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Equine oestrogens + bazedoxifene (Duavive°) and menopause. Inadequately evaluated harms

FEATURED REVIEW A new product combining equine oestrogens and bazedoxifene (Duavive°, Pfizer) has been authorised in the European Union for menopausal disorders in non-hysterectomised postmenopausal women. Past experience suggests that this new combination should be considered with caution, and avoided until these foreseeable adverse effects have been properly evaluated.
Full review (2 pages) available for download by subscribers.

In practice

  • The use of systemic hormone therapy in postmenopausal women exposes them to serious and fatal adverse effects. It should therefore only be used rarely, when the symptoms of menopause are very troublesome. Oestrogen-progestogen combinations have been in use for a long time, and their harms are relatively well known, enabling patient participation in informed decision-making.
     
  • None of the clinical trials of the equine oestrogens + bazedoxifene combination versus placebo or an oestrogen-progestogen combination have followed patients for more than one year. The degree to which this combination increases the risk of deep vein thrombosis and pulmonary embolism, or the risk of hormone-dependent cancers (breast, ovarian or uterine cancer) is unknown. It has some efficacy against hot flushes, but this is not sufficient to justify its use in the absence of long-term evaluation.
     
  • The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) did not approve all the indications requested by the company, limiting its use to non-hysterectomised women for whom treatment with progestin-containing hormone therapy is not appropriate. But it would have been more reasonable to refuse to authorise Duavive°, in order to protect women from inadequately evaluated harms.
     
  •  NOT ACCEPTABLE  For women with very troublesome menopausal symptoms, the harm-benefit balance of the oral fixed-dose combination of equine oestrogens + bazedoxifene is unknown, because the risks of venous thromboembolism, pulmonary embolism and hormone-dependent cancers have not been adequately evaluated. Past experience with oestrogen-progestogen combinations given to postmenopausal women suggests that this new combination should be considered with caution, and avoided until these foreseeable adverse effects have been properly evaluated.

©Prescrire 1 July 2017

"Equine oestrogens + bazedoxifene (Duavive°) and menopause. Inadequately evaluated harms" Prescrire Int 2017; 26 (184): 145-146. (Pdf, subscribers only)
Download the full review.
Pdf, subscribers only

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See also:

Menopausal hormone
therapy: in addition to
other risks, an increased
risk of ovarian cancer
(January 2016)
Free

Menopause: hormone
replacement therapy
and breast cancer
(January 2009)
Free

Numerous other texts
available via the Search
function using the keywords
"menopause hormone
replacement therapy"
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