NAMS 2014 Annual Meeting

NATIONAL HARBOR, MD. – If you’re one of the many physicians with an X-ray absorptiometry machine collecting dust in the nether regions of your clinic, recent findings from a small pilot study might interest you.

Dr. Steven R. Goldstein said he found that roughly 20% of postmenopausal women whose body mass index (BMI) measurement indicated they had a normal weight actually had body fat measurements greater than the 75th percentile when their body fat was assessed using a X-ray absorptiometry (DXA) scanner.

Similarly, about a fifth of postmenopausal women in the study whose BMI indicated they were in the overweight range actually had DXA scanner readings indicating their percentage of body fat placed them below the 25th percentile.

“When you have 20% in each group, that’s not a tiny number,” Dr. Goldstein said in an interview at this year’s annual meeting of the North American Menopause Society. “BMI or weight alone does not always predict metabolic health.”

BMI, a measurement first created for use by insurance actuaries by Belgian mathematician Adolphe Quetelet in the mid-1800s, has come under scrutiny across the specialties in recent years, particularly since 1998 when the Centers for Disease Control and Prevention aligned with the World Health Organization determined that the criteria for being overweight was a BMI of 25 kg/m² instead of 27.8 kg/m².

“This instantly rendered 29 million previously healthy Americans as now being overweight,” Dr. Goldstein, a professor of obstetrics and gynecology at New York (N.Y.) University Langone Medical Center, told the audience.

Additionally, as one audience member noted during the question and answer period of the presentation, many members of nonAnglo populations, such as those from Mexico and Central America, are strong, healthy endomorphs, even though their BMIs would indicate otherwise.

“Most people don’t think about the fact that BMI is 170 years old and that with it, a 25-year-old man who weighs 150 pounds and is 5 foot 8 inches, has the same BMI as a 60-year-old woman who also weighs 150 pounds,” Dr. Goldstein said in an interview. “And yet, it’s used almost as another vital sign.”

Instead, Dr. Goldstein said that data from DXA scanners could be used by insurance companies to make more accurate decisions about obesity-related medical procedures, such as bariatric surgery. Studies have shown that some adults considered normal weight have cardiovascular abnormalities, and some considered obese are metabolically healthy (Arch. Intern. Med. 2008;168:1617-24).

“Using BMI, some people are being denied bariatric surgery when they need it, but there may be other people who are having the surgery who don’t actually need it,” Dr. Goldstein said.

The scanners also have met with some darker times, especially as reimbursements for the technology primarily used to determine bone mineral density in an aging population have fluctuated over the years, leaving many physicians with thousands of dollars in equipment they no longer use for fear they will not be paid for their time.

DXA scanners use two different energy levels that are absorbed differently by bone and lean and fat tissues, then uses the differences between them to determine the amount of lean and fat tissue across the entire body.

Dr. Goldstein and his colleagues analyzed DXA data taken from 50 postmenopausal women who visited his clinic for a routine bone mass DXA scan. The scanner software was used to calculate the women’s body fat percentile according to age and sex. Women who were between the 25th and 75th percentile were considered to have “normal” body fat, whereas below the 25th percentile or above the 75th percentile was considered abnormally lean or heavy, respectively. The measurements then were compared with the women’s BMI measurements.

Just over 18% of the cohort had normal BMI readings but placed above the 75th percentile for body fat when measured by the scanner. Conversely, 22% of women in the lowest percentile for body fat per their DXA scan also had normal BMI weight. Twenty-three percent of women considered overweight according to their BMI fell into the normal range for DXA body fat results. All of the women in the study considered obese by BMI were in the 100th percentile using the DXA scanner.

“DXA determination of body fat percentile seems like a reasonable and probable surrogate for metabolic health that is more accurate than BMI,” Dr. Goldstein said.

“We have the equipment, it’s just a matter of updating the software,” he said.

Dr. Goldstein said he had no relevant disclosures.

[email protected]

On Twitter @whitneymcknight

NATIONAL HARBOR, MD. – If you’re one of the many physicians with an X-ray absorptiometry machine collecting dust in the nether regions of your clinic, recent findings from a small pilot study might interest you.

Dr. Steven R. Goldstein said he found that roughly 20% of postmenopausal women whose body mass index (BMI) measurement indicated they had a normal weight actually had body fat measurements greater than the 75th percentile when their body fat was assessed using a X-ray absorptiometry (DXA) scanner.

Similarly, about a fifth of postmenopausal women in the study whose BMI indicated they were in the overweight range actually had DXA scanner readings indicating their percentage of body fat placed them below the 25th percentile.

“When you have 20% in each group, that’s not a tiny number,” Dr. Goldstein said in an interview at this year’s annual meeting of the North American Menopause Society. “BMI or weight alone does not always predict metabolic health.”

BMI, a measurement first created for use by insurance actuaries by Belgian mathematician Adolphe Quetelet in the mid-1800s, has come under scrutiny across the specialties in recent years, particularly since 1998 when the Centers for Disease Control and Prevention aligned with the World Health Organization determined that the criteria for being overweight was a BMI of 25 kg/m² instead of 27.8 kg/m².

“This instantly rendered 29 million previously healthy Americans as now being overweight,” Dr. Goldstein, a professor of obstetrics and gynecology at New York (N.Y.) University Langone Medical Center, told the audience.

Additionally, as one audience member noted during the question and answer period of the presentation, many members of nonAnglo populations, such as those from Mexico and Central America, are strong, healthy endomorphs, even though their BMIs would indicate otherwise.

“Most people don’t think about the fact that BMI is 170 years old and that with it, a 25-year-old man who weighs 150 pounds and is 5 foot 8 inches, has the same BMI as a 60-year-old woman who also weighs 150 pounds,” Dr. Goldstein said in an interview. “And yet, it’s used almost as another vital sign.”

Instead, Dr. Goldstein said that data from DXA scanners could be used by insurance companies to make more accurate decisions about obesity-related medical procedures, such as bariatric surgery. Studies have shown that some adults considered normal weight have cardiovascular abnormalities, and some considered obese are metabolically healthy (Arch. Intern. Med. 2008;168:1617-24).

“Using BMI, some people are being denied bariatric surgery when they need it, but there may be other people who are having the surgery who don’t actually need it,” Dr. Goldstein said.

The scanners also have met with some darker times, especially as reimbursements for the technology primarily used to determine bone mineral density in an aging population have fluctuated over the years, leaving many physicians with thousands of dollars in equipment they no longer use for fear they will not be paid for their time.

DXA scanners use two different energy levels that are absorbed differently by bone and lean and fat tissues, then uses the differences between them to determine the amount of lean and fat tissue across the entire body.

Dr. Goldstein and his colleagues analyzed DXA data taken from 50 postmenopausal women who visited his clinic for a routine bone mass DXA scan. The scanner software was used to calculate the women’s body fat percentile according to age and sex. Women who were between the 25th and 75th percentile were considered to have “normal” body fat, whereas below the 25th percentile or above the 75th percentile was considered abnormally lean or heavy, respectively. The measurements then were compared with the women’s BMI measurements.

Just over 18% of the cohort had normal BMI readings but placed above the 75th percentile for body fat when measured by the scanner. Conversely, 22% of women in the lowest percentile for body fat per their DXA scan also had normal BMI weight. Twenty-three percent of women considered overweight according to their BMI fell into the normal range for DXA body fat results. All of the women in the study considered obese by BMI were in the 100th percentile using the DXA scanner.

“DXA determination of body fat percentile seems like a reasonable and probable surrogate for metabolic health that is more accurate than BMI,” Dr. Goldstein said.

“We have the equipment, it’s just a matter of updating the software,” he said.

Dr. Goldstein said he had no relevant disclosures.

[email protected]

On Twitter @whitneymcknight

NATIONAL HARBOR, MD. – If you’re one of the many physicians with an X-ray absorptiometry machine collecting dust in the nether regions of your clinic, recent findings from a small pilot study might interest you.

Dr. Steven R. Goldstein said he found that roughly 20% of postmenopausal women whose body mass index (BMI) measurement indicated they had a normal weight actually had body fat measurements greater than the 75th percentile when their body fat was assessed using a X-ray absorptiometry (DXA) scanner.

Similarly, about a fifth of postmenopausal women in the study whose BMI indicated they were in the overweight range actually had DXA scanner readings indicating their percentage of body fat placed them below the 25th percentile.

“When you have 20% in each group, that’s not a tiny number,” Dr. Goldstein said in an interview at this year’s annual meeting of the North American Menopause Society. “BMI or weight alone does not always predict metabolic health.”

BMI, a measurement first created for use by insurance actuaries by Belgian mathematician Adolphe Quetelet in the mid-1800s, has come under scrutiny across the specialties in recent years, particularly since 1998 when the Centers for Disease Control and Prevention aligned with the World Health Organization determined that the criteria for being overweight was a BMI of 25 kg/m² instead of 27.8 kg/m².

“This instantly rendered 29 million previously healthy Americans as now being overweight,” Dr. Goldstein, a professor of obstetrics and gynecology at New York (N.Y.) University Langone Medical Center, told the audience.

Additionally, as one audience member noted during the question and answer period of the presentation, many members of nonAnglo populations, such as those from Mexico and Central America, are strong, healthy endomorphs, even though their BMIs would indicate otherwise.

“Most people don’t think about the fact that BMI is 170 years old and that with it, a 25-year-old man who weighs 150 pounds and is 5 foot 8 inches, has the same BMI as a 60-year-old woman who also weighs 150 pounds,” Dr. Goldstein said in an interview. “And yet, it’s used almost as another vital sign.”

Instead, Dr. Goldstein said that data from DXA scanners could be used by insurance companies to make more accurate decisions about obesity-related medical procedures, such as bariatric surgery. Studies have shown that some adults considered normal weight have cardiovascular abnormalities, and some considered obese are metabolically healthy (Arch. Intern. Med. 2008;168:1617-24).

“Using BMI, some people are being denied bariatric surgery when they need it, but there may be other people who are having the surgery who don’t actually need it,” Dr. Goldstein said.

The scanners also have met with some darker times, especially as reimbursements for the technology primarily used to determine bone mineral density in an aging population have fluctuated over the years, leaving many physicians with thousands of dollars in equipment they no longer use for fear they will not be paid for their time.

DXA scanners use two different energy levels that are absorbed differently by bone and lean and fat tissues, then uses the differences between them to determine the amount of lean and fat tissue across the entire body.

Dr. Goldstein and his colleagues analyzed DXA data taken from 50 postmenopausal women who visited his clinic for a routine bone mass DXA scan. The scanner software was used to calculate the women’s body fat percentile according to age and sex. Women who were between the 25th and 75th percentile were considered to have “normal” body fat, whereas below the 25th percentile or above the 75th percentile was considered abnormally lean or heavy, respectively. The measurements then were compared with the women’s BMI measurements.

Just over 18% of the cohort had normal BMI readings but placed above the 75th percentile for body fat when measured by the scanner. Conversely, 22% of women in the lowest percentile for body fat per their DXA scan also had normal BMI weight. Twenty-three percent of women considered overweight according to their BMI fell into the normal range for DXA body fat results. All of the women in the study considered obese by BMI were in the 100th percentile using the DXA scanner.

“DXA determination of body fat percentile seems like a reasonable and probable surrogate for metabolic health that is more accurate than BMI,” Dr. Goldstein said.

“We have the equipment, it’s just a matter of updating the software,” he said.

Dr. Goldstein said he had no relevant disclosures.

[email protected]

On Twitter @whitneymcknight

NATIONAL HARBOR, MD. – Ospemifene, a treatment for dyspareunia in postmenopausal women, also improved other symptoms of vaginal vulvar atrophy, according to a secondary analysis of two pivotal phase III trials presented here.

Marketed as Osphena (Shionogi), ospemifene is an oral estrogen agonist/antagonist approved in 2013 by the U.S. Food and Drug Administration for use in postmenopausal women with dyspareunia.

Had the drug been approved prior to FDA guidance added in 2013, however, ospemifene’s indications might have been more inclusive.

“A lot of people will look at this indication and [think], ‘Why would you just improve dyspareunia when you’re actually working with the estrogen receptor?’ ” said Dr. Ginger Constantine, a researcher at EndoRheum in Malvern, Pa., and a presenter at this year’s annual meeting of the North American Menopause Society, whose secondary analysis of the studies indicated the drug also eases vaginal dryness, itching, irritation, and painful urination in postmenopausal women.

“One would think that you would also be improving dryness ... and that is what you do see,” she said. However, when the patient-reported most bothersome symptom experienced at baseline is considered, different endpoints are achieved, resulting in packaging inserts that don’t necessarily reflect the full scope of what the product can successfully be used to treat, according to Dr. Constantine.

The estradiol acetate vaginal ring, Femring (Actavis), which was FDA-approved in 2002, has a more general indication, based on several combined study endpoints of relief from moderate to severe menopausal symptoms, including vulvar and vaginal atrophy.

Current guidance is more specific, calling for improvement in the patient-reported most bothersome symptom at baseline, as rated on a scale of 0-3, with 2 being moderate and 3 being severe. Dr. Constantine said this has led to controversy because women often have more than one symptom. “A patient might score a 3 for vaginal dryness and a 2 for dyspareunia, but she may not be so worried about her vaginal dryness,” Dr. Constantine said. “It’s her dyspareunia that’s more problematic [for her].”

Factoring in only the most bothersome symptom could impair investigators’ ability to detect statistical significance, and the result of predicating a product’s indication on the most bothersome symptom as part of a study’s construct has the potential to confuse both the clinician and the patient. “Most [postmenopausal] women have vaginal dryness, and now we’re asking them to tell us what ‘really’ bothers them, and they have to flip a coin,” Dr. Constantine said in response to an audience member’s question about whether the FDA’s labeling was too restrictive.

For the analysis, Dr. Constantine and her associates reviewed data from a 12-week, double-blind, pivotal phase III study of 826 postmenopausal women randomly assigned to either 30 mg of daily oral ospemifene, 60 mg daily of the study drug, or placebo.

Although 544 women across the study reported more than one symptom at baseline, the study’s endpoint was improvement in the most bothersome symptom. At baseline, a third of all participants reported experiencing vaginal dryness; 43% reported dyspareunia; and nearly a fifth reported vaginal itching and irritation. However, the No. 1 most bothersome symptom was dyspareunia, with nearly half, 45%, of all women reporting it as their chief complaint.

By the study’s end, the severity scores for the 120 women who’d reported dyspareunia as their most bothersome symptom were significantly improved from baseline (P = .023).

When dryness was assessed either with or without the consideration of a most bothersome symptom, then significant improvements were found (P = .001 and P = .021, respectively).

In a second pivotal, double-blind, phase III study reviewed by Dr. Constantine and her coinvestigators, 919 postmenopausal women were randomly assigned to 60 mg of daily oral ospemifene or placebo for 12 weeks, and were stratified according to the most bothersome symptom of either dyspareunia or dryness.

When compared with placebo, an improvement in dryness as the most bothersome symptom was not statistically significant (P = .0803), although an improvement from baseline in moderate to severe dryness was (P < .001).

Because the endpoints in both studies were improvement in the most bothersome symptom, the treatment was given the indication for dyspareunia only. As to why the statistical significance for dryness was diminished, Dr. Constantine said that because the women studied were allowed to use lubricants, which meant “the dryness really did get better,” it could have interfered with the results.

Compared with placebo, dyspareunia was significantly improved both as a moderate to severe symptom at baseline, and as the most bothersome symptom (P = .0003 and P < .0001, respectively).

Other symptoms such as irritation, itching, and painful urination also were improved, but did not achieve statistical significance in either study.

Given the data seen in this context, Dr. Constantine concluded that ospemifene’s limited indication was predicated more on study constructs than on failure to provide relief from other moderate to severe symptoms.

Dr. Constantine is a paid consultant and board member for Shionogi, the maker of Osphena.

[email protected]

On Twitter @whitneymcknight

NATIONAL HARBOR, MD. – Ospemifene, a treatment for dyspareunia in postmenopausal women, also improved other symptoms of vaginal vulvar atrophy, according to a secondary analysis of two pivotal phase III trials presented here.

Marketed as Osphena (Shionogi), ospemifene is an oral estrogen agonist/antagonist approved in 2013 by the U.S. Food and Drug Administration for use in postmenopausal women with dyspareunia.

Had the drug been approved prior to FDA guidance added in 2013, however, ospemifene’s indications might have been more inclusive.

“A lot of people will look at this indication and [think], ‘Why would you just improve dyspareunia when you’re actually working with the estrogen receptor?’ ” said Dr. Ginger Constantine, a researcher at EndoRheum in Malvern, Pa., and a presenter at this year’s annual meeting of the North American Menopause Society, whose secondary analysis of the studies indicated the drug also eases vaginal dryness, itching, irritation, and painful urination in postmenopausal women.

“One would think that you would also be improving dryness ... and that is what you do see,” she said. However, when the patient-reported most bothersome symptom experienced at baseline is considered, different endpoints are achieved, resulting in packaging inserts that don’t necessarily reflect the full scope of what the product can successfully be used to treat, according to Dr. Constantine.

The estradiol acetate vaginal ring, Femring (Actavis), which was FDA-approved in 2002, has a more general indication, based on several combined study endpoints of relief from moderate to severe menopausal symptoms, including vulvar and vaginal atrophy.

Current guidance is more specific, calling for improvement in the patient-reported most bothersome symptom at baseline, as rated on a scale of 0-3, with 2 being moderate and 3 being severe. Dr. Constantine said this has led to controversy because women often have more than one symptom. “A patient might score a 3 for vaginal dryness and a 2 for dyspareunia, but she may not be so worried about her vaginal dryness,” Dr. Constantine said. “It’s her dyspareunia that’s more problematic [for her].”

Factoring in only the most bothersome symptom could impair investigators’ ability to detect statistical significance, and the result of predicating a product’s indication on the most bothersome symptom as part of a study’s construct has the potential to confuse both the clinician and the patient. “Most [postmenopausal] women have vaginal dryness, and now we’re asking them to tell us what ‘really’ bothers them, and they have to flip a coin,” Dr. Constantine said in response to an audience member’s question about whether the FDA’s labeling was too restrictive.

For the analysis, Dr. Constantine and her associates reviewed data from a 12-week, double-blind, pivotal phase III study of 826 postmenopausal women randomly assigned to either 30 mg of daily oral ospemifene, 60 mg daily of the study drug, or placebo.

Although 544 women across the study reported more than one symptom at baseline, the study’s endpoint was improvement in the most bothersome symptom. At baseline, a third of all participants reported experiencing vaginal dryness; 43% reported dyspareunia; and nearly a fifth reported vaginal itching and irritation. However, the No. 1 most bothersome symptom was dyspareunia, with nearly half, 45%, of all women reporting it as their chief complaint.

By the study’s end, the severity scores for the 120 women who’d reported dyspareunia as their most bothersome symptom were significantly improved from baseline (P = .023).

When dryness was assessed either with or without the consideration of a most bothersome symptom, then significant improvements were found (P = .001 and P = .021, respectively).

In a second pivotal, double-blind, phase III study reviewed by Dr. Constantine and her coinvestigators, 919 postmenopausal women were randomly assigned to 60 mg of daily oral ospemifene or placebo for 12 weeks, and were stratified according to the most bothersome symptom of either dyspareunia or dryness.

When compared with placebo, an improvement in dryness as the most bothersome symptom was not statistically significant (P = .0803), although an improvement from baseline in moderate to severe dryness was (P < .001).

Because the endpoints in both studies were improvement in the most bothersome symptom, the treatment was given the indication for dyspareunia only. As to why the statistical significance for dryness was diminished, Dr. Constantine said that because the women studied were allowed to use lubricants, which meant “the dryness really did get better,” it could have interfered with the results.

Compared with placebo, dyspareunia was significantly improved both as a moderate to severe symptom at baseline, and as the most bothersome symptom (P = .0003 and P < .0001, respectively).

Other symptoms such as irritation, itching, and painful urination also were improved, but did not achieve statistical significance in either study.

Given the data seen in this context, Dr. Constantine concluded that ospemifene’s limited indication was predicated more on study constructs than on failure to provide relief from other moderate to severe symptoms.

Dr. Constantine is a paid consultant and board member for Shionogi, the maker of Osphena.

[email protected]

On Twitter @whitneymcknight

NATIONAL HARBOR, MD. – Ospemifene, a treatment for dyspareunia in postmenopausal women, also improved other symptoms of vaginal vulvar atrophy, according to a secondary analysis of two pivotal phase III trials presented here.

Marketed as Osphena (Shionogi), ospemifene is an oral estrogen agonist/antagonist approved in 2013 by the U.S. Food and Drug Administration for use in postmenopausal women with dyspareunia.

Had the drug been approved prior to FDA guidance added in 2013, however, ospemifene’s indications might have been more inclusive.

“A lot of people will look at this indication and [think], ‘Why would you just improve dyspareunia when you’re actually working with the estrogen receptor?’ ” said Dr. Ginger Constantine, a researcher at EndoRheum in Malvern, Pa., and a presenter at this year’s annual meeting of the North American Menopause Society, whose secondary analysis of the studies indicated the drug also eases vaginal dryness, itching, irritation, and painful urination in postmenopausal women.

“One would think that you would also be improving dryness ... and that is what you do see,” she said. However, when the patient-reported most bothersome symptom experienced at baseline is considered, different endpoints are achieved, resulting in packaging inserts that don’t necessarily reflect the full scope of what the product can successfully be used to treat, according to Dr. Constantine.

The estradiol acetate vaginal ring, Femring (Actavis), which was FDA-approved in 2002, has a more general indication, based on several combined study endpoints of relief from moderate to severe menopausal symptoms, including vulvar and vaginal atrophy.

Current guidance is more specific, calling for improvement in the patient-reported most bothersome symptom at baseline, as rated on a scale of 0-3, with 2 being moderate and 3 being severe. Dr. Constantine said this has led to controversy because women often have more than one symptom. “A patient might score a 3 for vaginal dryness and a 2 for dyspareunia, but she may not be so worried about her vaginal dryness,” Dr. Constantine said. “It’s her dyspareunia that’s more problematic [for her].”

Factoring in only the most bothersome symptom could impair investigators’ ability to detect statistical significance, and the result of predicating a product’s indication on the most bothersome symptom as part of a study’s construct has the potential to confuse both the clinician and the patient. “Most [postmenopausal] women have vaginal dryness, and now we’re asking them to tell us what ‘really’ bothers them, and they have to flip a coin,” Dr. Constantine said in response to an audience member’s question about whether the FDA’s labeling was too restrictive.

For the analysis, Dr. Constantine and her associates reviewed data from a 12-week, double-blind, pivotal phase III study of 826 postmenopausal women randomly assigned to either 30 mg of daily oral ospemifene, 60 mg daily of the study drug, or placebo.

Although 544 women across the study reported more than one symptom at baseline, the study’s endpoint was improvement in the most bothersome symptom. At baseline, a third of all participants reported experiencing vaginal dryness; 43% reported dyspareunia; and nearly a fifth reported vaginal itching and irritation. However, the No. 1 most bothersome symptom was dyspareunia, with nearly half, 45%, of all women reporting it as their chief complaint.

By the study’s end, the severity scores for the 120 women who’d reported dyspareunia as their most bothersome symptom were significantly improved from baseline (P = .023).

When dryness was assessed either with or without the consideration of a most bothersome symptom, then significant improvements were found (P = .001 and P = .021, respectively).

In a second pivotal, double-blind, phase III study reviewed by Dr. Constantine and her coinvestigators, 919 postmenopausal women were randomly assigned to 60 mg of daily oral ospemifene or placebo for 12 weeks, and were stratified according to the most bothersome symptom of either dyspareunia or dryness.

When compared with placebo, an improvement in dryness as the most bothersome symptom was not statistically significant (P = .0803), although an improvement from baseline in moderate to severe dryness was (P < .001).

Because the endpoints in both studies were improvement in the most bothersome symptom, the treatment was given the indication for dyspareunia only. As to why the statistical significance for dryness was diminished, Dr. Constantine said that because the women studied were allowed to use lubricants, which meant “the dryness really did get better,” it could have interfered with the results.

Compared with placebo, dyspareunia was significantly improved both as a moderate to severe symptom at baseline, and as the most bothersome symptom (P = .0003 and P < .0001, respectively).

Other symptoms such as irritation, itching, and painful urination also were improved, but did not achieve statistical significance in either study.

Given the data seen in this context, Dr. Constantine concluded that ospemifene’s limited indication was predicated more on study constructs than on failure to provide relief from other moderate to severe symptoms.

Dr. Constantine is a paid consultant and board member for Shionogi, the maker of Osphena.

[email protected]

On Twitter @whitneymcknight

NATIONAL HARBOR, MD. – Soy isoflavones are safe for postmenopausal women to take long term, having no treatment effect on endometrial thickness, reproductive hormones, or thyroid function, the results of a 3-year study have shown.

Despite previous reports that soy isoflavones have deleterious effects, they still are often used by postmenopausal women as an alternative to hormone therapy, according to study author, D. Lee Alekel, Ph.D., program director of women’s health at the National Center for Complementary and Alternative Medicine at the National Institutes of Health.

©BananaStock/thinkstockphotos.com

“It behooves us to examine the safety-related outcomes and rates of any adverse events in women consuming over-the-counter soy isoflavone supplements, which could be 100 mg of isoflavones a day or more,” Dr. Alekel said at the annual meeting of the North American Menopause Society. “That’s five times the intake from typical Asian diets, so it’s quite a bit more.”

The findings are from the dual-site, double-blind, placebo-controlled Soy Isoflavones for Reducing Bone Loss (SIRBL) study of women randomly assigned to placebo, or either 80 mg or 120 mg of daily soy isoflavones. No treatment effects on endometrial thickness or circulating hormone concentrations, including thyroid function, were detected using transvaginal ultrasound in any of the study groups (Menopause 2014 [doi: 10.1097/GME.0000000000000280]).

All women in the study were between 48 and 65 years of age at the time of enrollment, had experienced natural onset of menopause, did not smoke, agreed to avoid soy-based foods for the duration of the study, and maintained a healthy weight. The investigators also took into account lactation duration, and excluded from the study any women using hormone therapy or chronic medication. All participants had to have an annual physical, mammogram, gynecologic exam, and breast exam performed by their own physicians in order to remain in the study.

After losing 12% to follow-up, 224 women remained in the intent-to-treat analysis, and 208 women who were compliant with their assigned treatment fully completed the study.

Assessments done at 6, 12, 18, 24, and 36 months showed declines in median endometrial thickness in all three treatment groups: from 1.5 to 1.1 mm at the Iowa site, and from 2.6 to 1.9 mm at the California site. Neither the 80 mg nor the 120 mg dose were found to have a treatment effect (P = .57 and P = 0.43, respectively).

Adverse event rates varied by site, but not treatment arms: a higher rate of upper respiratory tract infections was noted in women studied in Iowa, compared with women enrolled at the second site in southern California (P ≤ .0001). The investigators theorized this difference was due to Iowa having longer, harsher winters. The 80-mg arm had more genitourinary issues (P = .005), primarily urinary tract infections, than did the 120-mg group.

Previous studies also have suggested soy isoflavones have no adverse effect on the endometrium, regardless of the form or dose of isoflavone; however, one study cited by Dr. Alekel “did show that 150 mg of soy taken per day for up to 5 years increased endometrial hyperplasia about 4%, but there was no endometrial carcinoma detected” (Fertil. Steril. 2004 Jul;82:145-8).

[email protected]

On Twitter @whitneymcknight

NATIONAL HARBOR, MD. – Soy isoflavones are safe for postmenopausal women to take long term, having no treatment effect on endometrial thickness, reproductive hormones, or thyroid function, the results of a 3-year study have shown.

Despite previous reports that soy isoflavones have deleterious effects, they still are often used by postmenopausal women as an alternative to hormone therapy, according to study author, D. Lee Alekel, Ph.D., program director of women’s health at the National Center for Complementary and Alternative Medicine at the National Institutes of Health.

©BananaStock/thinkstockphotos.com

“It behooves us to examine the safety-related outcomes and rates of any adverse events in women consuming over-the-counter soy isoflavone supplements, which could be 100 mg of isoflavones a day or more,” Dr. Alekel said at the annual meeting of the North American Menopause Society. “That’s five times the intake from typical Asian diets, so it’s quite a bit more.”

The findings are from the dual-site, double-blind, placebo-controlled Soy Isoflavones for Reducing Bone Loss (SIRBL) study of women randomly assigned to placebo, or either 80 mg or 120 mg of daily soy isoflavones. No treatment effects on endometrial thickness or circulating hormone concentrations, including thyroid function, were detected using transvaginal ultrasound in any of the study groups (Menopause 2014 [doi: 10.1097/GME.0000000000000280]).

All women in the study were between 48 and 65 years of age at the time of enrollment, had experienced natural onset of menopause, did not smoke, agreed to avoid soy-based foods for the duration of the study, and maintained a healthy weight. The investigators also took into account lactation duration, and excluded from the study any women using hormone therapy or chronic medication. All participants had to have an annual physical, mammogram, gynecologic exam, and breast exam performed by their own physicians in order to remain in the study.

After losing 12% to follow-up, 224 women remained in the intent-to-treat analysis, and 208 women who were compliant with their assigned treatment fully completed the study.

Assessments done at 6, 12, 18, 24, and 36 months showed declines in median endometrial thickness in all three treatment groups: from 1.5 to 1.1 mm at the Iowa site, and from 2.6 to 1.9 mm at the California site. Neither the 80 mg nor the 120 mg dose were found to have a treatment effect (P = .57 and P = 0.43, respectively).

Adverse event rates varied by site, but not treatment arms: a higher rate of upper respiratory tract infections was noted in women studied in Iowa, compared with women enrolled at the second site in southern California (P ≤ .0001). The investigators theorized this difference was due to Iowa having longer, harsher winters. The 80-mg arm had more genitourinary issues (P = .005), primarily urinary tract infections, than did the 120-mg group.

Previous studies also have suggested soy isoflavones have no adverse effect on the endometrium, regardless of the form or dose of isoflavone; however, one study cited by Dr. Alekel “did show that 150 mg of soy taken per day for up to 5 years increased endometrial hyperplasia about 4%, but there was no endometrial carcinoma detected” (Fertil. Steril. 2004 Jul;82:145-8).

[email protected]

On Twitter @whitneymcknight

NATIONAL HARBOR, MD. – Soy isoflavones are safe for postmenopausal women to take long term, having no treatment effect on endometrial thickness, reproductive hormones, or thyroid function, the results of a 3-year study have shown.

Despite previous reports that soy isoflavones have deleterious effects, they still are often used by postmenopausal women as an alternative to hormone therapy, according to study author, D. Lee Alekel, Ph.D., program director of women’s health at the National Center for Complementary and Alternative Medicine at the National Institutes of Health.

©BananaStock/thinkstockphotos.com

“It behooves us to examine the safety-related outcomes and rates of any adverse events in women consuming over-the-counter soy isoflavone supplements, which could be 100 mg of isoflavones a day or more,” Dr. Alekel said at the annual meeting of the North American Menopause Society. “That’s five times the intake from typical Asian diets, so it’s quite a bit more.”

The findings are from the dual-site, double-blind, placebo-controlled Soy Isoflavones for Reducing Bone Loss (SIRBL) study of women randomly assigned to placebo, or either 80 mg or 120 mg of daily soy isoflavones. No treatment effects on endometrial thickness or circulating hormone concentrations, including thyroid function, were detected using transvaginal ultrasound in any of the study groups (Menopause 2014 [doi: 10.1097/GME.0000000000000280]).

All women in the study were between 48 and 65 years of age at the time of enrollment, had experienced natural onset of menopause, did not smoke, agreed to avoid soy-based foods for the duration of the study, and maintained a healthy weight. The investigators also took into account lactation duration, and excluded from the study any women using hormone therapy or chronic medication. All participants had to have an annual physical, mammogram, gynecologic exam, and breast exam performed by their own physicians in order to remain in the study.

After losing 12% to follow-up, 224 women remained in the intent-to-treat analysis, and 208 women who were compliant with their assigned treatment fully completed the study.

Assessments done at 6, 12, 18, 24, and 36 months showed declines in median endometrial thickness in all three treatment groups: from 1.5 to 1.1 mm at the Iowa site, and from 2.6 to 1.9 mm at the California site. Neither the 80 mg nor the 120 mg dose were found to have a treatment effect (P = .57 and P = 0.43, respectively).

Adverse event rates varied by site, but not treatment arms: a higher rate of upper respiratory tract infections was noted in women studied in Iowa, compared with women enrolled at the second site in southern California (P ≤ .0001). The investigators theorized this difference was due to Iowa having longer, harsher winters. The 80-mg arm had more genitourinary issues (P = .005), primarily urinary tract infections, than did the 120-mg group.

Previous studies also have suggested soy isoflavones have no adverse effect on the endometrium, regardless of the form or dose of isoflavone; however, one study cited by Dr. Alekel “did show that 150 mg of soy taken per day for up to 5 years increased endometrial hyperplasia about 4%, but there was no endometrial carcinoma detected” (Fertil. Steril. 2004 Jul;82:145-8).

[email protected]

On Twitter @whitneymcknight

NATIONAL HARBOR, MD. – Relizen, a nonhormonal purified pollen extract with demonstrated efficacy in treating vasomotor symptoms of menopause, had negligible effects on the CYP2D6 enzyme at five times the recommended daily dose, according to a poster presentation.

Because tamoxifen is metabolized into endoxifen, the active metabolite in the CYP2D6 enzyme, the findings could mean women with severe hot flashes who are taking tamoxifen now have a viable treatment option that won’t increase their risk of death from breast cancer.

“Tamoxifen creates some of the worst hot flashes we will ever see,” Dr. Steven R. Goldstein, professor of obstetrics and gynecology at New York University, said in an interview at this year’s annual meeting of the North American Menopause Society. Even so, because systemic estrogen is contraindicated in women using either tamoxifen or raloxifene for the treatment or chemoprevention of breast cancer, and questions remain about the safety of phytoestrogens, many of these women forgo the commonly prescribed estrogen-based treatments for menopausal symptoms.

Instead, some physicians will prescribe off-label low doses of antidepressants to treat vasomotor symptoms in this patient population. However, a 2010 population-based cohort study of 2,430 Canadian women taking tamoxifen concurrently with an SSRI showed that the risk of death from breast cancer increased 24%-91% in those taking paroxetine in particular, depending on the increasing overlap of tamoxifen treatment and antidepressant use (BMJ 2010;340:c693 [doi:10.1136/bmj.c693]). Last year, the Food and Drug Administration approved the vasomotor symptoms of menopause as an indication for the SSRI paroxetine (Paxil, Brisdelle), but required Noven, the drug’s manufacturer, to state paroxetine’s countering effect on tamoxifen’s efficacy.

Until now, according to Dr. Goldstein, fears over estrogen and SSRI’s potential ill-effects have meant that many women have chosen to “tough it out” when it comes to hot flashes, night sweats, and other symptoms.

The importance of his study, he said, is that because Relizen (Sérélyspharma, France), a powdered, pollen cytoplasmic extract harvested in southern Sweden, doesn’t affect the CYP enzyme system, it’s safe to give to tamoxifen patients. “It is the only nonpharmacologic product that I have ever been aware of that has a double-blind, randomized, placebo-controlled, parallel study showing that it reduces vasomotor symptoms and improves quality of life in menopausal women,” Dr. Goldstein said.

In an in vitro study of Relizen’s effect on the isoenzyme CYP2D6 in pooled human liver microsomes, Dr. Goldstein and his colleagues tested the supplement against quinidine, a known CYP2D6 inhibitor. The end point was the conversion of bufuralol to 1-OH-bufuralol in the CYP enzyme system. Six concentrations of each compound were tested, with all reactions being performed in triplicate. The Relizen concentrations ranged from 1.65 mcg/mL to 400 mcg/mL, five times the Relizen recommended daily dose of 80 mcg/mL. The quinidine concentrations ranged from 2.06 nM to 500 nM.

The study compound’s inhibition of CYP2D6 was negligible, ranging from –6.53% to 10.67%, compared with quinidine’s CYP2D6 linear dose-related increase from –7.07% at 2.06 nM to 84.05% at 500 nM.

Relizen’s apparent clinical utility in women at high risk of death from breast cancer is the “low-hanging fruit,” Dr. Goldstein said. “The tamoxifen patient has no other place to go. But if a woman is 51 years old and she comes to me and says she has hot flashes, now I have multiple options. I can give her hormones, I can give her 7.5 mg of paroxetine, or I can give her Relizen. This is just another arrow in my quiver.”

In the placebo-controlled study of Relizen, 65% of the active treatment group of 32 peri- and postmenopausal women reported decreased vasomotor symptoms by the end of the 12 week trial, compared with 38% of the placebo group (Climacteric 2005; 8:162-70).

“I know [Relizen] is effective, and it’s tested against placebo,” Dr. Goldstein said. “But is it as strong as estrogen? I have no clue. A head-to-head trial is not going to happen.”

Relizen has been widely available in Europe under a variety of names, including Femal, since 1999, and has had no reported adverse effects, according to the manufacturer. JDS Pharmaceuticals (Noven) began distributing the supplement in the United States earlier this year.

Dr. Goldstein is a paid consultant for JDS Pharmaceuticals, a division of Noven. The study was sponsored by the supplement manufacturer, Sérélyspharma(France). JDS Pharmaceuticals (Noven) is the licensed distributor of Relizen in the United States.

NATIONAL HARBOR, MD. – Relizen, a nonhormonal purified pollen extract with demonstrated efficacy in treating vasomotor symptoms of menopause, had negligible effects on the CYP2D6 enzyme at five times the recommended daily dose, according to a poster presentation.

Because tamoxifen is metabolized into endoxifen, the active metabolite in the CYP2D6 enzyme, the findings could mean women with severe hot flashes who are taking tamoxifen now have a viable treatment option that won’t increase their risk of death from breast cancer.

“Tamoxifen creates some of the worst hot flashes we will ever see,” Dr. Steven R. Goldstein, professor of obstetrics and gynecology at New York University, said in an interview at this year’s annual meeting of the North American Menopause Society. Even so, because systemic estrogen is contraindicated in women using either tamoxifen or raloxifene for the treatment or chemoprevention of breast cancer, and questions remain about the safety of phytoestrogens, many of these women forgo the commonly prescribed estrogen-based treatments for menopausal symptoms.

Instead, some physicians will prescribe off-label low doses of antidepressants to treat vasomotor symptoms in this patient population. However, a 2010 population-based cohort study of 2,430 Canadian women taking tamoxifen concurrently with an SSRI showed that the risk of death from breast cancer increased 24%-91% in those taking paroxetine in particular, depending on the increasing overlap of tamoxifen treatment and antidepressant use (BMJ 2010;340:c693 [doi:10.1136/bmj.c693]). Last year, the Food and Drug Administration approved the vasomotor symptoms of menopause as an indication for the SSRI paroxetine (Paxil, Brisdelle), but required Noven, the drug’s manufacturer, to state paroxetine’s countering effect on tamoxifen’s efficacy.

Until now, according to Dr. Goldstein, fears over estrogen and SSRI’s potential ill-effects have meant that many women have chosen to “tough it out” when it comes to hot flashes, night sweats, and other symptoms.

The importance of his study, he said, is that because Relizen (Sérélyspharma, France), a powdered, pollen cytoplasmic extract harvested in southern Sweden, doesn’t affect the CYP enzyme system, it’s safe to give to tamoxifen patients. “It is the only nonpharmacologic product that I have ever been aware of that has a double-blind, randomized, placebo-controlled, parallel study showing that it reduces vasomotor symptoms and improves quality of life in menopausal women,” Dr. Goldstein said.

In an in vitro study of Relizen’s effect on the isoenzyme CYP2D6 in pooled human liver microsomes, Dr. Goldstein and his colleagues tested the supplement against quinidine, a known CYP2D6 inhibitor. The end point was the conversion of bufuralol to 1-OH-bufuralol in the CYP enzyme system. Six concentrations of each compound were tested, with all reactions being performed in triplicate. The Relizen concentrations ranged from 1.65 mcg/mL to 400 mcg/mL, five times the Relizen recommended daily dose of 80 mcg/mL. The quinidine concentrations ranged from 2.06 nM to 500 nM.

The study compound’s inhibition of CYP2D6 was negligible, ranging from –6.53% to 10.67%, compared with quinidine’s CYP2D6 linear dose-related increase from –7.07% at 2.06 nM to 84.05% at 500 nM.

Relizen’s apparent clinical utility in women at high risk of death from breast cancer is the “low-hanging fruit,” Dr. Goldstein said. “The tamoxifen patient has no other place to go. But if a woman is 51 years old and she comes to me and says she has hot flashes, now I have multiple options. I can give her hormones, I can give her 7.5 mg of paroxetine, or I can give her Relizen. This is just another arrow in my quiver.”

In the placebo-controlled study of Relizen, 65% of the active treatment group of 32 peri- and postmenopausal women reported decreased vasomotor symptoms by the end of the 12 week trial, compared with 38% of the placebo group (Climacteric 2005; 8:162-70).

“I know [Relizen] is effective, and it’s tested against placebo,” Dr. Goldstein said. “But is it as strong as estrogen? I have no clue. A head-to-head trial is not going to happen.”

Relizen has been widely available in Europe under a variety of names, including Femal, since 1999, and has had no reported adverse effects, according to the manufacturer. JDS Pharmaceuticals (Noven) began distributing the supplement in the United States earlier this year.

Dr. Goldstein is a paid consultant for JDS Pharmaceuticals, a division of Noven. The study was sponsored by the supplement manufacturer, Sérélyspharma(France). JDS Pharmaceuticals (Noven) is the licensed distributor of Relizen in the United States.

NATIONAL HARBOR, MD. – Relizen, a nonhormonal purified pollen extract with demonstrated efficacy in treating vasomotor symptoms of menopause, had negligible effects on the CYP2D6 enzyme at five times the recommended daily dose, according to a poster presentation.

Because tamoxifen is metabolized into endoxifen, the active metabolite in the CYP2D6 enzyme, the findings could mean women with severe hot flashes who are taking tamoxifen now have a viable treatment option that won’t increase their risk of death from breast cancer.

“Tamoxifen creates some of the worst hot flashes we will ever see,” Dr. Steven R. Goldstein, professor of obstetrics and gynecology at New York University, said in an interview at this year’s annual meeting of the North American Menopause Society. Even so, because systemic estrogen is contraindicated in women using either tamoxifen or raloxifene for the treatment or chemoprevention of breast cancer, and questions remain about the safety of phytoestrogens, many of these women forgo the commonly prescribed estrogen-based treatments for menopausal symptoms.

Instead, some physicians will prescribe off-label low doses of antidepressants to treat vasomotor symptoms in this patient population. However, a 2010 population-based cohort study of 2,430 Canadian women taking tamoxifen concurrently with an SSRI showed that the risk of death from breast cancer increased 24%-91% in those taking paroxetine in particular, depending on the increasing overlap of tamoxifen treatment and antidepressant use (BMJ 2010;340:c693 [doi:10.1136/bmj.c693]). Last year, the Food and Drug Administration approved the vasomotor symptoms of menopause as an indication for the SSRI paroxetine (Paxil, Brisdelle), but required Noven, the drug’s manufacturer, to state paroxetine’s countering effect on tamoxifen’s efficacy.

Until now, according to Dr. Goldstein, fears over estrogen and SSRI’s potential ill-effects have meant that many women have chosen to “tough it out” when it comes to hot flashes, night sweats, and other symptoms.

The importance of his study, he said, is that because Relizen (Sérélyspharma, France), a powdered, pollen cytoplasmic extract harvested in southern Sweden, doesn’t affect the CYP enzyme system, it’s safe to give to tamoxifen patients. “It is the only nonpharmacologic product that I have ever been aware of that has a double-blind, randomized, placebo-controlled, parallel study showing that it reduces vasomotor symptoms and improves quality of life in menopausal women,” Dr. Goldstein said.

In an in vitro study of Relizen’s effect on the isoenzyme CYP2D6 in pooled human liver microsomes, Dr. Goldstein and his colleagues tested the supplement against quinidine, a known CYP2D6 inhibitor. The end point was the conversion of bufuralol to 1-OH-bufuralol in the CYP enzyme system. Six concentrations of each compound were tested, with all reactions being performed in triplicate. The Relizen concentrations ranged from 1.65 mcg/mL to 400 mcg/mL, five times the Relizen recommended daily dose of 80 mcg/mL. The quinidine concentrations ranged from 2.06 nM to 500 nM.

The study compound’s inhibition of CYP2D6 was negligible, ranging from –6.53% to 10.67%, compared with quinidine’s CYP2D6 linear dose-related increase from –7.07% at 2.06 nM to 84.05% at 500 nM.

Relizen’s apparent clinical utility in women at high risk of death from breast cancer is the “low-hanging fruit,” Dr. Goldstein said. “The tamoxifen patient has no other place to go. But if a woman is 51 years old and she comes to me and says she has hot flashes, now I have multiple options. I can give her hormones, I can give her 7.5 mg of paroxetine, or I can give her Relizen. This is just another arrow in my quiver.”

In the placebo-controlled study of Relizen, 65% of the active treatment group of 32 peri- and postmenopausal women reported decreased vasomotor symptoms by the end of the 12 week trial, compared with 38% of the placebo group (Climacteric 2005; 8:162-70).

“I know [Relizen] is effective, and it’s tested against placebo,” Dr. Goldstein said. “But is it as strong as estrogen? I have no clue. A head-to-head trial is not going to happen.”

Relizen has been widely available in Europe under a variety of names, including Femal, since 1999, and has had no reported adverse effects, according to the manufacturer. JDS Pharmaceuticals (Noven) began distributing the supplement in the United States earlier this year.

Dr. Goldstein is a paid consultant for JDS Pharmaceuticals, a division of Noven. The study was sponsored by the supplement manufacturer, Sérélyspharma(France). JDS Pharmaceuticals (Noven) is the licensed distributor of Relizen in the United States.

NATIONAL HARBOR, MD. – Relizen, a nonhormonal purified pollen extract with demonstrated efficacy in treating vasomotor symptoms of menopause, had negligible effects on the CYP2D6 enzyme at five times the recommended daily dose, according to a poster presentation.

Because tamoxifen is metabolized into endoxifen, the active metabolite in the CYP2D6 enzyme, the findings could mean women with severe hot flashes who are taking tamoxifen now have a viable treatment option that won’t increase their risk of death from breast cancer.

“Tamoxifen creates some of the worst hot flashes we will ever see,” Dr. Steven R. Goldstein, professor of obstetrics and gynecology at New York University, said in an interview at this year’s annual meeting of the North American Menopause Society. Even so, because systemic estrogen is contraindicated in women using either tamoxifen or raloxifene for the treatment or chemoprevention of breast cancer, and questions remain about the safety of phytoestrogens, many of these women forgo the commonly prescribed estrogen-based treatments for menopausal symptoms.

Instead, some physicians will prescribe off-label low doses of antidepressants to treat vasomotor symptoms in this patient population. However, a 2010 population-based cohort study of 2,430 Canadian women taking tamoxifen concurrently with an SSRI showed that the risk of death from breast cancer increased 24%-91% in those taking paroxetine in particular, depending on the increasing overlap of tamoxifen treatment and antidepressant use (BMJ 2010;340:c693 [doi:10.1136/bmj.c693]). Last year, the Food and Drug Administration approved the vasomotor symptoms of menopause as an indication for the SSRI paroxetine (Paxil, Brisdelle), but required Noven, the drug’s manufacturer, to state paroxetine’s countering effect on tamoxifen’s efficacy.

Until now, according to Dr. Goldstein, fears over estrogen and SSRI’s potential ill-effects have meant that many women have chosen to “tough it out” when it comes to hot flashes, night sweats, and other symptoms.

The importance of his study, he said, is that because Relizen (Sérélyspharma, France), a powdered, pollen cytoplasmic extract harvested in southern Sweden, doesn’t affect the CYP enzyme system, it’s safe to give to tamoxifen patients. “It is the only nonpharmacologic product that I have ever been aware of that has a double-blind, randomized, placebo-controlled, parallel study showing that it reduces vasomotor symptoms and improves quality of life in menopausal women,” Dr. Goldstein said.

In an in vitro study of Relizen’s effect on the isoenzyme CYP2D6 in pooled human liver microsomes, Dr. Goldstein and his colleagues tested the supplement against quinidine, a known CYP2D6 inhibitor. The end point was the conversion of bufuralol to 1-OH-bufuralol in the CYP enzyme system. Six concentrations of each compound were tested, with all reactions being performed in triplicate. The Relizen concentrations ranged from 1.65 mcg/mL to 400 mcg/mL, five times the Relizen recommended daily dose of 80 mcg/mL. The quinidine concentrations ranged from 2.06 nM to 500 nM.

The study compound’s inhibition of CYP2D6 was negligible, ranging from –6.53% to 10.67%, compared with quinidine’s CYP2D6 linear dose-related increase from –7.07% at 2.06 nM to 84.05% at 500 nM.

Relizen’s apparent clinical utility in women at high risk of death from breast cancer is the “low-hanging fruit,” Dr. Goldstein said. “The tamoxifen patient has no other place to go. But if a woman is 51 years old and she comes to me and says she has hot flashes, now I have multiple options. I can give her hormones, I can give her 7.5 mg of paroxetine, or I can give her Relizen. This is just another arrow in my quiver.”

In the placebo-controlled study of Relizen, 65% of the active treatment group of 32 peri- and postmenopausal women reported decreased vasomotor symptoms by the end of the 12 week trial, compared with 38% of the placebo group (Climacteric 2005; 8:162-70).

“I know [Relizen] is effective, and it’s tested against placebo,” Dr. Goldstein said. “But is it as strong as estrogen? I have no clue. A head-to-head trial is not going to happen.”

Relizen has been widely available in Europe under a variety of names, including Femal, since 1999, and has had no reported adverse effects, according to the manufacturer. JDS Pharmaceuticals (Noven) began distributing the supplement in the United States earlier this year.

Dr. Goldstein is a paid consultant for JDS Pharmaceuticals, a division of Noven. The study was sponsored by the supplement manufacturer, Sérélyspharma(France). JDS Pharmaceuticals (Noven) is the licensed distributor of Relizen in the United States.

[email protected]

On Twitter @whitneymcknight

NATIONAL HARBOR, MD. – Relizen, a nonhormonal purified pollen extract with demonstrated efficacy in treating vasomotor symptoms of menopause, had negligible effects on the CYP2D6 enzyme at five times the recommended daily dose, according to a poster presentation.

Because tamoxifen is metabolized into endoxifen, the active metabolite in the CYP2D6 enzyme, the findings could mean women with severe hot flashes who are taking tamoxifen now have a viable treatment option that won’t increase their risk of death from breast cancer.

“Tamoxifen creates some of the worst hot flashes we will ever see,” Dr. Steven R. Goldstein, professor of obstetrics and gynecology at New York University, said in an interview at this year’s annual meeting of the North American Menopause Society. Even so, because systemic estrogen is contraindicated in women using either tamoxifen or raloxifene for the treatment or chemoprevention of breast cancer, and questions remain about the safety of phytoestrogens, many of these women forgo the commonly prescribed estrogen-based treatments for menopausal symptoms.

Instead, some physicians will prescribe off-label low doses of antidepressants to treat vasomotor symptoms in this patient population. However, a 2010 population-based cohort study of 2,430 Canadian women taking tamoxifen concurrently with an SSRI showed that the risk of death from breast cancer increased 24%-91% in those taking paroxetine in particular, depending on the increasing overlap of tamoxifen treatment and antidepressant use (BMJ 2010;340:c693 [doi:10.1136/bmj.c693]). Last year, the Food and Drug Administration approved the vasomotor symptoms of menopause as an indication for the SSRI paroxetine (Paxil, Brisdelle), but required Noven, the drug’s manufacturer, to state paroxetine’s countering effect on tamoxifen’s efficacy.

Until now, according to Dr. Goldstein, fears over estrogen and SSRI’s potential ill-effects have meant that many women have chosen to “tough it out” when it comes to hot flashes, night sweats, and other symptoms.

The importance of his study, he said, is that because Relizen (Sérélyspharma, France), a powdered, pollen cytoplasmic extract harvested in southern Sweden, doesn’t affect the CYP enzyme system, it’s safe to give to tamoxifen patients. “It is the only nonpharmacologic product that I have ever been aware of that has a double-blind, randomized, placebo-controlled, parallel study showing that it reduces vasomotor symptoms and improves quality of life in menopausal women,” Dr. Goldstein said.

In an in vitro study of Relizen’s effect on the isoenzyme CYP2D6 in pooled human liver microsomes, Dr. Goldstein and his colleagues tested the supplement against quinidine, a known CYP2D6 inhibitor. The end point was the conversion of bufuralol to 1-OH-bufuralol in the CYP enzyme system. Six concentrations of each compound were tested, with all reactions being performed in triplicate. The Relizen concentrations ranged from 1.65 mcg/mL to 400 mcg/mL, five times the Relizen recommended daily dose of 80 mcg/mL. The quinidine concentrations ranged from 2.06 nM to 500 nM.

The study compound’s inhibition of CYP2D6 was negligible, ranging from –6.53% to 10.67%, compared with quinidine’s CYP2D6 linear dose-related increase from –7.07% at 2.06 nM to 84.05% at 500 nM.

Relizen’s apparent clinical utility in women at high risk of death from breast cancer is the “low-hanging fruit,” Dr. Goldstein said. “The tamoxifen patient has no other place to go. But if a woman is 51 years old and she comes to me and says she has hot flashes, now I have multiple options. I can give her hormones, I can give her 7.5 mg of paroxetine, or I can give her Relizen. This is just another arrow in my quiver.”

In the placebo-controlled study of Relizen, 65% of the active treatment group of 32 peri- and postmenopausal women reported decreased vasomotor symptoms by the end of the 12 week trial, compared with 38% of the placebo group (Climacteric 2005; 8:162-70).

“I know [Relizen] is effective, and it’s tested against placebo,” Dr. Goldstein said. “But is it as strong as estrogen? I have no clue. A head-to-head trial is not going to happen.”

Relizen has been widely available in Europe under a variety of names, including Femal, since 1999, and has had no reported adverse effects, according to the manufacturer. JDS Pharmaceuticals (Noven) began distributing the supplement in the United States earlier this year.

Dr. Goldstein is a paid consultant for JDS Pharmaceuticals, a division of Noven. The study was sponsored by the supplement manufacturer, Sérélyspharma(France). JDS Pharmaceuticals (Noven) is the licensed distributor of Relizen in the United States.

[email protected]

On Twitter @whitneymcknight

NATIONAL HARBOR, MD. – Relizen, a nonhormonal purified pollen extract with demonstrated efficacy in treating vasomotor symptoms of menopause, had negligible effects on the CYP2D6 enzyme at five times the recommended daily dose, according to a poster presentation.

Because tamoxifen is metabolized into endoxifen, the active metabolite in the CYP2D6 enzyme, the findings could mean women with severe hot flashes who are taking tamoxifen now have a viable treatment option that won’t increase their risk of death from breast cancer.

“Tamoxifen creates some of the worst hot flashes we will ever see,” Dr. Steven R. Goldstein, professor of obstetrics and gynecology at New York University, said in an interview at this year’s annual meeting of the North American Menopause Society. Even so, because systemic estrogen is contraindicated in women using either tamoxifen or raloxifene for the treatment or chemoprevention of breast cancer, and questions remain about the safety of phytoestrogens, many of these women forgo the commonly prescribed estrogen-based treatments for menopausal symptoms.

Instead, some physicians will prescribe off-label low doses of antidepressants to treat vasomotor symptoms in this patient population. However, a 2010 population-based cohort study of 2,430 Canadian women taking tamoxifen concurrently with an SSRI showed that the risk of death from breast cancer increased 24%-91% in those taking paroxetine in particular, depending on the increasing overlap of tamoxifen treatment and antidepressant use (BMJ 2010;340:c693 [doi:10.1136/bmj.c693]). Last year, the Food and Drug Administration approved the vasomotor symptoms of menopause as an indication for the SSRI paroxetine (Paxil, Brisdelle), but required Noven, the drug’s manufacturer, to state paroxetine’s countering effect on tamoxifen’s efficacy.

Until now, according to Dr. Goldstein, fears over estrogen and SSRI’s potential ill-effects have meant that many women have chosen to “tough it out” when it comes to hot flashes, night sweats, and other symptoms.

The importance of his study, he said, is that because Relizen (Sérélyspharma, France), a powdered, pollen cytoplasmic extract harvested in southern Sweden, doesn’t affect the CYP enzyme system, it’s safe to give to tamoxifen patients. “It is the only nonpharmacologic product that I have ever been aware of that has a double-blind, randomized, placebo-controlled, parallel study showing that it reduces vasomotor symptoms and improves quality of life in menopausal women,” Dr. Goldstein said.

In an in vitro study of Relizen’s effect on the isoenzyme CYP2D6 in pooled human liver microsomes, Dr. Goldstein and his colleagues tested the supplement against quinidine, a known CYP2D6 inhibitor. The end point was the conversion of bufuralol to 1-OH-bufuralol in the CYP enzyme system. Six concentrations of each compound were tested, with all reactions being performed in triplicate. The Relizen concentrations ranged from 1.65 mcg/mL to 400 mcg/mL, five times the Relizen recommended daily dose of 80 mcg/mL. The quinidine concentrations ranged from 2.06 nM to 500 nM.

The study compound’s inhibition of CYP2D6 was negligible, ranging from –6.53% to 10.67%, compared with quinidine’s CYP2D6 linear dose-related increase from –7.07% at 2.06 nM to 84.05% at 500 nM.

Relizen’s apparent clinical utility in women at high risk of death from breast cancer is the “low-hanging fruit,” Dr. Goldstein said. “The tamoxifen patient has no other place to go. But if a woman is 51 years old and she comes to me and says she has hot flashes, now I have multiple options. I can give her hormones, I can give her 7.5 mg of paroxetine, or I can give her Relizen. This is just another arrow in my quiver.”

In the placebo-controlled study of Relizen, 65% of the active treatment group of 32 peri- and postmenopausal women reported decreased vasomotor symptoms by the end of the 12 week trial, compared with 38% of the placebo group (Climacteric 2005; 8:162-70).

“I know [Relizen] is effective, and it’s tested against placebo,” Dr. Goldstein said. “But is it as strong as estrogen? I have no clue. A head-to-head trial is not going to happen.”

Relizen has been widely available in Europe under a variety of names, including Femal, since 1999, and has had no reported adverse effects, according to the manufacturer. JDS Pharmaceuticals (Noven) began distributing the supplement in the United States earlier this year.

Dr. Goldstein is a paid consultant for JDS Pharmaceuticals, a division of Noven. The study was sponsored by the supplement manufacturer, Sérélyspharma(France). JDS Pharmaceuticals (Noven) is the licensed distributor of Relizen in the United States.

[email protected]

On Twitter @whitneymcknight

NATIONAL HARBOR, MD. – Menopausal women who experience vaginal dryness often find the resultant pain of sexual intercourse so prohibitive that, according to Dr. JoAnne Pinkerton, often these women go months or years without intimate relations.

There are many treatment options that can benefit patients with the condition, explained Dr. Pinkerton, medical director of the Midlife Health Center at the University of Virginia, Charlottesville, but physicians aren’t always aware of what’s available.

In a video interview at annual meeting of the North American Menopause Society, Dr. Pinkerton discussed the range of therapies physicians can offer menopausal patients with vaginal dryness.

[email protected]

On Twitter @whitneymcknight

NATIONAL HARBOR, MD. – Menopausal women who experience vaginal dryness often find the resultant pain of sexual intercourse so prohibitive that, according to Dr. JoAnne Pinkerton, often these women go months or years without intimate relations.

There are many treatment options that can benefit patients with the condition, explained Dr. Pinkerton, medical director of the Midlife Health Center at the University of Virginia, Charlottesville, but physicians aren’t always aware of what’s available.

In a video interview at annual meeting of the North American Menopause Society, Dr. Pinkerton discussed the range of therapies physicians can offer menopausal patients with vaginal dryness.

[email protected]

On Twitter @whitneymcknight

NATIONAL HARBOR, MD. – Menopausal women who experience vaginal dryness often find the resultant pain of sexual intercourse so prohibitive that, according to Dr. JoAnne Pinkerton, often these women go months or years without intimate relations.

There are many treatment options that can benefit patients with the condition, explained Dr. Pinkerton, medical director of the Midlife Health Center at the University of Virginia, Charlottesville, but physicians aren’t always aware of what’s available.

In a video interview at annual meeting of the North American Menopause Society, Dr. Pinkerton discussed the range of therapies physicians can offer menopausal patients with vaginal dryness.

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NATIONAL HARBOR, MD. – Does the Food and Drug Administration’s black-box warning on estrogen contribute to noncompliance – or worse, to clinicians being unwilling to prescribe estrogen treatments – leaving many women to suffer untreated menopause symptoms?

The leadership of the North American Menopause Society thinks so, and the organization has started a campaign to get the FDA to reconsider how it labels estrogen.

“We would like the label for low-dose, vaginal estrogen to better reflect the true safety and risk profile,” said Dr. JoAnn Manson, chair of this year’s NAMS scientific committee.

In a video interview, Dr. Manson discusses how the current black-box labeling may impede effective treatment, and why revised, more-nuanced estrogen labeling could improve outcomes for many women.

NATIONAL HARBOR, MD. – Does the Food and Drug Administration’s black-box warning on estrogen contribute to noncompliance – or worse, to clinicians being unwilling to prescribe estrogen treatments – leaving many women to suffer untreated menopause symptoms?

The leadership of the North American Menopause Society thinks so, and the organization has started a campaign to get the FDA to reconsider how it labels estrogen.

“We would like the label for low-dose, vaginal estrogen to better reflect the true safety and risk profile,” said Dr. JoAnn Manson, chair of this year’s NAMS scientific committee.

In a video interview, Dr. Manson discusses how the current black-box labeling may impede effective treatment, and why revised, more-nuanced estrogen labeling could improve outcomes for many women.

NATIONAL HARBOR, MD. – Does the Food and Drug Administration’s black-box warning on estrogen contribute to noncompliance – or worse, to clinicians being unwilling to prescribe estrogen treatments – leaving many women to suffer untreated menopause symptoms?

The leadership of the North American Menopause Society thinks so, and the organization has started a campaign to get the FDA to reconsider how it labels estrogen.

“We would like the label for low-dose, vaginal estrogen to better reflect the true safety and risk profile,” said Dr. JoAnn Manson, chair of this year’s NAMS scientific committee.

In a video interview, Dr. Manson discusses how the current black-box labeling may impede effective treatment, and why revised, more-nuanced estrogen labeling could improve outcomes for many women.

NATIONAL HARBOR, MD. – Does the Food and Drug Administration’s black-box warning on estrogen contribute to noncompliance – or worse, to clinicians being unwilling to prescribe estrogen treatments – leaving many women to suffer untreated menopause symptoms?

The leadership of the North American Menopause Society thinks so, and the organization has started a campaign to get the FDA to reconsider how it labels estrogen.

“We would like the label for low-dose, vaginal estrogen to better reflect the true safety and risk profile,” said Dr. JoAnn Manson, chair of this year’s NAMS scientific committee.

In a video interview, Dr. Manson discusses how the current black-box labeling may impede effective treatment, and why revised, more-nuanced estrogen labeling could improve outcomes for many women.

[email protected] 


On Twitter @whitneymcknight

NATIONAL HARBOR, MD. – Does the Food and Drug Administration’s black-box warning on estrogen contribute to noncompliance – or worse, to clinicians being unwilling to prescribe estrogen treatments – leaving many women to suffer untreated menopause symptoms?

The leadership of the North American Menopause Society thinks so, and the organization has started a campaign to get the FDA to reconsider how it labels estrogen.

“We would like the label for low-dose, vaginal estrogen to better reflect the true safety and risk profile,” said Dr. JoAnn Manson, chair of this year’s NAMS scientific committee.

In a video interview, Dr. Manson discusses how the current black-box labeling may impede effective treatment, and why revised, more-nuanced estrogen labeling could improve outcomes for many women.

[email protected] 


On Twitter @whitneymcknight

NATIONAL HARBOR, MD. – Does the Food and Drug Administration’s black-box warning on estrogen contribute to noncompliance – or worse, to clinicians being unwilling to prescribe estrogen treatments – leaving many women to suffer untreated menopause symptoms?

The leadership of the North American Menopause Society thinks so, and the organization has started a campaign to get the FDA to reconsider how it labels estrogen.

“We would like the label for low-dose, vaginal estrogen to better reflect the true safety and risk profile,” said Dr. JoAnn Manson, chair of this year’s NAMS scientific committee.

In a video interview, Dr. Manson discusses how the current black-box labeling may impede effective treatment, and why revised, more-nuanced estrogen labeling could improve outcomes for many women.

[email protected] 


On Twitter @whitneymcknight