Conjugated oestrogens 450microgram / Bazedoxifene 20mg modified-release tablets

Decreasing levels of estrogens during menopause are associated with reduced bone density and an increased risk of osteoporosis. Many women also experience bothersome vasomotor and vaginal symptoms during the menopausal transition. Results of systematic reviews and meta-analyses of randomized controlled trials have shown that both systemic estrogen therapy or hormone therapy (estrogen combined with a progestin) are useful to prevent bone loss, and they are the most effective treatment for such climacteric symptoms as hot flushes, sweating, vaginal dryness, and dyspareunia. Unfortunately, estrogen therapy and hormone therapy increase the risk of endometrial and breast cancer, respectively. The selective estrogen receptor modulators (SERMs) result in positive estrogenic effects on bone, with no negative effects on the endometrium and breast but do not provide relief from postmenopausal symptoms. The combination of a SERM with estrogen as a tissue selective estrogen complex (TSEC) is a new strategy for the prevention of bone loss and the treatment of climacteric symptoms. This combination is particularly interesting from a clinical point of view, taking into account that estrogen alone did not increase breast cancer risk by the Women’s Health Initiative. TSEC is hypothesized to provide the benefits of estrogen-alone therapy, with an improved tolerability profile because the SERM component can make possible the elimination of progestin. The objective of this review was to critically evaluate the evidence from the reports published to date on the use of bazedoxifene (a third-generation SERM) in combination with conjugated estrogens in postmenopausal women. The conclusion is that effectively, the combination of bazedoxifene and conjugated estrogens may be a promising alternative to hormone therapy for the prevention of osteoporosis and the treatment of postmenopausal symptoms in non-hysterectomized postmenopausal women.

Abstract licence: CC BY-NC 3.0

Abstract Objective To examine the effect of vaginal oestrogen cream on pessary continuation rates in pelvic organ prolapse. Design Multicentre, randomised, double blind, placebo controlled trial. Setting 12 academic medical centres in China (May 2020-June 2023). Participants Postmenopausal women with symptomatic pelvic organ prolapse ≥stage 2 and successfully fitted with ring pessaries were randomly assigned in a 1:1 ratio to receive oestrogen cream or placebo cream. Interventions One gram of conjugated oestrogen cream (0.625 mg/g) or placebo cream was inserted vaginally every night for the first two weeks after successful pessary fitting followed by twice weekly for 12 months. Main outcome measures The primary outcome was the pessary continuation rate with satisfaction, which was defined as the proportion of participants who continued using the pessary and reported a response of very much better or much better on the Patient Global Impression of Improvement questionnaire at 12 months. Secondary outcomes included self-reported pelvic floor symptoms and adverse events. All analyses were based on a modified intention-to-treat approach, including participants who had at least one visit. Results Of 420 postmenopausal women randomised, 411 had at least one visit and were included in the modified intention-to-treat analysis (208 in the vaginal oestrogen group and 203 in the placebo group). The mean age of participants was 66 years. Pessary continuation rate with satisfaction did not differ significantly between the oestrogen group and the placebo group (181/208 (87.0%) v 176/203 (86.7%); risk difference 0.3%, 95% confidence interval −6.2% to 6.9%; P=0.92). Excessive discharge (34/208 (16.3%) v 52/203 (25.6%); −9.3%, −17.1% to −1.4%), vaginal erosion or ulcer (4/208 (1.9%) v 14/203 (6.9%); −5.0%, −8.9% to −1.0%), and vaginal bleeding (3/208 (1.4%) v 13/203 (6.4%); −5.0%, −8.7% to −1.2%) were less common in the vaginal oestrogen group. Conclusions Oestrogen cream did not improve the continuation rate of ring pessary use with satisfaction. Use of oestrogen cream might be associated with a lower risk of common adverse events. The clinical decision to use vaginal oestrogen should take into account its benefits and risks and the patient’s personal preferences. Trial registration ClinicalTrials.gov NCT04393194.

Abstract licence: CC BY-NC