[Tibolone treatment of diabetic postmenopausal women: clinical and laboratory safety parameters].
OBJECTIVE
To determine the clinical-laboratory safety profile of tibolone treatment in postmenopausal women with NIDDM.


METHODS
a prospective, longitudinal, open and uncontrolled study involving 24 postmenopausal women with NIDDM sequentially treated with placebo (6 months) and 2.5 mg/day tibolone (6 months). Clinical evaluation, anthropometric parameters, biochemical and hormonal measurements, and transvaginal ultrasonography were performed at baseline and after 6 (time 1) and 12 months of follow-up (time 2). Statistical analysis was performed by repeated measures analysis of variance, with the level of significance set at 5%.


RESULTS
Side effects were present only during tibolone use (headache and mastalgia in 8.3% and genital bleeding in 16.6%). There was a significant reduction in the climacteric symptoms evaluated by Blatt-Kupperman index [22.2 +/- 7.1 (baseline) vs. 13.6 +/- 6.7 (time 1) vs. 3.1 +/- 3.3 (time 2); p< 0.0001]. After the tibolone use, we observed significant reductions in % body fat, diastolic arterial pressure, aminotransferases, triglycerides and HDL-cholesterol. There were no significant variations in systolic arterial pressure, heart rate, body mass index, waist to hip ratio, or in the glycemic, glycosylated hemoglobin, urea, total cholesterol and LDL-cholesterol levels. Ultrasonographic evaluation showed no significant changes in uterine volume or endometrial thickness.


CONCLUSIONS
Short-term treatment with tibolone showed a good clinical-laboratory safety profile in postmenopausal women with NIDDM.
Departamento de Ginecologia e Obstetrícia, Faculdade de Medicina de Ribeirão Preto, USP, Ribeirão Preto, SP.
Ana Karla M S O
AK
Freitas
Reginaldo A O
RA
Freitas
Maria Fernanda M
MF
Prado
George D
GD
Azevedo
Milton C
MC
Foss
Marcos F
MF
Silva-de-Sá
Rui A
RA
Ferriani
D000704:Analysis of Variance; D000886:Anthropometry; D003924:Diabetes Mellitus, Type 2 / Q000378:metabolism*; D020847:Estrogen Receptor Modulators / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D050356:Lipid Metabolism; D008055:Lipids / Q000097:blood; D008875:Middle Aged; D009652:Norpregnenes / Q000009:adverse effects / Q000627:therapeutic use*; D017698:Postmenopause / Q000187:drug effects* / Q000378:metabolism; D011446:Prospective Studies; D014463:Ultrasonography; D014621:Vagina / Q000000981:diagnostic imaging
D020847:Estrogen Receptor Modulators; D008055:Lipids; D009652:Norpregnenes; C027385:tibolone