title: Effects of toremifene and tamoxifen on lipid profiles in post-menopausal patients with early breast cancer: interim results from a Japanese phase III trial.
abstract: OBJECTIVE
  Toremifene and tamoxifen have been used for adjuvant therapy in post-menopausal patients with breast cancer in Japan. Dyslipidemias are common in post-menopausal women. However, limited data are available on the effects of these agents on lipid profiles in Japanese patients. The Japan Toremifene Cooperative Study Group has been conducting a Phase III randomized trial of post-menopausal patients with breast cancer. One of its secondary endpoints is to confirm the effects of these agents on serum lipid profiles.
  
  
  METHODS
  The subjects were post-menopausal Japanese patients who had undergone surgery for early breast cancer. Toremifene or tamoxifen was administered for 2 years. Lipid levels were measured before and up to 24 months after initiation.
  
  
  RESULTS
  Compared with baseline, at 24 months, the toremifene group (n = 123) showed significantly decreased total cholesterol (P < 0.001) and low-density lipoprotein cholesterol levels (P < 0.001), and significantly increased high-density lipoprotein cholesterol levels (P < 0.001). Their triglyceride levels were not affected (P = 0.677). The tamoxifen group (n = 120) also showed significantly decreased total cholesterol (P < 0.001) and low-density lipoprotein cholesterol levels (P < 0.001); no significant changes occurred in high-density lipoprotein cholesterol (P = 0.297) or triglyceride levels (P = 0.120).
  
  
  CONCLUSIONS
  Distinct differences between two selective estrogen receptor modulators on lipids were observed. Toremifene improved lipid profiles, particularly as an enhancer of high-density lipoprotein cholesterol. To a large extent, tamoxifen improved low-density lipoprotein cholesterol levels. The impact of these improved lipid profiles on the risk of cardiovascular diseases needs further confirmation.
authors.affiliation: Breast Cancer Center, Toyosu Hospital, Showa University, Tokyo, Japan. t-tominaga@hkg.odn.ne.jp
authors.forename: Takeshi
authors.initials: T
authors.lastname: Tominaga
authors.forename: Izo
authors.initials: I
authors.lastname: Kimijima
authors.forename: Morihiko
authors.initials: M
authors.lastname: Kimura
authors.forename: Yuichi
authors.initials: Y
authors.lastname: Takatsuka
authors.forename: Shigemitsu
authors.initials: S
authors.lastname: Takashima
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Nomura
authors.forename: Fujio
authors.initials: F
authors.lastname: Kasumi
authors.forename: Akihiro
authors.initials: A
authors.lastname: Yamaguchi
authors.forename: Norikazu
authors.initials: N
authors.lastname: Masuda
authors.forename: Shinzaburo
authors.initials: S
authors.lastname: Noguchi
authors.forename: Nobuoki
authors.initials: N
authors.lastname: Eshima
mesh_terms: D000368:Aged; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000097:blood / Q000188:drug therapy*; D017024:Chemotherapy, Adjuvant; D005260:Female; D006801:Humans; D007564:Japan; D008055:Lipids / Q000097:blood*; D008875:Middle Aged; D017698:Postmenopause; D013629:Tamoxifen / Q000627:therapeutic use*; D017312:Toremifene / Q000627:therapeutic use*
chemical_list: D018931:Antineoplastic Agents, Hormonal; D008055:Lipids; D013629:Tamoxifen; D017312:Toremifene