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(Arteriosclerosis, Thrombosis, and Vascular Biology. 2003;23:1889.)
© 2003 American Heart Association, Inc.

Atherosclerosis and Lipoproteins

Significant Differential Effects of Hormone Therapy or Tibolone on Markers of Cardiovascular Disease in Postmenopausal Women

A Randomized, Double-Blind, Placebo-Controlled, Crossover Study

Kwang Kon Koh; Jeong Yeal Ahn; Dong Kyu Jin; Byung-Koo Yoon; Hyung Sik Kim; Dae Sung Kim; Woong Chol Kang; Seung Hwan Han; In Suck Choi; Eak Kyun Shin

From the Divisions of Cardiology (K.K.K., D.K.J., W.C.K., S.H.H., I.S.C., E.K.S.), Clinical Pathology (J.Y.A.), Obstetrics and Gynecology (Samsung Medical Center, Sungkyunkwan University) (B.-K.Y.), Radiology (H.S.K.), and Preventive Medicine (Biostatistics) (D.S.K.), Gachon Medical School, Incheon, Korea.

Correspondence to Kwang Kon Koh, MD, FACC, FAHA, Prof of Medicine, Director, Vascular Medicine and Atherosclerosis Unit, Division of Cardiology, Gil Heart Center, Gachon Medical School, 1198 Kuwol-dong, Namdong-gu, Incheon, Korea 405-760. E-mail kwangk{at}ghil.com

Objective— The objective was to compare the effects of tibolone and hormone therapy (HT) on lipid profile, vasodilation, and factors associated with inflammation and hemostasis.

Methods and Results— Fifty-three women received micronized progesterone (MP, 100 mg) with conjugated equine estrogen (CEE, 0.625 mg) or tibolone (2.5 mg) daily for 2 months, with a 2-month washout period. Compared with HT, tibolone significantly reduced total cholesterol (P<0.001), triglyceride (P<0.001), and HDL cholesterol (P<0.001) levels as well as triglyceride/HDL cholesterol ratios (P<0.001) but not LDL cholesterol levels. Tibolone significantly improved flow-mediated brachial artery dilator response to hyperemia from baseline values (P<0.001) by a magnitude similar to that found with HT (P=0.628). Compared with tibolone, which showed no changes, HT significantly increased high-sensitivity C-reactive protein (hsCRP, P=0.030) and reduced antithrombin III (P<0.001). HT and tibolone significantly increased prothrombin fragment 1+2 (F1+2) from baseline values (P<0.001 and P=0.004, respectively). The effects of HT and tibolone on hsCRP, antithrombin III, and F1+2 were significantly different. HT and tibolone significantly reduced plasma levels of plasminogen activator inhibitor type 1 antigen from baseline levels (P=0.006 and P=0.005, respectively) to a similar degree (P=0.988).

Conclusions— Tibolone significantly improved flow-mediated brachial artery dilator response by a magnitude similar to that found with CEE+MP; however, tibolone did not significantly change hsCRP and antithrombin III, and tibolone increased F1+2 less than did CEE+MP.

Key Words: hormone therapy • tibolone • endothelial function • inflammation • hemostasis

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