Effects of a combination of 2 mg estradiol valerate and 3 mg dienogest on coagulation, lipid profile, and glucose metabolism in postmenopausal women

Estradiol valerate/dienogest (EV/DNG) is an oral continuous combined hormone replacement therapy (HRT) preparation containing 2.0 mg estradiol valerate and 3.0 mg dienogest, an antiandrogenic progestogen. The effects of EV/DNG (n = 43) and placebo (n = 40) on coagulation, plasma lipid profile and glucose metabolism of postmenopausal women were compared in a randomized, double-blind, multicenter study. General safety, tolerability and efficacy were also assessed. EV/DNG produced a smaller reduction in prothrombin fragments 1+2, a parameter that reflects dynamic changes in coagulation compared with placebo (31 vs. 57%; p <0.001). EV/DNG had no clinically important effects on other coagulation parameters, although moderate stimulation of fibrinolysis occurred. The effects of EV/DNG on the lipid profile were generally neutral, with significant reductions in total, low density lipoprotein (LDL), and high density lipoprotein (HDL) cholesterol but no impact on the LDL/HDL ratio. EV/DNG did not influence glucose metabolism. Although adverse events were more common during EV/DNG treatment than placebo, they were either associated with HRT or were nonspecific. EV/DNG suppressed endometrial thickness to <5 mm, and reversed atrophic changes in the vaginal mucosa. EV/DNG was also significantly (p <0.05) more effective than placebo in relieving climacteric symptoms, particularly hot flushes, as assessed by the Kuppermann index. (C) 2001 Prous Science. All rights reserved.