Toremifene improves lipid profiles in men receiving androgen-deprivation therapy for prostate cancer: interim analysis of a multicenter phase III study.

Abstract

PURPOSE:

Androgen-deprivation therapy (ADT) is associated with greater risk of incident coronary heart disease and hospital admission for myocardial infarction; treatment-related increases in serum lipids may contribute to greater cardiovascular disease risk. We evaluated the effects of toremifene, a selective estrogen-receptor modulator, on fasting serum lipid levels in men receiving ADT for prostate cancer.

PATIENTS AND METHODS:

In an ongoing, multicenter, double-blind, placebo-controlled phase III fracture-prevention study, 1,389 men receiving ADT for prostate cancer were randomly assigned to receive toremifene (80 mg/d) or placebo. In this interim analysis of 188 patients, changes in fasting serum lipids from baseline to month 12 were compared between the placebo and toremifene groups.

RESULTS:

Changes in serum lipids differed significantly between the groups. Mean (+/- SE) total cholesterol decreased by 1.0% +/- 1.7% from baseline to month 12 in the placebo group and decreased by 8.1% +/- 1.4% in the toremifene group (P = .001 for between group comparison). Low-density lipoprotein (LDL) cholesterol increased by 0.8% +/- 2.5% in the placebo group and decreased by 8.2% +/- 2.5% in the toremifene group (P = .003). In contrast, high-density lipoprotein (HDL) cholesterol decreased by 4.9% +/- 1.2% in the placebo group and increased by 0.5% +/- 2.2% in the toremifene group (P = .018). Triglycerides increased by 6.9% +/- 4.2% in the placebo group and decreased by 13.2% +/- 3.6% in the toremifene group (P = .003).

CONCLUSION:

Toremifene significantly decreased total cholesterol, LDL cholesterol, and triglycerides, and increased HDL cholesterol in men receiving ADT for prostate cancer.

• Authors: Matthew R Smith, S Bruce Malkowicz, Franklin Chu, John Forrest, Paul Sieber, K Gary Barnette, Domingo Rodriquez, Mitchell S Steiner
• Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 26 Issue 11 Pg. 1824-9 (Apr 10 2008) ISSN: 1527-7755 [Electronic] United States
• PMID: 18398147 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Androgen Antagonists
• Antineoplastic Agents, Hormonal
• Bone Density Conservation Agents
• Cholesterol, HDL
• Cholesterol, LDL
• Lipids
• Triglycerides
• Toremifene
• Cholesterol

Topics

• Aged
• Aged, 80 and over
• Androgen Antagonists (therapeutic use)
• Antineoplastic Agents, Hormonal (therapeutic use)
• Bone Density Conservation Agents (therapeutic use)
• Cholesterol (blood)
• Cholesterol, HDL (blood)
• Cholesterol, LDL (blood)
• Double-Blind Method
• Fractures, Malunited (prevention & control)
• Humans
• Lipids (blood)
• Male
• Middle Aged
• Osteoporosis (prevention & control)
• Prostatic Neoplasms (drug therapy, metabolism)
• Toremifene (therapeutic use)
• Triglycerides (blood)