What is Duavive and what is it used for - conjugated estrogens, bazedoxifene?
Duavive is a medicine used to treat symptoms (including hot flashes) caused by low blood levels of the female sex hormone estrogen in women who have gone through the menopause. It is used in patients who still have a uterus and cannot be treated with medicines containing progestogens (medicines derived from the hormone called progesterone). Duavive contains two active substances: conjugated estrogens and bazedoxifene.
How is Duavive used - conjugated estrogens, bazedoxifene?
Duavive can only be obtained with a prescription. It is available as modified-release tablets (containing 0.45 mg conjugated estrogen and 20 mg bazedoxifene), which release bazedoxifene immediately and conjugated estrogens over a longer period of time. The recommended dose of Duavive is one tablet once a day Treatment should be continued for the shortest possible duration as long as the benefits outweigh the risks.
How does Duavive work - conjugated estrogens, bazedoxifene?
One of Duavive's active ingredients, conjugated estrogens, acts as a hormone replacement therapy. It replaces estrogen hormones that are no longer naturally produced in women who have gone through menopause, thereby relieving symptoms such as hot flashes. When used alone, however, estrogen can cause hyperplasia (growth) of the endometrium (the lining of the womb), which can result in endometrial cancer. Therefore Duavive also contains the active substance bazedoxifene, which blocks the effects of estrogen on the uterus thereby reducing the risk of endometrial cancer. Both active substances have been available in the European Union (EU) for several years. Conjugated estrogens have been available for many years as hormone replacement therapy, while bazedoxifene was authorized in 2009 for the treatment of osteoporosis (a disease that makes bones fragile) in women who have gone through the menopause.
What benefit has Duavive shown - conjugated estrogens, bazedoxifene shown during the studies?
Duavive was compared with placebo (a dummy treatment) in two main studies involving 996 women who have been through the menopause, to look at their effects on hot flashes or vulvovaginal atrophy (dryness, irritation and pain around the genital area). . An additional study also looked at the effects of Duavive on osteoporosis. In the study looking at the effects on hot flashes, treatment with Duavive (conjugated estrogen 0.45 mg and bazedoxifene 20 mg) over 12 weeks reduced the mean daily number of moderate and severe hot flashes of 7.6 compared to 4.9 reduced hot flashes with placebo. Duavive treatment also resulted in a greater mean decline in daily hot flash severity score than placebo: 0.9 versus 0.3. Similar results were seen with a higher dose of conjugated estrogen (0.625 mg) and bazedoxifene 20 mg compared with placebo. The study examining the effects of Duavive on vulvovaginal atrophy found, compared to placebo, an improvement in some signs of vaginal atrophy but not in the more troublesome symptoms. As studies carried out with a combination of higher strengths did not adequately demonstrate that this combination was more effective than the approved strength of Duavive, the company withdrew the application for the above combination. One of the studies also looked at the effects of Duavive on osteoporosis; however, because Duavive did not demonstrate a greater benefit than using the individual components, the company withdrew its application for Duavive to treat osteoporosis.
What is the risk associated with Duavive - conjugated estrogens, bazedoxifene?
The most common side effect of Duavive (which may affect more than 1 in 10 people) is abdominal pain (stomach pain). Some women should not use Duavive: these include patients who have had problems with venous thromboembolism (formation blood clots in the veins) such as deep vein thrombosis, pulmonary embolism (formation of a blood clot in the lungs) and retinal vein thrombosis (formation of a blood clot in the vein at the back of the eye), or patients who are at increased risk of developing such conditions. It should also not be used in women who have had a stroke or myocardial infarction. Finally, it must not be used in patients who are affected or are likely to develop or have had breast cancer or other cancers known to have an estrogen-dependent component. Duavive is only indicated in women who have passed the menopause. Therefore, it should not be used in women of childbearing age. For the full list of side effects and limitations reported with Duavive, see the package leaflet.
Why has Duavive been approved - conjugated estrogens, bazedoxifene?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Duavive's benefits are greater than its risks and recommended that it be approved for use in the EU. Duavive has been shown to improve symptoms caused by lack of estrogen in postmenopausal women compared to placebo. As the therapeutic effects observed were lower than the effects seen with alternative therapies (progestogen-based therapies), the CHMP concluded that the use of Duavive should be limited to patients who they cannot take such alternative medicines. Regarding safety, the long-term risk of endometrial hyperplasia has not been fully investigated and the CHMP recommended further studies. The CHMP also noted that long-term use of Duavive is associated with a risk of stroke and venous thromboembolism similar to the risk observed with the use of conjugated estrogens and bazedoxifene alone.
What measures are being taken to ensure the safe and effective use of Duavive - conjugated estrogens, bazedoxifene?
A risk management plan has been developed to ensure that Duavive is used as safely as possible. Based on this plan, safety information has been added to the summary of product characteristics and package leaflet for Duavive, including the appropriate precautions to be followed by healthcare professionals and patients. Further information can be found in the summary of the risk management plan.
Other information about Duavive - conjugated estrogens, bazedoxifene
On December 16, 2014, the European Commission issued a "Marketing Authorization" for Duavive, valid throughout the European Union. For the full version of the EPAR and the summary of the Duavive Risk Management Plan, please visit the website Agency: ema.Europa.eu/Find medicine / Human medicines / European public assessment reports. For more information on Duavive therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist. Last update of this summary: 12-2014.
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