WASHINGTON — Postmenopausal women who took a low-dose estrogen/progestin hormone therapy reported significant improvements in vasomotor symptoms and quality of life after 6 months, according to findings from an open-label efficacy study.
The therapy caused a significant increase in mean triglycerides, from 129 mg/dL at baseline to 168 mg/dL after 6 months. But the women had no other significant changes in their lipid profiles or in their body weight, body mass index, or blood glucose during the study period, Dr. Fernando Ayala Aguilera of the Hospital Universitario, Monterrey (Mexico) and colleagues reported in a poster presentation at the annual meeting of the American Society for Reproductive Medicine.
In the study, sponsored by Wyeth Pharmaceuticals, 68 postmenopausal women aged 45–55 years who reported at least four hot flashes per day received a combination of 1 mg 17β-estradiol and 0.125 mg trimegestone orally each day for 6 months. The study criteria excluded women without an intact uterus, with known or suspected breast cancer, or with abnormal bleeding.
Overall, patient scores on the MENQOL (a questionnaire designed specifically to evaluate the quality-of-life symptoms in menopausal women) dropped from an average of 78 at baseline to an average of 5 after 6 months of treatment.
The average total cholesterol remained stable between baseline and 6 months (201.3 vs. 200.2 mg/dL). Blood glucose, body weight, and body mass index were essentially unchanged from baseline to the 6-month follow-up: Average blood glucose was 92 at both baseline and 6 months, average body weight was 67 kg at baseline vs. 66 kg at 6 months, and average BMI was 27 kg/m
High triglycerides may be a cause for concern, but the triglycerides in this study did not reach unhealthy levels (above 200 mg/dL).
Although the findings were limited by a small number of patients and a short follow-up period, the preliminary results from this ongoing study suggest that a 17β-estradiol/trimegestone combination may provide enough relief from menopausal symptoms to outweigh the potential risks of increased triglycerides in the absence of other adverse effects on lipid profiles.