OESCLIM ®: summary of tolerability and safety

Abstract

Introduction: 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 μg/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. Conclusion: 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.