DUAVEE是首个也是唯一一种将共轭雌激素和一种雌激素激动剂/拮抗剂（又名雌激素受体调节剂SERM）配伍的药物。此次批准，是DUAVEE在全球范围内获得的首个监管批准，该药为每日一次的口服片剂。
商品名：Duavee 
通用名：conjugated estrogens/bazedoxifene 
中文名：共轭雌激素/巴多昔芬
活性成分：共轭雌激素/巴多昔芬，共轭雌激素天然提取的雌激素混合物
结构式如下：

作用机理：
共轭雌激素（商品名：Premarin）本身具有治疗绝经后潮热、骨质疏松的作用，巴多昔芬是一种选择性雌激素受体调节剂，能够降低子宫内膜增生风险。
适应症：
治疗绝经引起的中度至重度潮热，预防绝经后骨质疏松。
临床试验：
III期临床试验中，治疗组与安慰剂组初始平均日潮热次数分别为10次、11次，经过12周的治疗后，治疗组与安慰剂组平均日潮热次数分别为3次、6次，换而言之，治疗组与安慰剂组平均日潮热次数分别减少74%、47%。
黑框警告：
本品含雌激素，有雌激素的相关风险。
不良反应：
肌痉挛、恶心、腹泻、消化不良、上腹疼痛、咽喉痛、头晕、头痛。
剂型规格：
本品为片剂，每片含0.45mg共轭雌激素/20mg巴多昔芬。
药企：Pfizer Inc.

IMPORTANT SAFETY INFORMATIONExpand

Do not take additional estrogens, progestins, or estrogen agonists/antagonists while taking DUAVEE™ (conjugated estrogens/bazedoxifene).
Using estrogen alone may increase your chance of getting cancer of the uterus. Report any unusual vaginal bleeding right away while taking DUAVEE. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus. A healthcare provider should check unusual vaginal bleeding to find the cause.
Do not use estrogens to prevent heart disease, heart attacks, strokes, or dementia.
Estrogens may increase the chance of getting blood clots or strokes.
Using estrogens may increase the chance of getting dementia, based on a study of women 65 years of age or older.
Do not use DUAVEE if you have or had blood clots; are allergic to any of its ingredients; have unusual vaginal bleeding; have or had certain cancers (e.g., uterine or breast), liver problems, or bleeding disorders; or are pregnant, may become pregnant, or are breastfeeding a baby.
The use of estrogen alone has been reported to result in an increase in abnormal mammograms requiring further evaluation. The effect of treatment with DUAVEE on the risk of breast and ovarian cancer is unknown.
Estrogens increase the risk of gallbladder disease. Discontinue estrogen if loss of vision, pancreatitis, or jaundice occurs.
The most common side effects include muscle spasms, nausea, diarrhea, upset stomach, abdominal pain, throat pain, dizziness, and neck pain.
INDICATIONS
DUAVEE is used after menopause for women with a uterus, to reduce moderate to severe hot flashes and to help reduce the chances of developing osteoporosis.
If you use DUAVEE only to prevent osteoporosis due to menopause, talk with your healthcare provider about whether a different treatment or medicine without estrogens might be better for you. DUAVEE should be taken for the shortest time possible and only for as long as treatment is needed. You and your healthcare provider should talk regularly about whether you still need treatment with DUAVEE.

DUAVEE Rx
Pharmacological Class:
Conjugated estrogens + estrogen agonist/antagonist.

Active Ingredient(s):
Conjugated estrogens 0.45mg, bazedoxifene 20mg; tabs.

Company
Pfizer Inc.

Indication(s):
Treatment of moderate-to-severe vasomotor symptoms associated with menopause. Prevention of postmenopausal osteoporosis. Limitation of use: use for shortest duration consistent with treatment goals and risks.

Pharmacology:
Conjugated estrogens agonize estrogen α/β receptors. Bazedoxifene agonizes some estrogen-sensitive tissues and antagonizes others (eg, uterus). Bazedoxifene reduces the risk of endometrial hyperplasia that can occur with conjugated estrogens.

Clinical Trials:
The safety and efficacy of Duavee for moderate-to-severe vasomotor symptoms associated with menopause and the prevention of postmenopausal osteoporosis was evaluated in several Phase 3 clinical trials. Results from one trial demonstrated that Duavee significantly reduced the number of moderate-to-severe hot flashes by 74% at 12 weeks, as compared with placebo (47%). In addition, significant decreases in mean hot flash severity were seen at 12 weeks (39%), as compared with placebo (13%).

In other clinical trials, at years one and two, ­Duavee significantly increased bone mineral density in the total hip and lumbar spine from baseline vs. decreases seen with placebo.

For more clinical trial data, see full labeling.

Legal Classification:
Rx

Adults:
Swallow whole. 1 tablet daily. Postmenopausal osteoporosis: may supplement diet with calcium and/or Vitamin D, if inadequate.

Children:
Not applicable.

Contraindication(s):
Undiagnosed abnormal uterine bleeding. Known, suspected or history of breast cancer. Known or suspected estrogen-dependent neoplasia. Active DVT, PE or history of. Active arterial thromboembolic disease or history of. Hepatic impairment. Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders. Pregnancy (Category X). Women who may become pregnant. Nursing mothers.

Warnings/Precautions:
Not for prevention of cardiovascular disease. Increased risk of cardiovascular disorders (eg, stroke, DVT, VTE); discontinue if occurs or suspected. Discontinue at least 4–6 weeks before surgery type associated with increased risk of thromboembolism or during prolonged immobilization. Endometrial, breast, or ovarian cancer. Gallbladder disease. Visual abnormalities. Hypertriglyceridemia. Discontinue if cholestatic jaundice, pancreatitis, or retinal vascular lesions occur. Monitor thyroid function. Conditions aggravated by fluid retention. Renal impairment: not recommended. Hypoparathyroidism. Hereditary angioedema. ­Caution in asthma, diabetes, epilepsy, migraine, porphyria, SLE, and hepatic hemangiomas. Do initial complete physical and repeat yearly (include Pap smear, mammogram, BP). Premenopausal women or women >75 years of age: not recommended. Risk of probable dementia in women >65 years of age. Women with BMI >27kg/m2: increased risk of endometrial hyperplasia. Reevaluate ­periodically.

Interaction(s)
Avoid concomitant progestins, additional estrogens, or estrogen agonist/antagonists. Antagonized by CYP3A4 inducers (eg, phenobarbital, carbamazepine, rifampin, St. John’s Wort). Potentiated by CYP3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir, grapefruit juice). Concomitant thyroid replacement; may need to increase thyroid dose. Bazedoxifene: may be antagonized by UGT inducers (eg, rifampin, phenobarbital, carbamazepine, phenytoin). May affect or be affected by ibuprofen, atorvastatin, azithromycin, aluminum and magnesium hydroxide. Duavee may interfere with lab tests (eg, thyroid, PT, glucose tolerance, HDL/LDL, triglycerides, hormone concentrations, other binding proteins).

Adverse Reaction(s)
Muscle spasms, nausea, diarrhea, dyspepsia, upper abdominal pain, oropharyngeal pain, dizziness, neck pain.

How Supplied:
Blisters—2 × 15

LAST UPDATED:
3/10/2014
FDA批准辉瑞DUAVEE用于治疗潮热和预防骨质疏松
近日，FDA已批准DUAVEE（conjugated estrogens/bazedoxifene，共轭雌激素/巴多昔芬，0.45mg/20mg）片，用于未切除子宫的绝经后女性，治疗中度至重度更年期相关的血管舒缩症状（潮热）及预防绝经后骨质疏松症。当仅用于预防骨质疏松时，DUAVEE应仅用于高危个体，同时需充分考虑非雌激素药物。
DUAVEE是首个也是唯一一种将共轭雌激素和一种雌激素激动剂/拮抗剂（又名雌激素受体调节剂SERM）配伍的药物。此次批准，是DUAVEE在全球范围内获得的首个监管批准，该药为每日一次的口服片剂，辉瑞预计将于2014年第一季度在美国推出该药。
与所有更年期雌激素疗法一样，DUAVEE应根据女性的治疗目标和风险，尽可能短时间地应用。
目前，在美国45岁-59岁女性约有3300万人，平均绝经年龄为51岁。根据调查数据，约有50%的绝经后女性会出现中度至重度的血管舒缩症状，即“潮热”。
关于DUAVEE
雌激素（estrogen）已作为激素疗法，用于帮助管理更年期症状。单独使用雌激素，可能增加子宫内膜患癌的风险。当用于未切除子宫的绝经后女性时，雌激素传统上一直与孕激素（progestin）联合用药，可以减少子宫内膜增生的风险，而子宫内膜增生可能是子宫内膜癌的前兆。
DUAVEE是首个也是唯一一种将共轭雌激素（CE）与一种雌激素激动剂/拮抗剂配伍的疗法。DUAVEE使用bazedoxifene（巴多昔芬）而非孕激素，来帮助保护雌激素疗法可能导致的子宫内膜增生。