Grand Rounds

Tolerability and Safety of Ospemifene

BACKGROUND AND PURPOSE:

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

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

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

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

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