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Morphology index guides adnexal mass workup in postmenopausal women
PHILADELPHIA – The report provides guidelines for risk stratification and diagnostic evaluation when an ovarian mass is found.
Accurate and thorough evaluation of an adnexal mass in a menopausal woman must respect cancer prevalence data, Frederick Ueland, MD, one of the report’s coauthors, said at the annual meeting of the North American Menopause Society. In premenopausal women, there are “many tumors, but few cancers,” he said. Only about 15% of ovarian tumors are malignant when found before menopause.
But after menopause, there are “few tumors, but many cancers,” Dr. Ueland said. Up to 50% of tumors in postmenopausal women are malignant, with epithelial ovarian cancer, metastatic cancer, and granulosa cell tumors predominating.
Multiple clinical trials have taught physicians that “tumor morphology helps stratify cancer risk,” he noted.
Ultrasound is the best imaging modality to evaluate adnexal masses, he said. At his institution, the use of a morphology index to guide management of adnexal masses has reduced the number of surgeries performed to remove one cancer over the years, said Dr. Ueland, chief of the division of gynecologic oncology at the University of Kentucky, Lexington.
During the 1990s, when the Morphology Index was first used at the University of Kentucky, surgeons performed 12.5 surgeries per cancer. In the 2000s, that number fell to 5.2, and during the present decade, one cancer is detected in every 4 surgeries, he reported.
Limiting subjectivity is a key to accurate cancer detection when evaluating adnexal masses, so that the dual goals of accurate cancer detection and avoidance of unnecessary surgeries can be met, Dr. Ueland said. To address these dual needs, the first international consensus report on adnexal masses was issued in May 2017 (J Ultrasound Med. 2017 May;36[5]:849-863).
The report noted the sharp discrepancy between surgery rates in the United States and Europe. “In the United States, there are approximately 9.1 surgeries per malignancy, compared with the European International Ovarian Tumor Analysis center trials, with only 2.3 (oncology centers) and 5.9 (other centers) reported surgeries per malignancy, suggesting that there is room to improve our preoperative assessments,” the investigators wrote.
In reviewing management guidelines, Dr. Ueland said that, when the risk of malignancy is low, as with smooth-walled, unilocular or septate cysts, the mass can be monitored without surgery, with ultrasound reevaluation at the 6-month mark. If there are no concerning changes, the mass can then be imaged annually for 5 years. No further follow-up is needed at the 5-year mark, barring growth or other changes of the mass.
If the ultrasound evaluation of the mass shows intermediate risk, then secondary testing is needed. Masses that show as partly solid or that have small, irregular wall abnormalities, or atypical nonpapillary projections on ultrasound fall into this category. Secondary testing may be accomplished either by serial ultrasound or by using biomarker testing.
Commercially available triage biomarker tests such as OVA1, ROMA, and Overa may offer higher detection rates than cancer antigen 125 (CA 125) testing alone, Dr. Ueland said. For instance, OVA1, a multivariate index assay, detected 76% of malignancies missed by CA 125 (Am J Obstet Gynecol. 2016 Jul;215[1]:82.e1-11).
If the mass has high-risk characteristics, then a prompt surgical referral to a gynecologic oncologist is a must. Included in this category are mostly solid masses and those with papillary projections, as well as those associated with any ascites. No secondary testing or watchful waiting is recommended in these cases, said Dr. Ueland, since they carry a greater than 25% risk of malignancy.
Dr. Ueland is currently enrolling patients in a clinical trial to assess whether serial transvaginal ultrasonography with Morphology Index can reduce false-positive results by more accurately distinguishing benign from malignant ovarian tumors. He reported having no financial disclosures.
[email protected]
On Twitter @karioakes
PHILADELPHIA – The report provides guidelines for risk stratification and diagnostic evaluation when an ovarian mass is found.
Accurate and thorough evaluation of an adnexal mass in a menopausal woman must respect cancer prevalence data, Frederick Ueland, MD, one of the report’s coauthors, said at the annual meeting of the North American Menopause Society. In premenopausal women, there are “many tumors, but few cancers,” he said. Only about 15% of ovarian tumors are malignant when found before menopause.
But after menopause, there are “few tumors, but many cancers,” Dr. Ueland said. Up to 50% of tumors in postmenopausal women are malignant, with epithelial ovarian cancer, metastatic cancer, and granulosa cell tumors predominating.
Multiple clinical trials have taught physicians that “tumor morphology helps stratify cancer risk,” he noted.
Ultrasound is the best imaging modality to evaluate adnexal masses, he said. At his institution, the use of a morphology index to guide management of adnexal masses has reduced the number of surgeries performed to remove one cancer over the years, said Dr. Ueland, chief of the division of gynecologic oncology at the University of Kentucky, Lexington.
During the 1990s, when the Morphology Index was first used at the University of Kentucky, surgeons performed 12.5 surgeries per cancer. In the 2000s, that number fell to 5.2, and during the present decade, one cancer is detected in every 4 surgeries, he reported.
Limiting subjectivity is a key to accurate cancer detection when evaluating adnexal masses, so that the dual goals of accurate cancer detection and avoidance of unnecessary surgeries can be met, Dr. Ueland said. To address these dual needs, the first international consensus report on adnexal masses was issued in May 2017 (J Ultrasound Med. 2017 May;36[5]:849-863).
The report noted the sharp discrepancy between surgery rates in the United States and Europe. “In the United States, there are approximately 9.1 surgeries per malignancy, compared with the European International Ovarian Tumor Analysis center trials, with only 2.3 (oncology centers) and 5.9 (other centers) reported surgeries per malignancy, suggesting that there is room to improve our preoperative assessments,” the investigators wrote.
In reviewing management guidelines, Dr. Ueland said that, when the risk of malignancy is low, as with smooth-walled, unilocular or septate cysts, the mass can be monitored without surgery, with ultrasound reevaluation at the 6-month mark. If there are no concerning changes, the mass can then be imaged annually for 5 years. No further follow-up is needed at the 5-year mark, barring growth or other changes of the mass.
If the ultrasound evaluation of the mass shows intermediate risk, then secondary testing is needed. Masses that show as partly solid or that have small, irregular wall abnormalities, or atypical nonpapillary projections on ultrasound fall into this category. Secondary testing may be accomplished either by serial ultrasound or by using biomarker testing.
Commercially available triage biomarker tests such as OVA1, ROMA, and Overa may offer higher detection rates than cancer antigen 125 (CA 125) testing alone, Dr. Ueland said. For instance, OVA1, a multivariate index assay, detected 76% of malignancies missed by CA 125 (Am J Obstet Gynecol. 2016 Jul;215[1]:82.e1-11).
If the mass has high-risk characteristics, then a prompt surgical referral to a gynecologic oncologist is a must. Included in this category are mostly solid masses and those with papillary projections, as well as those associated with any ascites. No secondary testing or watchful waiting is recommended in these cases, said Dr. Ueland, since they carry a greater than 25% risk of malignancy.
Dr. Ueland is currently enrolling patients in a clinical trial to assess whether serial transvaginal ultrasonography with Morphology Index can reduce false-positive results by more accurately distinguishing benign from malignant ovarian tumors. He reported having no financial disclosures.
[email protected]
On Twitter @karioakes
PHILADELPHIA – The report provides guidelines for risk stratification and diagnostic evaluation when an ovarian mass is found.
Accurate and thorough evaluation of an adnexal mass in a menopausal woman must respect cancer prevalence data, Frederick Ueland, MD, one of the report’s coauthors, said at the annual meeting of the North American Menopause Society. In premenopausal women, there are “many tumors, but few cancers,” he said. Only about 15% of ovarian tumors are malignant when found before menopause.
But after menopause, there are “few tumors, but many cancers,” Dr. Ueland said. Up to 50% of tumors in postmenopausal women are malignant, with epithelial ovarian cancer, metastatic cancer, and granulosa cell tumors predominating.
Multiple clinical trials have taught physicians that “tumor morphology helps stratify cancer risk,” he noted.
Ultrasound is the best imaging modality to evaluate adnexal masses, he said. At his institution, the use of a morphology index to guide management of adnexal masses has reduced the number of surgeries performed to remove one cancer over the years, said Dr. Ueland, chief of the division of gynecologic oncology at the University of Kentucky, Lexington.
During the 1990s, when the Morphology Index was first used at the University of Kentucky, surgeons performed 12.5 surgeries per cancer. In the 2000s, that number fell to 5.2, and during the present decade, one cancer is detected in every 4 surgeries, he reported.
Limiting subjectivity is a key to accurate cancer detection when evaluating adnexal masses, so that the dual goals of accurate cancer detection and avoidance of unnecessary surgeries can be met, Dr. Ueland said. To address these dual needs, the first international consensus report on adnexal masses was issued in May 2017 (J Ultrasound Med. 2017 May;36[5]:849-863).
The report noted the sharp discrepancy between surgery rates in the United States and Europe. “In the United States, there are approximately 9.1 surgeries per malignancy, compared with the European International Ovarian Tumor Analysis center trials, with only 2.3 (oncology centers) and 5.9 (other centers) reported surgeries per malignancy, suggesting that there is room to improve our preoperative assessments,” the investigators wrote.
In reviewing management guidelines, Dr. Ueland said that, when the risk of malignancy is low, as with smooth-walled, unilocular or septate cysts, the mass can be monitored without surgery, with ultrasound reevaluation at the 6-month mark. If there are no concerning changes, the mass can then be imaged annually for 5 years. No further follow-up is needed at the 5-year mark, barring growth or other changes of the mass.
If the ultrasound evaluation of the mass shows intermediate risk, then secondary testing is needed. Masses that show as partly solid or that have small, irregular wall abnormalities, or atypical nonpapillary projections on ultrasound fall into this category. Secondary testing may be accomplished either by serial ultrasound or by using biomarker testing.
Commercially available triage biomarker tests such as OVA1, ROMA, and Overa may offer higher detection rates than cancer antigen 125 (CA 125) testing alone, Dr. Ueland said. For instance, OVA1, a multivariate index assay, detected 76% of malignancies missed by CA 125 (Am J Obstet Gynecol. 2016 Jul;215[1]:82.e1-11).
If the mass has high-risk characteristics, then a prompt surgical referral to a gynecologic oncologist is a must. Included in this category are mostly solid masses and those with papillary projections, as well as those associated with any ascites. No secondary testing or watchful waiting is recommended in these cases, said Dr. Ueland, since they carry a greater than 25% risk of malignancy.
Dr. Ueland is currently enrolling patients in a clinical trial to assess whether serial transvaginal ultrasonography with Morphology Index can reduce false-positive results by more accurately distinguishing benign from malignant ovarian tumors. He reported having no financial disclosures.
[email protected]
On Twitter @karioakes
EXPERT ANALYSIS FROM NAMS 2017
Papillary thyroid microcarcinoma: Is ‘less is more’ the right approach?
Surgeons treated 95% of preoperatively diagnosed cases of papillary thyroid microcarcinoma with total thyroidectomy, compared with only 69% of postoperatively diagnosed cases, in to a single-center retrospective cohort study.
“During the study period, thyroid lobectomy was an acceptable alternative endorsed by the American Thyroid Association,” said Susan C. Pitt, MD, and her associates at the University of Wisconsin, Madison. “Nonetheless, documentation rarely stated that [thyroid lobectomy] was discussed as an option. Whether this finding indicates a true lack of discussion or a deficit in documentation is unclear, but emphasizes the need to improve the quality of the [electronic health record] and capture all elements of shared decision-making.”
Papillary thyroid microcarcinomas (PTMC) measure 1 cm or less, affect up to a third of adults, and explain about half of the recent rise in rates of papillary thyroid cancer, the investigators stated. Most cases are found incidentally and there is no evidence that they contribute to a rise in mortality, which stands at about 0.5 deaths per 100,000 diagnoses of thyroid carcinoma. Accordingly, in 2015, the American Thyroid Association (ATA) endorsed active surveillance and thyroid lobectomy as acceptable management strategies for most patients with PTMC (Thyroid. 2016 Jan 12;26[1]:1-133).
“The pendulum for the ATA guidelines has swung back and forth,” Dr. Pitt said in an interview. “I think the current 2015 ATA guidelines are still controversial – some surgeons and endocrinologists think we have swung too far [in the other direction]. Moving the field from total thyroidectomy to active surveillance is a big jump. Understanding the factors underlying current decisions will help us to implement less extensive management, like lobectomy and active surveillance.”
To do that, Dr. Pitt and her associates reviewed medical records from 125 patients with PTMC treated at the University of Wisconsin between 2008 and 2016. Most of the patients (90%) were white, 85% were female, average age was 50 years, and nearly all had classic or follicular-variant disease. Only 27% of patients underwent thyroid lobectomy; the rest underwent total thyroidectomy. Furthermore, among 19 patients diagnosed preoperatively, 95% underwent total thyroidectomy and 21% had a complication, including one (5%) case of permanent hypocalcemia that less extensive surgery might have avoided (J Surg Res. 2017;218:237-45).
“In all cases, documentation indicated that these preoperatively diagnosed patients followed the surgeon’s recommendation regarding the extent of surgery,” the researchers wrote. Surgeons cited various reasons for recommending total thyroidectomy, including – in about 20% of cases – a belief that it was the recommended treatment.
Only one of the 19 preoperatively diagnosed patients had a documented discussion of thyroid lobectomy, the researchers found.
While physicians might be concerned about recurrence or other “downstream” outcomes of a less-is-more approach to PTMC, Dr. Pitt noted that, in a recent large study, only 3.4% of these tumors metastasized over 10 years (World J Surg. 2010 Jan;34[1]:28-35).
“At the same time, I think that we have a better sense [that] patient-centered outcomes after thyroidectomy, such as health-related quality of life, swallowing, and voice outcomes, can be worse after a total thyroidectomy,” she added.
As surgical and medical therapies expand for PTMC and other nonmalignant diseases, it becomes increasingly vital that surgeons and patients undertake shared decision-making, she said. At the University of Wisconsin, physicians can enter free text in the EHR to document such discussions. She gave an example of how she does that: “‘Total thyroidectomy and lobectomy are both appropriate approaches for Ms. Smith. We discussed these options at length, including X, Y, and Z. Given Mrs. Smith’s (strong) preference to avoid X, we will proceed with a lobectomy.”
In her own practice, Dr. Pitt added, “when I look back at a note, I want to know what the decision was, and why it was made.”
Shared decision-making differs from informed consent by focusing on patient preferences, she noted. “I have used my notes in the operating room to help me decide what to do. I can look back and have a window into our conversation and what an individual patient values.” For PTMC, shared decisions should focus less on cancer risk and more on quality of life and outcomes a year later, she said.
“Patients don’t die from PTMC, and most live longer than the age-matched population. Given the risks of more extensive surgery and our current data on surgical and patient-centered outcomes, I think that thyroid lobectomy should be the initial treatment for most patients with PTMC, and surgeons should help their patients make informed decisions,” Dr. Pitt said.
The National Institutes of Health provided funding. The researchers reported having no conflicts of interest.
Surgeons treated 95% of preoperatively diagnosed cases of papillary thyroid microcarcinoma with total thyroidectomy, compared with only 69% of postoperatively diagnosed cases, in to a single-center retrospective cohort study.
“During the study period, thyroid lobectomy was an acceptable alternative endorsed by the American Thyroid Association,” said Susan C. Pitt, MD, and her associates at the University of Wisconsin, Madison. “Nonetheless, documentation rarely stated that [thyroid lobectomy] was discussed as an option. Whether this finding indicates a true lack of discussion or a deficit in documentation is unclear, but emphasizes the need to improve the quality of the [electronic health record] and capture all elements of shared decision-making.”
Papillary thyroid microcarcinomas (PTMC) measure 1 cm or less, affect up to a third of adults, and explain about half of the recent rise in rates of papillary thyroid cancer, the investigators stated. Most cases are found incidentally and there is no evidence that they contribute to a rise in mortality, which stands at about 0.5 deaths per 100,000 diagnoses of thyroid carcinoma. Accordingly, in 2015, the American Thyroid Association (ATA) endorsed active surveillance and thyroid lobectomy as acceptable management strategies for most patients with PTMC (Thyroid. 2016 Jan 12;26[1]:1-133).
“The pendulum for the ATA guidelines has swung back and forth,” Dr. Pitt said in an interview. “I think the current 2015 ATA guidelines are still controversial – some surgeons and endocrinologists think we have swung too far [in the other direction]. Moving the field from total thyroidectomy to active surveillance is a big jump. Understanding the factors underlying current decisions will help us to implement less extensive management, like lobectomy and active surveillance.”
To do that, Dr. Pitt and her associates reviewed medical records from 125 patients with PTMC treated at the University of Wisconsin between 2008 and 2016. Most of the patients (90%) were white, 85% were female, average age was 50 years, and nearly all had classic or follicular-variant disease. Only 27% of patients underwent thyroid lobectomy; the rest underwent total thyroidectomy. Furthermore, among 19 patients diagnosed preoperatively, 95% underwent total thyroidectomy and 21% had a complication, including one (5%) case of permanent hypocalcemia that less extensive surgery might have avoided (J Surg Res. 2017;218:237-45).
“In all cases, documentation indicated that these preoperatively diagnosed patients followed the surgeon’s recommendation regarding the extent of surgery,” the researchers wrote. Surgeons cited various reasons for recommending total thyroidectomy, including – in about 20% of cases – a belief that it was the recommended treatment.
Only one of the 19 preoperatively diagnosed patients had a documented discussion of thyroid lobectomy, the researchers found.
While physicians might be concerned about recurrence or other “downstream” outcomes of a less-is-more approach to PTMC, Dr. Pitt noted that, in a recent large study, only 3.4% of these tumors metastasized over 10 years (World J Surg. 2010 Jan;34[1]:28-35).
“At the same time, I think that we have a better sense [that] patient-centered outcomes after thyroidectomy, such as health-related quality of life, swallowing, and voice outcomes, can be worse after a total thyroidectomy,” she added.
As surgical and medical therapies expand for PTMC and other nonmalignant diseases, it becomes increasingly vital that surgeons and patients undertake shared decision-making, she said. At the University of Wisconsin, physicians can enter free text in the EHR to document such discussions. She gave an example of how she does that: “‘Total thyroidectomy and lobectomy are both appropriate approaches for Ms. Smith. We discussed these options at length, including X, Y, and Z. Given Mrs. Smith’s (strong) preference to avoid X, we will proceed with a lobectomy.”
In her own practice, Dr. Pitt added, “when I look back at a note, I want to know what the decision was, and why it was made.”
Shared decision-making differs from informed consent by focusing on patient preferences, she noted. “I have used my notes in the operating room to help me decide what to do. I can look back and have a window into our conversation and what an individual patient values.” For PTMC, shared decisions should focus less on cancer risk and more on quality of life and outcomes a year later, she said.
“Patients don’t die from PTMC, and most live longer than the age-matched population. Given the risks of more extensive surgery and our current data on surgical and patient-centered outcomes, I think that thyroid lobectomy should be the initial treatment for most patients with PTMC, and surgeons should help their patients make informed decisions,” Dr. Pitt said.
The National Institutes of Health provided funding. The researchers reported having no conflicts of interest.
Surgeons treated 95% of preoperatively diagnosed cases of papillary thyroid microcarcinoma with total thyroidectomy, compared with only 69% of postoperatively diagnosed cases, in to a single-center retrospective cohort study.
“During the study period, thyroid lobectomy was an acceptable alternative endorsed by the American Thyroid Association,” said Susan C. Pitt, MD, and her associates at the University of Wisconsin, Madison. “Nonetheless, documentation rarely stated that [thyroid lobectomy] was discussed as an option. Whether this finding indicates a true lack of discussion or a deficit in documentation is unclear, but emphasizes the need to improve the quality of the [electronic health record] and capture all elements of shared decision-making.”
Papillary thyroid microcarcinomas (PTMC) measure 1 cm or less, affect up to a third of adults, and explain about half of the recent rise in rates of papillary thyroid cancer, the investigators stated. Most cases are found incidentally and there is no evidence that they contribute to a rise in mortality, which stands at about 0.5 deaths per 100,000 diagnoses of thyroid carcinoma. Accordingly, in 2015, the American Thyroid Association (ATA) endorsed active surveillance and thyroid lobectomy as acceptable management strategies for most patients with PTMC (Thyroid. 2016 Jan 12;26[1]:1-133).
“The pendulum for the ATA guidelines has swung back and forth,” Dr. Pitt said in an interview. “I think the current 2015 ATA guidelines are still controversial – some surgeons and endocrinologists think we have swung too far [in the other direction]. Moving the field from total thyroidectomy to active surveillance is a big jump. Understanding the factors underlying current decisions will help us to implement less extensive management, like lobectomy and active surveillance.”
To do that, Dr. Pitt and her associates reviewed medical records from 125 patients with PTMC treated at the University of Wisconsin between 2008 and 2016. Most of the patients (90%) were white, 85% were female, average age was 50 years, and nearly all had classic or follicular-variant disease. Only 27% of patients underwent thyroid lobectomy; the rest underwent total thyroidectomy. Furthermore, among 19 patients diagnosed preoperatively, 95% underwent total thyroidectomy and 21% had a complication, including one (5%) case of permanent hypocalcemia that less extensive surgery might have avoided (J Surg Res. 2017;218:237-45).
“In all cases, documentation indicated that these preoperatively diagnosed patients followed the surgeon’s recommendation regarding the extent of surgery,” the researchers wrote. Surgeons cited various reasons for recommending total thyroidectomy, including – in about 20% of cases – a belief that it was the recommended treatment.
Only one of the 19 preoperatively diagnosed patients had a documented discussion of thyroid lobectomy, the researchers found.
While physicians might be concerned about recurrence or other “downstream” outcomes of a less-is-more approach to PTMC, Dr. Pitt noted that, in a recent large study, only 3.4% of these tumors metastasized over 10 years (World J Surg. 2010 Jan;34[1]:28-35).
“At the same time, I think that we have a better sense [that] patient-centered outcomes after thyroidectomy, such as health-related quality of life, swallowing, and voice outcomes, can be worse after a total thyroidectomy,” she added.
As surgical and medical therapies expand for PTMC and other nonmalignant diseases, it becomes increasingly vital that surgeons and patients undertake shared decision-making, she said. At the University of Wisconsin, physicians can enter free text in the EHR to document such discussions. She gave an example of how she does that: “‘Total thyroidectomy and lobectomy are both appropriate approaches for Ms. Smith. We discussed these options at length, including X, Y, and Z. Given Mrs. Smith’s (strong) preference to avoid X, we will proceed with a lobectomy.”
In her own practice, Dr. Pitt added, “when I look back at a note, I want to know what the decision was, and why it was made.”
Shared decision-making differs from informed consent by focusing on patient preferences, she noted. “I have used my notes in the operating room to help me decide what to do. I can look back and have a window into our conversation and what an individual patient values.” For PTMC, shared decisions should focus less on cancer risk and more on quality of life and outcomes a year later, she said.
“Patients don’t die from PTMC, and most live longer than the age-matched population. Given the risks of more extensive surgery and our current data on surgical and patient-centered outcomes, I think that thyroid lobectomy should be the initial treatment for most patients with PTMC, and surgeons should help their patients make informed decisions,” Dr. Pitt said.
The National Institutes of Health provided funding. The researchers reported having no conflicts of interest.
FROM THE JOURNAL OF SURGICAL RESEARCH
Key clinical point: Nearly all patients with a preoperative diagnosis of PTMC underwent total thyroidectomy, usually at their surgeon’s recommendation.
Major finding: 95% of preoperatively diagnosed patients underwent total thyroidectomy, versus 69% of those diagnosed postoperatively (P = .02). A discussion of thyroid lobectomy was documented in only one preoperatively diagnosed case.
Data source: A single-center retrospective study of 125 patients with papillary thyroid microcarcinoma.
Disclosures: The National Institutes of Health provided funding. The researchers reported having no conflicts of interest.
Clinical pearls from NAMS 2017
Visit the NAMS annual meetings website
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
Dr. Kaunitz is University of Florida Term Professor and Associate Chairman, Department of Obstetrics and Gynecology, University of Florida College of Medicine-Jacksonville. He is Medical Director and Director of Menopause and Gynecologic Ultrasound Services at UF Women's Health Specialists-Emerson. He also serves on the OBG Management Board of Editors.
Dr. Kaunitz reports that he serves as a consultant to Allergan, AMAG, Bayer HealthCare Pharmaceuticals, Pfizer, Sebela, and Shionogi. He receives research grants (funds paid to the University of Florida) from Allergan, Bayer HealthCare Pharmaceuticals, Endoceutics, Millendo, and TherapeuticsMD, and he receives royalties from UpToDate.
Dr. Kaunitz is University of Florida Term Professor and Associate Chairman, Department of Obstetrics and Gynecology, University of Florida College of Medicine-Jacksonville. He is Medical Director and Director of Menopause and Gynecologic Ultrasound Services at UF Women's Health Specialists-Emerson. He also serves on the OBG Management Board of Editors.
Dr. Kaunitz reports that he serves as a consultant to Allergan, AMAG, Bayer HealthCare Pharmaceuticals, Pfizer, Sebela, and Shionogi. He receives research grants (funds paid to the University of Florida) from Allergan, Bayer HealthCare Pharmaceuticals, Endoceutics, Millendo, and TherapeuticsMD, and he receives royalties from UpToDate.
Dr. Kaunitz is University of Florida Term Professor and Associate Chairman, Department of Obstetrics and Gynecology, University of Florida College of Medicine-Jacksonville. He is Medical Director and Director of Menopause and Gynecologic Ultrasound Services at UF Women's Health Specialists-Emerson. He also serves on the OBG Management Board of Editors.
Dr. Kaunitz reports that he serves as a consultant to Allergan, AMAG, Bayer HealthCare Pharmaceuticals, Pfizer, Sebela, and Shionogi. He receives research grants (funds paid to the University of Florida) from Allergan, Bayer HealthCare Pharmaceuticals, Endoceutics, Millendo, and TherapeuticsMD, and he receives royalties from UpToDate.
Visit the NAMS annual meetings website
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
Visit the NAMS annual meetings website
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
VIDEO: Expert roundtable on hormone therapy
PHILADELPHIA – The updated hormone therapy position statement from the North American Menopause Society tells clinicians to move away from “lowest dose for the shortest time” and toward prescribing the appropriate dose, formulation, and route of administration to meet treatment goals.
At the group’s annual meeting, some of the authors of the position statement outlined the latest evidence for the safety of hormone therapy and special clinical considerations based on age or time of menopause and unique health risks like breast cancer. Additionally, the authors said there should not be an arbitrary “stop date” for hormone therapy.
The authors also discussed the risks of using compounded bioidentical hormones to treat menopausal symptoms.
This roundtable discussion includes JoAnn V. Pinkerton, MD, NAMS executive director and professor of obstetrics and gynecology at the University of Virginia, Charlottesville; Andrew Kaunitz, MD, associate chairman of the department of obstetrics and gynecology at the University of Florida, Jacksonville; and Cynthia A. Stuenkel, MD, clinical professor of medicine at the University of California, San Diego.
Dr. Pinkerton reported institutional research support from TherapeuticsMD. Dr. Kaunitz reported consultant/advisory board work for Allergan, Amag Pharmaceuticals, Bayer, Mithra Pharmaceuticals, Pfizer, and Shionogi. He has also received grant/research support from Bayer, Radius Health, TherapeuticsMD, and Millendo Therapeutics. Dr. Stuenkel reported having no financial disclosures.
[email protected]
On Twitter @maryellenny
PHILADELPHIA – The updated hormone therapy position statement from the North American Menopause Society tells clinicians to move away from “lowest dose for the shortest time” and toward prescribing the appropriate dose, formulation, and route of administration to meet treatment goals.
At the group’s annual meeting, some of the authors of the position statement outlined the latest evidence for the safety of hormone therapy and special clinical considerations based on age or time of menopause and unique health risks like breast cancer. Additionally, the authors said there should not be an arbitrary “stop date” for hormone therapy.
The authors also discussed the risks of using compounded bioidentical hormones to treat menopausal symptoms.
This roundtable discussion includes JoAnn V. Pinkerton, MD, NAMS executive director and professor of obstetrics and gynecology at the University of Virginia, Charlottesville; Andrew Kaunitz, MD, associate chairman of the department of obstetrics and gynecology at the University of Florida, Jacksonville; and Cynthia A. Stuenkel, MD, clinical professor of medicine at the University of California, San Diego.
Dr. Pinkerton reported institutional research support from TherapeuticsMD. Dr. Kaunitz reported consultant/advisory board work for Allergan, Amag Pharmaceuticals, Bayer, Mithra Pharmaceuticals, Pfizer, and Shionogi. He has also received grant/research support from Bayer, Radius Health, TherapeuticsMD, and Millendo Therapeutics. Dr. Stuenkel reported having no financial disclosures.
[email protected]
On Twitter @maryellenny
PHILADELPHIA – The updated hormone therapy position statement from the North American Menopause Society tells clinicians to move away from “lowest dose for the shortest time” and toward prescribing the appropriate dose, formulation, and route of administration to meet treatment goals.
At the group’s annual meeting, some of the authors of the position statement outlined the latest evidence for the safety of hormone therapy and special clinical considerations based on age or time of menopause and unique health risks like breast cancer. Additionally, the authors said there should not be an arbitrary “stop date” for hormone therapy.
The authors also discussed the risks of using compounded bioidentical hormones to treat menopausal symptoms.
This roundtable discussion includes JoAnn V. Pinkerton, MD, NAMS executive director and professor of obstetrics and gynecology at the University of Virginia, Charlottesville; Andrew Kaunitz, MD, associate chairman of the department of obstetrics and gynecology at the University of Florida, Jacksonville; and Cynthia A. Stuenkel, MD, clinical professor of medicine at the University of California, San Diego.
Dr. Pinkerton reported institutional research support from TherapeuticsMD. Dr. Kaunitz reported consultant/advisory board work for Allergan, Amag Pharmaceuticals, Bayer, Mithra Pharmaceuticals, Pfizer, and Shionogi. He has also received grant/research support from Bayer, Radius Health, TherapeuticsMD, and Millendo Therapeutics. Dr. Stuenkel reported having no financial disclosures.
[email protected]
On Twitter @maryellenny
EXPERT ANALYSIS FROM NAMS 2017
VIDEO: Dr. Andrew Kaunitz’s top lessons from NAMS 2017
PHILADELPHIA – Andrew Kaunitz, MD, the chair of the 2017 scientific program committee for the annual meeting of the North American Menopause Society, shared his top take-home messages from the meeting.
New anabolic medications that increase bone mineral density and dramatically reduce fracture risk are in the pipeline, Dr. Kaunitz, a professor in the department of obstetrics and gynecology at the University of Florida, Jacksonville, said in a video interview.
Another finding from the meeting is that type 2 diabetes, despite being associated with an increased body mass index, actually elevates a woman’s risk for fracture. “That was something new for me, and I think it was something new for a lot of the practitioners attending the NAMS meeting,” Dr. Kaunitz said.
The meeting also offered tips for managing polycystic ovarian syndrome in women who are in midlife, including the importance of screening for diabetes and assessing for lipid disorders. Additionally, attendees learned about the management of migraines in menopausal women and older reproductive-age women.
A well-attended session on breast imaging explored how breast tomosynthesis can reduce false positives and recalls, as well as how new technology can reduce the radiation exposure associated with tomosynthesis. The session also featured evidence that screening mammography has lower-than-reported sensitivity, but offered a hopeful note on the promise of improved sensitivity through molecular breast imaging.
Dr. Kaunitz reported consultant/advisory board work for Allergan, Amag Pharmaceuticals, Bayer, Mithra Pharmaceuticals, Pfizer, and Shionogi. He has received grant/research support from Bayer, Radius Health, TherapeuticsMD, and Millendo Therapeutics.
[email protected]
On Twitter @maryellenny
PHILADELPHIA – Andrew Kaunitz, MD, the chair of the 2017 scientific program committee for the annual meeting of the North American Menopause Society, shared his top take-home messages from the meeting.
New anabolic medications that increase bone mineral density and dramatically reduce fracture risk are in the pipeline, Dr. Kaunitz, a professor in the department of obstetrics and gynecology at the University of Florida, Jacksonville, said in a video interview.
Another finding from the meeting is that type 2 diabetes, despite being associated with an increased body mass index, actually elevates a woman’s risk for fracture. “That was something new for me, and I think it was something new for a lot of the practitioners attending the NAMS meeting,” Dr. Kaunitz said.
The meeting also offered tips for managing polycystic ovarian syndrome in women who are in midlife, including the importance of screening for diabetes and assessing for lipid disorders. Additionally, attendees learned about the management of migraines in menopausal women and older reproductive-age women.
A well-attended session on breast imaging explored how breast tomosynthesis can reduce false positives and recalls, as well as how new technology can reduce the radiation exposure associated with tomosynthesis. The session also featured evidence that screening mammography has lower-than-reported sensitivity, but offered a hopeful note on the promise of improved sensitivity through molecular breast imaging.
Dr. Kaunitz reported consultant/advisory board work for Allergan, Amag Pharmaceuticals, Bayer, Mithra Pharmaceuticals, Pfizer, and Shionogi. He has received grant/research support from Bayer, Radius Health, TherapeuticsMD, and Millendo Therapeutics.
[email protected]
On Twitter @maryellenny
PHILADELPHIA – Andrew Kaunitz, MD, the chair of the 2017 scientific program committee for the annual meeting of the North American Menopause Society, shared his top take-home messages from the meeting.
New anabolic medications that increase bone mineral density and dramatically reduce fracture risk are in the pipeline, Dr. Kaunitz, a professor in the department of obstetrics and gynecology at the University of Florida, Jacksonville, said in a video interview.
Another finding from the meeting is that type 2 diabetes, despite being associated with an increased body mass index, actually elevates a woman’s risk for fracture. “That was something new for me, and I think it was something new for a lot of the practitioners attending the NAMS meeting,” Dr. Kaunitz said.
The meeting also offered tips for managing polycystic ovarian syndrome in women who are in midlife, including the importance of screening for diabetes and assessing for lipid disorders. Additionally, attendees learned about the management of migraines in menopausal women and older reproductive-age women.
A well-attended session on breast imaging explored how breast tomosynthesis can reduce false positives and recalls, as well as how new technology can reduce the radiation exposure associated with tomosynthesis. The session also featured evidence that screening mammography has lower-than-reported sensitivity, but offered a hopeful note on the promise of improved sensitivity through molecular breast imaging.
Dr. Kaunitz reported consultant/advisory board work for Allergan, Amag Pharmaceuticals, Bayer, Mithra Pharmaceuticals, Pfizer, and Shionogi. He has received grant/research support from Bayer, Radius Health, TherapeuticsMD, and Millendo Therapeutics.
[email protected]
On Twitter @maryellenny
EXPERT ANALYSIS FROM NAMS 2017
VIDEO: Does genitourinary syndrome of menopause capture all the symptoms?
PHILADELPHIA – Genitourinary syndrome of menopause (GSM) replaced vulvovaginal atrophy in 2014 as a way to describe the changes to the genital and urinary tracts after menopause, but preliminary research shows it may be missing some symptoms.
In 2015, Amanda Clark, MD, a urogynecologist at the Kaiser Center for Health Research in Portland, Ore., and her colleagues surveyed women aged 55 years and older about their vulvar, vaginal, urinary, and sexual symptoms within 2 weeks of a well-woman visit to their primary care physician or gynecologist in the Kaiser system. In total, 1,533 provided valid data.
The researchers then used factor analysis to see if the symptoms matched up with GSM. If GSM is a true syndrome and only a single syndrome, then all of the factors would fit together in a one-factor model, Dr. Clark explained at the annual meeting of the North American Menopause Society. Instead, the researchers found that a three-factor model – with vulvovaginal symptoms of irritation and pain in one group, urinary symptoms in another group, and vaginal discharge and odor in a third group – fit best with the symptoms reported in their survey.
“This work is very preliminary and needs to be replicated in many other samples and looked at carefully,” Dr. Clark said in an interview. “But what we think is that genitourinary syndrome of menopause is a starting point.”
The study was funded by a Pfizer Independent Grant for Learning & Change and the North American Menopause Society. Dr. Clark reported having no relevant financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @maryellenny
PHILADELPHIA – Genitourinary syndrome of menopause (GSM) replaced vulvovaginal atrophy in 2014 as a way to describe the changes to the genital and urinary tracts after menopause, but preliminary research shows it may be missing some symptoms.
In 2015, Amanda Clark, MD, a urogynecologist at the Kaiser Center for Health Research in Portland, Ore., and her colleagues surveyed women aged 55 years and older about their vulvar, vaginal, urinary, and sexual symptoms within 2 weeks of a well-woman visit to their primary care physician or gynecologist in the Kaiser system. In total, 1,533 provided valid data.
The researchers then used factor analysis to see if the symptoms matched up with GSM. If GSM is a true syndrome and only a single syndrome, then all of the factors would fit together in a one-factor model, Dr. Clark explained at the annual meeting of the North American Menopause Society. Instead, the researchers found that a three-factor model – with vulvovaginal symptoms of irritation and pain in one group, urinary symptoms in another group, and vaginal discharge and odor in a third group – fit best with the symptoms reported in their survey.
“This work is very preliminary and needs to be replicated in many other samples and looked at carefully,” Dr. Clark said in an interview. “But what we think is that genitourinary syndrome of menopause is a starting point.”
The study was funded by a Pfizer Independent Grant for Learning & Change and the North American Menopause Society. Dr. Clark reported having no relevant financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @maryellenny
PHILADELPHIA – Genitourinary syndrome of menopause (GSM) replaced vulvovaginal atrophy in 2014 as a way to describe the changes to the genital and urinary tracts after menopause, but preliminary research shows it may be missing some symptoms.
In 2015, Amanda Clark, MD, a urogynecologist at the Kaiser Center for Health Research in Portland, Ore., and her colleagues surveyed women aged 55 years and older about their vulvar, vaginal, urinary, and sexual symptoms within 2 weeks of a well-woman visit to their primary care physician or gynecologist in the Kaiser system. In total, 1,533 provided valid data.
The researchers then used factor analysis to see if the symptoms matched up with GSM. If GSM is a true syndrome and only a single syndrome, then all of the factors would fit together in a one-factor model, Dr. Clark explained at the annual meeting of the North American Menopause Society. Instead, the researchers found that a three-factor model – with vulvovaginal symptoms of irritation and pain in one group, urinary symptoms in another group, and vaginal discharge and odor in a third group – fit best with the symptoms reported in their survey.
“This work is very preliminary and needs to be replicated in many other samples and looked at carefully,” Dr. Clark said in an interview. “But what we think is that genitourinary syndrome of menopause is a starting point.”
The study was funded by a Pfizer Independent Grant for Learning & Change and the North American Menopause Society. Dr. Clark reported having no relevant financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @maryellenny
AT NAMS 2017
CBT for insomnia and hot flashes lifts mood in midlife
PHILADELPHIA – Cognitive-behavioral therapy tailored to perimenopausal and postmenopausal women who were experiencing both insomnia and vasomotor symptoms effectively improved both sleep and mood, according to a small controlled study.
When 40 women were randomized to receive either cognitive-behavioral therapy for menopausal insomnia (CBTMI) or education about menopause and sleep, those who received CBTMI had significantly reduced scores on both objective and subjective scales of depression, and their sleep also improved.
The CBTMI intervention was effective even for women with high scores on the depression scales at baseline, Sara Nowakowski, PhD, said at a top abstracts session at the annual meeting of the North American Menopause Society.
Over the 8 weeks of the study intervention, women in the CBTMI arm received four 50-minute individual sessions with either a social worker or a psychologist in a gynecology clinic outpatient setting. Counseling during the sessions focused both on hot flashes and insomnia, using evidence-based CBT techniques to address both. These included sleep restriction, changing behaviors to strengthen the association of the bed with sleep, cognitive therapy to address maladaptive beliefs about both sleep and host flashes, general sleep hygiene, hot flash coping mechanisms, and relaxation training.
Those in the menopause education control arm had a 1-hour educational session about menopausal symptoms and sleep hygiene, received written material, and were told they could make any changes desired.
Participants, whose mean age was 55 years, were included if they reported at least one nocturnal hot flash per night and met criteria for the sleep disorder of insomnia. Although patients who met criteria for major depression were not excluded, women with surgical menopause or cancer treatment–related menopause were excluded, as were those with substance use disorder, significant other psychiatric comorbidities, and those with obstructive sleep apnea or periodic limb movements/restless leg syndrome.
Dr. Nowakowski, a clinical psychologist in the department of obstetrics and gynecology, University of Texas, Galveston, and her colleagues administered the Insomnia Severity Index (ISI), the Center for Epidemiologic Studies Depression Scale (CES-D), and the Hamilton Depression Rating Scale (HDRS) both before and after the 8-week intervention.
The investigators used a mixed-models statistical analysis, finding a significant improvement over time during the study period in both patient-reported (P = .001) and clinician-assessed (P = .001) ratings of depression for the CBTMI group.
When the effect of the treatment arm was analyzed, CBTMI also offered significantly greater improvement in patient-reported (P = .009) and clinician-assessed (P = .022) depression ratings.
Patients were divided into high and low depression severity, with a score over 8 on the CES-D and 16 on the HDRS putting the participant into the high-severity category. Both groups had significant improvement on the ISI from baseline. “Treatment response for insomnia severity did not differ based on baseline depression severity,” Dr. Nowakowski said.
The efficacy of the relatively brief intervention has clinical relevance to those caring for the 39%-60% of women in midlife who have symptoms of insomnia and the 8%-40% of midlife women who report elevated depression symptoms. “Comprehensive interventions that simultaneously improve sleep and mood in midlife women are greatly needed,” she said.
The National Institutes of Health and the Hogg Foundation for Mental Health funded the study. Dr. Nowakowski reported no conflicts of interest.
[email protected]
On Twitter @karioakes
PHILADELPHIA – Cognitive-behavioral therapy tailored to perimenopausal and postmenopausal women who were experiencing both insomnia and vasomotor symptoms effectively improved both sleep and mood, according to a small controlled study.
When 40 women were randomized to receive either cognitive-behavioral therapy for menopausal insomnia (CBTMI) or education about menopause and sleep, those who received CBTMI had significantly reduced scores on both objective and subjective scales of depression, and their sleep also improved.
The CBTMI intervention was effective even for women with high scores on the depression scales at baseline, Sara Nowakowski, PhD, said at a top abstracts session at the annual meeting of the North American Menopause Society.
Over the 8 weeks of the study intervention, women in the CBTMI arm received four 50-minute individual sessions with either a social worker or a psychologist in a gynecology clinic outpatient setting. Counseling during the sessions focused both on hot flashes and insomnia, using evidence-based CBT techniques to address both. These included sleep restriction, changing behaviors to strengthen the association of the bed with sleep, cognitive therapy to address maladaptive beliefs about both sleep and host flashes, general sleep hygiene, hot flash coping mechanisms, and relaxation training.
Those in the menopause education control arm had a 1-hour educational session about menopausal symptoms and sleep hygiene, received written material, and were told they could make any changes desired.
Participants, whose mean age was 55 years, were included if they reported at least one nocturnal hot flash per night and met criteria for the sleep disorder of insomnia. Although patients who met criteria for major depression were not excluded, women with surgical menopause or cancer treatment–related menopause were excluded, as were those with substance use disorder, significant other psychiatric comorbidities, and those with obstructive sleep apnea or periodic limb movements/restless leg syndrome.
Dr. Nowakowski, a clinical psychologist in the department of obstetrics and gynecology, University of Texas, Galveston, and her colleagues administered the Insomnia Severity Index (ISI), the Center for Epidemiologic Studies Depression Scale (CES-D), and the Hamilton Depression Rating Scale (HDRS) both before and after the 8-week intervention.
The investigators used a mixed-models statistical analysis, finding a significant improvement over time during the study period in both patient-reported (P = .001) and clinician-assessed (P = .001) ratings of depression for the CBTMI group.
When the effect of the treatment arm was analyzed, CBTMI also offered significantly greater improvement in patient-reported (P = .009) and clinician-assessed (P = .022) depression ratings.
Patients were divided into high and low depression severity, with a score over 8 on the CES-D and 16 on the HDRS putting the participant into the high-severity category. Both groups had significant improvement on the ISI from baseline. “Treatment response for insomnia severity did not differ based on baseline depression severity,” Dr. Nowakowski said.
The efficacy of the relatively brief intervention has clinical relevance to those caring for the 39%-60% of women in midlife who have symptoms of insomnia and the 8%-40% of midlife women who report elevated depression symptoms. “Comprehensive interventions that simultaneously improve sleep and mood in midlife women are greatly needed,” she said.
The National Institutes of Health and the Hogg Foundation for Mental Health funded the study. Dr. Nowakowski reported no conflicts of interest.
[email protected]
On Twitter @karioakes
PHILADELPHIA – Cognitive-behavioral therapy tailored to perimenopausal and postmenopausal women who were experiencing both insomnia and vasomotor symptoms effectively improved both sleep and mood, according to a small controlled study.
When 40 women were randomized to receive either cognitive-behavioral therapy for menopausal insomnia (CBTMI) or education about menopause and sleep, those who received CBTMI had significantly reduced scores on both objective and subjective scales of depression, and their sleep also improved.
The CBTMI intervention was effective even for women with high scores on the depression scales at baseline, Sara Nowakowski, PhD, said at a top abstracts session at the annual meeting of the North American Menopause Society.
Over the 8 weeks of the study intervention, women in the CBTMI arm received four 50-minute individual sessions with either a social worker or a psychologist in a gynecology clinic outpatient setting. Counseling during the sessions focused both on hot flashes and insomnia, using evidence-based CBT techniques to address both. These included sleep restriction, changing behaviors to strengthen the association of the bed with sleep, cognitive therapy to address maladaptive beliefs about both sleep and host flashes, general sleep hygiene, hot flash coping mechanisms, and relaxation training.
Those in the menopause education control arm had a 1-hour educational session about menopausal symptoms and sleep hygiene, received written material, and were told they could make any changes desired.
Participants, whose mean age was 55 years, were included if they reported at least one nocturnal hot flash per night and met criteria for the sleep disorder of insomnia. Although patients who met criteria for major depression were not excluded, women with surgical menopause or cancer treatment–related menopause were excluded, as were those with substance use disorder, significant other psychiatric comorbidities, and those with obstructive sleep apnea or periodic limb movements/restless leg syndrome.
Dr. Nowakowski, a clinical psychologist in the department of obstetrics and gynecology, University of Texas, Galveston, and her colleagues administered the Insomnia Severity Index (ISI), the Center for Epidemiologic Studies Depression Scale (CES-D), and the Hamilton Depression Rating Scale (HDRS) both before and after the 8-week intervention.
The investigators used a mixed-models statistical analysis, finding a significant improvement over time during the study period in both patient-reported (P = .001) and clinician-assessed (P = .001) ratings of depression for the CBTMI group.
When the effect of the treatment arm was analyzed, CBTMI also offered significantly greater improvement in patient-reported (P = .009) and clinician-assessed (P = .022) depression ratings.
Patients were divided into high and low depression severity, with a score over 8 on the CES-D and 16 on the HDRS putting the participant into the high-severity category. Both groups had significant improvement on the ISI from baseline. “Treatment response for insomnia severity did not differ based on baseline depression severity,” Dr. Nowakowski said.
The efficacy of the relatively brief intervention has clinical relevance to those caring for the 39%-60% of women in midlife who have symptoms of insomnia and the 8%-40% of midlife women who report elevated depression symptoms. “Comprehensive interventions that simultaneously improve sleep and mood in midlife women are greatly needed,” she said.
The National Institutes of Health and the Hogg Foundation for Mental Health funded the study. Dr. Nowakowski reported no conflicts of interest.
[email protected]
On Twitter @karioakes
AT NAMS 2017
Key clinical point:
Major finding: Patient-reported and clinician-assessed depression scores dropped after the intervention (P = .001 for both).
Data source: Randomized controlled trial of 40 midlife women with insomnia and hot flashes.
Disclosures: The National Institutes of Health and the Hogg Foundation for Mental Health funded the study. Dr. Nowakowski reported no conflicts of interest.
Oral bioidentical combo improves quality of life, vasomotor symptoms
PHILADELPHIA – An oral estradiol/progesterone formulation significantly improved menopause-related quality of life, compared with placebo, for up to 1 year after beginning treatment, according to a new study.
If approved, the new formulation “may be an option for the estimated millions of women currently using less-regulated and unapproved compounded bioidentical hormone therapy,” said James Simon, MD, the study’s senior author.
Patients receiving the combination therapy, termed TX-001HR, experienced a significant improvement in quality of life, compared with placebo and compared with baseline, at all study points, said Dr. Simon of George Washington University, Washington.
Using the Menopause-Specific Quality of Life questionnaire (MENQOL), Dr. Simon and his coinvestigators found that women taking the combination therapy saw reductions in the vasomotor domain of MENQOL within 12 weeks of beginning the study. The significant symptomatic improvement persisted for the full year that patients were followed.
For patients with particularly bothersome vasomotor symptoms, vasomotor domain scores ranged from 6.9 to 7.2 at baseline and were 2.8-3.6 with TX-001HR and 4.4 with placebo at month 12, according to Dr. Simon.
Speaking during a top abstracts session at the annual meeting of the North American Menopause Society, Dr. Simon said that TX-001HR combines the physiologic sex hormones 17-beta estradiol and progesterone (E2/P4) into a single oral soft-gel.
The phase 3 randomized, double blind, placebo-controlled REPLENISH trial explored the safety and efficacy of one of four dose combinations of E2/P4. A total of 1,833 patients were randomized to receive E2/P4 in doses of 1.0/100 mg, 0.5/100 mg, 0.5/50 mg, or 0.25/50 mg, or to receive placebo. An approximately equal number of patients were allocated to each study arm, except that 151 patients were allocated to receive placebo.
The MENQOL is structured so that the 29 items in the symptom inventory are grouped into four domains: vasomotor, psychosocial, physical, and sexual. Significant reductions were seen at 12 weeks for all patients in overall MENQOL scores and for the four domains.
The REPLENISH investigators also performed a separate analysis of data from the subset of patients who had moderate to severe vasomotor symptoms (VMS). At the 6- and 12-month assessment points, the VMS patients on all but the lowest dose of TX-001HR had significant improvement over placebo.
“Independent of treatment, the largest correlation observed was between changes in moderate to severe VMS frequency and changes in the MENQOL vasomotor symptom domain score at 12 weeks,” said Dr. Simon. The quality of life and moderate to severe VMS frequency were highly correlated, he added (rho = 0.561, P less than .0001). Improvements in the other MENQOL domains were also highly correlated with reduction in moderate to severe frequency (P less than .0001 for all).
Among patients who reported significant improvement on the MENQOL, said Dr. Simon, more of the TX-001HR patients had improvements that were judged to be clinically significant compared to those taking placebo. Women who experienced a minimal clinically important difference in their symptoms had a weekly improvement of 34 fewer VMS events. Those who had a stronger response, which was judged to be clinically important, had a weekly improvement of 44 fewer VMS events.
Dr. Simon reported financial relationships with several pharmaceutical companies, including TherapeuticsMD, the sponsor of the THX-001HR clinical trials.
[email protected]
On Twitter @karioakes
PHILADELPHIA – An oral estradiol/progesterone formulation significantly improved menopause-related quality of life, compared with placebo, for up to 1 year after beginning treatment, according to a new study.
If approved, the new formulation “may be an option for the estimated millions of women currently using less-regulated and unapproved compounded bioidentical hormone therapy,” said James Simon, MD, the study’s senior author.
Patients receiving the combination therapy, termed TX-001HR, experienced a significant improvement in quality of life, compared with placebo and compared with baseline, at all study points, said Dr. Simon of George Washington University, Washington.
Using the Menopause-Specific Quality of Life questionnaire (MENQOL), Dr. Simon and his coinvestigators found that women taking the combination therapy saw reductions in the vasomotor domain of MENQOL within 12 weeks of beginning the study. The significant symptomatic improvement persisted for the full year that patients were followed.
For patients with particularly bothersome vasomotor symptoms, vasomotor domain scores ranged from 6.9 to 7.2 at baseline and were 2.8-3.6 with TX-001HR and 4.4 with placebo at month 12, according to Dr. Simon.
Speaking during a top abstracts session at the annual meeting of the North American Menopause Society, Dr. Simon said that TX-001HR combines the physiologic sex hormones 17-beta estradiol and progesterone (E2/P4) into a single oral soft-gel.
The phase 3 randomized, double blind, placebo-controlled REPLENISH trial explored the safety and efficacy of one of four dose combinations of E2/P4. A total of 1,833 patients were randomized to receive E2/P4 in doses of 1.0/100 mg, 0.5/100 mg, 0.5/50 mg, or 0.25/50 mg, or to receive placebo. An approximately equal number of patients were allocated to each study arm, except that 151 patients were allocated to receive placebo.
The MENQOL is structured so that the 29 items in the symptom inventory are grouped into four domains: vasomotor, psychosocial, physical, and sexual. Significant reductions were seen at 12 weeks for all patients in overall MENQOL scores and for the four domains.
The REPLENISH investigators also performed a separate analysis of data from the subset of patients who had moderate to severe vasomotor symptoms (VMS). At the 6- and 12-month assessment points, the VMS patients on all but the lowest dose of TX-001HR had significant improvement over placebo.
“Independent of treatment, the largest correlation observed was between changes in moderate to severe VMS frequency and changes in the MENQOL vasomotor symptom domain score at 12 weeks,” said Dr. Simon. The quality of life and moderate to severe VMS frequency were highly correlated, he added (rho = 0.561, P less than .0001). Improvements in the other MENQOL domains were also highly correlated with reduction in moderate to severe frequency (P less than .0001 for all).
Among patients who reported significant improvement on the MENQOL, said Dr. Simon, more of the TX-001HR patients had improvements that were judged to be clinically significant compared to those taking placebo. Women who experienced a minimal clinically important difference in their symptoms had a weekly improvement of 34 fewer VMS events. Those who had a stronger response, which was judged to be clinically important, had a weekly improvement of 44 fewer VMS events.
Dr. Simon reported financial relationships with several pharmaceutical companies, including TherapeuticsMD, the sponsor of the THX-001HR clinical trials.
[email protected]
On Twitter @karioakes
PHILADELPHIA – An oral estradiol/progesterone formulation significantly improved menopause-related quality of life, compared with placebo, for up to 1 year after beginning treatment, according to a new study.
If approved, the new formulation “may be an option for the estimated millions of women currently using less-regulated and unapproved compounded bioidentical hormone therapy,” said James Simon, MD, the study’s senior author.
Patients receiving the combination therapy, termed TX-001HR, experienced a significant improvement in quality of life, compared with placebo and compared with baseline, at all study points, said Dr. Simon of George Washington University, Washington.
Using the Menopause-Specific Quality of Life questionnaire (MENQOL), Dr. Simon and his coinvestigators found that women taking the combination therapy saw reductions in the vasomotor domain of MENQOL within 12 weeks of beginning the study. The significant symptomatic improvement persisted for the full year that patients were followed.
For patients with particularly bothersome vasomotor symptoms, vasomotor domain scores ranged from 6.9 to 7.2 at baseline and were 2.8-3.6 with TX-001HR and 4.4 with placebo at month 12, according to Dr. Simon.
Speaking during a top abstracts session at the annual meeting of the North American Menopause Society, Dr. Simon said that TX-001HR combines the physiologic sex hormones 17-beta estradiol and progesterone (E2/P4) into a single oral soft-gel.
The phase 3 randomized, double blind, placebo-controlled REPLENISH trial explored the safety and efficacy of one of four dose combinations of E2/P4. A total of 1,833 patients were randomized to receive E2/P4 in doses of 1.0/100 mg, 0.5/100 mg, 0.5/50 mg, or 0.25/50 mg, or to receive placebo. An approximately equal number of patients were allocated to each study arm, except that 151 patients were allocated to receive placebo.
The MENQOL is structured so that the 29 items in the symptom inventory are grouped into four domains: vasomotor, psychosocial, physical, and sexual. Significant reductions were seen at 12 weeks for all patients in overall MENQOL scores and for the four domains.
The REPLENISH investigators also performed a separate analysis of data from the subset of patients who had moderate to severe vasomotor symptoms (VMS). At the 6- and 12-month assessment points, the VMS patients on all but the lowest dose of TX-001HR had significant improvement over placebo.
“Independent of treatment, the largest correlation observed was between changes in moderate to severe VMS frequency and changes in the MENQOL vasomotor symptom domain score at 12 weeks,” said Dr. Simon. The quality of life and moderate to severe VMS frequency were highly correlated, he added (rho = 0.561, P less than .0001). Improvements in the other MENQOL domains were also highly correlated with reduction in moderate to severe frequency (P less than .0001 for all).
Among patients who reported significant improvement on the MENQOL, said Dr. Simon, more of the TX-001HR patients had improvements that were judged to be clinically significant compared to those taking placebo. Women who experienced a minimal clinically important difference in their symptoms had a weekly improvement of 34 fewer VMS events. Those who had a stronger response, which was judged to be clinically important, had a weekly improvement of 44 fewer VMS events.
Dr. Simon reported financial relationships with several pharmaceutical companies, including TherapeuticsMD, the sponsor of the THX-001HR clinical trials.
[email protected]
On Twitter @karioakes
AT NAMS 2017
Key clinical point:
Major finding: Patients taking TX-100HR had significant improvements in a menopause-related quality of life scale at all study time points.
Data source: REPLENISH, a phase 3, randomized, double blind, placebo-controlled study of 1,833 postmenopausal women.
Disclosures: Dr. Simon reported financial relationships with multiple pharmaceutical companies, including TherapeuticsMD, sponsor of the REPLENISH trial.
Time to take the fear out of the hormone therapy conversation
PHILADELPHIA – It’s time to be clear about the benefits of hormone therapy for many women in midlife, JoAnn Pinkerton, MD, executive director of the North American Menopause Society, said during the keynote address at the group’s annual meeting.
“I want to take fear out of the conversation. Hormone therapy remains the most effective treatment for vasomotor symptoms and the genitourinary syndrome of menopause and has been shown to prevent bone loss and fracture,” said Dr. Pinkerton, who also chaired the advisory panel that penned the 2017 NAMS position statement on hormone therapy.
Hormone therapy is currently approved by the Food and Drug Administration as first-line therapy to relieve vasomotor symptoms (VMS). Low-dose vaginal estrogen therapy is also a first-line treatment for the genitourinary syndrome of menopause, since it can directly address vulvovaginal atrophy.
An additional approved indication for systemic hormone therapy (HT) is the prevention of bone loss and fracture reduction in postmenopausal women who have increased risk of osteoporosis or fractures. It’s also FDA approved for women who had hypogonadism, primary ovarian insufficiency, or premature surgical menopause, who may use HT until the average age of menopause – about 52 years.
Unopposed systemic estrogen should not be used as HT in women with an intact uterus because of the elevated risk of endometrial cancer, and all indications assume there are no contraindications to HT use.
The position statement was developed by an expert panel, and has been endorsed by a number of international menopause societies, other American women’s health societies, and the American Association of Clinical Endocrinologists.
Cardiovascular risks
Early analysis of cardiovascular health data from the large, prospective Women’s Health Initiative trial raised significant concerns about increased risk. But further study of data from the Women’s Health Initiative, as well as meta-analyses of randomized controlled trials, have yielded a more nuanced view of the relationship between HT and cardiovascular disease, she said.
“Age matters,” Dr. Pinkerton said. “Data show that there is reduced heart disease in women who start [hormone replacement] early.” There is increasing data, she said, to support the “timing hypothesis.”
“Women who start HT before the age of 60 years, or within 10 years of menopause, may have a reduced risk of coronary heart disease,” Dr. Pinkerton said. “There is concern of increased risk of [coronary heart disease] in women who initiate hormone therapy more than 10 or 20 years from menopause.”
Use of HT is associated with a significantly increased risk of venous thromboembolism, a risk that increases with time, as does the risk of stroke and pulmonary embolism. Using lower doses or transdermal HT may reduce this risk, but “the lack of comparative randomized controlled trial data limit recommendations,” she said.
Transdermal therapy can also be considered for women with metabolic syndrome, hypertriglyceridemia, and fatty liver, since this route avoids first-pass hepatic metabolism.
Breast cancer
“The effect of hormone therapy on breast cancer risk is complex and conflicting,” said Dr Pinkerton, noting that breast cancer risk from HT may depend on many factors, including whether progestins are added to estrogen, the dose and duration of HT use, and how HT is administered.
Regarding the use of vaginal estrogen for women who have had breast cancer, Dr. Pinkerton said, “It’s a data-free zone.” Systemic absorption of vaginally-dosed estrogen is minimal, but the decision to use vaginal estrogen for a breast cancer survivor who is experiencing genitourinary syndrome of menopause symptoms should always be made in consultation with the woman’s oncologist and in shared decision-making with the patient herself, Dr. Pinkerton added.
Bioidentical HT
“Unique concerns about safety surround the use of compounded bioidentical hormone therapy,” Dr. Pinkerton said.
The lack of regulation and monitoring, together with lax labeling requirements, are areas of concern. Accurate dosing may not be occurring, and data are lacking to support safety and efficacy of compounded bioidentical products, she said. Neither is there evidence to support routine testing of serum or salivary hormone levels, she added.
Symptom relief
For isolated symptoms of genitourinary syndrome of menopause, low-dose vaginal preparations are safe and effective, Dr. Pinkerton said. For women who are symptomatic, use of either low-dose vaginal estrogen or systemic HT increases sexual function scores; however, she said, “hormone therapy is not recommended as the sole treatment of other sexual function problems,” such as diminished libido, though it can be a useful adjunct.
“Hormone therapy is the most effective treatment for hot flashes,” said Dr. Pinkerton, and using HT improves sleep quality and duration in women with bothersome nighttime hot flashes.
Fracture prevention
Data from the Women’s Health Initiative showed a highly significant 33% reduction in hip fractures for women using both estrogen alone and estrogen with progestogen. “That seems to get forgotten,” Dr. Pinkerton said. Though HT’s osteoporosis and fracture prevention effects stop when HT is discontinued, there’s no evidence of elevated fracture risk above baseline in women who have used HT and then stopped.
“Younger women may need higher doses to protect bone, but make sure you get adequate endometrial protection if you do that,” said Dr. Pinkerton, professor of obstetrics and gynecology at the University of Virginia.
Unapproved uses
“Hormone therapy is not recommended at any age to prevent or treat cognition or dementia,” said Dr. Pinkerton, citing a lack of data to support its use for these reasons. Observational data may show some reduction in risk of Alzheimer’s disease in women who use HT at younger ages or soon after menopause, she said.
Though HT users have a reduced risk of developing type 2 diabetes, diabetes prevention is not a Food and Drug Administration–approved indication for HT. Abdominal fat accumulation and weight gain may be reduced by HT as well, Dr. Pinkerton said.
Similarly, there are no data to support the use of HT for the treatment of clinical depression. Perimenopausal – but not postmenopausal – women may see some benefit from estrogen therapy; progestins may actually contribute to mood disturbance, she said.
Special populations
“Systemic hormone therapy is not recommended for survivors of breast cancer,” Dr. Pinkerton said. Any consideration for systemic HT in this population should include the oncologist, and only be entertained after other nonhormonal options have been tried, she said.
Women with a family history of breast or ovarian cancer, or with the BRCA mutation, do not appear to have their risk increased by the use of HT, though the ovarian cancer data are limited and observational, Dr. Pinkerton said.
The NAMS position statement also addresses the use of HT in other special populations, including survivors of other cancers and women who have primary ovarian insufficiency or early menopause, BRCA-positive women who have undergone oophorectomy, and those over age 65 years.
“The recommendation to routinely discontinue systemic hormone therapy after age 65 is not supported by data,” Dr. Pinkerton said. “I would tell you that there’s a lack of good data about prolonged duration. What I tell patients is, we really are in another data-free zone.” She recommends an individualized approach that balances benefits and risks and includes ongoing surveillance.
New message
“So what do I want us to do? I want us to change the message,” she said. Rather than advocating for HT to be used in “the lowest dose, for the shortest period of time,” she said the new message should be for women to use “appropriate hormone therapy to meet their treatment goals.”
The bottom line? After accounting for women who should avoid HT for specific contraindications, “benefits are likely to outweigh risks for symptomatic women who initiate hormone therapy when aged younger than 60 years and within 10 years of menopause,” Dr. Pinkerton said.
Dr. Pinkerton reported that she has received grant or research support from TherapeuticsMD.
[email protected]
On Twitter @karioakes
PHILADELPHIA – It’s time to be clear about the benefits of hormone therapy for many women in midlife, JoAnn Pinkerton, MD, executive director of the North American Menopause Society, said during the keynote address at the group’s annual meeting.
“I want to take fear out of the conversation. Hormone therapy remains the most effective treatment for vasomotor symptoms and the genitourinary syndrome of menopause and has been shown to prevent bone loss and fracture,” said Dr. Pinkerton, who also chaired the advisory panel that penned the 2017 NAMS position statement on hormone therapy.
Hormone therapy is currently approved by the Food and Drug Administration as first-line therapy to relieve vasomotor symptoms (VMS). Low-dose vaginal estrogen therapy is also a first-line treatment for the genitourinary syndrome of menopause, since it can directly address vulvovaginal atrophy.
An additional approved indication for systemic hormone therapy (HT) is the prevention of bone loss and fracture reduction in postmenopausal women who have increased risk of osteoporosis or fractures. It’s also FDA approved for women who had hypogonadism, primary ovarian insufficiency, or premature surgical menopause, who may use HT until the average age of menopause – about 52 years.
Unopposed systemic estrogen should not be used as HT in women with an intact uterus because of the elevated risk of endometrial cancer, and all indications assume there are no contraindications to HT use.
The position statement was developed by an expert panel, and has been endorsed by a number of international menopause societies, other American women’s health societies, and the American Association of Clinical Endocrinologists.
Cardiovascular risks
Early analysis of cardiovascular health data from the large, prospective Women’s Health Initiative trial raised significant concerns about increased risk. But further study of data from the Women’s Health Initiative, as well as meta-analyses of randomized controlled trials, have yielded a more nuanced view of the relationship between HT and cardiovascular disease, she said.
“Age matters,” Dr. Pinkerton said. “Data show that there is reduced heart disease in women who start [hormone replacement] early.” There is increasing data, she said, to support the “timing hypothesis.”
“Women who start HT before the age of 60 years, or within 10 years of menopause, may have a reduced risk of coronary heart disease,” Dr. Pinkerton said. “There is concern of increased risk of [coronary heart disease] in women who initiate hormone therapy more than 10 or 20 years from menopause.”
Use of HT is associated with a significantly increased risk of venous thromboembolism, a risk that increases with time, as does the risk of stroke and pulmonary embolism. Using lower doses or transdermal HT may reduce this risk, but “the lack of comparative randomized controlled trial data limit recommendations,” she said.
Transdermal therapy can also be considered for women with metabolic syndrome, hypertriglyceridemia, and fatty liver, since this route avoids first-pass hepatic metabolism.
Breast cancer
“The effect of hormone therapy on breast cancer risk is complex and conflicting,” said Dr Pinkerton, noting that breast cancer risk from HT may depend on many factors, including whether progestins are added to estrogen, the dose and duration of HT use, and how HT is administered.
Regarding the use of vaginal estrogen for women who have had breast cancer, Dr. Pinkerton said, “It’s a data-free zone.” Systemic absorption of vaginally-dosed estrogen is minimal, but the decision to use vaginal estrogen for a breast cancer survivor who is experiencing genitourinary syndrome of menopause symptoms should always be made in consultation with the woman’s oncologist and in shared decision-making with the patient herself, Dr. Pinkerton added.
Bioidentical HT
“Unique concerns about safety surround the use of compounded bioidentical hormone therapy,” Dr. Pinkerton said.
The lack of regulation and monitoring, together with lax labeling requirements, are areas of concern. Accurate dosing may not be occurring, and data are lacking to support safety and efficacy of compounded bioidentical products, she said. Neither is there evidence to support routine testing of serum or salivary hormone levels, she added.
Symptom relief
For isolated symptoms of genitourinary syndrome of menopause, low-dose vaginal preparations are safe and effective, Dr. Pinkerton said. For women who are symptomatic, use of either low-dose vaginal estrogen or systemic HT increases sexual function scores; however, she said, “hormone therapy is not recommended as the sole treatment of other sexual function problems,” such as diminished libido, though it can be a useful adjunct.
“Hormone therapy is the most effective treatment for hot flashes,” said Dr. Pinkerton, and using HT improves sleep quality and duration in women with bothersome nighttime hot flashes.
Fracture prevention
Data from the Women’s Health Initiative showed a highly significant 33% reduction in hip fractures for women using both estrogen alone and estrogen with progestogen. “That seems to get forgotten,” Dr. Pinkerton said. Though HT’s osteoporosis and fracture prevention effects stop when HT is discontinued, there’s no evidence of elevated fracture risk above baseline in women who have used HT and then stopped.
“Younger women may need higher doses to protect bone, but make sure you get adequate endometrial protection if you do that,” said Dr. Pinkerton, professor of obstetrics and gynecology at the University of Virginia.
Unapproved uses
“Hormone therapy is not recommended at any age to prevent or treat cognition or dementia,” said Dr. Pinkerton, citing a lack of data to support its use for these reasons. Observational data may show some reduction in risk of Alzheimer’s disease in women who use HT at younger ages or soon after menopause, she said.
Though HT users have a reduced risk of developing type 2 diabetes, diabetes prevention is not a Food and Drug Administration–approved indication for HT. Abdominal fat accumulation and weight gain may be reduced by HT as well, Dr. Pinkerton said.
Similarly, there are no data to support the use of HT for the treatment of clinical depression. Perimenopausal – but not postmenopausal – women may see some benefit from estrogen therapy; progestins may actually contribute to mood disturbance, she said.
Special populations
“Systemic hormone therapy is not recommended for survivors of breast cancer,” Dr. Pinkerton said. Any consideration for systemic HT in this population should include the oncologist, and only be entertained after other nonhormonal options have been tried, she said.
Women with a family history of breast or ovarian cancer, or with the BRCA mutation, do not appear to have their risk increased by the use of HT, though the ovarian cancer data are limited and observational, Dr. Pinkerton said.
The NAMS position statement also addresses the use of HT in other special populations, including survivors of other cancers and women who have primary ovarian insufficiency or early menopause, BRCA-positive women who have undergone oophorectomy, and those over age 65 years.
“The recommendation to routinely discontinue systemic hormone therapy after age 65 is not supported by data,” Dr. Pinkerton said. “I would tell you that there’s a lack of good data about prolonged duration. What I tell patients is, we really are in another data-free zone.” She recommends an individualized approach that balances benefits and risks and includes ongoing surveillance.
New message
“So what do I want us to do? I want us to change the message,” she said. Rather than advocating for HT to be used in “the lowest dose, for the shortest period of time,” she said the new message should be for women to use “appropriate hormone therapy to meet their treatment goals.”
The bottom line? After accounting for women who should avoid HT for specific contraindications, “benefits are likely to outweigh risks for symptomatic women who initiate hormone therapy when aged younger than 60 years and within 10 years of menopause,” Dr. Pinkerton said.
Dr. Pinkerton reported that she has received grant or research support from TherapeuticsMD.
[email protected]
On Twitter @karioakes
PHILADELPHIA – It’s time to be clear about the benefits of hormone therapy for many women in midlife, JoAnn Pinkerton, MD, executive director of the North American Menopause Society, said during the keynote address at the group’s annual meeting.
“I want to take fear out of the conversation. Hormone therapy remains the most effective treatment for vasomotor symptoms and the genitourinary syndrome of menopause and has been shown to prevent bone loss and fracture,” said Dr. Pinkerton, who also chaired the advisory panel that penned the 2017 NAMS position statement on hormone therapy.
Hormone therapy is currently approved by the Food and Drug Administration as first-line therapy to relieve vasomotor symptoms (VMS). Low-dose vaginal estrogen therapy is also a first-line treatment for the genitourinary syndrome of menopause, since it can directly address vulvovaginal atrophy.
An additional approved indication for systemic hormone therapy (HT) is the prevention of bone loss and fracture reduction in postmenopausal women who have increased risk of osteoporosis or fractures. It’s also FDA approved for women who had hypogonadism, primary ovarian insufficiency, or premature surgical menopause, who may use HT until the average age of menopause – about 52 years.
Unopposed systemic estrogen should not be used as HT in women with an intact uterus because of the elevated risk of endometrial cancer, and all indications assume there are no contraindications to HT use.
The position statement was developed by an expert panel, and has been endorsed by a number of international menopause societies, other American women’s health societies, and the American Association of Clinical Endocrinologists.
Cardiovascular risks
Early analysis of cardiovascular health data from the large, prospective Women’s Health Initiative trial raised significant concerns about increased risk. But further study of data from the Women’s Health Initiative, as well as meta-analyses of randomized controlled trials, have yielded a more nuanced view of the relationship between HT and cardiovascular disease, she said.
“Age matters,” Dr. Pinkerton said. “Data show that there is reduced heart disease in women who start [hormone replacement] early.” There is increasing data, she said, to support the “timing hypothesis.”
“Women who start HT before the age of 60 years, or within 10 years of menopause, may have a reduced risk of coronary heart disease,” Dr. Pinkerton said. “There is concern of increased risk of [coronary heart disease] in women who initiate hormone therapy more than 10 or 20 years from menopause.”
Use of HT is associated with a significantly increased risk of venous thromboembolism, a risk that increases with time, as does the risk of stroke and pulmonary embolism. Using lower doses or transdermal HT may reduce this risk, but “the lack of comparative randomized controlled trial data limit recommendations,” she said.
Transdermal therapy can also be considered for women with metabolic syndrome, hypertriglyceridemia, and fatty liver, since this route avoids first-pass hepatic metabolism.
Breast cancer
“The effect of hormone therapy on breast cancer risk is complex and conflicting,” said Dr Pinkerton, noting that breast cancer risk from HT may depend on many factors, including whether progestins are added to estrogen, the dose and duration of HT use, and how HT is administered.
Regarding the use of vaginal estrogen for women who have had breast cancer, Dr. Pinkerton said, “It’s a data-free zone.” Systemic absorption of vaginally-dosed estrogen is minimal, but the decision to use vaginal estrogen for a breast cancer survivor who is experiencing genitourinary syndrome of menopause symptoms should always be made in consultation with the woman’s oncologist and in shared decision-making with the patient herself, Dr. Pinkerton added.
Bioidentical HT
“Unique concerns about safety surround the use of compounded bioidentical hormone therapy,” Dr. Pinkerton said.
The lack of regulation and monitoring, together with lax labeling requirements, are areas of concern. Accurate dosing may not be occurring, and data are lacking to support safety and efficacy of compounded bioidentical products, she said. Neither is there evidence to support routine testing of serum or salivary hormone levels, she added.
Symptom relief
For isolated symptoms of genitourinary syndrome of menopause, low-dose vaginal preparations are safe and effective, Dr. Pinkerton said. For women who are symptomatic, use of either low-dose vaginal estrogen or systemic HT increases sexual function scores; however, she said, “hormone therapy is not recommended as the sole treatment of other sexual function problems,” such as diminished libido, though it can be a useful adjunct.
“Hormone therapy is the most effective treatment for hot flashes,” said Dr. Pinkerton, and using HT improves sleep quality and duration in women with bothersome nighttime hot flashes.
Fracture prevention
Data from the Women’s Health Initiative showed a highly significant 33% reduction in hip fractures for women using both estrogen alone and estrogen with progestogen. “That seems to get forgotten,” Dr. Pinkerton said. Though HT’s osteoporosis and fracture prevention effects stop when HT is discontinued, there’s no evidence of elevated fracture risk above baseline in women who have used HT and then stopped.
“Younger women may need higher doses to protect bone, but make sure you get adequate endometrial protection if you do that,” said Dr. Pinkerton, professor of obstetrics and gynecology at the University of Virginia.
Unapproved uses
“Hormone therapy is not recommended at any age to prevent or treat cognition or dementia,” said Dr. Pinkerton, citing a lack of data to support its use for these reasons. Observational data may show some reduction in risk of Alzheimer’s disease in women who use HT at younger ages or soon after menopause, she said.
Though HT users have a reduced risk of developing type 2 diabetes, diabetes prevention is not a Food and Drug Administration–approved indication for HT. Abdominal fat accumulation and weight gain may be reduced by HT as well, Dr. Pinkerton said.
Similarly, there are no data to support the use of HT for the treatment of clinical depression. Perimenopausal – but not postmenopausal – women may see some benefit from estrogen therapy; progestins may actually contribute to mood disturbance, she said.
Special populations
“Systemic hormone therapy is not recommended for survivors of breast cancer,” Dr. Pinkerton said. Any consideration for systemic HT in this population should include the oncologist, and only be entertained after other nonhormonal options have been tried, she said.
Women with a family history of breast or ovarian cancer, or with the BRCA mutation, do not appear to have their risk increased by the use of HT, though the ovarian cancer data are limited and observational, Dr. Pinkerton said.
The NAMS position statement also addresses the use of HT in other special populations, including survivors of other cancers and women who have primary ovarian insufficiency or early menopause, BRCA-positive women who have undergone oophorectomy, and those over age 65 years.
“The recommendation to routinely discontinue systemic hormone therapy after age 65 is not supported by data,” Dr. Pinkerton said. “I would tell you that there’s a lack of good data about prolonged duration. What I tell patients is, we really are in another data-free zone.” She recommends an individualized approach that balances benefits and risks and includes ongoing surveillance.
New message
“So what do I want us to do? I want us to change the message,” she said. Rather than advocating for HT to be used in “the lowest dose, for the shortest period of time,” she said the new message should be for women to use “appropriate hormone therapy to meet their treatment goals.”
The bottom line? After accounting for women who should avoid HT for specific contraindications, “benefits are likely to outweigh risks for symptomatic women who initiate hormone therapy when aged younger than 60 years and within 10 years of menopause,” Dr. Pinkerton said.
Dr. Pinkerton reported that she has received grant or research support from TherapeuticsMD.
[email protected]
On Twitter @karioakes
AT NAMS 2017
Gap in osteoporosis diagnosis and treatment stirs concern
DENVER – A recent study of Medicare recipients who experienced a hip fracture found that just 19% of them had been receiving a bone-active osteoporosis treatment before the fracture occurred. That number reveals an alarming trend of underdiagnosis of osteoporosis.
But that number – from a 2016 study in JAMA Internal Medicine – is just the start. After the fracture, the percentage of women receiving treatment barely changed, rising to just 21% (JAMA Intern Med. 2016 Oct 1;176[10]:1531-8).
This trend of under-diagnosis and treatment of osteoporosis has occurred in spite of the fact that effective therapy exists to reduce future fractures. In fact, a single dose of zoledronic acid has been shown to reduce clinical fractures by 35%, and mortality by 28% over an average 2-year follow-up (N Engl J Med. 2007;357:1799-1809).
“To me, this is really a shame,” Douglas Bauer, MD, professor of medicine at the University of California, San Francisco, said at a session at the annual meeting of the American Society for Bone and Mineral Research that was dedicated to the issue.
It remains unclear why the fracture rate declined despite low levels of diagnosis and treatment. Some researchers, such as Bo Abrahamsen, MD, PhD, suggest there is a population effect. At the ASBMR annual meeting, Dr. Abrahamsen of the University of Southern Denmark, Odense, noted that in the western world, women born in the 1930s appear to be less prone to fractures than other birth cohorts, and it could be that this group contributed to the decline in fracture rates. A Danish study, he said, seems to confirm this idea. As other birth cohorts age, the numbers could well get worse.
And that’s worrying, because a gap in treatment and diagnosis of osteoporosis could lead to an epidemic of new fractures. “We need to address this crisis in health care for a very preventable disease,” Meryl LeBoff, MD, director of the skeletal health and osteoporosis center and bone density unit at Brigham and Women’s Hospital, Boston, said in an interview.
There are several likely causes of declining treatment and diagnosis rates. In 2003, a report surfaced that osteonecrosis of the jaw occurred in cancer patients taking bisphosphonates to prevent metastasis to bone. Those patients received doses that were far higher than the typical osteoporosis patient, but the reports spooked patients. In 2005, researchers pinned another rare side effect on bisphosphonates – atypical femur fractures.
Other factors contributed. In 2007, the Centers for Medicare & Medicaid Services cut the reimbursement rate for bone densitometry (DXA) testing, which has led to a drop in the number of tests, from a peak of 17.9% of women over age 65 years having been tested in 2009 to 14.8% in 2014. That has complicated efforts to diagnose osteoporosis, and may be affecting patients’ willingness to undergo therapy. A patient may go to the hospital for a hip fracture, but without a bone density test to raise concerns, she may write the fracture off as an accident. A DXA test that returns an abnormal value can change that. “If you have low BMD and a fracture, you have a worse prognosis and a higher risk of the next fracture. It’s much easier to convince patients [to begin therapy],” said John Carey, MD, a rheumatologist at Galway (Ireland) University Hospitals and president of the International Society for Clinical Densitometry.
Others emphasized the need to get DXA reimbursement raised, at least to a point where physicians can break even on the test. “Unfortunately, what’s happening is that as DXA reimbursement goes down, physicians are investing less in the education of their staff according to current guidelines,” Dr. Lewiecki said. He noted that there is draft legislation in Congress to raise DXA reimbursement (H.R. 1898), although it is currently in committee.
The forces that create the treatment and diagnostic gap aren’t simple, and no single strategy is likely to fix the problem. A number have been proposed.
FLS programs seek to quickly identify and provide treatment and monitoring for individuals who are at high risk for additional fractures. The programs identify patients who have suffered a fragility fracture and place them into a coordinated care model. For example, if a radiologist identified a patient of concern, she can be immediately referred to the FLS for quick follow-up, to include bone density scans and other steps to ensure proper diagnosis and treatment. In the absence of an FLS, it could be months before a patient is seen again, if a radiologist refers her at all. “You lose patients. But if they are tied into a coordination of care model, the patient is brought in immediately and they get the attention and awareness. They’re not just lost,” said Debbie Zeldow, executive director of the National Bone Health Alliance (NBHA).
Despite their effectiveness, FLS programs could be a tough sell for the upfront investment they require. To help organizations determine the cost-effectiveness of an FLS, the National Bone Health Alliance has developed a return on investment calculator.
And in fact, FLS programs are gaining traction, according to Ms. Zeldow. NBHA has posted a variety of resources for establishing an FLS on its website, which contains webinars and other resources, including the text of patient flyers produced by Kaiser Permanente translated into many languages. “There’s been a huge jump in interest in implementation. I’m getting calls on a daily basis from sites that want to implement an FLS. People are being pinged for readmission, and they’re looking for ways for their hospital or practice to improve outcomes. It’s definitely a way for hospitals to differentiate themselves around care,” Ms. Zeldow said in an interview.
FLS programs reduce secondary fractures, but the ultimate goal is to catch osteoporosis earlier and prevent even first-time fractures. That will require better communication with primary care providers, who bear the brunt of osteoporosis diagnosis and care.
“We need to do a better job of reducing barriers for primary care doctors, to try to minimize unnecessary treatment complexity, and address the fact that this is one of the many prevention issues that physicians are asked to manage, and all that in an increasingly time-constrained world,” Dr. Bauer said.
With that goal in mind, the American College of Physicians released new guidelines in May (Ann Intern Med. 2017;166[11]:818-39). They were intended to identify first-line therapies and simplify matters for primary care physicians, but they drew the ire of many endocrinologists for being too general. NBHA has formed an ACP guideline working group that aims to refine those guidelines. The committee is drafting a statement and a document for patients to help clarify the guidelines, particularly with respect to high-risk patients. The committee also seeks to avoid any rancor. “We’ve made a concerted effort to include primary care doctors, to make sure there’s not a disconnect between experts and general practitioners. We want to make sure it’s a useful tool and we’re not just bashing the guidelines,” Ms. Zeldow said.
Another way to help overburdened primary care providers is to provide training for physicians, especially in underserved areas. The National Osteoporosis Foundation’s TeleECHO program is a remote training service that can help interested local providers elevate their knowledge so they can become a local osteoporosis expert. “Patients can get better care, at more convenience and at lower cost, rather than having to travel to a specialist center far away,” Dr. Lewiecki said.
Patient concerns about side effects, the changing health care climate, and the challenges facing primary care providers add up to difficult environment for countering the reductions in diagnosis and treatment of osteoporosis, but Dr. Lewiecki is hopeful. “Fracture liaison services combined with better education of health care providers through new educational methods I think have great promise. It’s just a matter of getting those things online,” he said.
Dr. Carey has been a speaker for Roche, Pfizer, and AbbVie. Dr. Lewiecki has consulted for Amgen. Dr. Leder has received funding from Lilly and Amgen, and has been a consultant for Lilly, Amgen, and Radius. Dr. Bauer and Ms. Zeldow reported having no financial disclosures.
DENVER – A recent study of Medicare recipients who experienced a hip fracture found that just 19% of them had been receiving a bone-active osteoporosis treatment before the fracture occurred. That number reveals an alarming trend of underdiagnosis of osteoporosis.
But that number – from a 2016 study in JAMA Internal Medicine – is just the start. After the fracture, the percentage of women receiving treatment barely changed, rising to just 21% (JAMA Intern Med. 2016 Oct 1;176[10]:1531-8).
This trend of under-diagnosis and treatment of osteoporosis has occurred in spite of the fact that effective therapy exists to reduce future fractures. In fact, a single dose of zoledronic acid has been shown to reduce clinical fractures by 35%, and mortality by 28% over an average 2-year follow-up (N Engl J Med. 2007;357:1799-1809).
“To me, this is really a shame,” Douglas Bauer, MD, professor of medicine at the University of California, San Francisco, said at a session at the annual meeting of the American Society for Bone and Mineral Research that was dedicated to the issue.
It remains unclear why the fracture rate declined despite low levels of diagnosis and treatment. Some researchers, such as Bo Abrahamsen, MD, PhD, suggest there is a population effect. At the ASBMR annual meeting, Dr. Abrahamsen of the University of Southern Denmark, Odense, noted that in the western world, women born in the 1930s appear to be less prone to fractures than other birth cohorts, and it could be that this group contributed to the decline in fracture rates. A Danish study, he said, seems to confirm this idea. As other birth cohorts age, the numbers could well get worse.
And that’s worrying, because a gap in treatment and diagnosis of osteoporosis could lead to an epidemic of new fractures. “We need to address this crisis in health care for a very preventable disease,” Meryl LeBoff, MD, director of the skeletal health and osteoporosis center and bone density unit at Brigham and Women’s Hospital, Boston, said in an interview.
There are several likely causes of declining treatment and diagnosis rates. In 2003, a report surfaced that osteonecrosis of the jaw occurred in cancer patients taking bisphosphonates to prevent metastasis to bone. Those patients received doses that were far higher than the typical osteoporosis patient, but the reports spooked patients. In 2005, researchers pinned another rare side effect on bisphosphonates – atypical femur fractures.
Other factors contributed. In 2007, the Centers for Medicare & Medicaid Services cut the reimbursement rate for bone densitometry (DXA) testing, which has led to a drop in the number of tests, from a peak of 17.9% of women over age 65 years having been tested in 2009 to 14.8% in 2014. That has complicated efforts to diagnose osteoporosis, and may be affecting patients’ willingness to undergo therapy. A patient may go to the hospital for a hip fracture, but without a bone density test to raise concerns, she may write the fracture off as an accident. A DXA test that returns an abnormal value can change that. “If you have low BMD and a fracture, you have a worse prognosis and a higher risk of the next fracture. It’s much easier to convince patients [to begin therapy],” said John Carey, MD, a rheumatologist at Galway (Ireland) University Hospitals and president of the International Society for Clinical Densitometry.
Others emphasized the need to get DXA reimbursement raised, at least to a point where physicians can break even on the test. “Unfortunately, what’s happening is that as DXA reimbursement goes down, physicians are investing less in the education of their staff according to current guidelines,” Dr. Lewiecki said. He noted that there is draft legislation in Congress to raise DXA reimbursement (H.R. 1898), although it is currently in committee.
The forces that create the treatment and diagnostic gap aren’t simple, and no single strategy is likely to fix the problem. A number have been proposed.
FLS programs seek to quickly identify and provide treatment and monitoring for individuals who are at high risk for additional fractures. The programs identify patients who have suffered a fragility fracture and place them into a coordinated care model. For example, if a radiologist identified a patient of concern, she can be immediately referred to the FLS for quick follow-up, to include bone density scans and other steps to ensure proper diagnosis and treatment. In the absence of an FLS, it could be months before a patient is seen again, if a radiologist refers her at all. “You lose patients. But if they are tied into a coordination of care model, the patient is brought in immediately and they get the attention and awareness. They’re not just lost,” said Debbie Zeldow, executive director of the National Bone Health Alliance (NBHA).
Despite their effectiveness, FLS programs could be a tough sell for the upfront investment they require. To help organizations determine the cost-effectiveness of an FLS, the National Bone Health Alliance has developed a return on investment calculator.
And in fact, FLS programs are gaining traction, according to Ms. Zeldow. NBHA has posted a variety of resources for establishing an FLS on its website, which contains webinars and other resources, including the text of patient flyers produced by Kaiser Permanente translated into many languages. “There’s been a huge jump in interest in implementation. I’m getting calls on a daily basis from sites that want to implement an FLS. People are being pinged for readmission, and they’re looking for ways for their hospital or practice to improve outcomes. It’s definitely a way for hospitals to differentiate themselves around care,” Ms. Zeldow said in an interview.
FLS programs reduce secondary fractures, but the ultimate goal is to catch osteoporosis earlier and prevent even first-time fractures. That will require better communication with primary care providers, who bear the brunt of osteoporosis diagnosis and care.
“We need to do a better job of reducing barriers for primary care doctors, to try to minimize unnecessary treatment complexity, and address the fact that this is one of the many prevention issues that physicians are asked to manage, and all that in an increasingly time-constrained world,” Dr. Bauer said.
With that goal in mind, the American College of Physicians released new guidelines in May (Ann Intern Med. 2017;166[11]:818-39). They were intended to identify first-line therapies and simplify matters for primary care physicians, but they drew the ire of many endocrinologists for being too general. NBHA has formed an ACP guideline working group that aims to refine those guidelines. The committee is drafting a statement and a document for patients to help clarify the guidelines, particularly with respect to high-risk patients. The committee also seeks to avoid any rancor. “We’ve made a concerted effort to include primary care doctors, to make sure there’s not a disconnect between experts and general practitioners. We want to make sure it’s a useful tool and we’re not just bashing the guidelines,” Ms. Zeldow said.
Another way to help overburdened primary care providers is to provide training for physicians, especially in underserved areas. The National Osteoporosis Foundation’s TeleECHO program is a remote training service that can help interested local providers elevate their knowledge so they can become a local osteoporosis expert. “Patients can get better care, at more convenience and at lower cost, rather than having to travel to a specialist center far away,” Dr. Lewiecki said.
Patient concerns about side effects, the changing health care climate, and the challenges facing primary care providers add up to difficult environment for countering the reductions in diagnosis and treatment of osteoporosis, but Dr. Lewiecki is hopeful. “Fracture liaison services combined with better education of health care providers through new educational methods I think have great promise. It’s just a matter of getting those things online,” he said.
Dr. Carey has been a speaker for Roche, Pfizer, and AbbVie. Dr. Lewiecki has consulted for Amgen. Dr. Leder has received funding from Lilly and Amgen, and has been a consultant for Lilly, Amgen, and Radius. Dr. Bauer and Ms. Zeldow reported having no financial disclosures.
DENVER – A recent study of Medicare recipients who experienced a hip fracture found that just 19% of them had been receiving a bone-active osteoporosis treatment before the fracture occurred. That number reveals an alarming trend of underdiagnosis of osteoporosis.
But that number – from a 2016 study in JAMA Internal Medicine – is just the start. After the fracture, the percentage of women receiving treatment barely changed, rising to just 21% (JAMA Intern Med. 2016 Oct 1;176[10]:1531-8).
This trend of under-diagnosis and treatment of osteoporosis has occurred in spite of the fact that effective therapy exists to reduce future fractures. In fact, a single dose of zoledronic acid has been shown to reduce clinical fractures by 35%, and mortality by 28% over an average 2-year follow-up (N Engl J Med. 2007;357:1799-1809).
“To me, this is really a shame,” Douglas Bauer, MD, professor of medicine at the University of California, San Francisco, said at a session at the annual meeting of the American Society for Bone and Mineral Research that was dedicated to the issue.
It remains unclear why the fracture rate declined despite low levels of diagnosis and treatment. Some researchers, such as Bo Abrahamsen, MD, PhD, suggest there is a population effect. At the ASBMR annual meeting, Dr. Abrahamsen of the University of Southern Denmark, Odense, noted that in the western world, women born in the 1930s appear to be less prone to fractures than other birth cohorts, and it could be that this group contributed to the decline in fracture rates. A Danish study, he said, seems to confirm this idea. As other birth cohorts age, the numbers could well get worse.
And that’s worrying, because a gap in treatment and diagnosis of osteoporosis could lead to an epidemic of new fractures. “We need to address this crisis in health care for a very preventable disease,” Meryl LeBoff, MD, director of the skeletal health and osteoporosis center and bone density unit at Brigham and Women’s Hospital, Boston, said in an interview.
There are several likely causes of declining treatment and diagnosis rates. In 2003, a report surfaced that osteonecrosis of the jaw occurred in cancer patients taking bisphosphonates to prevent metastasis to bone. Those patients received doses that were far higher than the typical osteoporosis patient, but the reports spooked patients. In 2005, researchers pinned another rare side effect on bisphosphonates – atypical femur fractures.
Other factors contributed. In 2007, the Centers for Medicare & Medicaid Services cut the reimbursement rate for bone densitometry (DXA) testing, which has led to a drop in the number of tests, from a peak of 17.9% of women over age 65 years having been tested in 2009 to 14.8% in 2014. That has complicated efforts to diagnose osteoporosis, and may be affecting patients’ willingness to undergo therapy. A patient may go to the hospital for a hip fracture, but without a bone density test to raise concerns, she may write the fracture off as an accident. A DXA test that returns an abnormal value can change that. “If you have low BMD and a fracture, you have a worse prognosis and a higher risk of the next fracture. It’s much easier to convince patients [to begin therapy],” said John Carey, MD, a rheumatologist at Galway (Ireland) University Hospitals and president of the International Society for Clinical Densitometry.
Others emphasized the need to get DXA reimbursement raised, at least to a point where physicians can break even on the test. “Unfortunately, what’s happening is that as DXA reimbursement goes down, physicians are investing less in the education of their staff according to current guidelines,” Dr. Lewiecki said. He noted that there is draft legislation in Congress to raise DXA reimbursement (H.R. 1898), although it is currently in committee.
The forces that create the treatment and diagnostic gap aren’t simple, and no single strategy is likely to fix the problem. A number have been proposed.
FLS programs seek to quickly identify and provide treatment and monitoring for individuals who are at high risk for additional fractures. The programs identify patients who have suffered a fragility fracture and place them into a coordinated care model. For example, if a radiologist identified a patient of concern, she can be immediately referred to the FLS for quick follow-up, to include bone density scans and other steps to ensure proper diagnosis and treatment. In the absence of an FLS, it could be months before a patient is seen again, if a radiologist refers her at all. “You lose patients. But if they are tied into a coordination of care model, the patient is brought in immediately and they get the attention and awareness. They’re not just lost,” said Debbie Zeldow, executive director of the National Bone Health Alliance (NBHA).
Despite their effectiveness, FLS programs could be a tough sell for the upfront investment they require. To help organizations determine the cost-effectiveness of an FLS, the National Bone Health Alliance has developed a return on investment calculator.
And in fact, FLS programs are gaining traction, according to Ms. Zeldow. NBHA has posted a variety of resources for establishing an FLS on its website, which contains webinars and other resources, including the text of patient flyers produced by Kaiser Permanente translated into many languages. “There’s been a huge jump in interest in implementation. I’m getting calls on a daily basis from sites that want to implement an FLS. People are being pinged for readmission, and they’re looking for ways for their hospital or practice to improve outcomes. It’s definitely a way for hospitals to differentiate themselves around care,” Ms. Zeldow said in an interview.
FLS programs reduce secondary fractures, but the ultimate goal is to catch osteoporosis earlier and prevent even first-time fractures. That will require better communication with primary care providers, who bear the brunt of osteoporosis diagnosis and care.
“We need to do a better job of reducing barriers for primary care doctors, to try to minimize unnecessary treatment complexity, and address the fact that this is one of the many prevention issues that physicians are asked to manage, and all that in an increasingly time-constrained world,” Dr. Bauer said.
With that goal in mind, the American College of Physicians released new guidelines in May (Ann Intern Med. 2017;166[11]:818-39). They were intended to identify first-line therapies and simplify matters for primary care physicians, but they drew the ire of many endocrinologists for being too general. NBHA has formed an ACP guideline working group that aims to refine those guidelines. The committee is drafting a statement and a document for patients to help clarify the guidelines, particularly with respect to high-risk patients. The committee also seeks to avoid any rancor. “We’ve made a concerted effort to include primary care doctors, to make sure there’s not a disconnect between experts and general practitioners. We want to make sure it’s a useful tool and we’re not just bashing the guidelines,” Ms. Zeldow said.
Another way to help overburdened primary care providers is to provide training for physicians, especially in underserved areas. The National Osteoporosis Foundation’s TeleECHO program is a remote training service that can help interested local providers elevate their knowledge so they can become a local osteoporosis expert. “Patients can get better care, at more convenience and at lower cost, rather than having to travel to a specialist center far away,” Dr. Lewiecki said.
Patient concerns about side effects, the changing health care climate, and the challenges facing primary care providers add up to difficult environment for countering the reductions in diagnosis and treatment of osteoporosis, but Dr. Lewiecki is hopeful. “Fracture liaison services combined with better education of health care providers through new educational methods I think have great promise. It’s just a matter of getting those things online,” he said.
Dr. Carey has been a speaker for Roche, Pfizer, and AbbVie. Dr. Lewiecki has consulted for Amgen. Dr. Leder has received funding from Lilly and Amgen, and has been a consultant for Lilly, Amgen, and Radius. Dr. Bauer and Ms. Zeldow reported having no financial disclosures.
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