The American Journal of Medicine
Volume 122, Issue 8 , Pages 754-761 , August 2009

Raloxifene and Risk for Stroke Based on the Framingham Stroke Risk Score

  • Elizabeth Barrett-Connor, MD

      Affiliations

    • Departments of Family and Preventive Medicine, University of California, San Diego, La Jolla, Calif
    • Corresponding Author InformationRequests for reprints should be addressed to Elizabeth Barrett-Connor, MD, Division of Epidemiology, Department of Family and Preventive Medicine, University of California, San Diego, 9500 Gilman Drive 0607, La Jolla, CA 92093-0607
  • ,
  • David A. Cox, PhD

      Affiliations

    • Lilly Research Laboratories, Indianapolis, Ind
  • ,
  • Jingli Song, PhD

      Affiliations

    • Lilly Research Laboratories, Indianapolis, Ind
  • ,
  • Bruce Mitlak, MD

      Affiliations

    • Lilly Research Laboratories, Indianapolis, Ind
  • ,
  • Lori Mosca, MD, PhD

      Affiliations

    • Preventive Cardiology, Columbia University Medical Center, New York, NY
  • ,
  • Deborah Grady, MD

      Affiliations

    • University of California, San Francisco and the San Francisco VA Medical Center, Calif

  • Image Result

    Incidence of A) nonfatal stroke, and B) fatal stroke among participants in the MORE trial, and by quartiles of baseline Framingham stroke risk score for RUTH participants. HR=hazard ratio (95% confide

    Incidence of A) nonfatal stroke, and B) fatal stroke among participants in the MORE trial, and by quartiles of baseline Framingham stroke risk score for RUTH participants. HR=hazard ratio (95% confidence interval). Note: MORE data are shown as placebo versus pooled raloxifene 60 mg and 120 mg dose groups (ie, approximately twice as many women assigned to raloxifene as placebo). P-values are for test for interaction of hazard ratio with quartile of Framingham Stroke Risk Score in RUTH. MORE=Multiple Outcomes of Raloxifene Evaluation; RUTH=Raloxifene Use for The Heart.

  • Image Result
    Absolute difference (per 1000 woman-years) in incidence of fatal stroke (raloxifene compared with placebo) among participants in the MORE trial and by quartile of Framingham Stroke Risk Score in RUTH.

    Absolute difference (per 1000 woman-years) in incidence of fatal stroke (raloxifene compared with placebo) among participants in the MORE trial and by quartile of Framingham Stroke Risk Score in RUTH. FSRS=Framingham stroke risk score; MORE=Multiple Outcomes of Raloxifene Evaluation; RUTH=Raloxifene Use for The Heart.

  • Image Result
    Cumulative incidence curves for fatal stroke for RUTH trial participants at A) higher or B) lower risk for stroke, as determined by the Framingham stroke risk score. P-value for interaction between th

    Cumulative incidence curves for fatal stroke for RUTH trial participants at A) higher or B) lower risk for stroke, as determined by the Framingham stroke risk score. P-value for interaction between the effect of treatment and higher vs lower baseline Framingham stroke risk score=0.33. The absolute risk difference (raloxifene vs placebo) was: 1.3 (95% CI, 0.05-2.5) events per 1000 woman-years in the higher risk group and 0.07 (95% CI, −0.8-0.8) events per 1000 woman-years in lower risk group. RUTH=Raloxifene Use for The Heart; HR=hazard ratio; CI=confidence interval.

 Funding: Studies funded by Lilly Research Laboratories.

 Conflict of Interest: Elizabeth Barrett-Connor and Deborah Grady were paid external investigators for the Raloxifene MORE and RUTH studies by Lilly Research Laboratories. Lori Mosca was a paid external investigator for the Raloxifene RUTH study by Lilly Research Laboratories. David A. Cox, Jingli Song, and Bruce Mitlak are employees of Lilly Research Laboratories and have financial interest in the company.

 Authorship: All authors had access to the data and a role in writing the manuscript.

PII: S0002-9343(09)00333-7

doi: 10.1016/j.amjmed.2009.01.033

The American Journal of Medicine
Volume 122, Issue 8 , Pages 754-761 , August 2009