Efficacy and tolerability of a low-dose of Oesclim (R) (25 mcg daily) in the management of symptomatic menopausal women: A French open-label study

Objective : To establish the proportion of symptomatic postmenopausal women , whose HRT treatment is initiated on Oesclim(R) 25, who call be satisfacto rily maintained on this low dose after two months. Study design and patients : This was an open-label, multicentre, non-compar ative, four-month treatment study. Treatment was initiated with Oesclim(R) 25 (17 beta-oestradiol transdermal patch, 25 mg/day). Dosage could be incre ased to Oesclim(R) 50 if required after two months, according to clinical e valuation. Sequential treatment with an oral progestagen was also given for greater than or equal to 12 days/month ill all non-hysterectomised women. A total of 1465 women were included in the study. Results : 82.3% (CI:80. 1-84.4) of patients remained on Oesclim(R) 25 acros s the whole study. The mean number of hot flushes was reduced similarly by 93% and 94% at month 4 in the Oesclim(R) 25 group and Oesclim(R) 50 group, respectively. However, at month 2 the decrease in hot flushes and other men opausal symptoms was less marked until the dose was adjusted in patients sw itching to Oesclim(R) 50. In a global evaluation, 97.5% of the investigator s and 95.7% of the patients rated the overall efficacy of the treatment as good/very good. Overall, treatment initiated at a low dose was well tolerat ed throughout the study, with a trend showing Oesclim(R) 25 as being better tolerated than Oesclim(R) 50. Conclusion: Oesclim(R) law dose (25 mcg) can effectively reduce symptoms in most postmenopausal women with a very satisfactory level of tolerability. The risk/benefit ratio observed is probably one key reason for good patient compliance.