Tag Archives: Hormone therapy

Hormone Therapy Combination Granted FDA Approval for Treating Menopausal Women

Posted on by MaryO

 

Officials with the FDA have approved TherapeuticsMD’s Bijuva (estradiol and progesterone) capsules, 1 mg/100 mg, the company announced Monday. According to TherapeuticsMD, Bijuva is the first and only FDA-approved bio-identical hormone therapy combination of estradiol and progesterone in a single, oral capsule for the treatment of moderate to severe vasomotor symptoms due to menopause in women with a uterus.

“The approval of Bijuva represents an important and new opportunity for menopausal women suffering from moderate to severe vasomotor symptoms. Menopausal women and their healthcare providers have been seeking bio-identical combination therapies for many years without an FDA-approved option,” said Dr. Brian Bernick, Co-Founder and Director of TherapeuticsMD, in a prepared statement. “Bijuva is the first and only FDA-approved combination of bio-identical hormones, offering a proven balance of bio-identical estradiol to reduce moderate to severe hot flashes combined with bio-identical progesterone to reduce the risks to the endometrium.”

The approval is based on the Bijuva clinical development program that included the pivotal Phase III Replenish Trial. This trial evaluated the safety and efficacy of Bijuva in generally healthy, postmenopausal women with a uterus for the treatment of moderate to severe hot flashes. Consistent with FDA guidance, the co-primary efficacy endpoints in the Replenish Trial were the change from baseline in the number and severity of hot flashes at weeks 4 and 12, as compared to placebo. The primary safety endpoint was the incidence of endometrial hyperplasia with up to 12 months of treatment.

Bijuva demonstrated a statistically significant reduction from baseline in both the frequency and severity of hot flashes compared to placebo while reducing the risks to the endometrium. The most common adverse reactions (≥3 percent) were breast tenderness, headache, vaginal bleeding, vaginal discharge, and pelvic pain. Additionally, there were no clinically significant changes in lipid, coagulation or glucose parameters as compared to placebo. There were no unexpected safety signals.

“For the first time, we have a combination hormone therapy of bio-identical estradiol with bioidentical progesterone evaluated in a large, well-controlled, randomized clinical trial that has demonstrated both safety and efficacy for the treatment of moderate to severe hot flashes due to menopause,” said Dr. James Liu, M.D., President of the North American Menopause Society and Chairman of the Department of Obstetrics and Gynecology, UH Cleveland Medical Center, in a prepared statement. “The approval of Bijuva represents an important, novel and effective treatment option for women and their healthcare providers to manage the vasomotor symptoms of menopause.”

Bijuva is expected to be available in the United States in 2019.

Reference

TherapeuticsMD Announces FDA Approval of TX-001HR: BIJUVA (Estradiol and Progesterone) Capsules for the Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause [news release]. Boca Raton, FL; October 29, 2018: TherapeuticsMD.

From https://www.pharmacytimes.com/resource-centers/womens-health/hormone-therapy-combination-granted-fda-approval-for-treating-menopausal-women-

Menopausal Hormone Therapy

Posted on by MaryO

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Menopausal Hormone Therapy and Health Outcomes During the Intervention and Extended Poststopping Phases of the Women’s Health Initiative Randomized Trials

JAMA, 10/02/2013  Evidence Based Medicine  Clinical Article

Manson JE et al. – Menopausal hormone therapy continues in clinical use but questions remain regarding its risks and benefits for chronic disease prevention. To report a comprehensive, integrated overview of findings from the 2 Women’s Health Initiative (WHI) hormone therapy trials with extended postintervention follow–up. Menopausal hormone therapy has a complex pattern of risks and benefits. Findings from the intervention and extended postintervention follow–up of the 2 WHI hormone therapy trials do not support use of this therapy for chronic disease prevention, although it is appropriate for symptom management in some women.

Methods

  • A total of 27 347 postmenopausal women aged 50 to 79 years were enrolled at 40 US centers.
  • Women with an intact uterus received conjugated equine estrogens (CEE; 0.625 mg/d) plus medroxyprogesterone acetate (MPA; 2.5 mg/d) (n = 8506) or placebo (n = 8102).
  • Women with prior hysterectomy received CEE alone (0.625 mg/d) (n = 5310) or placebo (n = 5429).
  • The intervention lasted a median of 5.6 years in CEE plus MPA trial and 7.2 years in CEE alone trial with 13 years of cumulative follow–up until September 30, 2010.
  • Primary efficacy and safety outcomes were coronary heart disease (CHD) and invasive breast cancer, respectively.
  • A global index also included stroke, pulmonary embolism, colorectal cancer, endometrial cancer, hip fracture, and death.

Results

  • During the CEE plus MPA intervention phase, the numbers of CHD cases were 196 for CEE plus MPA vs 159 for placebo (hazard ratio [HR], 1.18; 95% CI, 0.95–1.45) and 206 vs 155, respectively, for invasive breast cancer (HR, 1.24; 95% CI, 1.01–1.53).
  • Other risks included increased stroke, pulmonary embolism, dementia (in women aged >=65 years), gallbladder disease, and urinary incontinence; benefits included decreased hip fractures, diabetes, and vasomotor symptoms.
  • Most risks and benefits dissipated postintervention, although some elevation in breast cancer risk persisted during cumulative follow–up (434 cases for CEE plus MPA vs 323 for placebo; HR, 1.28 [95% CI, 1.11–1.48]).
  • The risks and benefits were more balanced during the CEE alone intervention with 204 CHD cases for CEE alone vs 222 cases for placebo (HR, 0.94; 95% CI, 0.78–1.14) and 104 vs 135, respectively, for invasive breast cancer (HR, 0.79; 95% CI, 0.61–1.02); cumulatively, there were 168 vs 216, respectively, cases of breast cancer diagnosed (HR, 0.79; 95% CI, 0.65–0.97).
  • Results for other outcomes were similar to CEE plus MPA.
  • Neither regimen affected all–cause mortality.
  • For CEE alone, younger women (aged 50–59 years) had more favorable results for all–cause mortality, myocardial infarction, and the global index (nominal P < .05 for trend by age).
  • Absolute risks of adverse events (measured by the global index) per 10 000 women annually taking CEE plus MPA ranged from 12 excess cases for ages of 50–59 years to 38 for ages of 70–79 years; for women taking CEE alone, from 19 fewer cases for ages of 50–59 years to 51 excess cases for ages of 70–79 years.
  • Quality–of–life outcomes had mixed results in both trials.

From http://www.mdlinx.com/internal-medicine/newsl-article.cfm/4870253/ZZ4747461521296427210947/?news_id=466&newsdt=100213&utm_source=Newsletter&utm_medium=DailyNL&utm_content=General-Article&utm_campaign=Article-Section

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