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Effects of ospemifene, a novel SERM, on vascular markers and function in healthy, postmenopausal women

Ylikorkala, Olavi MD, PhD, FRCOG1; Cacciatore, Bruno MD, PhD1; Halonen, Kaija MSc2; Lassila, Riitta MD, PhD3; Lammintausta, Risto MD, PhD2; Rutanen, Eeva-Marja MD, PhD1; Heikkinen, Jorma MD, PhD4; Komi, Janne MD, PhD2

doi: 10.1097/01.GME.0000063566.84134.98
Articles

Objective Ospemifene, a novel selective estrogen receptor modulator (SERM), shows promise for bone preservation in postmenopausal women. This study examined the effects of ospemifene on different vascular surrogate markers.

Design A double-blinded study was conducted in 160 healthy, postmenopausal women who used, in a randomized order, ospemifene (at daily doses of 30, 60, or 90 mg) or placebo for 3 months.

Results Although ospemifene caused falls from basal levels in total cholesterol, low-density lipoprotein cholesterol, oxidized low-density lipoprotein cholesterol, and a rise in high-density lipoprotein cholesterol, the only statistically significant difference between ospemifene and placebo was an increase of triglyceride levels (11.3%) in the 90-mg group. Ospemifene caused no significant effect on endothelial markers or homocysteine. Of the markers reflecting coagulation and fibrinolysis, plasma fibrinogen was significantly reduced in the 60- and 90-mg groups of ospemifene (8.7% and 8.5%, respectively) when compared with the placebo group. No changes were seen in generation of thrombin or degradation of crosslinked fibrin D-dimer. The uterine or carotid arteries and 24-h ambulatory blood pressure were not affected by ospemifene. Ospemifene caused no changes in basal insulin or in a 2-h glucose tolerance test, suggesting unaltered insulin sensitivity.

Conclusions Neutral effects of short-term use of ospemifene on vascular surrogate markers imply no effect for ospemifene on the risk for cardiovascular disorders in healthy, postmenopausal women.

From the 1Department of Obstetrics and Gynecology, Helsinki University Central Hospital, Helsinki, Finland; 2Hormos Medical Corporation, Turku, Finland; 3Wihuri Research Center, Helsinki, Finland; and 4Oulu Deaconess Institute, Oulu, Finland.

Received May 21, 2002; revised and accepted February 5, 2003.

The study was supported by a research grant from Hormos Medical Corporation.

Address correspondence to: Olavi Ylikorkala, MD, Helsinki University Central Hospital, Department of Obstetrics and Gynecology, PO Box 140, 00029 HUS, Finland. E-mail: olavi.ylikorkala@hus.fi.

©2003The North American Menopause Society