A comparative study of two hormone replacement therapy regimens on safety and efficacy variables

Objective: To assess the effect of tibolone on endometrial safety, plasma estradiol concentrations, lipid metabolism and climacteric symptoms in comparison to sequential conjugated equine estrogens and medroxyprogesterone acetate in postmenopausal women. Methods: In a randomised, open-label, 6-cycle...

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Bibliographic Details
Published in:	Maturitas Vol. 21; no. 3; pp. 201 - 210
Main Authors:	Siseles, Nestor O., Halperin, Haydée, Benencia, Haydée J., Berg, Gabriela, Pilnik, Susana, Mesch, Viviana, Arrighi, Beatriz, Wikinski, Regina W.W.
Format:	Journal Article Conference Proceeding
Language:	English
Published:	Shannon Elsevier Ireland Ltd 01-04-1995 Elsevier Science
Subjects:	Anabolic Agents - administration & dosage Anabolic Agents - adverse effects Biological and medical sciences Cervix Uteri - cytology Cervix Uteri - drug effects Climacteric symptoms Conjugated equine estrogens Endometrium - cytology Endometrium - drug effects Estradiol - blood Estrogen Estrogen Replacement Therapy - adverse effects Estrogens, Conjugated (USP) - administration & dosage Estrogens, Conjugated (USP) - adverse effects Female Hormones. Endocrine system Humans Lipids Lipids - blood Lipoproteins - blood Medical sciences Medroxyprogesterone acetate Medroxyprogesterone Acetate - administration & dosage Medroxyprogesterone Acetate - adverse effects Middle Aged Norpregnenes - administration & dosage Norpregnenes - adverse effects Pharmacology. Drug treatments Postmenopause - blood Tibolone Vagina - cytology Vagina - drug effects Lipids Climacteric symptoms Conjugated equine estrogens Medroxyprogesterone acetate Tibolone Estrogen Human Chemotherapy Replacement therapy Menopause Medroxyprogesterone Female Administration schedule Sex steroid hormone Comparative study Progestagen
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Summary:	Objective: To assess the effect of tibolone on endometrial safety, plasma estradiol concentrations, lipid metabolism and climacteric symptoms in comparison to sequential conjugated equine estrogens and medroxyprogesterone acetate in postmenopausal women. Methods: In a randomised, open-label, 6-cycle, group-comparative study, the effects on the aforementioned parameters were studied with tibolone 2.5 mg/day ( N = 13) continuously, and with conjugated equine estrogens 0.625 mg/day continuously, combined with medroxyprogesterone acetate 5 mg/day ( N = 11) ( CEE MPA ) sequentially, during 12 days of each 28-day cycle. Within-group statistical analysis was performed with Student's t-test for paired samples, whereas between-group statistics were performed using the Student's t-test for independent groups. Results: Cytological evaluation revealed no endometrial stimulation in either group. In the tibolone group, there were no effects on estradiol levels, whereas in the CEE MPA group, an increase in total and non-SHBG-bound estradiol plasma levels was reported. In the tibolone group, there were significant decreases in plasma total cholesterol, triglycerides, HDL-cholesterol and VLDL-cholesterol, whereas no significant changes in LDL-cholesterol and IDL-cholesterol were reported. In the CEE MPA group there were significant decreases in plasma total cholesterol, HDL-cholesterol and LDL-cholesterol, whereas there were no significant changes in triglycerides, IDL-cholesterol and VLDL-cholesterol. Climacteric symptoms, particularly vasomotor episodes, decreased similarly in both groups. Conclusions: Both tibolone and CEE MPA were safe with respect to effects on the endometrium and both treatments induced changes in the plasma profiles of certain 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
ISSN:	0378-5122 1873-4111
DOI:	10.1016/0378-5122(94)00889-F