The lipid and clinical effects of sequential transdermal estradiol and estradiol/norethisterone acetate in 674 women

Objective: To measure lipid changes induced by patches delivering continuous estradiol (E2) and sequential norethisterone acetate (NETA) in a large population of symptomatic menopausal women, compared with a non-symptomatic control group. Patients and methods: A total of 748 women recruited in 42 different hospital services and clinics in Spain were invited to participate in a prospective, open, controlled study for 48 weeks. Six hundred and seventy-four women were evaluated in the treatment group, and 74 in the control group. Treatment consisted of patches delivering 0.05 mg/day E 2 for the first 14 days of the cycle, and 0.05 mg/day E2 plus 0.25 mg/day NETA for another 14 days. Results: Use of patches led to a slight, but significant decrease of 1.3% and 0.9% in concentrations of total cholesterol and low-density lipoprotein cholesterol (LDL-C), respectively. A substantial 37.0% decrease in triglycerides concentration was observed in treated women. The treatment effectively reduced climacteric symptoms (Kupperman index) for the duration of the study. Compliance was acceptable, with 489 (72.6%) women completing the study. Adverse events were reported by 137 (20.3%) women. Conclusions: Transdermal administration of E2 and sequential NETA for a period of 48 weeks (twelve 28-day cycles) was associated with beneficial changes, albeit of differing magnitudes, in the concentration of total cholesterol, LDL-C and triglycerides. This protective lipid profile, together with satisfactory clinical efficacy and acceptable safety and compliance, makes this system a good alternative in hormone replacement therapy.