COMMENTARY

Cool Tips for Menopausal Hot Flashes

Sandra Adamson Fryhofer, MD

Disclosures

August 12, 2014

In This Article

Hot Flash Relief With Bone Help

In October 2013, the FDA approved a combination of conjugated estrogen (0.45 mg) with bazedoxifene (Duavee®; 20 mg) for prevention of osteoporosis and treatment of moderate to severe vasomotor symptoms.[3,7]

A clinical trial known as SMART (Selective Estrogens, Menopause, And Response to Therapy) demonstrated a 74% reduction in moderate to severe hot flashes at 12 weeks. Clinical trials described in the package insert showed significantly increased bone density at the hip and lumbar spine compared with reductions in bone density seen in patients receiving placebo.[7]

This dual agent was developed by Wyeth (remember Premarin®, a conjugated equine estrogen derived from pregnant horse urine?) and is now owned by Pfizer. Although the label has taken "equine" off of the ingredient list, it does source the conjugated estrogen as being derived from the urine of pregnant horses. Bazedoxifene is a SERM with both estrogen-agonist effects (bone) and -antagonist effects (endometrium). This antagonistic effect on the endometrium prevents estrogen-associated endometrial hyperplasia, which can lead to uterine cancer. Thus, bazedoxifene provides an alternative to progestin that is protective of the endometrial lining.[3,7]

The combination drug is indicated only for women who have a uterus. Any vaginal bleeding in patients taking this medication must be evaluated. Warnings in the package insert discourage taking additional estrogens, progestins, or estrogen agonist/antagonists in addition to this combination drug.[3]

There are some drug (and juice!) interactions that you need to be aware of. Concomitant use with CYP3A4 inhibitors, including erythromycin, clarithromycin, ketoconazole, itraconazole, and ritonavir, and also grapefruit juice, lessens the drug's protective effect by increasing estrogen exposure; this could increase risk for endometrial hyperplasia.[7] The package insert says this combination should not be used by women with blood clots or a history of blood clots, liver problems, breast cancer, or uterine cancer.[7]

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