OESCLIM: summary of tolerability and safety.
BACKGROUND
The benefits of transdermally administered estradiol have been well documented in a number of studies. OESCLIM is a new transdermal matrix system which has been developed with the objective of providing improved local skin tolerability and adhesion, whilst minimising hyperestrogenic effects.


METHODS
Data relating to OESCLIM's tolerability and safety profile were reviewed.


RESULTS
In a randomised, controlled comparative clinical trial, OESCLIM resulted in less than half as many application site reactions than Estraderm TTS (4.3 compared to 9.5%). In addition, the duration of reactions was significantly lower in the OESCLIM group. OESCLIM has been well tolerated in all clinical trials and was reported to have comparable estrogen-specific tolerability as Estraderm TTS. Low dose OESCLIM (25 microg/day) is associated with a reduction in hyperestrogenic side effects compared to higher doses. In a study of long term OESCLIM therapy, 79% of patients wished to continue therapy after 1 year, and in a follow up study 79.8% wished to continue at the end of the 3 year study.


CONCLUSIONS
OESCLIM offers doctors an alternative to current transdermal therapy that is safe and effective and suitable for the majority of women. It has a better local tolerability and safety profile than Estraderm TTS and its safety has been proven in both short and long-term trials. The extensive range of OESCLIM doses available means doctors have a large flexibility and choice when it comes to deciding on an appropriate regimen including the option to initiate therapy at a low dose.
Brackman
F
F
Laboratoires Fournier, Garches, France.
D000279:Administration, Cutaneous; D004958:Estradiol / Q000008:administration & dosage / Q000009:adverse effects; D015914:Estrogen Replacement Therapy / Q000009:adverse effects; D004967:Estrogens / Q000097:blood; D005260:Female; D006801:Humans; D016032:Randomized Controlled Trials as Topic
D004967:Estrogens; D004958:Estradiol