Effects of the combined hormonal replacement drug estradiol valerate/levonorgestrel on climacteric complaints, endometrium and lipid profile of peri-and postmenopausal women

The effects of the combined hormone replacement (HRT) drug estradiol valera te/levonorgestrel (Klimonorm(R)) on climacteric complaints , endometrial st atus and lipid profile was studied in 100 peri- and postmenopausal women ag ed between 41 and 57 years. The duration of therapy was 6 months. The follo wing parameters were investigated: Kuppermann index, endometrial thickness, duration of bleeding, arterial blood pressure, body weight and serum lipid s and lipoproteins (total cholesterol TC, LDL cholesterol, HDL cholesterol, and triglycerides [TG]). A separate analysis was made for 27 patients who had abnormal lipid status before treatment. total cholesterol above 6.0 mmo l/l and/or LDL of more than 3.5 mmol/l was considered abnormal and those pa tients were labeled as "high risk". The results showed a statistically sign ificant reduction in the severity of climacteric symptoms (Kupperman index) . A large decrease in this score was observed during the first 3 months of treatment (from 27.9 at the start to mean values of 9.3, p<0.001). A furthe r slight decrease of the score to 4.0 (p<0.001) was seen after 6 months of treatment. Endometrial thickness did not change. At the start of the treatm ent the mean duration of bleeding was 5.1 +/-0.3 days and at the end of the 6 month it was 3.8 +/-0.2 days (p<0.001), Klimonorm(R) favorably affected lipid profile. TC decreased significantly during the therapy: by 5.2% (p<0. 05) in all women and 7.1% (p<0.05) in the high risk group, LDL cholesterol decreased slightly: by 4.5% (p<0.05) in all women and was more pronounced i n the high risk group (7.0%, p<0.01). HDL cholesterol increased by 12.1% (p <0.01) in all women and by 14.7% (p<0.001) in the high risk group. TG were elevated slightly by 9.5% (p<0.05) in all women and 3.9% (p>0.05) in the hi gh risk group. LDL/HDL ratio decreased from 2.7 to 2.3 in all women and fro m 3.0 to 2.4 (p<0.05) in the high risk group. No significant changes in sys tolic and diastolic blood pressure were recorded. Body weight did not chang e significantly during the treatment period. (C) 2001 Prous Science. All ri ghts reserved.