A COMPARATIVE-STUDY OF 2 HORMONE REPLACEMENT THERAPY REGIMENS ON SAFETY AND EFFICACY VARIABLES

Objective: To assess the effect of tibolone on endometrial safety, pla sma estradiol concentrations, lipid metabolism and climacteric symptom s in comparison to sequential conjugated equine estrogens and medroxyp rogesterone acetate in postmenopausal women. Methods: In a randomised, open-label, 6-cycle, group-comparative study, the effects on the afor ementioned parameters were studied with tibolone 2.5 mg/day (N= 13) co ntinuously, and with conjugated equine estrogens 0.625 mg/day continuo usly, combined with medroxyprogesterone acetate 5 mg/day (N=11) (CEE/M PA) sequentially, during 12 days of each 28-day cycle. Within-group st atistical analysis was performed with Student's t-test for paired samp les, whereas between-group statistics were performed using the Student 's t-test for independent groups. Results: Cytological evaluation reve aled no endometrial stimulation in either group. In the tibolone group , there were no effects on estradiol levels, whereas in the CEE/MPA gr oup, an increase in total and non-SHBG-bound estradiol plasma levels w as reported. In the tibolone group, there were significant decreases i n plasma total cholesterol, triglycerides, HDL-cholesterol and VLDL-ch olesterol, whereas no significant changes in LDL-cholesterol and IDL-c holesterol were reported. In the CEE/MPA group there were significant decreases in plasma total cholesterol, HDL-cholesterol and LDL-cholest erol, whereas there were no significant changes in triglycerides,IDL-c holesterol and VLDL-cholesterol. Climacteric symptoms, particularly va somotor episodes, decreased similarly in both groups. Conclusions: Bot h tibolone and CEE/MPA were safe with respect to effects on the endome trium and both treatments induced changes in the plasma profiles of ce rtain lipid and lipoprotein parameters. However, the overall clinical implications of these changes are unknown. Finally, both regimens were equally effective in the treatment of climacteric symptoms.