Duavive® is a combination product containing conjugated estrogens and bazedoxifene. This novel therapeutic combination is termed a tissue-selective estrogen complex (TSEC) and negates the need for opposing progestogen therapy. Duavive® is a new option for the treatment of moderate to severe vasomotor symptoms of menopause in women with a uterus.

Conjugated estrogens act as agonists at estrogen receptors, relieving symptoms associated with estrogen deficiency. Bazedoxifene is a selective estrogen receptor modulator (SERM) with agonist activity in bone and antagonist activity in breast and endometrial tissue. A recent study demonstrated a 30.4% relative risk reduction of new vertebral fractures in women with osteoporosis who were treated with bazedoxifene 20mg compared to placebo. Although the effect of Duavive® on the risk of breast cancer is unknown, the SMART studies show treatment is associated with a small, but significant, decrease in breast density. These trials also suggest a neutral effect on the endometrium. Rates of endometrial hyperplasia were <1% and, although one study showed an increase in endometrial thickness, no cases of endometrial carcinoma were reported.

Adverse effects occurred at a similar rate in the experimental and placebo groups, including no significant difference in the risk of ischaemic stroke, venous thromboembolism, and coronary heart disease. However, Duavive® is contraindicated in patients with thrombophilic disorders and an active or past history of thromboembolic disease. The most common adverse effects leading to discontinuation of therapy were abdominal pain and nausea.

References:

  1. Duavive® (conjugated estrogens/bazedoxifene) Australian approved product information. West Ryde: Pfizer Australia. Approved December 2016.
  2. Palacios S, Silverman SL, De Villers TJ, Levine AB, Goemaere S, Brown JP, et al. A 7-Year randomized, placebo-controlled trial assessing the long-term efficacy and safety of bazedoxifene in postmenopausal women with osteoporosis. Menopause 2015; 22(8): 806-13.
  3. Pazhekattu R, Lau AN, Adachi JD. The tissue-selective estrogen complex: a review of current evidence. Rheumatol Ther. 2015; 2(1): 47-58.

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