COMPARISON OF BAZEDOXIFENE/CONJUGATED OESTROGENS VS CURRENT THERAPIES IN THE TREATMENT OF POSTMENOPAUSAL SYMPTOMS- SYSTEMATIC REVIEW AND META-ANALYSIS

Author(s)

Mitchell SA1, Paine A2, Moffatt M3, Neale TA1, Orme ME4, Hawes C5, Orme M4
1Abacus International, Bicester, UK, 2Zedediah Consulting, Wokingham, UK, 3Pfizer Inc, New York, NY, USA, 4ICERA Consulting Ltd, Swindon, UK, 5Pfizer Inc., Surrey, UK

OBJECTIVES: Menopausal symptoms associated with reduction in the levels of oestrogen can be alleviated through the use of pharmacotherapy.  A systematic review and meta-analysis were conducted to compare the relative efficacy/safety of conjugated oestrogens (CE) 0.45mg/bazedoxifene (BZA) 20mg with other available treatments for management of postmenopausal symptoms (PMS). METHODS: MEDLINE, EMBASE and Cochrane databases were systematically searched (December 2014) to identify randomised controlled trials evaluating CE/BZA, tibolone, oestradiol (E2)/(micronised) progestin combinations and placebo in this indication. Eligible trials included women with an intact uterus and at least 12 months since last menses. Vasomotor symptoms (VMS, number of “moderate/severe” hot flushes [HF]) at 4 weeks and the rate of uterine bleeding (UB) were analysed via Bayesian network meta-analysis (NMA) with results presented as weighted mean difference (WMD) and hazard ratios (HR), respectively, along with 95% credible intervals (Crls). A direct pairwise meta-analysis was conducted on the number of “moderate/severe” HF at 12 weeks and severity at 4 and 12 weeks, expressed as WMD and 95% confidence intervals (CIs). Data were validated by Abacus International. RESULTS: Twenty-two studies met the inclusion criteria for the meta-analysis. CE/BZA significantly lowered the daily number of “moderate/severe” HF compared with placebo at both 4 weeks (WMD:-3.10 [95% CrI:-4.34, -1.88]) and 12 weeks (WMD:-3.21 [95% CI:-4.30, -2.12; p<0.05]). The HF severity score was significantly lower in patients treated with CE/BZA versus placebo at both 4 weeks (WMD:-0.39 [95% CI:-0.58, -0.20]; p<0.05) and 12 weeks (WMD:-0.66 [95% CI:‑0.89, ‑0.44]; p<0.001). The rate of UB with CE/BZA was not significantly different versus placebo (HR: 0.81 [95% CrI: 0.30, 2.20]) and was significantly less than tibolone 2.5mg (HR: 0.28 [95% CrI: 0.08, 0.93]).  CONCLUSIONS: CE/BZA demonstrates a favourable risk-benefit profile for management of PMS. CE/BZA treated patients reported a significant improvement in VMS with no increased risk of UB versus placebo.

Conference/Value in Health Info

2015-11, ISPOR Europe 2015, Milan, Italy

Value in Health, Vol. 18, No. 7 (November 2015)

Code

PIH2

Topic

Clinical Outcomes, Epidemiology & Public Health

Topic Subcategory

Comparative Effectiveness or Efficacy, Safety & Pharmacoepidemiology

Disease

Reproductive and Sexual Health

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