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Ospemifene in the treatment of vulvovaginal atrophy.
Barnes, Kylie N; Pearce, Erica F; Yancey, Abigail M; Forinash, Alicia B.
Afiliação
  • Barnes KN; University of Missouri Kansas City School of Pharmacy, Kansas City, MO, USA.
Ann Pharmacother ; 48(6): 752-7, 2014 Jun.
Article em En | MEDLINE | ID: mdl-24615631
ABSTRACT

OBJECTIVE:

To review the pharmacology, efficacy, and safety of ospemifene in the management of dyspareunia. DATA SOURCES Literature was sought using PubMed (1966-January 2014) and EMBASE (1973-January 2014). Search terms included ospemifene, FC-1271a, dyspareunia, vulvovaginal atrophy, and vaginal atrophy. STUDY SELECTION AND DATA EXTRACTION All studies, including studies on humans, published in English with data assessing the efficacy and safety of ospemifene in the management of dyspareunia were evaluated. DATA

SYNTHESIS:

Ospemifene is a new oral estrogen receptor agonist/antagonist indicated for moderate to severe dyspareunia. Clinical trials evaluating efficacy have shown a significant improvement in superficial cells, parabasal cells, vaginal pH, vaginal dryness, and dyspareunia. The most frequently reported adverse drug reactions in the clinical trials included hot flashes, vaginal discharge, muscle spasms, and hyperhidrosis. Similar to systemic estrogen, boxed warnings with ospemifene include risk for thromboembolism and cerebrovascular disease. Additionally, patients with a uterus still need to use a progestogen with ospemifene to reduce the risk of hyperplasia.

CONCLUSIONS:

Ospemifene has been effective in improving symptoms of vulvovaginal atrophy when compared with placebo; however, no studies comparing ospemifene with estrogen products exist. Additional clinical trials are needed to evaluate the efficacy and safety in specialty populations, and long-term safety data are needed to assess the potential for serious adverse events. With the risks being similar to that for systemic estrogen therapy, ospemifene appears to be an alternative agent to estrogen therapy but does not have any advantages over estrogen.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Tamoxifeno / Vagina / Vulva / Moduladores Seletivos de Receptor Estrogênico / Dispareunia Tipo de estudo: Clinical_trials / Systematic_reviews Limite: Female / Humans Idioma: En Revista: Ann Pharmacother Assunto da revista: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Ano de publicação: 2014 Tipo de documento: Article País de afiliação: Estados Unidos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Tamoxifeno / Vagina / Vulva / Moduladores Seletivos de Receptor Estrogênico / Dispareunia Tipo de estudo: Clinical_trials / Systematic_reviews Limite: Female / Humans Idioma: En Revista: Ann Pharmacother Assunto da revista: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Ano de publicação: 2014 Tipo de documento: Article País de afiliação: Estados Unidos