Mid-Atlantic Section of the American Urological Association
Home | About Us | Contact Us   
  Home
  Members
    Members Only Area
    Member Directory
    Join the MA-AUA
  Annual Meeting
  Board of Directors
  Committees
  Careers
  Newsletters
  Visit the AUA
  Advocacy Efforts
  MAAUA Research
  Scholarship
Didusch Museum
About the Mid-Atlantic Section of the American Urological Association (MAAUA)

 
  Members Only
  Username
 
  Password
 
   Forgot Password?

 

 

Effect of Atrasentan on Slowing Onset of Bone Pain in Hormone-Refractory Prostate Cancer Patients

Darryl J Sleep*, Sandra M Hulting*, Jeffrey D Isaacson*
Abbott, Abbott Park, IL

Introduction: Debilitating bone pain is the major cause of morbidity for prostate cancer patients with bone metastases whose disease has become refractory to standard hormonal therapies (HRPC). Atrasentan is a selective endothelin A receptor antagonist that helps block osteoblast proliferation and exacerbation of metastases to bone. Methods: The effect of atrasentan on bone pain was evaluated for 684 HRPC patients in a large phase 3 randomized double-blind placebo-controlled study whose bone metastases at baseline were confirmed by independent radiologic review (n=352 for 10 mg atrasentan; n=332 for placebo). Kaplan-Meier methods were used to estimate time to an adverse event of bone pain. Treatment effect was compared using log-rank test and Cox proportional hazards ratio (HR). Incidence of bone pain was compared for the treatment arms using Fisher's exact test.
Results: Significantly more placebo recipients experienced bone pain than did atrasentan recipients.
Incidence of Bone Pain
n/N (%)
Cox Proportional Model of
Time to Bone Pain
Placebo10 mg AtrasentanP valueHazard Ratio95% CILog-rank P value
209/332 (63.0%)189/352 (53.7%).016.780.640, .949.012
Median time to bone pain was 44 days longer for atrasentan-treated subjects than for placebo-treated subjects (121 days versus 77 days). Atrasentan reduced the hazard associated with experiencing bone pain by 22%.
Conclusions: These data demonstrate that atrasentan provides clinical benefit for HRPC patients with bone metastases, specifically a significantly lower incidence and delay in onset of bone pain.

Back to Final Program

 

 

Copyright © 2012 Mid-Atlantic Section of the American Urological Association. All Rights Reserved.
Read Privacy Policy.