUNICH, June 28, 2010 /PRNewswire/ –

– 3D Images Provide New Approach to Monitoring Bone Changes

Interim data from a prospective Investigator Initiated Trial (IIT)
presented today at the ECTS, the 37th European Symposium on Calcified
Tissues, in Glasgow, demonstrates that EVISTA(R) (raloxifene 60mg;
once-daily, distributed in 34 countries by DAIICHI SANKYO), indicated for the
treatment and prevention of osteoporosis in postmenopausal women, improves
bone quality as measured by the high-resolution peripheral quantitative
computed tomography (HRpQCT). Dr. Radspieler, Investigator of the IIT at the
Osteoporosis Diagnostic- und Therapy centre Munich, evaluated prospectively
micro-architectural changes of the bone of patients being treated with
EVISTA(R) for 15.1 months. The trial showed that, all parameters analysed
improved over the treatment period. Exemplary, raloxifene increased
volumetric trabecular by 2.9% and 3.9% and cortical bone densities by 1.1%
and 0.7% in the radius and the tibia respectively.

Dr. Helmut Radspieler comments: “With the help of 3D images we can now
actually see into the micro-structure of bones. This makes it possible to
determine the efficacy of different treatments, as shown here with
raloxifene.” He continues; “We now understand better and are also able to
visualise that bone structure and not bone density alone is crucial to retain
bone quality”.

Bone mineral density (BMD) assessed by dual-energy X-ray absorptiometry
(DXA) is the current gold standard for the diagnosis of osteoporosis,
however, it is not as effective in the measurement of the therapeutic effect
of an osteoporosis treatment(1). By using a new three-dimensional imaging
technique called HRpQCT researchers were able to look inside the bone at the
specific bone structure and quality. This provides a new approach to
monitoring bone changes, especially while being treated medically for

It was shown in clinical studies that raloxifene significantly increased
BMD by 2% in both osteopenic and osteoporotic postmenopausal women compared
to placebo(1). Compared with other osteoporotic drugs the numeric BMD
increase with raloxifene is relatively low, although the vertebral fracture
risk reduction is similar. The MORE (Multiple Outcome of Raloxifene
Evaluation) study demonstrated that EVISTA(R) had a 55% relative risk
reduction of vertebral fractures vs. placebo with a 2.4% absolute risk
reduction in the risk of 1st vertebral fracture in patients with osteoporosis
over 3 years(2). In addition, even the population of patients who lost BMD in
the MORE study demonstrated a fracture risk reduction(3). Taking into account
that bone strength is determined by both bone density and bone quality, it is
assumed that less than 4% of fracture risk reduction is correlated to BMD
after raloxifene treatment(3).

About Disease state for product information:

Osteoporosis, meaning ‘porous bones’ is a progressive disease which
increases the risk of fracture, particularly in the spine, wrists and hips
due to a reduction in bone strength. Osteoporosis can cause pain, loss of
movement, inability to perform daily tasks, and in many cases, death. The
declining level of oestrogen results in an increase in bone breakdown
(resorption), which can lead to a loss of bone density and hence stability6.

About EVISTA(R):

EVISTA(R) (raloxifene 60mg) is a prescription medication called a
Selective Estrogen Receptor Modulator (SERM). It is indicated for the
treatment and prevention of osteoporosis in postmenopausal women. It has been
shown that raloxifene made bones stronger and less likely to break(4).
EVISTA(R) has been taken by up to 30,8 million women worldwide, up to 8
million of them were treated in Europe(5).


DAIICHI SANKYO is a global pharmaceutical company that focuses on
researching and marketing innovative medications. The company was created in
2005 through the merger of two traditional Japanese enterprises, Daiichi and
Sankyo. With net sales of nearly 7.3 billion EUR in fiscal year 2009 (as of
March 31st) , DAIICHI SANKYO is one of the world’s 20 leading pharmaceutical
companies. The company’s world headquarters is in Tokyo, its European base is
located in Munich. DAIICHI SANKYO has affiliates in 12 European countries and
has been one of the strongest Japanese pharmaceutical companies located in
Europe since it set up European production facilities and marketing offices
in 1990. The company’s research activities focus on the areas of
cardiovascular diseases, hematology, anti-infectives and cancer. Its aim is
to develop medications that are “best” in their class or to create new
classes of pharmaceutical drugs. For more information, please visit:


Forward-looking statements

This press release contains forward-looking statements and information
about future developments in the sector, and the legal and business
conditions of DAIICHI SANKYO EUROPE GmbH. Such forward-looking statements are
uncertain and are subject at all times to the risks of change, particularly
to the usual risks faced by a global pharmaceutical company, including the
impact of the prices for products and raw materials, medication safety,
changes in exchange rates, government regulations, employee relations, taxes,
political instability and terrorism as well as the results of independent
demands and governmental inquiries that affect the affairs of the company.
All forward-looking statements contained in this release hold true as of the
date of publication. They do not represent any guarantee of future
performance. Actual events and developments could differ materially from the
forward-looking statements that are explicitly expressed or implied in these
statements. DAIICHI SANKYO EUROPE GmbH assumes no responsibility for the
updating of such forward-looking statements about future developments of the
sector, legal and business conditions and the company.


1. Evista Summary of Product Characteristics. Latest Update: August 2008

2. Delmas PD, Ensrud KE, Adachi JD et al (2002) Efficacy of raloxifene on
vertebral fracture risk reduction in postmenopausal women with osteoporosis:
four-year results from a randomized clinical trial. J Clin Endocrinol Metab.

3. Sarkar S, Mitlak BH, Wong M et al (2002) Relationships between bone
mineral density and incident vertebral fracture risk with raloxifene therapy.
J Bone Miner Res. Jan;17(1):1-10.

4) Maricic M, Adachi JD, Sarkar S, Wu W, Wong M, Harper KD, (2002) Early
effects of raloxifene on clinical vertebral fractures at 12 months in
postmenopausal women with osteoporosis. Arch Intern Med.;162(10 ):1140-3

5. Periodic safety Update Report, PSUR 19 Global (10-June-2009 TO
09-December 2009)/ Data on File

6. Condren L. As oestrogen declines. World of Irish Nursing. 2002; 10(3);

http://www.inmo.ie/INMOPage_8_66.aspx last access 06.05.2010

SOURCE Daiichi-Sankyo

Source: newswire

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