New High-Resolution Computer Tomography Data Demonstrates Evista's Effect on Bone Quality in Osteoporotic Patients
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
osteoporosis.
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).
About DAIICHI SANKYO
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:
http://www.daiichi-sankyo.eu
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.
References
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. Aug;87(8)
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); 31-32
http://www.inmo.ie/INMOPage_8_66.aspx last access
06.05.2010
Source: Daiichi-Sankyo
Contact: Dr. Iris Marr, International Brand Management, Phone
+49(0)89-78-08-807, iris.marr@daiichi-sankyo.eu. Dr. Michaela
Paudler-Debus, Corporate Communications and Public Affairs, Phone
+49(0)89-78-08-685, michaela.paudler-debus@daiichi-sankyo.eu
Posted: June 2010
