Highlights
- •Ospemifene is a novel selective estrogen receptor modulator for the treatment of vulvo-vaginal atrophy and dyspareunia.
- •This meta-analysis reviews all the published randomized controlled trials on the side -effects and safety of ospemifene.
- •The results suggests that ospemifene is well tolerated and has a good safety profile.
Abstract
Objective
To evaluate the tolerability and safety of ospemifene in treating dyspareunia associated
with postmenopausal vulvo- vaginal atrophy (VVA).
Methods
The literature was searched through to 31 July 2018 to identify randomized controlled
trials comparing ospemifene 60 mg against placebo for the treatment of VVA. Two groups
of outcomes were selected: 1) side-effects, including hot flushes, urinary tract infection
(UTI), headache, deep venous thrombosis (DVT), coronary heart disease (CHD), cardiovascular
event (CVE), discontinuation due to side-effects, serious adverse event (SAE); 2)
Safety, in relation to endometrial thickness, vaginal bleeding, breast tenderness,
breast and endometrial cancer. A random-effects model was used in the meta-analysis.
Study quality and bias risk were assessed with the Cochrane tool.
Results
In the group of patients treated with ospemifene, there was a slightly higher rate
of hot flushes (OR:2.36, 95% CI 1.26–4.42; p = 0.007) and UTI (OR:1.97, 95% CI 1.23–3.14,
p = 0.005) at 12 weeks of treatment, but no differences were noted after 52 weeks.
The incidence of headaches, DVT, CHD, CVE, discontinuation of treatment, and SAEs
was not significantly different between groups. Ospemifene treatment was statistically
associated with a greater endometrial thickness in women with an intact uterus both
at 12 weeks (SMD: 0.40, (95% CI 0.17 to 0.63, p < 0.0005) and at 52 weeks (SMD: 0.62,
95% CI 0.23–1.01, p = 0.002); however, this increase was not clinically relevant.
The incidence of vaginal bleeding, endometrial cancer, breast tenderness, breast and
endometrial cancer was not significantly different between groups.
Conclusions
This meta-analysis suggests that ospemifene treatment is well tolerated and presents
a good safety profile. Long-term safety studies with larger samples, which include
patients at high risk, are warranted.
Keywords
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References
- Prevalence of postmen- opausal symptoms in North America and Europe.Menopause. 2015; 22: 1231-1238https://doi.org/10.1097/GME.0000000000000464
- Vulvovaginal atrophy.Mayo Clin. Proc. 2010; 85: 87-94https://doi.org/10.4065/mcp.2009.0413
- Clarifying Vaginal Atrophy’s Impact on Sex and Re- lationships(CLOSER) survey: emotional and physical impact of vaginal discomfort on North American post- menopausal women and their partners.Menopause. 2014; 21: 137-142https://doi.org/10.1097/GME.0b013e318295236f
- Gir- aldi A. The CLOSER survey: impact of postmenopausal vaginal discomfort on relationships between women and their partners in Northern and Southern Europe.Maturitas. 2013; 75: 373-379https://doi.org/10.1016/j
- Management of symptomatic vulvovaginal atrophy: 2013 position statement of the North American Menopause Society.Menopause. 2013; 20 (quiz 903-4): 888-902https://doi.org/10.1097/GME.0b013e3182a122c2
- Vaginal health: insights, views & attitudes (VIVA)—results from an international survey.Climacteric. 2012; 15: 36-44https://doi.org/10.3109/13697137.2011.647840
- Non-hormonal topical treatment of vulvovaginal atrophy: an up-to-date overview.Climacteric. 2013; 16: 305-312https://doi.org/10.3109/13697137.2012.756466
- Senshio (60 Mg Film-coated Tablets). Ospemifene Summary of Product Characteristics.UK: Shionogi, Inc., London2015
- Osphena [(ospemifene) Tablets, for Oral Use]. Prescribing Information.NJ: Shionogi, Inc., Florham Park2013
- Effects of ospemifene, a novel SERM, on hormones, genital tract, climacteric symptoms, and quality of life in postmenopausal women: a double-blind, randomized trial.Menopause. 2003; 10: 433-439
- Ospemifene effectively treats vulvo- vaginal atrophy in postmenopausal women: results from a pivotal phase 3 study.Menopause. 2010; 17: 480-486
- One-year long-term safety extension study of ospemifene for the treatment of vulvar and vaginal atrophy in postmenopausal women with a uterus.Menopause: J. North Am. Menopause Soc. 2013; 20: 418-427https://doi.org/10.1097/gme.0b013e31826d36ba
- Ospemifene 12-month safety and efficacy in postmenopausal women with vulvar and vaginal atrophy.Climateric. 2014; 17: 173-182https://doi.org/10.3109/13697137.2013.834493
- Ospemifene, a novel selective estrogen receptor modulator for treating dyspareunia associated with postmenopausal vulvar and vaginal atrophy.Menopause: J. North Am. Menopause Soc. 2014; 20: 623-630https://doi.org/10.1097/gme.0b013e318279ba64
- Ospemifene, a non-oestrogen selective oestrogen receptor modulator for the treatment ovaginal dryness associated with postmenopausal vulvar and vaginal atrophy: A randomised, placebo-controlled, phase III trial.Maturitas. 2014; 78: 91-98https://doi.org/10.1016/j.maturitas.2014.02.015
Higgins JPT, Green S,eds. Cochrane handbook for systematic reviews of interventions, v.5.1. New Jersey: Wiley-Blackwell; updated March 2011. Cochrane Collaboration Web site. Available at: http://www.cochrane-handbook.org.
- Overall safety of Ospemifene in postmenopausal women from placebo-controlled phase 2 and 3 trials. Simon JA, Altomare C, Cort S, Jiang W, pinkerton JV.J. Womens Health (Larchmt). 2018; 27: 14-23https://doi.org/10.1089/jwh.2017.6385
- Ospemifene for the treatment of dyspareunia associated with vulvar and vaginal atrophy: potential benefits in bone and breast.Int. J. Womens Health. 2013; 25: 605-611https://doi.org/10.2147/IJWH.S39146
- Effects of ospemifene on breast tissue morphology and proliferation: a comparative study versus other selective estrogen receptor modulators in ovariectomized rats.Horm. Metab. Res. 2014; 46: 328-332https://doi.org/10.1055/s-0034-1367032
- Effects of ospemifene, a novel selective estrogen-receptor modulator, on human breast tissue ex vivo.Menopause. 2016; 23: 719-730https://doi.org/10.1097/GME.0000000000000624
- Ospemifene’s effects on lipids and coagulation factors: a post hoc analysis of phase 2 and 3 clinical trial data.Menopause: J. North Am. Menopause Soc. 2017; 24https://doi.org/10.1097/GME.0000000000000900
Article info
Publication history
Published online: November 28, 2018
Accepted:
November 22,
2018
Received in revised form:
November 19,
2018
Received:
November 10,
2018
Identification
Copyright
© 2018 Published by Elsevier B.V.
