Hormonal replacement therapy with 17 beta estradiol-dydrogesterone: results of a three-month prospective open label study

Hormone replacement therapy is well known for its beneficial effects on cli macteric symptoms and is also used for the prevention of osteoporosis. In a prospective open label study we evaluated the efficacy and safety of hormo ne replacement therapy with 17 beta estradiol dydrogesterone (Femoston(R), 17 beta estradiol/ continuously and dydrogesterone/sequentially). We observ ed 704 women who were treated with 17 beta estradiol-dydrogesterone over th ree months. 448 of the women previously had not used hormone replacement therapy, 224 w omen had been treated with a different hormone replacement therapy before t hey were entered into the study; for 20 women this information was not avai lable. The physicians were asked to assess the severity of climacteric symp toms at baseline and after three months of hormone replacement therapy. In addition, the following parameters were evaluated before and at the end of the study: blood pressure, total cholesterol, LDL cholesterol, HDL choleste rol, triglycerides, blood glucose, alkaline phosphatase and gamma glutamylt ransferase. Twelve women did not tolerate 17 beta estradiol-dydrogesterone and therefor e dropped out of the study. Climacteric symptoms clearly improved after tre atment with 17 beta estradiol-dydrogesterone. During our open label prospec tive study, a significant decrease in blood pressure and serum levels of to tal cholesterol, LDL cholesterol and the LDL/HDL ratio were observed, where as serum levels of HDL cholesterol increased significantly. Surprisingly, t riglyceride levels also decreased significantly. Serum levels of alkaline p hosphatase decreased significantly in women who had received a different ho rmone replacement therapy before they took 17 beta estradiol-dydrogesterone . We conclude that hormone replacement therapy with 17 beta estradiol-dydroge sterone is highly effective and well tolerated. Hormone replacement therapy with 17 beta estradiol-dydrogesterone appears to have a positive effect on blood pressure and the serum lipid profile. We therefore hypothesise that prolonged treatment with 17 beta estradiol-dydrogesterone may reduce morbid ity and mortality secondary to cardiovascular diseases.