Pharmacokinetics, pharmacodynamics and clinical efficacy of ospemifene for the treatment of dyspareunia and genitourinary syndrome of menopause
| Autor: | Annalisa Racca, Umberto Leone Roberti Maggiore, Carolina Scala, Simone Ferrero, Chiara Bondi, Pier Luigi Venturini, E. Tafi |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
Selective Estrogen Receptor Modulators
medicine.medical_specialty Phases of clinical research menopause 030209 endocrinology & metabolism Toxicology atrophy clinical efficacy dyspareunia genitourinary syndrome ospemifene pharmacodynamics pharmacokinetics Vaginal estrogen 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Ospemifene Internal medicine medicine Animals Humans Pharmacology Gynecology 030219 obstetrics & reproductive medicine business.industry Syndrome General Medicine medicine.disease Female Urogenital Diseases Postmenopause Menopause Tamoxifen chemistry Tolerability Selective estrogen receptor modulator Pharmacodynamics Female business medicine.drug |
| Popis: | Ospemifene is a selective estrogen receptor modulator recently approved by the FDA for the treatment postmenopausal women experiencing moderate-to-severe dyspareunia and by the EMA for the treatment of moderate-to-severe symptomatic genitourinary syndrome of menopause (GSM) in women who are not suitable candidates for local vaginal estrogen therapy.This review offers an explanation of the pharmacodynamics and of the pharmacokinetics of ospemifene, and gives readers a complete overview of Phase II and III studies on the clinical efficacy, tolerability and safety of this agent in the setting of GSM.Ospemifene is efficacious for improving vaginal dryness or dyspareunia as the patient-identified most bothersome symptom, and Phase III clinical trials (4648 patients) have shown good efficacy in terms of improvement of objective and subjective signs and measures of GSM in postmenopausal women. Future studies with a long-term follow-up are required to better elucidate its safety profile. In particular, on the basis of preclinical and early clinical findings of antagonistic to neutral effect on breast tissue, more research is needed to assess the treatment with ospemifene in breast cancer survivors. |
| Databáze: | OpenAIRE |
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