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67th Annual Meeting Abstracts
Phase III Trial Of Toremifene 80 Mg Compared To Placebo In Men On ADT Demonstrates A Positive Impact On Lipid Profile
Bruce Malkowicz1, *Sylvia Salazar1, Greg Eure2, Robert W Given2, *Ronald Morton3
1University of Pennsylvania, Philadelphia, PA;2Urology of Virginia, Norfolk, VA;3GTx, Inc, Memphis, TN
Introduction:
Many men are on ADT for 10 or more years subjecting them to estrogen deficiency side effects such as adverse changes in lipoproteins. We conducted a double-blind, randomized, placebo-controlled trial to determine if toremifene 80 mg would prevent fractures in men on ADT and also assessed the effect of toremifene on lipoproteins
Materials & Methods:
1389 men with prostate cancer were randomized to receive toremifene or placebo orally. The primary endpoint was new morphometric vertebral fractures. Secondary endpoints included change in lipoproteins, BMD, worsening vertebral fractures, breast pain, and hot flashes.
Results:
Changes in lipoproteins differed significantly between the toremifene and placebo groups. At 24 months, total cholesterol, LDL, and triglycerides decreased by 10.0% (95% CI, 8.1% to 11.9%), 16.6% (95% CI, 13.8% to 19.4%), and 7.9% (95% CI, 3.2% to 12.5%), respectively, in the toremifene group as compared to the placebo group (p<0.001 for all comparisons). In contrast, HDL increased by 10.1% (95% CI, 7.5% to 12.6%) in the toremifene group as compared to the placebo group (p<0.001).
Conclusions:
Adverse lipid changes are a common asymptomatic side effect of ADT. In this randomized, placebo controlled trial, toremifene 80 mg demonstrated a reduction in total cholesterol, LDL, and triglycerides; and an increase in HDL. These results suggest that men on toremifene for the prevention of fractures due to ADT may benefit from a statistically significant improvement in their lipid profile
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