Developed under the direction and sponsorshop of Berlex, Inc. Contains promotional material.
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Developed under the direction and sponsorshop of Berlex, Inc. Contains promotional material. |
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An interview with David Archer, MD, Professor of Obstetrics and Gynecology at the Eastern Virginia Medical School, and Director of the Endocrinology and Infertility Fellowship Program at the Jones Institute for Reproductive Medicine and Endocrinology, Norfolk, Virginia. Dr. Archer is also Editor of Menopausal Medicine, a quarterly publication of the American Society of Reproductive Medicine.
Q. What has been the experience of your patients who have tried ANGELIQ?
Dr. Archer. The experience has mostly been very positive, mainly from the standpoint that these women get relief from moderate to severe menopausal vasomotor symptoms quite quickly. And I think that among the women who have tried ANGELIQ that there has been the perception that it had few side effects. That's very encouraging, because what the physician in private practice wants to see is a product that is efficacious and has minimal side effects.
Q. What patient type do you think would benefit the most from ANGELIQ?
Dr. Archer. ANGELIQ is a good product for initial therapy in the recently menopausal woman - usually a couple of months out from her last menstrual period - because it offers estradiol and good efficacy in terms of hot flash control. Once a woman gets used to taking another product, if she is happy with that product she is usually going to want to stick with it; but for a recently menopausal woman ANGELIQ is a good option. Drospirenone is a unique progestin with a fingerprint that is different from other progestins that we have had available. It is effective on the endometrium at a low 0.5 mg dose, and has no effect on salt and water metabolism. So I think that it is also a viable alternative for women who are experiencing difficulty with other hormonal preparations, such as breast discomfort.
Q. What do you consider to be the appropriate oral dose of estradiol for most postmenopausal women?
Dr. Archer. Well, 1 mg is the estradiol dose most commonly used around the world. Although I think that some physicians might think about starting with a lower estradiol dose, such as 0.5 mg, 1 mg of estradiol probably provides the best efficacy with respect to reduction of hot flashes, maintenance of bone mineral density, and protection against vulvovaginal atrophy.
Q. What are the typical bleeding rates that have been seen with ANGELIQ?
Dr. Archer. In a clinical study, bleeding dropped off noticeably after the first couple of months. The number of women with no bleeding in cycle 1 was around 78%, and in cycle 13 it was almost 83%. It is difficult to use the results of different clinical trials to compare the bleeding seen with one progestin against the bleeding seen with another, but it is clear that drospirenone is a potent progestational agent that might be useful as an alternative for women who are experiencing bleeding problems with another hormone therapy preparation.
Important Safety Information
ANGELIQ contains 0.5 mg of the progestin drospirenone that has antialdosterone activity, including the potential for hyperkalemia in high-risk patients.
ANGELIQ should not be used in patients with conditions that predispose to hyperkalemia (ie, renal insufficiency, hepatic dysfunction, and adrenal insufficiency).
Use caution when prescribing ANGELIQ to women who regularly take other medications that can increase potassium, such as NSAIDs, potassium-sparing diuretics, potassium supplements, ACE inhibitors, angiotensin-II receptor antagonists, and heparin. Consider checking serum potassium levels during the first treatment cycle in high-risk patients.
The most common side effects, including upper respiratory infection, breast pain, abdominal pain, headaches, and vaginal bleeding, were mild and transitory, and similar to those of other hormonal therapies.
Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia. (See WARNINGS. Cardiovascular disorders and Dementia.)
The Women's Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5 years of treatment with oral conjugated equine estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) relative to placebo. (See CLINICAL PHARMACOLOGY, Clinical Studies and WARNINGS, Cardiovascular disorders and Malignant neoplasms, Breast cancer.)
The Women's Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with conjugated estrogens alone and during 4 years of treatment with oral conjugated estrogens plus medroxyprogesterone acetate, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. (See CLINICAL PHARMACOLOGY, Clinical Studies, WARNINGS, Dementia and PRECAUTIONS, Geriatric Use.)
Other doses of oral conjugated estrogens with medroxyprogesterone acetate, and other combinations and dosage forms of estrogens and progestins were not studied in the WHI clinical trials, and, in the absence of comparable data, these risks should be assumed to be similar. Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
Progestogens/estrogens should not be used in individuals with any of the following conditions: Undiagnosed abnormal genital bleeding; known, suspected, or history of cancer of the breast; known or suspected estrogen dependent neoplasia; active deep vein thrombosis, pulmonary embolism, or history of these conditions; active or recent (eg, within the past year) arterial thromboembolic disease (eg, stroke, myocardial infarction); renal insufficiency; liver dysfunction or disease; or adrenal insufficiency. ANGELIQ should not be used in patients with known hypersensitivity to its ingredients, or known or suspected pregnancy. There is no indication for ANGELIQ in pregnancy. There appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins from oral contraceptives inadvertently during early pregnancy. (See PRECAUTIONS.)
Please see full Prescribing Information | www.ANGELIQ-us.com
