Efficacy and tolerability of a low-dose of Oesclim (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 25, who can be satisfactorily maintained on this low dose after two months.


METHODS
This was an open-label, multicentre, non-comparative, four-month treatment study. Treatment was initiated with Oesclim 25 (17 beta-oestradiol transdermal patch, 25 mcg/day). Dosage could be increased to Oesclim 50 if required after two months, according to clinical evaluation. Sequential treatment with an oral progestagen was also given for > or = 12 days/month in 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 25 across the whole study. The mean number of hot flushes was reduced similarly by 93% and 94% at month 4 in the Oesclim 25 group and Oesclim 50 group, respectively. However, at month 2 the decrease in hot flushes and other menopausal symptoms was less marked until the dose was adjusted, in patients switching to Oesclim 50. In a global evaluation, 97.5% of the investigators 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 tolerated throughout the study, with a trend showing Oesclim 25 as being better tolerated than Oesclim 50.


CONCLUSIONS
Oesclim low 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.
Elia
D
D
Menopause Centres, Paris, France.
Tamborini
A
A
Leocmach
Y
Y
Chadha-Boreham
H
H
D000279:Administration, Cutaneous; D004305:Dose-Response Relationship, Drug; D004958:Estradiol / Q000008:administration & dosage* / Q000627:therapeutic use; D005260:Female; D020249:Hormone Replacement Therapy / Q000009:adverse effects / Q000379:methods*; D019584:Hot Flashes / Q000517:prevention & control; D006801:Humans; D008875:Middle Aged; D010349:Patient Compliance; D017698:Postmenopause
D004958:Estradiol