Showing posts with label NAMS. Show all posts
Showing posts with label NAMS. Show all posts

Wednesday, August 29, 2018

North American Menopause Society (NAMS) video series about important midlife health topics: Nonhormone Prescription Options for Hot Flashes

The North American Menopause Society (NAMS) provides practical information on important midlife health topics for women. All the interviews in the series are hosted by NAM Board of Trustees Member and Immediate Past-President Dr. Marla Shapiro, a Canadian physician who led this exciting initiative. Dr. Shapiro is also the medical consultant for CTV News.

HRT remains the most effective solution for the relief of menopausal hot flashes but not all women want to use hormones, or it may be contraindicated in some as women with breast cancer. Fortunately, there are some non-hormonal therapy that provide some relief, although they may not be as effective as estrogen.

In this informative video of 2018 series, Dr. Shapiro interviews Dr. James Simon, Clinical Professor, Department of Obstetrics and Gynecology, the George Washington University School of Medicine. Dr. Simon explains the efficacy of nonhormone options for hot flashes.





Wednesday, June 6, 2018

FDA approves Imvexxy to treat moderate to severe dyspareunia due to menopause


The United States Food and Drug Administration (FDA) has approved TX-004HR: IMVEXXY (estradiol vaginal inserts) for the treatment of moderate-to-severe dyspareunia due to vulvar and vaginal atrophy (VVA) of menopause.



Imvexxy is the only product in its therapeutic class to offer a 4 mcg and 10 mcg dose, the 4 mcg representing the lowest approved dose of vaginal estradiol currently available in the market. The product will be available to the consumers in July.

Imvexxy should be administered intravaginally as follows: one vaginal insert daily for 2 weeks, followed by one insert twice weekly.

Brian Bernick, MD, Chief Clinical Officer of TherapeuticsMD, said in a press release, “Imvexxy is a bio-identical vaginal estrogen product that offers a fraction of the estrogen contained in the average doses of many existing products currently on the market.”

“Imvexxy is the only product specifically designed to be applicator-free. It dissolves completely without mess or additional cleanup and can be used any time of day. It allows women the freedom to immediately return to their normal daily activities. Studies showed that, in patients who used Imvexxy, systemic absorption of estradiol remained within postmenopausal range," he further added.

The product was approved following the results of Phase 3, randomized, double-blind, placebo-controlled study (REJOICENCT02253173), published in April 2017 issue of Journal Menopause. The study results showed that Imvexxy was safe and well tolerated in all three doses (4, 10, and 25 μg).

In 2 weeks there was considerable improvement in dyspareunia, even with the lowest dose of 4 μg and vaginal dryness as early as 6 weeks as compared to women who received placebo.

A substudy of the REJOICE trial evaluated the pharmacokinetics of the 4-μg and 10-μg inserts and placebo.

There was negligible or very low systemic absorption as evident by the serum levels with no accumulation of the drug as seen by the low endogenous values observed at day 84.

Other products like vaginal estradiol tablet, vaginal creams, and vaginal estrogen ring used for the treatment of VVA limit systemic estrogen absorption but does not completely eliminate it.

The Pharmacokinetics profile for Imvexxy (ie, negligible to very low systemic absorption) could allow clinicians to follow the recommendation of The North American Menopause Society (NAMS) to use low-dose vaginal estrogens without a concomitant progestin.

It could also be used for the treatment of vaginal symptoms in survivors of estrogen-dependent breast cancer as recommended by the American Congress of Obstetricians and Gynecologists (ACOG).

The most commonly reported side effect by the users of vaginal inserts was a headache but it was not statistically significant when compared to placebo users.

VVA affects an estimated 32 million postmenopausal women in the United States. Approximately 7% (2.3 million) of these women receive prescription treatment. In addition, nearly 1 out of 2 women will experience pain during intercourse due to VVA at some point during their lives.

Dr. Sheryl Kingsberg, President, North American Menopause Society, said in a statement issued by TherapeuticsMD, “Studies have shown that many women are not seeking treatment for VVA, and 81% are unaware that VVA is a treatable medical condition and part of a constellation of symptoms associated with loss of estrogens."

 "I am delighted that our patients will now have a convenient treatment option with IMVEXXY and hope that the excitement generated by this new option will encourage women to talk to their healthcare provider and get relief from their pain and discomfort due to VVA,” she further added.

The product comes with a boxed warning about the increased risk of endometrial cancer, stroke, deep vein thrombosis (DVT), and dementia when used as estrogen-alone therapy without progesterone therapy.

Imvexxy is contraindicated in women with any of the following conditions: undiagnosed abnormal genital bleeding; known, suspected, or history of breast cancer; known or suspected estrogen-dependent neoplasia; active DVT, PE, or history of these conditions; active arterial thromboembolic disease or a history of these conditions; known anaphylactic reaction or angioedema to Imvexxy; known liver impairment or disease; known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders.


Sunday, February 4, 2018

Younger age at hysterectomy linked to increased risk of heart disease later in life


Ovarian conservation at hysterectomy does not reduce the risk of future cardiometabolic diseases reports the results of large prospective cohort study published in Menopause, the journal of The North American Menopause Society (NAMS).

This is one of the few studies that focuses on long term effect of hysterectomy with ovarian conservation. Earlier studies have documented strong evidence between increased incidence of cardiovascular diseases(CVD) and other chronic diseases after hysterectomy with bilateral oophorectomy.

The risk was especially increased if the hysterectomy was carried out before the age of 35.
Using Epidemiological project record, the researchers identified 2094 women who underwent hysterectomy with ovarian conservation between 1980 and 2002. Each woman was age matched with a control residing in the same county and who have neither undergone hysterectomy nor bilateral oophorectomy.

Cox proportional hazard models and Kaplan-Meier analysis was used to calculate hazards ratios and absolute risk after taking into consideration 20 risks factors and other potential confounders.

The two cohort were followed up for a period of 22 years, and women who have undergone hysterectomy were at increased risk of obesity, hyperlipidemia, hypertension, cardiac arrhythmias and coronary artery diseases.

Women who had hysterectomy under the age of 35 years were at nearly 5 times increased risk of congestive heart failure and 2.5 times increased risks of coronary artery disease.

Dr. JoAnn Pinkerton, NAMS executive director said in a NAMS press release, “These study results suggest that alternative uterine-preserving treatments may need to be considered more often in lieu of hysterectomies, especially in benign situations. For those women having hysterectomy, hormone therapy should be considered for added protection, because ovarian function appears to be impaired by the surgery.”

Media courtesy: Detroit Free Press




Tuesday, January 16, 2018

North American Menopause Society (NAMS) video series about important midlife health topics: New Treatment Option for Painful Intercourse

The North American Menopause Society (NAMS) is proud of its comprehensive video series for women on important midlife health topics. All the interviews in the series are hosted by NAM Board of Trustees Member and Immediate Past-President Dr. Marla Shapiro, a Canadian physician who led this exciting initiative. Dr. Shapiro is also the medical consultant for CTV News.

In this latest video, New Treatment Option for Painful Intercourse, Dr. Shapiro interviews Dr. Gloria A. Richard-Davis, NAMS Board Member, Division Director of Reproductive Endocrinology and Infertility at the University of Arkansas Medical Sciences and Medical Director of the Physician Assistant Program in Little Rock. Dr. Richard-Davis discusses a new nonestrogen, FDA-approved product (prasterone) and how it differs from other available products. She also answers questions about how to use it as well as how to initiate a conversation with your healthcare provider. 



Thursday, June 15, 2017

North American Menopause Society (NAMS) video series about important midlife health topics:Individualizing Hormone Therapy

The North American Menopause Society (NAMS) has started comprehensive video series for clinicians about important midlife health topics. All the interviews in the series are hosted by NAMS Board of Trustees Member and President Dr. Marla Shapiro, a Canadian physician, who led this exciting initiative.


In this video The North American Menopause Society answers questions about individualizing hormone therapy—its history, recommendations, timing hypothesis, and routes of administration. Dr. Schnatz also discusses the concept of the appropriate dose with the appropriate route for the appropriate duration.




Sunday, April 9, 2017

North American Menopause Society (NAMS) video series about important midlife health topics: April 2017.

The North American Menopause Society (NAMS) has started comprehensive video series for clinicians about important midlife health topics. All the interviews in the series are hosted by NAMS Board of Trustees Member and President Dr. Marla Shapiro, a Canadian physician, who led this exciting initiative.


In this monthly series, the latest video is “treatment for perimenopause and postmenopausal bleeding” Dr. Goldstein discusses what action must be taken for spotting, staining, or bleeding for perimenopausal and postmenopausal women.


                             Dr Steven Goldstein discusses treatment for bleeding.


Sunday, March 6, 2016

Managing Menopause: Is it time to take a second look at the Women's Health Initiative (WHI) study results?



Menopause is an important life event for a woman that signifies the end of her reproductive era and transitioning into a period of increasing health risk from cardiovascular disease, osteoporosis, and other chronic diseases.

According to a census in 1998, there were more than 477 million postmenopausal women in the world, and the number is going to rise to approximately 1.1 billion by 2015. Life expectancy for women worldwide was 65 years in 1998 which has currently increased to 73.2 years (81 years in developed countries).  With increasing life expectancy women spend one third of life in this phase of life.  

In the year 2000, there were an estimated 45.6 million postmenopausal women in the United States, out of which about 40 million were older than age 51, the average age of natural menopause in the Western world.                                    

According to a book chapter by Dr.  JoAnn E. Manson, MD, DrPH professor of medicine at Harvard Medical School and Brigham and Women's Hospital “Aging of the female reproductive system begins at 20 weeks gestation with regard to follicle atresia and proceeds as a continuum. It consists of a steady loss of oocytes from atresia or ovulation, and does not necessarily occur at a constant rate. Because of the relatively wide age range (40-58 y) for natural menopause, chronologic age is a poor indicator of the beginning or the end of the menopause transition.

This article is based on a perspective by JoAnn E. Manson, M.D., Dr.P.H., and Andrew M. Kaunitz, M.D. in March 03, 2016 edition of  The New England Journal of Medicine( NEJM).

Menopausal symptoms are well tolerated by some women, but may be very troublesome to other women. Often there is underreporting of menopausal symptoms due to cultural taboos. The attitude towards menopause varies according to culture and ethnicity, with 80% African women reporting symptoms versus very few Asian women reporting symptoms.

There has been an ongoing confusion regarding the findings of WHI study and prescription of hormonal therapy to relieve the symptoms of menopause.

The Women's Health Initiative (WHI) was launched in 1991 and consisted of a set of clinical trials and an observational study, which together involved 161,808 generally healthy postmenopausal women.
The clinical trials were designed to test the effects of postmenopausal hormone therapy, diet modification, and calcium and vitamin D supplements on heart disease, fractures, and breast and colorectal cancer. The trials were specifically designed to address questions about effect of initiating menopausal hormone therapy for the prevention of chronic disease in postmenopausal women across a broad range of ages, including many women in their 60s and 70s?

In 2002, the study results ripped the widely held belief that hormone replacement therapy protected women from heart disease and other chronic illnesses.  Instead, the Women's Health Initiative study found concluded that taking estrogen plus progestin hormone replacement therapy — HRT — actually increased a woman's risk of heart disease and breast cancer.

Within months of the results, number of women using HRT dropped by half. 

The results of the study were extrapolated to women in 40s and 50s who had severe vasomotor symptoms disrupting quality of life. In-fact, these women had trouble finding clinician who could prescribe them with HRT.  

But, studies conducted during Extended Poststopping Phases of the Women’s Health Initiative Randomized Trials when broken down according to age groups showed entirely different outcomes. Subgroup analysis stratified according to age and time since menopause onset modified the effect of HRT on some of the outcomes. The study concluded that HRT is a reasonable option for the management of moderate to severe menopausal symptoms among generally healthy women during early menopause.

In-fact, the USPSTF in its recommendation made a specific mention that “This recommendation applies only to postmenopausal women who are considering hormone therapy for the primary prevention of chronic medical conditions. This is not a recommendation about the use of hormone therapy to treat menopausal symptoms, such as hot flashes or vaginal dryness; the USPSTF did not review the evidence related to this possible indication because it falls outside of the mission and scope of the USPSTF. This recommendation also does not apply to women younger than 50 years who have had surgical menopause”.

The North American Menopause Society (NAMS), the Endocrine Society, the American College of Obstetricians and Gynecologists (ACOG) endorse the use of HRT in younger women for treating postmenopausal symptoms, who do not have specific contraindication for the therapy.

This will definitely improve the quality of life and it is quite likely that the benefit would outweigh the risks.

These organizations have many resources that help clinicians in decision making, the NAMS have a MenoPro Mobile App, which helps in personalization of treatment to individual patient and help patient in shared decision making.

The MenoPro app has several unique features, including the ability to calculate your 10-year risk of heart disease and stroke, which is important in deciding whether a treatment option is safe for you. It also has links to online tools that assess your risk of breast cancer and osteoporosis and fracture.


Photo courtesy: NAMS

Finally Dr. JoAnn E. Manson emphasized the need of training young healthcare providers to keep up with the variety of options in treating postmenopausal women. This will certainly help in improving the quality of life of a growing population.





References:

Manson JE, Kaunitz A. Menopause management: getting clinical care back on track. N Engl J Med. 2016;374:803-806.





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