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What is the hormone replacement therapy Angelique?

4 min read

According to the U.S. FDA, Angelique (drospirenone/estradiol) was first approved in 2005 for treating postmenopausal symptoms. So, what is the hormone replacement therapy Angelique? It is a continuous combined medication designed to alleviate moderate to severe vasomotor and vaginal symptoms associated with menopause in women with an intact uterus.

Quick Summary

Angelique is a continuous combined hormone replacement therapy (HRT) containing estradiol and drospirenone, used to treat moderate to severe menopausal symptoms, including hot flashes and vaginal atrophy. It is taken as a once-daily tablet.

Key Points

  • Combined Oral HRT: Angelique is a once-daily tablet containing two hormones, estradiol (estrogen) and drospirenone (progestin), for menopausal symptom relief.

  • For Women with an Intact Uterus: The medication is specifically for postmenopausal women who have not had a hysterectomy, as the progestin protects the uterine lining.

  • Treats Vasomotor and Vaginal Symptoms: It is prescribed for moderate to severe hot flashes, night sweats, and vulvar/vaginal dryness and irritation.

  • Drospirenone Manages Fluid Retention: The unique progestin drospirenone helps counteract the fluid and sodium retention that can be associated with estrogen.

  • Potential for Hyperkalemia: Due to the drospirenone component, individuals with predisposing conditions (e.g., renal or adrenal issues) should be monitored for high blood potassium levels.

  • Associated with Safety Warnings: Like other HRTs, Angelique carries boxed warnings concerning cardiovascular events, certain cancers, and dementia risk, especially in older women.

  • Not a Contraceptive: Despite containing hormones similar to birth control pills, Angelique is not a contraceptive and will not prevent pregnancy.

In This Article

What is Angelique HRT?

Angelique, also spelled Angeliq, is a brand-name, continuous combined hormone replacement therapy (HRT). It is an oral medication that contains two active ingredients: drospirenone (a progestin) and estradiol (an estrogen). The therapy is designed for women who have gone through menopause and still have their uterus. By replacing the hormones that the body produces less of after menopause, Angelique helps to alleviate a number of uncomfortable and disruptive symptoms.

The active ingredients: Drospirenone and Estradiol

  • Estradiol: This is a bioidentical estrogen, meaning it is the same form of estrogen naturally produced by the ovaries before menopause. Its purpose in Angelique is to replace the lost estrogen, which in turn reduces symptoms like hot flashes and vaginal dryness.
  • Drospirenone: As a synthetic progestin, drospirenone plays a crucial role in protecting the uterus. When a woman with a uterus takes estrogen, the hormone can cause the uterine lining (endometrium) to grow excessively, increasing the risk of uterine cancer. The addition of drospirenone helps balance the effect of estrogen, preventing this overgrowth. Drospirenone also has antimineralocorticoid activity, which helps to counteract the water and sodium retention that can be a side effect of estrogen.

How does Angelique work?

The mechanism of action for Angelique involves supplementing the body with the hormones that decline during menopause. As a woman enters menopause, her ovaries produce less estrogen and progesterone, leading to a variety of symptoms. Angelique works by providing a steady, continuous dose of both hormones. This continuous regimen is different from other HRT types that involve cyclical bleeding. The estradiol component addresses the estrogen deficiency, while the drospirenone protects the uterine lining from potential endometrial hyperplasia. In clinical trials, the combination has been shown to effectively reduce the frequency and severity of menopausal symptoms within a few weeks of starting treatment.

Indications and Treatment Targets

Angelique is specifically indicated for women with a uterus to treat the following conditions:

  • Moderate to severe vasomotor symptoms: This includes hot flashes and night sweats, which are common and often disruptive symptoms of menopause.
  • Moderate to severe vulvar and vaginal atrophy: This refers to the thinning, drying, and inflammation of the vaginal walls due to reduced estrogen, which can cause discomfort, dryness, and irritation. When prescribing treatment solely for these symptoms, a healthcare provider should first consider topical vaginal products.

Potential Risks and Side Effects

Like all medications, Angelique carries potential risks and side effects, and it is important for a patient and their doctor to discuss them thoroughly. The U.S. FDA has issued a boxed warning for estrogen plus progestin therapies like Angelique, highlighting potential increased risks for certain conditions.

Important Safety Information

  • Cardiovascular Risks: HRT is not used to prevent heart disease. Estrogen with progestin may increase the risk of heart attacks, strokes, deep vein thrombosis (DVT), and pulmonary embolism (PE).
  • Malignant Neoplasms: Combined HRT may increase the risk of breast and uterine cancer. The progestin in Angelique is included to mitigate the risk of endometrial cancer, but vigilance is still required.
  • Hyperkalemia: Due to its drospirenone component, Angelique can increase serum potassium levels in some individuals, particularly those with kidney disease, adrenal insufficiency, or those taking other medications that raise potassium. Potassium levels may be monitored, especially during the first month of treatment.
  • Dementia: Studies involving women aged 65 and older showed an increased risk of developing probable dementia with combined HRT. It is unknown if this applies to younger women.

Common side effects

Common adverse reactions reported in clinical trials include:

  • Headache
  • Breast pain or discomfort
  • Abdominal pain and bloating
  • Irregular vaginal bleeding or spotting
  • Mood swings
  • Nausea
  • Weight gain (potentially due to fluid retention)

Comparison with Other HRT Options

HRT comes in various forms, including patches, gels, and other oral tablets. The best option depends on individual health, lifestyle, and symptom profile. A discussion with a healthcare provider is essential.

Feature Angelique (Drospirenone/Estradiol Oral Tablet) Estradiol Transdermal Patch (e.g., Climara, Vivelle-Dot)
Hormones Continuous combined estradiol and drospirenone Contains only estradiol (estrogen)
Administration Once-daily oral tablet Patch applied to the skin, typically twice weekly
Protection for Uterus Contains progestin (drospirenone) to protect uterine lining. Appropriate for women with a uterus. Requires a separate progestin for women with a uterus to prevent endometrial cancer.
Systemic Exposure The oral route leads to systemic exposure that can affect the liver. The transdermal route avoids the first-pass effect in the liver.
Effect on Blood Pressure Drospirenone has antimineralocorticoid properties, which can help manage fluid retention. Blood pressure should be monitored. Does not have the specific properties of drospirenone.
Generic Availability No generic version currently available. Lower-cost generic versions are available.

Administration

Angelique is taken as one tablet daily, every day, without interruption. It is crucial to take the tablet at approximately the same time each day to maintain consistent hormone levels. If a dose is missed, it should be taken as soon as possible, but if more than 24 hours have passed, the missed dose should be skipped. There are different available strengths to address various menopausal symptoms.

Conclusion

Angelique is a continuous combined hormone replacement therapy that effectively treats moderate to severe menopausal symptoms like hot flashes and vaginal atrophy in women with an an intact uterus by providing a combination of estradiol and drospirenone. The inclusion of a progestin like drospirenone is vital for protecting the uterine lining from potential cancer risks associated with estrogen-only therapy. While generally well-tolerated, it is crucial to be aware of the potential side effects and safety warnings, particularly regarding cardiovascular events, certain cancers, and hyperkalemia. The lowest effective dose for the shortest duration consistent with treatment goals is recommended. As with any HRT, the decision to use Angelique should be made in close consultation with a healthcare provider, considering individual health risks and symptom severity.

For more detailed information, consult the U.S. FDA prescribing information for Angelique.

Frequently Asked Questions

The main difference is its formulation as a continuous combined oral tablet containing a specific progestin, drospirenone, alongside estradiol. This provides a steady hormone level without a withdrawal bleed and offers antimineralocorticoid properties, which can help manage fluid retention.

No, Angelique is not a birth control pill. While it contains hormones similar to contraceptives, the dosage and hormone combination are different. Women using Angelique can still become pregnant if not using a separate form of birth control.

Serious risks associated with Angelique include an increased risk of blood clots (DVT, PE), stroke, heart attack, certain cancers (breast, uterine), and dementia in women 65 and older. The drospirenone component also poses a risk of high potassium levels in susceptible individuals.

Angelique is taken once daily, with one tablet each day from the 28-day pack. It should be taken at the same time every day to maintain consistent hormone levels.

No, Angelique contains a progestin specifically to protect the uterine lining from overgrowth caused by estrogen. Since women who have had a hysterectomy no longer have a uterus, they do not need the progestin component and should not use Angelique.

According to clinical trials, Angelique can reduce the frequency and severity of vasomotor symptoms within four weeks of starting therapy, although individual results may vary.

Yes, caution is advised with medications that can increase potassium levels, such as NSAIDs, ACE inhibitors, and potassium-sparing diuretics. Other drugs, including certain antifungals and HIV/HCV protease inhibitors, can also interact with Angelique.

References

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.