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Activity Number:
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472
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Type:
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Contributed
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Date/Time:
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Wednesday, August 9, 2006 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #307476 |
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Title:
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Quantitative Risk-Benefit Assessment in the Multiple Outcomes of Raloxifene Evaluation (MORE) Trial: an Application of the Global Benefit-Risk Assessment
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Author(s):
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Messan G. Amewou-Atisso*+ and Yili Pritchett
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Companies:
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Eli Lilly and Company and Abbott Laboratories
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Address:
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Lilly Corporate Center, Indianapolis, IN, 46285,
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Keywords:
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osteoporosis ; selective estrogen receptor modulator (SERM) ; global benefit-risk assessment
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Abstract:
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The risk-benefit profile of 4-year treatment with raloxifene, a SERM indicated for the prevention and treatment of osteoporosis was assessed in the Multiple Outcomes of Raloxifene Evaluation (MORE) trial using the global benefit-risk (GBR) approach. The Women's Health Initiative (WHI) global index was applied to the MORE data that demonstrated a favorable benefit-risk profile for raloxifene compared to placebo. In the GBR approach, "benefit" was defined as the absence of events that raloxifene might reduce the incidence of, based on the mechanism of action and the results of raloxifene registration trials; "risk" was defined as occurrence of any of other serious adverse events. Statistically significant superiority of raloxifene over placebo was observed for different definitions of benefit-risk categories, and the results are consistent with those by the WHI global index.
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