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

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Abstract

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 E2 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.

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Acknowledgement.

This study was prepared and completed through the generous support of Novartis Farmacéutica Spain.

Author information

Authors and Affiliations

  1. Department of Pediatrics, Obstetrics and Gynecology, Faculty of Medicine and Dentistry, University of Valencia, Avda. Blasco Ibañez, 17, 46010 Valencia, Spain, Spain

    Antonio Cano & Javier Molina

  2. Obstetrics and Gynecology Service, Hospital de Santa Creu i Sant Pau, Barcelona, Spain, Spain

    Joaquin Calaf

Authors
  1. Antonio Cano
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  2. Joaquin Calaf
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  3. Javier Molina
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Corresponding author

Correspondence to Antonio Cano.

Additional information

The following clinicians are co-authors of this paper (alphabetical order): M. Alcalde-Arroyo (Girona), R. Borrás-Borrás (Terrasa), J. Belascoain-Bastarreche (Cartagena), J.M. Bris-Orche (Madrid), M. Cebeiro-Lara (Pamplona), P. Clemente-Pérez (Tarragona), M.J. Cornellana (Barcelona), A. Cabero-Roura (Barcelona), F. Cristóbal-Valdor (San Sebastián), J.L. Cuadros (Granada), E. Cañadas-Pulido (Sevilla), M. Durán-Jordá (Barcelona), J. Díaz-Emparanza (Bilbao), A. Estévez-González (Sevilla), A. Fresnadillo-Raso (Terrasa), P. Fortes-Cadavid (Vigo), J. Ferrer-Barriendos (Oviedo), A. Gómez-de-Cádiz (Alicante), J.M. Gómez-Calatayud (Zaragoza), M. Guinot-Gasull (Barcelona), E. González-Carrera (Badajoz), J. Herrera-Peral (Málaga), O. Herrero-Cantalaprieda (Madrid), D. Juliá-Mollá (Valencia), J.L. Lanchares-Pérez (Salamanca), J. Meléndez-Rusiñol (Girona), A. Mariño-Mínguez (La Coruña), F. Madrid-Jorreto (Ciudad Real), L. Montoya-Videla (Madrid), F. Nohales-Alfonso (Gandía), R. Pérez (Gijón), A. Pérez de Castro (Madrid), F. Pérez-López (Zaragoza), F. Prieto-Muñoz (Jaén), C. Ribes-Rubira (Santander), J.J. Rodríguez-Callejo (Valladolid), J.F. Rodríguez-Pastor (Cádiz), A. Sánchez-Dehesa (Toledo), C. Sandoval (Madrid), L. Vaquer-Pérez (Alicante), J. Vergés-Agulló (Palma)

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Cano, A., Calaf, J. & Molina, J. The lipid and clinical effects of sequential transdermal estradiol and estradiol/norethisterone acetate in 674 women. Arch Gynecol Obstet 268, 317–322 (2003). https://doi.org/10.1007/s00404-002-0441-1

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