Here's another progestin option for HRT

November 7, 2005

Although estrogen replacement therapy is still the most effective way to manage menopausal symptoms, there is no one-size-fits-all solution. A new option, however, should be available in pharmacies by mid-2006.

Angeliq (Berlex) has been approved for treating moderate to severe vasomotor symptoms associated with menopause, of which hot flushes are the most common symptom. Of all women with hot flushes, 80% experience them for less than two years; 20%-25% of women experience them for more than five years.

Angeliq is the first hormone replacement therapy (HRT) to combine estradiol (1 mg) and drospirenone (0.5 mg) into a single tablet. Estradiol is the same estrogen that is produced by the ovaries prior to menopause; drospirenone is the progestin found in the oral contraceptive YASMIN (30 mcg ethinyl estradiol/3 mg drospirenone, Berlex).

In clinical trials with more than 1,759 postmenopausal women, Angeliq was associated with high rates of acceptability and compliance. Bothersome vasomotor symptoms typically disappeared with Angeliq, usually within four weeks of initiation of therapy, and few women dropped out of clinical trials because of side effects. The most common complaints were vaginal bleeding, breast pain, and headaches, adverse effects that were mild and transient.

Comparing Angeliq with other HRT products, David Archer, M.D., professor of obstetrics and gynecology at Eastern Virginia Medical School, said, "Many combination products have a 70%-80% incidence of bleeding or spotting within the first one to three months of use." By comparison, only 20% of women using Angeliq experienced bleeding, and 11%-14% were bothered by spotting. Also, a slight but significant reduction in weight gain was noted with Angeliq. In addition, Angeliq does not raise blood pressure.

Since drospirenone possesses anti-aldosterone activity similar to that of spironolactone, there is a risk of hyperkalemia. Thus, Angeliq should not be used in patients with renal insufficiency, hepatic dysfunction, or adrenal insufficiency-all conditions that predispose to hyperkalemia. Elena Umland, Pharm.D., the Barbara H. Korberly Associate Professor in Women's Leadership and Health at the University of the Sciences in Philadelphia, cautions that "Angeliq requires watching renal function to prevent hyperkalemia." Extra caution should also be used in women who regularly use other medications that increase potassium, such as potassium supplements, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor blockers, and nonsteroidal anti-inflammatory drugs.

As with any HRT, women should be aware of the outcomes of the Women's Health Initiative, which reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (ages 50-79) during five years' treatment with oral conjugated estrogens and medroxyprogesterone.

Because of the risks associated with HRT, Angeliq should be used for the shortest possible time.

As with all HRT products, Angeliq should not be used in women with undiagnosed, abnormal vaginal bleeding; known or suspected breast cancer; known or suspected estrogen-dependent tumors; blood clots; stroke or myocardial infarction; pregnancy; or liver disease. Likewise, women should see their healthcare provider if they develop warning signs that could signal serious adverse effects like breast lumps, dizziness and faintness, speech alterations, severe headaches, chest pain, shortness of breath, leg pain, or visual changes.

THE AUTHOR is a medical writer based in Pennsylvania.