Related Experiment Videos
OESCLIM: summary of tolerability and safety
1Laboratoires Fournier, Garches, France.
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 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.
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.
Related Concept Videos
Bioavailability Study Design: Healthy Subjects Versus Patients
Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence
Drug Toxicity: Allergic Reactions
Drug toxicity: Idiosyncratic Reactions
Drug Administration and Therapy Phases: Overview
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
Drug Toxicity: Overview