Objective: To determine the clinical-laboratory safety profile of tibolone treatment in postmenopausal women with NIDDM.
Method: 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.
Conclusion: Short-term treatment with tibolone showed a good clinical-laboratory safety profile in postmenopausal women with NIDDM.
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