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Grand Rounds

Tolerability and Safety of Ospemifene

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BACKGROUND AND PURPOSE: 

  • Donato et al. (Maturitas, 2018) assessed  the tolerability and safety of ospemifene in dyspareunia associated with postmenopausal vulvo-vaginal atrophy (VVA)

METHODS: 

  • Systematic review and meta-analysis  
  • Database search of RCTs 
    •  Ospemifene 60 mg compared against placebo for the treatment of VVA 
  • Two groups of outcomes were selected 
    • Side-effects: Hot flushes | UTI | Headache, DVT |  coronary heart disease (CHD) | Cardiovascular event (CVE) | Discontinuation due to side-effects | Serious adverse event (SAE) 
    •  Safety: Endometrial thickness | Vaginal bleeding | Breast tenderness | Breast and endometrial cancer

RESULTS: 

  • Comparing ospemifene to placebo at 12 weeks, there was a  higher rate of 
    • Hot flushes: OR 2.36 (95% CI 1.26–4.42; p = 0.007)  
    • UTI: OR 1.97 (95% CI 1.23–3.14, p = 0.005)  
  • There was no differences observed between groups after 52 weeks 
  • No difference was found for  headaches, DVT, CHD, CVE, discontinuation of treatment, and SAEs  
  • Ospemifene treatment was statistically associated with a greater endometrial thickness at 
    • 12 weeks: Standard mean difference (SMD) 0.40 (95% CI 0.17 to 0.63, p < 0.0005)  
    • 52 weeks: SMD 0.62 (95% CI 0.23–1.01, p = 0.002) 
  • Endometrial thickness while increased, was not clinically relevant 
  • The incidence of vaginal bleeding, endometrial cancer, breast tenderness, breast and endometrial cancer was not significantly different between groups

CONCLUSION: 

  • Ospemifine treatment is well tolerated in women and presents a good safety profile

Learn More – Primary Sources: 

Ospemifene for the treatment of vulvar and vaginal atrophy: A meta-analysis of randomized trials. Part II: Evaluation of tolerability and safety

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Related ObG Topics:

Prescribing Ospemifene for Postmenopausal Vaginal Atrophy
What is the Safety Data on Ospemifene Use in Postmenopausal Women?
Treating Postmenopausal Vaginal Atrophy When Estrogen is Not an Option

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