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

Munich, June 28, 2010 (ots/PRNewswire) - Interim data from a prospectiveInvestigator Initiated Trial (IIT) presented today at the ECTS, the37th European Symposium on Calcified Tissues, in Glasgow,demonstrates that EVISTA(R) (raloxifene 60mg; once-daily, distributedin 34 countries by DAIICHI SANKYO), indicated for the treatment andprevention of osteoporosis in postmenopausal women, improves bonequality as measured by the high-resolution peripheral quantitativecomputed tomography (HRpQCT). Dr. Radspieler, Investigator of the IITat the Osteoporosis Diagnostic- und Therapy centre Munich, evaluatedprospectively micro-architectural changes of the bone of patientsbeing 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% and3.9% and cortical bone densities by 1.1% and 0.7% in the radius andthe tibia respectively.

Dr. Helmut Radspieler comments: "With the help of 3D images wecan now actually see into the micro-structure of bones. This makes itpossible to determine the efficacy of different treatments, as shownhere with raloxifene." He continues; "We now understand better andare also able to visualise that bone structure and not bone densityalone is crucial to retain bone quality".

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

It was shown in clinical studies that raloxifene significantlyincreased BMD by 2% in both osteopenic and osteoporoticpostmenopausal women compared to placebo(1). Compared with otherosteoporotic drugs the numeric BMD increase with raloxifene isrelatively low, although the vertebral fracture risk reduction issimilar. The MORE (Multiple Outcome of Raloxifene Evaluation) studydemonstrated that EVISTA(R) had a 55% relative risk reduction ofvertebral fractures vs. placebo with a 2.4% absolute risk reductionin the risk of 1st vertebral fracture in patients with osteoporosisover 3 years(2). In addition, even the population of patients wholost BMD in the MORE study demonstrated a fracture risk reduction(3).Taking into account that bone strength is determined by both bonedensity and bone quality, it is assumed that less than 4% of fracturerisk reduction is correlated to BMD after raloxifene treatment(3).

About Disease state for product information:

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

About EVISTA(R):

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


DAIICHI SANKYO is a global pharmaceutical company that focuses onresearching and marketing innovative medications. The company wascreated in 2005 through the merger of two traditional Japaneseenterprises, Daiichi and Sankyo. With net sales of nearly 7.3 billionEUR in fiscal year 2009 (as of March 31st) , DAIICHI SANKYO is one ofthe world's 20 leading pharmaceutical companies. The company's worldheadquarters is in Tokyo, its European base is located in Munich.DAIICHI SANKYO has affiliates in 12 European countries and has beenone of the strongest Japanese pharmaceutical companies located inEurope since it set up European production facilities and marketingoffices in 1990. The company's research activities focus on the areasof cardiovascular diseases, hematology, anti-infectives and cancer.Its aim is to develop medications that are "best" in their class orto 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 andinformation about future developments in the sector, and the legaland business conditions of DAIICHI SANKYO EUROPE GmbH. Suchforward-looking statements are uncertain and are subject at all timesto the risks of change, particularly to the usual risks faced by aglobal pharmaceutical company, including the impact of the prices forproducts and raw materials, medication safety, changes in exchangerates, government regulations, employee relations, taxes, politicalinstability and terrorism as well as the results of independentdemands and governmental inquiries that affect the affairs of thecompany. All forward-looking statements contained in this releasehold true as of the date of publication. They do not represent anyguarantee of future performance. Actual events and developments coulddiffer materially from the forward-looking statements that areexplicitly expressed or implied in these statements. DAIICHI SANKYOEUROPE GmbH assumes no responsibility for the updating of suchforward-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 ofraloxifene on vertebral fracture risk reduction in postmenopausalwomen with osteoporosis: four-year results from a randomized clinicaltrial. J Clin Endocrinol Metab. Aug;87(8)

3. Sarkar S, Mitlak BH, Wong M et al (2002) Relationships betweenbone mineral density and incident vertebral fracture risk withraloxifene 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 at12 months in postmenopausal women with osteoporosis. Arch InternMed.;162(10 ):1140-3

5. Periodic safety Update Report, PSUR 19 Global (10-June-2009 TO09-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

ots Originaltext: DAIICHI SANKYO EUROPE GmbHIm Internet recherchierbar: http://www.presseportal.de

Contact:CONTACT: Contact: Dr. Iris Marr, International Brand Management, Phone+49(0)89-78-08-807, iris.marr@daiichi-sankyo.eu. Dr. MichaelaPaudler-Debus, Corporate Communications and Public Affairs, Phone+49(0)89-78-08-685, michaela.paudler-debus@daiichi-sankyo.eu


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