RESUMEN

OBJECTIVES: To study whether ageing affects the pharmacokinetics of estradiol valerate (E2V) or medroxyprogesterone acetate (MPA) in postmenopausal women. METHODS: Forty-six postmenopausal women from two essentially similar pharmacokinetic studies were divided into three age categories: under 60 years (n = 15), between 60 and 65 years (n = 18) and over 65 years (n = 13). They all were treated for 12 days or 14 days with four galenically identical tablets containing combinations of 1 mg or 2 mg E2V and 2.5 mg or 5 mg MPA. The studies followed an open, randomised cross-over design with no washout between the periods. Serum estradiol and MPA concentrations were measured at steady state on study day 12 or 14 of each period. RESULTS: No statistically significant differences were observed in the peak concentration (Cmax), time to peak (t(max)), AUC or elimination half-life for estradiol or MPA between the different age groups. In spite of the lack of statistical significance the AUC was on an average 1.6-fold and Cmax 1.40-fold higher in the oldest group of women than in the youngest group and age was found significant as a continuous variable for AUC and Cmax for MPA but not for estradiol. CONCLUSIONS: The results suggest that there would be no significant changes in the pharmacokinetics of estradiol between women under 60 and over 65 years of age. However, a significant trend towards higher MPA concentrations and bioavailability was observed with increasing age. The results suggest that from the pharmacokinetic point of view the relationship between estradiol and MPA dose to be used in elderly could be different from that in younger postmenopausal women, while no pharmacokinetic reasons to use lower estradiol doses in the elderly were observed.

Asunto(s)

Anticonceptivos Sintéticos Orales/farmacocinética , Estradiol/análogos & derivados , Estradiol/farmacocinética , Acetato de Medroxiprogesterona/farmacocinética , Posmenopausia/metabolismo , Factores de Edad , Anciano , Estudios Cruzados , Femenino , Humanos , Persona de Mediana Edad

RESUMEN

Hormone replacement therapy has been shown to effectively relieve postmenopausal symptoms. However, its impact on health-related quality of life is not well documented. There is no gold standard instrument available for measuring the effects of hormone replacement therapy on health-related quality of life of postmenopausal women. Furthermore, no systematic comparison of health-related quality of life measures has been undertaken within the field. An overview of the health-related quality of life measures and scales used in publications on hormone replacement therapy are reviewed. In addition, an analysis to compare the performance of two generic health-related quality of life measures, the Nottingham Health Profile and the 15D are conducted. Both measures performed well in postmenopausal women. However, only preference-based measures, such as 15D, can be used in cost-utility analyses.