New High-Resolution Computer Tomography Data Demonstrates EVISTA(R)'s Effect on Bone Quality in Osteoporotic Patients
By Daiichi-sankyo, PRNESunday, June 27, 2010
3D Images Provide New Approach to Monitoring Bone Changes
MUNICH, June 28, 2010 - 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:
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
www.inmo.ie/INMOPage_8_66.aspx last access 06.05.2010
Contact: Dr. Iris Marr, International Brand Management, Phone +49(0)89-78-08-807, iris.marr at daiichi-sankyo.eu. Dr. Michaela Paudler-Debus, Corporate Communications and Public Affairs, Phone +49(0)89-78-08-685, michaela.paudler-debus at daiichi-sankyo.eu
Tags: Daiichi-Sankyo, Germany, June 28, Munich