Effect of tibolone on markers of cardiovascular disease risk in postmenopausal women undergoing hemodialysis: a pilot study

OBJECTIVE: To assess the effect of tibolone on markers of vascular risk in postmenopausal women who were receiving hemodialysis. DESIGN: One-year open-label study. SETTING: "Zvezdara" University Medical Center, Belgrade, Serbia. PATIENT(S): Twenty-eight postmenopausal women undergoing chronic hemodialysis. INTERVENTION(S): Fifteen women received tibolone 2.5 mg three times per week; 13 other women served as controls. MAIN OUTCOME MEASURE(S): Mean arterial pressure and weight were measured at baseline and at 6 and 12 months, and blood was collected for insulin, total cholesterol, low-density lipoprotein, high-density lipoprotein, triglycerides, lipoprotein(a), high-sensitivity C-reactive protein (hs-CRP), endothelin-1 (ET-1), vascular endothelial growth factor (VEGF), and markers of renal function. RESULT(S): Mean arterial pressure fell in the tibolone but not in the control group at 6 and 12 months versus baseline (mean [SD]: 93 [15] vs. 105 [11] mmHg and 94 [10] vs. 105 [11] mmHg, respectively). Weight, insulin, lipids, lipoprotein(a), hs-CRP, ET-1, VEGF, and renal function remained unchanged within each group, but high-density lipoprotein concentrations fell in the tibolone group after 12 months (1.2 [0.3] vs. 1.6 [0.6] mmol/L). CONCLUSION(S): The effects of tibolone on markers of vascular risk in postmenopausal women who are receiving hemodialysis and healthy women appear to differ. This should be taken into account when tailoring menopausal therapies to the specific requirements of each individual.