Full Press Release Details
INDIANAPOLIS , May 29, 2013 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY ) today announced new data showing that FORTEO significantly increased lumbar spine volumetric bone mineral density (vBMD) compared to risedronate in men with glucocorticoid-induced osteoporosis. Glucocorticoid-induced osteoporosis is caused by excess intake of glucocorticoids, a class of steroid hormones used to treat inflammatory, autoimmune and allergic disorders. 1 Study results are published in the June issue of the Journal of Bone and Mineral Research .
Results from the study's primary endpoint showed that at 18 months, both FORTEO and risedronate significantly increased lumbar spine vBMD, and greater increases were observed in patients taking FORTEO (mean change from baseline: 16.3% vs. 3.8%; p=0.004). 2
Measurement was completed using conventional and high-resolution quantitative computed tomography (QCT), a newer technology that uses modern clinical scanners to provide tri-dimensional BMD and bone structural evaluations. QCT is better able to discriminate between subjects with and without prevalent vertebral fractures compared to conventional areal dual X-ray absorptiometry (DXA) and is better suited to identify patients with glucocorticoid-induced osteoporosis at highest risk for fracture. 3
"Though we often think of osteoporosis as a women's disease, men can get it too. In fact, approximately two million American men have osteoporosis," said Claus-C. Gluer, Ph.D., professor of medical physics, Department of Diagnostic Radiology, University Medical Center Schleswig-Holstein. "These study results can help healthcare professionals better determine which treatment may be best suited for individual male patients with glucocorticoid-induced osteoporosis."
Secondary outcomes observed in the study include: 2
"Data evaluating osteoporosis medications in men are relatively scarce," said Fernando Marin , M.D., Ph.D., medical fellow, EIi Lilly and Company. "Lilly is committed to furthering scientific knowledge in this underserved patient population to help reduce barriers to men with osteoporosis getting the treatment they need."
FORTEO is used in both men and postmenopausal women with osteoporosis who are at high risk for having broken bones (fractures). FORTEO is used in both men and women with osteoporosis due to use of glucocorticoid medicines, such as prednisone, for several months, who are at high risk for having broken bones (fractures). FORTEO can be used by people who have had a fracture related to osteoporosis, or who have several risk factors for fracture, or who cannot use other osteoporosis treatments. 4
During the drug testing process, the medicine in FORTEO caused some rats to develop osteosarcoma, which, in humans, is a serious but rare bone cancer. Osteosarcoma has been reported rarely in people who took FORTEO, and it is unknown if people who take FORTEO have a higher chance of getting the disease. Before patients take FORTEO, patients should tell their healthcare provider if they have Paget's disease of bone, are a child or young adult whose bones are still growing or have had radiation therapy. 4 For more information about FORTEO, please see the important safety information, including Boxed Warning regarding osteosarcoma, below.
About the Study 2
"Comparative Effects of Teriparatide and Risedronate in Glucocorticoid-Induced Osteoporosis in Men: 18-Month Results of the EuroGIOPS Trial" was an 18-month randomized, open-label, controlled trial conducted in four European countries in men who had taken glucocorticoids (steroids) for more than three months (prednisone equivalent >5 mg/d) and had an areal bone mineral density (BMD) T-score <-1.5 SD. Participants received either 20 mg/d teriparatide (TPTD, n=45) or 35 mg/wk risedronate (RIS, n=47) and 1 g calcium and 1200 IU vitamin D daily.
The primary objective was to compare the increase in lumbar spine (L1-L3) vBMD between groups, as measured by QCT. Secondary outcomes included changes in 3-D microstructure variables measured by high-resolution QCT (HRQCT) at T12, biomechanical effects evaluated by finite element (FE) analysis, areal BMD determined by DXA, biochemical markers and safety.
Radiological evaluations were performed at baseline, six and 18 months. The calibrated HRQCT images of T12 were converted into digital FE models and subjected to axial compression, anterior bending and axial torsion. Stiffness and strength were computed for each model and loading mode. A predefined mixed model repeated measures was used to analyze the changes from baseline and the between-group differences.
Important Safety Information about FORTEO
What is the most important information I should know about FORTEO?
WARNING: POTENTIAL RISK OF OSTEOSARCOMA
During the drug testing process, the medicine in FORTEO caused some rats to develop a bone cancer called osteosarcoma. In people, osteosarcoma is a serious but rare cancer. Osteosarcoma has been reported rarely in people who took FORTEO. It is not known if people who take FORTEO have a higher chance of getting osteosarcoma. Before you take FORTEO, you should tell your healthcare provider if you have Paget's disease of bone, are a child or young adult whose bones are still growing, or have had radiation therapy.
Who should not take FORTEO?
What should I tell my healthcare provider before taking FORTEO?
What are the possible side effects of FORTEO?
Additional safety information about FORTEO
How should I store FORTEO?
For more safety information, please see Medication Guide ( http://pi.lilly.com/us/forteo-medguide.pdf ) and Prescribing Information ( http://pi.lilly.com/us/forteo-pi.pdf ), including Boxed Warning regarding osteosarcoma. Please see full user manual that accompanies the delivery device.
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About Eli Lilly and Company
Eli Lilly and Company, a leading innovation-driven company, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind. , Lilly provides answers – through medicines and information – for some of the world's most urgent medical needs. Information about Lilly is available at www.lilly.com .
FORTEO ® is a registered trademark of Eli Lilly and Company.
This press release contains forward-looking statements about Forteo for the treatment of osteoporosis. It reflects Lilly's current beliefs; however, as with any such undertaking, there are substantial risks and uncertainties in the process of drug development and commercialization. There is no guarantee that future study results and patient experience will be consistent with study findings to date or that Forteo will continue to be commercially successful. For further discussion of these and other risks and uncertainties, please see Lilly's latest Forms 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.
1 The National Osteoporosis Foundation, "Medicines That May Cause Bone Loss." Accessed on May 9, 2013 from http://www.nof.org/articles/6 .
2 Gluer, C-C et al. "Comparative Effects of Teriparatide and Risedronate in Glucocorticoid-Induced Osteoporosis in Men: 18-Month Results of the EuroGIOPs Trial." Journal of Bone and Mineral Research (2013), DOI [10.1002/jbmr.1870].
3 Graeff C, et al. High Resolution Quantitative Computed Tomography-based Assessment of Trabecular Microstructure and Strength Estimates by Finite-element Analysis of the Spine, but not DXA, Reflects Vertebral Fracture Status in Men with Glucocorticoid-induced Osteoporosis. Bone . (2013); 52:568-577.
4 FORTEO PI. Available at http://pi.lilly.com/us/forteo-pi.pdf
Refer to: Teresa Shewman , (317) 292-8940; [email protected]
SOURCE Eli Lilly and Company