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Lilly Announces Review of Data on Long-Term Raloxifene Treatment for Postmenopausal Osteoporosis Published in Current Medical Research & Opinion
Date:8/9/2011

eriod between the end of the MORE trial and the beginning of the CORE trial experienced a significant decrease in BMD. Once treatment resumed in the CORE trial, lumbar spine and femoral neck BMD increased in the EVISTA group.
  • Bone turnover: In a previously unpublished analysis of data from the MORE study, patients who received EVISTA for three continuous years had lower bone resorption as measured by c-terminal telopeptide (CTX) values, with the average being similar to that found in premenopausal women. EVISTA is not for use in premenopausal women.
  • Iliac crest bone biopsies: Newly reported data from a subset of patients in the CORE trial included results of iliac crest biopsies in three patients treated with EVISTA for eight years. These iliac crest biopsies showed normal bone and bone cells and double label in all specimens.
  • Invasive breast cancer risk reduction: In a subset of postmenopausal women followed for up to eight years from randomization of the MORE trial to the end CORE, a reduction in the incidence of invasive breast cancer was observed in the EVISTA versus placebo group. The long term effects and the recommended length of therapy are not known.

  • Study safety findings included:

  • In clinical trials, patients in the EVISTA versus placebo group had higher incidence of venous thromboembolic events (blood clots in the legs, lungs or eyes), including deep vein thrombosis and pulmonary embolism, compared with patients who received placebo. EVISTA is contraindicated in women with active or past history of venous thromboembolism (VTE), including deep vein thrombosis, pulmonary embolism and retinal vein thrombosis.
  • The safety profile of EVISTA after four years of treatment was similar to that of EVISTA following three years of therapy.
  • Additional adverse events (>2% and more common with EVISTA than with placebo) included hot flashes, leg cramps, swelling, flu-like symptoms, joint
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  • SOURCE Eli Lilly and Company
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