Comparison of the efficacy and tolerability of a new once-a-week matricial estradiol transdermal system (Estrapatch^脗脗 40 and Estrapatch^脗脗 60) with a twice week system

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• 作者：Raynaud ; Jean-Pierre ; L脙脙vrier ; Marc ; Calaf ; Joaquim ; Laur ; Cl脙脙ment ; P脙脙lissier ; Clara
• 刊名：Journal of Steroid Biochemistry and Molecular Biology
• 出版年：2005
• 期刊代码：172_09600760
• 类别：med
• 出版时间：February, 2005
• 卷：93
• 期：2-5
• 页码：309-318
• 文件大小：120 K

摘要

Objective:

To compare the efficacy and tolerability of three transdermal systems (Estrapatch 40, Estrapatch 60 and Oesclim 50).

Methods:

Multicentre, randomized, open, 3 parallel group study on 421 postmenopausal women presenting with at least 35 hot flushes in the week preceding inclusion and treated for six 28-day cycles with either Estrapatch 40 (n = 141) or Estrapatch 60 (n = 140) once a week or Oesclim 50 (n = 140) twice a week, associated to oral NETA (Millligynon 2× 0.6 mg tablets daily) from day 15 to day 28. Hot flushes, mastodynia, bleeding, local skin tolerability and adhesiveness were reported on daily cards. Endometrial thickness and estrogens were measured before and after treatment.

Results:

Efficacy was clearly established for the three devices as early as after one cycle of treatment, with success rates (%of women with a decrease ≥ 50%of the number of hot flushes) over 97%from cycle 2. The three treatments were equivalent on this criteria, except at cycle 1 for Estrapatch 40 which was not equivalent to both other treatments. Incidence and severity of mastodynia, bleeding pattern, endometrial thickness and specific estrogen-related adverse events reflected a significant higher estrogenic stimulation with Oesclim 50. Adhesiveness was very satisfactory for the three systems.

Conclusions:

Estrapatch 40 and 60 presents a better benefit/risk ratio compared to Oesclim 50. Thus Estrapach 40 appears to be a good choice for a first-line estrogen replacement therapy with the possibility to increase the dose to Estrapatch 60.