News for Your Practice

Women who enter pregnancy with diabetes are 4.5 times more likely to experience fetal death and almost twice as likely to lose their infant in the first year of life, compared with women without diabetes, a new study shows.¹

Although previous investigations have explored the link between pre-existing maternal diabetes and fetal and infant death, they have not excluded congenital anomalies as a cause of death. In this newest study, Tennant and colleagues used data from several longstanding population-based registries in the north of England to explore the link in offspring without congenital anomalies.

Details of the study
Tennant and colleagues included all normally formed singleton offspring of women with pre-existing diabetes (1,206 with type 1 diabetes and 342 with type 2 diabetes) in the North of England from 1996 to 2008 in their study. Information on these pregnancies came from the Northern Diabetes in Pregnancy Survey. The relative risks (RR) of fetal death (death of a fetus at or after 20 weeks’ gestation) and infant death (death during the first year of life) were estimated by comparing these data with population data from the Northern Perinatal Morbidity and Mortality Survey. 

The RR of fetal death in pregnancies marked by preexisting diabetes was 4.56, and it was 1.86 for infant death, compared with pregnancies without diabetes. These risks did not vary between women with type 1 diabetes and those with type 2 diabetes. Other variables associated with a higher risk of fetal or infant death were glycated hemoglobin levels greater than 6.6%, prepregnancy retinopathy, and a lack of folic acid supplementation.

The prevalence of fetal death was 3% in women with preexisting diabetes, and the prevalence of infant death was 0.7%, compared with 0.7% and 0.4%, respectively, in women without diabetes.

Tennant and colleagues found no evidence that the risk of fetal and infant death associated with preexisting maternal diabetes had decreased over time, or that the relative risk of stillbirth varied by gestational age.

The average glycated hemoglobin level in the study was 7.8%. The target for glycated hemoglobin is 7% according to the American Diabetes Association (ADA) and 6.1% according to England’s National Institute for Health and Care Excellence (NICE). Tennant and colleagues estimate that the prevalence of fetal and infant death would have been about 40% lower if the women in their study had achieved either the ADA or NICE target.

Related Article: Does myoinositol supplementation reduce the rate of gestational diabetes in pregnant women with a family history of type 2 diabetes? E. Albert Reece, MD, PhD, MBA (Examining the Evidence, June 2013)

Clinical recommendations
“It’s disappointing to see so little improvement because, with the right care, most women with diabetes can—and will—have a healthy baby,” the authors commented. “Stillbirths and infant deaths are thankfully not common, but they could be even less common if all women with diabetes can be helped to achieve the best possible control of their blood glucose levels.”

“We already know that folic acid reduces the risk of certain congenital anomalies, such as spina bifida or cleft lip, which is why women with diabetes are advised to take high-dose supplements of 5 mg daily. These are available on prescription and should be taken for at least 3 months before conceiving. Our results suggest this simple action may also help to reduce the risk of stillbirth or infant death, even in babies without these conditions.”

Related Article: Does folic acid supplementation have long-term benefit to offspring? Paul L. Ogburn, Jr, MD (Examining the Evidence, January 2012)

WE WANT TO HEAR FROM YOU!
Drop us a line and let us know what you think about current articles, which topics you'd like to see covered in future issues, and what challenges you face in daily practice. Tell us what you think by emailing us at: obg@frontlinemedcom.com

Women who enter pregnancy with diabetes are 4.5 times more likely to experience fetal death and almost twice as likely to lose their infant in the first year of life, compared with women without diabetes, a new study shows.¹

Although previous investigations have explored the link between pre-existing maternal diabetes and fetal and infant death, they have not excluded congenital anomalies as a cause of death. In this newest study, Tennant and colleagues used data from several longstanding population-based registries in the north of England to explore the link in offspring without congenital anomalies.

Details of the study
Tennant and colleagues included all normally formed singleton offspring of women with pre-existing diabetes (1,206 with type 1 diabetes and 342 with type 2 diabetes) in the North of England from 1996 to 2008 in their study. Information on these pregnancies came from the Northern Diabetes in Pregnancy Survey. The relative risks (RR) of fetal death (death of a fetus at or after 20 weeks’ gestation) and infant death (death during the first year of life) were estimated by comparing these data with population data from the Northern Perinatal Morbidity and Mortality Survey. 

The RR of fetal death in pregnancies marked by preexisting diabetes was 4.56, and it was 1.86 for infant death, compared with pregnancies without diabetes. These risks did not vary between women with type 1 diabetes and those with type 2 diabetes. Other variables associated with a higher risk of fetal or infant death were glycated hemoglobin levels greater than 6.6%, prepregnancy retinopathy, and a lack of folic acid supplementation.

The prevalence of fetal death was 3% in women with preexisting diabetes, and the prevalence of infant death was 0.7%, compared with 0.7% and 0.4%, respectively, in women without diabetes.

Tennant and colleagues found no evidence that the risk of fetal and infant death associated with preexisting maternal diabetes had decreased over time, or that the relative risk of stillbirth varied by gestational age.

The average glycated hemoglobin level in the study was 7.8%. The target for glycated hemoglobin is 7% according to the American Diabetes Association (ADA) and 6.1% according to England’s National Institute for Health and Care Excellence (NICE). Tennant and colleagues estimate that the prevalence of fetal and infant death would have been about 40% lower if the women in their study had achieved either the ADA or NICE target.

Related Article: Does myoinositol supplementation reduce the rate of gestational diabetes in pregnant women with a family history of type 2 diabetes? E. Albert Reece, MD, PhD, MBA (Examining the Evidence, June 2013)

Clinical recommendations
“It’s disappointing to see so little improvement because, with the right care, most women with diabetes can—and will—have a healthy baby,” the authors commented. “Stillbirths and infant deaths are thankfully not common, but they could be even less common if all women with diabetes can be helped to achieve the best possible control of their blood glucose levels.”

“We already know that folic acid reduces the risk of certain congenital anomalies, such as spina bifida or cleft lip, which is why women with diabetes are advised to take high-dose supplements of 5 mg daily. These are available on prescription and should be taken for at least 3 months before conceiving. Our results suggest this simple action may also help to reduce the risk of stillbirth or infant death, even in babies without these conditions.”

Related Article: Does folic acid supplementation have long-term benefit to offspring? Paul L. Ogburn, Jr, MD (Examining the Evidence, January 2012)

WE WANT TO HEAR FROM YOU!
Drop us a line and let us know what you think about current articles, which topics you'd like to see covered in future issues, and what challenges you face in daily practice. Tell us what you think by emailing us at: obg@frontlinemedcom.com

Women who enter pregnancy with diabetes are 4.5 times more likely to experience fetal death and almost twice as likely to lose their infant in the first year of life, compared with women without diabetes, a new study shows.¹

Although previous investigations have explored the link between pre-existing maternal diabetes and fetal and infant death, they have not excluded congenital anomalies as a cause of death. In this newest study, Tennant and colleagues used data from several longstanding population-based registries in the north of England to explore the link in offspring without congenital anomalies.

Details of the study
Tennant and colleagues included all normally formed singleton offspring of women with pre-existing diabetes (1,206 with type 1 diabetes and 342 with type 2 diabetes) in the North of England from 1996 to 2008 in their study. Information on these pregnancies came from the Northern Diabetes in Pregnancy Survey. The relative risks (RR) of fetal death (death of a fetus at or after 20 weeks’ gestation) and infant death (death during the first year of life) were estimated by comparing these data with population data from the Northern Perinatal Morbidity and Mortality Survey. 

The RR of fetal death in pregnancies marked by preexisting diabetes was 4.56, and it was 1.86 for infant death, compared with pregnancies without diabetes. These risks did not vary between women with type 1 diabetes and those with type 2 diabetes. Other variables associated with a higher risk of fetal or infant death were glycated hemoglobin levels greater than 6.6%, prepregnancy retinopathy, and a lack of folic acid supplementation.

The prevalence of fetal death was 3% in women with preexisting diabetes, and the prevalence of infant death was 0.7%, compared with 0.7% and 0.4%, respectively, in women without diabetes.

Tennant and colleagues found no evidence that the risk of fetal and infant death associated with preexisting maternal diabetes had decreased over time, or that the relative risk of stillbirth varied by gestational age.

The average glycated hemoglobin level in the study was 7.8%. The target for glycated hemoglobin is 7% according to the American Diabetes Association (ADA) and 6.1% according to England’s National Institute for Health and Care Excellence (NICE). Tennant and colleagues estimate that the prevalence of fetal and infant death would have been about 40% lower if the women in their study had achieved either the ADA or NICE target.

Related Article: Does myoinositol supplementation reduce the rate of gestational diabetes in pregnant women with a family history of type 2 diabetes? E. Albert Reece, MD, PhD, MBA (Examining the Evidence, June 2013)

Clinical recommendations
“It’s disappointing to see so little improvement because, with the right care, most women with diabetes can—and will—have a healthy baby,” the authors commented. “Stillbirths and infant deaths are thankfully not common, but they could be even less common if all women with diabetes can be helped to achieve the best possible control of their blood glucose levels.”

“We already know that folic acid reduces the risk of certain congenital anomalies, such as spina bifida or cleft lip, which is why women with diabetes are advised to take high-dose supplements of 5 mg daily. These are available on prescription and should be taken for at least 3 months before conceiving. Our results suggest this simple action may also help to reduce the risk of stillbirth or infant death, even in babies without these conditions.”

Related Article: Does folic acid supplementation have long-term benefit to offspring? Paul L. Ogburn, Jr, MD (Examining the Evidence, January 2012)

WE WANT TO HEAR FROM YOU!
Drop us a line and let us know what you think about current articles, which topics you'd like to see covered in future issues, and what challenges you face in daily practice. Tell us what you think by emailing us at: obg@frontlinemedcom.com

Women who deliver a large infant before 40 weeks’ gestation have a higher risk of shoulder dystocia than those who deliver a large infant at 40 weeks’ gestation or later, according to a population-based study of all vaginal deliveries in Norway from 1969 to 2009 (n = 2,014,956).¹ The increased risk of shoulder dystocia in deliveries before 40 weeks’ gestation was especially pronounced in pregnancies complicated by diabetes.

Large infants were defined as those weighing 3,500 g or more at delivery.

Related Article: You are the second responder to a shoulder dystocia emergency. What do you do first? Robert L. Barbieri, MD (Editorial, May 2013)

DETAILS OF THE STUDY
Using the Medical Birth Registry of Norway, Overland and colleagues analyzed all vaginal deliveries of a singleton fetus in cephalic presentation over 30 years, calculating the incidence of shoulder dystocia by gestational age at delivery and estimating both crude and adjusted odds ratios.

Overall, the incidence of shoulder dystocia was 0.73%, and it increased along with gestational age at delivery. Using delivery at 40 to 41 weeks of gestation as the reference, Overland and colleagues found the following crude odds ratios (OR) for shoulder dystocia:

• delivery before 36 weeks: 0.27 (95% confidence interval [CI], 0.22–0.33)
• delivery at 42–43 weeks: 1.17 (95% CI, 1.11–1.22).

However, after adjustment for birth weight, the adjusted OR for shoulder dystocia was:

• delivery at 32–35 weeks: 2.92 (95% CI, 1.54–5.52)
• delivery at 42–43 weeks: 0.91 (95% CI, 0.50–1.66).  

Among gestations affected by diabetes (n = 11,188), the incidence of shoulder dystocia was 3.95%.

Related Article: STOP all activities that may lead to further shoulder impaction when you suspect possible shoulder dystocia Ronald T. Burkman, MD (Stop/Start, March 2013)

LONGER PREGNANCIES MAY BE BETTER “PRIMED” FOR DELIVERY
The surprising finding that the risk of shoulder dystocia is lower in postterm infants than in infants delivered prior to 40 weeks at a given birth weight “is not easily explained,” write Overland and colleagues.1 “A successful delivery depends on a complex interplay between the uterus, the pelvis (the pelvic girdle and the pelvic floor muscles) and the offspring…. The physiological changes that occur during pregnancy to prime the pregnant woman and the offspring for delivery are likely to be complete by the estimated term. Hence, the risk for delivery complications, such as shoulder dystocia, may be increased in deliveries before term,” the investigators theorize.¹

WE WANT TO HEAR FROM YOU!
Drop us a line and let us know what you think about current articles, which topics you'd like to see covered in future issues, and what challenges you face in daily practice. Tell us what you think by emailing us at: obg@frontlinemedcom.com

Women who deliver a large infant before 40 weeks’ gestation have a higher risk of shoulder dystocia than those who deliver a large infant at 40 weeks’ gestation or later, according to a population-based study of all vaginal deliveries in Norway from 1969 to 2009 (n = 2,014,956).¹ The increased risk of shoulder dystocia in deliveries before 40 weeks’ gestation was especially pronounced in pregnancies complicated by diabetes.

Large infants were defined as those weighing 3,500 g or more at delivery.

Related Article: You are the second responder to a shoulder dystocia emergency. What do you do first? Robert L. Barbieri, MD (Editorial, May 2013)

DETAILS OF THE STUDY
Using the Medical Birth Registry of Norway, Overland and colleagues analyzed all vaginal deliveries of a singleton fetus in cephalic presentation over 30 years, calculating the incidence of shoulder dystocia by gestational age at delivery and estimating both crude and adjusted odds ratios.

Overall, the incidence of shoulder dystocia was 0.73%, and it increased along with gestational age at delivery. Using delivery at 40 to 41 weeks of gestation as the reference, Overland and colleagues found the following crude odds ratios (OR) for shoulder dystocia:

• delivery before 36 weeks: 0.27 (95% confidence interval [CI], 0.22–0.33)
• delivery at 42–43 weeks: 1.17 (95% CI, 1.11–1.22).

However, after adjustment for birth weight, the adjusted OR for shoulder dystocia was:

• delivery at 32–35 weeks: 2.92 (95% CI, 1.54–5.52)
• delivery at 42–43 weeks: 0.91 (95% CI, 0.50–1.66).  

Among gestations affected by diabetes (n = 11,188), the incidence of shoulder dystocia was 3.95%.

Related Article: STOP all activities that may lead to further shoulder impaction when you suspect possible shoulder dystocia Ronald T. Burkman, MD (Stop/Start, March 2013)

LONGER PREGNANCIES MAY BE BETTER “PRIMED” FOR DELIVERY
The surprising finding that the risk of shoulder dystocia is lower in postterm infants than in infants delivered prior to 40 weeks at a given birth weight “is not easily explained,” write Overland and colleagues.1 “A successful delivery depends on a complex interplay between the uterus, the pelvis (the pelvic girdle and the pelvic floor muscles) and the offspring…. The physiological changes that occur during pregnancy to prime the pregnant woman and the offspring for delivery are likely to be complete by the estimated term. Hence, the risk for delivery complications, such as shoulder dystocia, may be increased in deliveries before term,” the investigators theorize.¹

WE WANT TO HEAR FROM YOU!
Drop us a line and let us know what you think about current articles, which topics you'd like to see covered in future issues, and what challenges you face in daily practice. Tell us what you think by emailing us at: obg@frontlinemedcom.com

Women who deliver a large infant before 40 weeks’ gestation have a higher risk of shoulder dystocia than those who deliver a large infant at 40 weeks’ gestation or later, according to a population-based study of all vaginal deliveries in Norway from 1969 to 2009 (n = 2,014,956).¹ The increased risk of shoulder dystocia in deliveries before 40 weeks’ gestation was especially pronounced in pregnancies complicated by diabetes.

Large infants were defined as those weighing 3,500 g or more at delivery.

Related Article: You are the second responder to a shoulder dystocia emergency. What do you do first? Robert L. Barbieri, MD (Editorial, May 2013)

DETAILS OF THE STUDY
Using the Medical Birth Registry of Norway, Overland and colleagues analyzed all vaginal deliveries of a singleton fetus in cephalic presentation over 30 years, calculating the incidence of shoulder dystocia by gestational age at delivery and estimating both crude and adjusted odds ratios.

Overall, the incidence of shoulder dystocia was 0.73%, and it increased along with gestational age at delivery. Using delivery at 40 to 41 weeks of gestation as the reference, Overland and colleagues found the following crude odds ratios (OR) for shoulder dystocia:

• delivery before 36 weeks: 0.27 (95% confidence interval [CI], 0.22–0.33)
• delivery at 42–43 weeks: 1.17 (95% CI, 1.11–1.22).

However, after adjustment for birth weight, the adjusted OR for shoulder dystocia was:

• delivery at 32–35 weeks: 2.92 (95% CI, 1.54–5.52)
• delivery at 42–43 weeks: 0.91 (95% CI, 0.50–1.66).  

Among gestations affected by diabetes (n = 11,188), the incidence of shoulder dystocia was 3.95%.

Related Article: STOP all activities that may lead to further shoulder impaction when you suspect possible shoulder dystocia Ronald T. Burkman, MD (Stop/Start, March 2013)

LONGER PREGNANCIES MAY BE BETTER “PRIMED” FOR DELIVERY
The surprising finding that the risk of shoulder dystocia is lower in postterm infants than in infants delivered prior to 40 weeks at a given birth weight “is not easily explained,” write Overland and colleagues.1 “A successful delivery depends on a complex interplay between the uterus, the pelvis (the pelvic girdle and the pelvic floor muscles) and the offspring…. The physiological changes that occur during pregnancy to prime the pregnant woman and the offspring for delivery are likely to be complete by the estimated term. Hence, the risk for delivery complications, such as shoulder dystocia, may be increased in deliveries before term,” the investigators theorize.¹

WE WANT TO HEAR FROM YOU!
Drop us a line and let us know what you think about current articles, which topics you'd like to see covered in future issues, and what challenges you face in daily practice. Tell us what you think by emailing us at: obg@frontlinemedcom.com

Health and Human Services Secretary Kathleen Sebelius and Congresswoman Debbie Wasserman Schultz announced on January 10, 2014, in a blog, that, “today the Department of Health & Human Services (HHS) issued guidance to clarify that under the Affordable Care Act, most health insurance companies and employer plans must cover tamoxifen and raloxifene—like other recommended preventive services—without co-pays or other out of pocket expenses for women at increased risk for breast cancer.”¹

Related Article: Women’s health under the Affordable Care Act: What is covered? Lucia DiVenere, MA (September 2012)

This move by HHS comes in response to the US Preventive Services Task Force (USPSTF) recommendation in late September that clinicians offer prescription medications such as tamoxifen and raloxifene to women who are shown to be at a higher relative risk for breast cancer and at low risk for adverse medication effects.²

Related Article: USPSTF recommends tamoxifen or raloxifene to reduce breast cancer risk in high-risk patients (October 2013)

The US Food and Drug Administration (FDA) has approved tamoxifen as a chemo-preventive in at-risk women aged 35 years and older, and raloxifene for this same use in postmenopausal women. Both medications are selective estrogen receptor (ER) modulators that have been shown to reduce the incidence of invasive, ER-positive breast cancer.²

Related Article: What is the gynecologist’s role in the care of BRCA previvors? Robert L. Barbieri, MD (Editorial, September 2013)

The new ruling applies to those whose private insurance policies were written after the law was signed in 2010, as well as for women on Medicaid or Medicare.³

“Access to medications like tamoxifen or raloxifene is just one of many ways the Affordable Care Act is helping the fight against cancer,” write Sebelius and Schultz. “Through the Health Insurance Marketplace, the new health care law is also helping by making health care more affordable and accessible to millions of Americans. And when you consider that Americans who are uninsured and diagnosed with cancer are 60 percent more likely to die from that cancer than those who have insurance—the work that we do together to expand access to health insurance is work that saves lives.”¹

Health and Human Services Secretary Kathleen Sebelius and Congresswoman Debbie Wasserman Schultz announced on January 10, 2014, in a blog, that, “today the Department of Health & Human Services (HHS) issued guidance to clarify that under the Affordable Care Act, most health insurance companies and employer plans must cover tamoxifen and raloxifene—like other recommended preventive services—without co-pays or other out of pocket expenses for women at increased risk for breast cancer.”¹

Related Article: Women’s health under the Affordable Care Act: What is covered? Lucia DiVenere, MA (September 2012)

This move by HHS comes in response to the US Preventive Services Task Force (USPSTF) recommendation in late September that clinicians offer prescription medications such as tamoxifen and raloxifene to women who are shown to be at a higher relative risk for breast cancer and at low risk for adverse medication effects.²

Related Article: USPSTF recommends tamoxifen or raloxifene to reduce breast cancer risk in high-risk patients (October 2013)

The US Food and Drug Administration (FDA) has approved tamoxifen as a chemo-preventive in at-risk women aged 35 years and older, and raloxifene for this same use in postmenopausal women. Both medications are selective estrogen receptor (ER) modulators that have been shown to reduce the incidence of invasive, ER-positive breast cancer.²

Related Article: What is the gynecologist’s role in the care of BRCA previvors? Robert L. Barbieri, MD (Editorial, September 2013)

The new ruling applies to those whose private insurance policies were written after the law was signed in 2010, as well as for women on Medicaid or Medicare.³

“Access to medications like tamoxifen or raloxifene is just one of many ways the Affordable Care Act is helping the fight against cancer,” write Sebelius and Schultz. “Through the Health Insurance Marketplace, the new health care law is also helping by making health care more affordable and accessible to millions of Americans. And when you consider that Americans who are uninsured and diagnosed with cancer are 60 percent more likely to die from that cancer than those who have insurance—the work that we do together to expand access to health insurance is work that saves lives.”¹

Health and Human Services Secretary Kathleen Sebelius and Congresswoman Debbie Wasserman Schultz announced on January 10, 2014, in a blog, that, “today the Department of Health & Human Services (HHS) issued guidance to clarify that under the Affordable Care Act, most health insurance companies and employer plans must cover tamoxifen and raloxifene—like other recommended preventive services—without co-pays or other out of pocket expenses for women at increased risk for breast cancer.”¹

Related Article: Women’s health under the Affordable Care Act: What is covered? Lucia DiVenere, MA (September 2012)

This move by HHS comes in response to the US Preventive Services Task Force (USPSTF) recommendation in late September that clinicians offer prescription medications such as tamoxifen and raloxifene to women who are shown to be at a higher relative risk for breast cancer and at low risk for adverse medication effects.²

Related Article: USPSTF recommends tamoxifen or raloxifene to reduce breast cancer risk in high-risk patients (October 2013)

The US Food and Drug Administration (FDA) has approved tamoxifen as a chemo-preventive in at-risk women aged 35 years and older, and raloxifene for this same use in postmenopausal women. Both medications are selective estrogen receptor (ER) modulators that have been shown to reduce the incidence of invasive, ER-positive breast cancer.²

Related Article: What is the gynecologist’s role in the care of BRCA previvors? Robert L. Barbieri, MD (Editorial, September 2013)

The new ruling applies to those whose private insurance policies were written after the law was signed in 2010, as well as for women on Medicaid or Medicare.³

“Access to medications like tamoxifen or raloxifene is just one of many ways the Affordable Care Act is helping the fight against cancer,” write Sebelius and Schultz. “Through the Health Insurance Marketplace, the new health care law is also helping by making health care more affordable and accessible to millions of Americans. And when you consider that Americans who are uninsured and diagnosed with cancer are 60 percent more likely to die from that cancer than those who have insurance—the work that we do together to expand access to health insurance is work that saves lives.”¹

In obese women, laparoscopic hysterectomy provided the shortest operating time with minimal blood loss when compared with vaginal hysterectomy, according to a poster presented at the 42nd AAGL Global Congress in Washington, DC, in November 2013.¹

Teresa Tam, MD, Gerald Harkins, MD, and researchers at Penn State Milton S. Hershey Medical Center in Hershey, Pennsylvania, reported on a retrospective cohort study conducted to compare the routes of hysterectomy and surgical outcomes in obese patients.

Of the 1,286 patients who underwent hysterectomy between December 1, 2009, and December 1, 2012, at Hershey Medical Center, 596 met the obese body mass index (BMI) inclusion criteria (BMI >30 kg/m²). Mean (SD) BMI was 36.5 (5.8) kg/m² and the mean (SD) patient age was 45 (10) years. Mean (SD) gravidity was 2.44 (1.85) and mean (SD) parity was 1.97 (1.41).

Reasons for surgery were restricted to benign indications, including leiomyoma (31%); abnormal uterine bleeding (29%); and endometriosis (17%).

The following approaches to hysterectomy were included:

• abdominal hysterectomy [total abdominal and supracervical] (AH; n = 7)
• vaginal hysterectomy (VH; n = 84)  
• laparoscopic-assisted vaginal hysterectomy (LAVH; n = 16)
• total laparoscopic hysterectomy [conventional and robotic] (TLH; n = 295)
• laparoscopic supracervical hysterectomy [conventional and robotic] (LSH; n = 194).

Comparisons to AH were not considered in the results (n = 7). Less than 1% of the hysterectomies were abdominal cases, with majority (5 out of 7 AHs) performed being combined cases, in conjunction with colorectal service for colon or rectal malignancies. Data on preoperative indications, estimated blood loss, operating time, length of stay, and postoperative complications were compared.

The largest differences in median (SD) operating time were between TLH and LAVH (80 min vs 137.5 min, respectively; P <.001) and LSH and LAVH (90 min vs 137.5 min, respectively; P <.001).

The only statistically significant difference with regard to patients’ median (SD) length of stay was between TLH and VH (1.07 days vs 1.12 days, respectively; P = .005), but the researchers did not consider a difference of 0.05 days (1.2 hours) to be clinically relevant.

The odds of estimated blood loss of 200 mL or greater were significantly higher with VH than with TLH (35.0% vs 3.4%, respectively; odds ratio [OR] = 15.3; 95% confidence interval [CI], 7.0–33.4; P <.001). The odds of estimated blood loss also were significantly higher with VH than with LSH (35.0% vs. 8.4%; OR = 5.9; 95% CI, 3.0–11.7; P <.001).

No association was found between high BMI and surgical complications, the authors reported. However, due to the study’s retrospective nature, Tam and Harkins note that surgeon selection bias on the route of hysterectomy could be based on concerns with operative access and outcomes in obese patients. The authors concur that more studies need to be performed comparing robotic with conventional laparoscopic routes of hysterectomy in the obese.

“In this study, laparoscopic hysterectomy offered the shortest operating time with minimal blood loss compared to the vaginal route in the obese patient population,” the authors concluded.

They noted, however, that, “Although performing hysterectomy in obese patients can be challenging, this study reaffirms that a minimally invasive approach to hysterectomy is both safe and effective. Providing either a vaginal or laparoscopic modality to hysterectomy is often requested by patients, and is supported by the American Congress of Obstetricians and Gynecologists (ACOG) and the AAGL.”

WE WANT TO HEAR FROM YOU!
Drop us a line and let us know what you think about current articles, which topics you'd like to see covered in future issues, and what challenges you face in daily practice. Tell us what you think by emailing us at: obg@frontlinemedcom.com

In obese women, laparoscopic hysterectomy provided the shortest operating time with minimal blood loss when compared with vaginal hysterectomy, according to a poster presented at the 42nd AAGL Global Congress in Washington, DC, in November 2013.¹

Teresa Tam, MD, Gerald Harkins, MD, and researchers at Penn State Milton S. Hershey Medical Center in Hershey, Pennsylvania, reported on a retrospective cohort study conducted to compare the routes of hysterectomy and surgical outcomes in obese patients.

Of the 1,286 patients who underwent hysterectomy between December 1, 2009, and December 1, 2012, at Hershey Medical Center, 596 met the obese body mass index (BMI) inclusion criteria (BMI >30 kg/m²). Mean (SD) BMI was 36.5 (5.8) kg/m² and the mean (SD) patient age was 45 (10) years. Mean (SD) gravidity was 2.44 (1.85) and mean (SD) parity was 1.97 (1.41).

Reasons for surgery were restricted to benign indications, including leiomyoma (31%); abnormal uterine bleeding (29%); and endometriosis (17%).

The following approaches to hysterectomy were included:

• abdominal hysterectomy [total abdominal and supracervical] (AH; n = 7)
• vaginal hysterectomy (VH; n = 84)  
• laparoscopic-assisted vaginal hysterectomy (LAVH; n = 16)
• total laparoscopic hysterectomy [conventional and robotic] (TLH; n = 295)
• laparoscopic supracervical hysterectomy [conventional and robotic] (LSH; n = 194).

Comparisons to AH were not considered in the results (n = 7). Less than 1% of the hysterectomies were abdominal cases, with majority (5 out of 7 AHs) performed being combined cases, in conjunction with colorectal service for colon or rectal malignancies. Data on preoperative indications, estimated blood loss, operating time, length of stay, and postoperative complications were compared.

The largest differences in median (SD) operating time were between TLH and LAVH (80 min vs 137.5 min, respectively; P <.001) and LSH and LAVH (90 min vs 137.5 min, respectively; P <.001).

The only statistically significant difference with regard to patients’ median (SD) length of stay was between TLH and VH (1.07 days vs 1.12 days, respectively; P = .005), but the researchers did not consider a difference of 0.05 days (1.2 hours) to be clinically relevant.

The odds of estimated blood loss of 200 mL or greater were significantly higher with VH than with TLH (35.0% vs 3.4%, respectively; odds ratio [OR] = 15.3; 95% confidence interval [CI], 7.0–33.4; P <.001). The odds of estimated blood loss also were significantly higher with VH than with LSH (35.0% vs. 8.4%; OR = 5.9; 95% CI, 3.0–11.7; P <.001).

No association was found between high BMI and surgical complications, the authors reported. However, due to the study’s retrospective nature, Tam and Harkins note that surgeon selection bias on the route of hysterectomy could be based on concerns with operative access and outcomes in obese patients. The authors concur that more studies need to be performed comparing robotic with conventional laparoscopic routes of hysterectomy in the obese.

“In this study, laparoscopic hysterectomy offered the shortest operating time with minimal blood loss compared to the vaginal route in the obese patient population,” the authors concluded.

They noted, however, that, “Although performing hysterectomy in obese patients can be challenging, this study reaffirms that a minimally invasive approach to hysterectomy is both safe and effective. Providing either a vaginal or laparoscopic modality to hysterectomy is often requested by patients, and is supported by the American Congress of Obstetricians and Gynecologists (ACOG) and the AAGL.”

WE WANT TO HEAR FROM YOU!
Drop us a line and let us know what you think about current articles, which topics you'd like to see covered in future issues, and what challenges you face in daily practice. Tell us what you think by emailing us at: obg@frontlinemedcom.com

In obese women, laparoscopic hysterectomy provided the shortest operating time with minimal blood loss when compared with vaginal hysterectomy, according to a poster presented at the 42nd AAGL Global Congress in Washington, DC, in November 2013.¹

Teresa Tam, MD, Gerald Harkins, MD, and researchers at Penn State Milton S. Hershey Medical Center in Hershey, Pennsylvania, reported on a retrospective cohort study conducted to compare the routes of hysterectomy and surgical outcomes in obese patients.

Of the 1,286 patients who underwent hysterectomy between December 1, 2009, and December 1, 2012, at Hershey Medical Center, 596 met the obese body mass index (BMI) inclusion criteria (BMI >30 kg/m²). Mean (SD) BMI was 36.5 (5.8) kg/m² and the mean (SD) patient age was 45 (10) years. Mean (SD) gravidity was 2.44 (1.85) and mean (SD) parity was 1.97 (1.41).

Reasons for surgery were restricted to benign indications, including leiomyoma (31%); abnormal uterine bleeding (29%); and endometriosis (17%).

The following approaches to hysterectomy were included:

• abdominal hysterectomy [total abdominal and supracervical] (AH; n = 7)
• vaginal hysterectomy (VH; n = 84)  
• laparoscopic-assisted vaginal hysterectomy (LAVH; n = 16)
• total laparoscopic hysterectomy [conventional and robotic] (TLH; n = 295)
• laparoscopic supracervical hysterectomy [conventional and robotic] (LSH; n = 194).

Comparisons to AH were not considered in the results (n = 7). Less than 1% of the hysterectomies were abdominal cases, with majority (5 out of 7 AHs) performed being combined cases, in conjunction with colorectal service for colon or rectal malignancies. Data on preoperative indications, estimated blood loss, operating time, length of stay, and postoperative complications were compared.

The largest differences in median (SD) operating time were between TLH and LAVH (80 min vs 137.5 min, respectively; P <.001) and LSH and LAVH (90 min vs 137.5 min, respectively; P <.001).

The only statistically significant difference with regard to patients’ median (SD) length of stay was between TLH and VH (1.07 days vs 1.12 days, respectively; P = .005), but the researchers did not consider a difference of 0.05 days (1.2 hours) to be clinically relevant.

The odds of estimated blood loss of 200 mL or greater were significantly higher with VH than with TLH (35.0% vs 3.4%, respectively; odds ratio [OR] = 15.3; 95% confidence interval [CI], 7.0–33.4; P <.001). The odds of estimated blood loss also were significantly higher with VH than with LSH (35.0% vs. 8.4%; OR = 5.9; 95% CI, 3.0–11.7; P <.001).

No association was found between high BMI and surgical complications, the authors reported. However, due to the study’s retrospective nature, Tam and Harkins note that surgeon selection bias on the route of hysterectomy could be based on concerns with operative access and outcomes in obese patients. The authors concur that more studies need to be performed comparing robotic with conventional laparoscopic routes of hysterectomy in the obese.

“In this study, laparoscopic hysterectomy offered the shortest operating time with minimal blood loss compared to the vaginal route in the obese patient population,” the authors concluded.

They noted, however, that, “Although performing hysterectomy in obese patients can be challenging, this study reaffirms that a minimally invasive approach to hysterectomy is both safe and effective. Providing either a vaginal or laparoscopic modality to hysterectomy is often requested by patients, and is supported by the American Congress of Obstetricians and Gynecologists (ACOG) and the AAGL.”

WE WANT TO HEAR FROM YOU!
Drop us a line and let us know what you think about current articles, which topics you'd like to see covered in future issues, and what challenges you face in daily practice. Tell us what you think by emailing us at: obg@frontlinemedcom.com

When the American Board of Obstetrics and Gynecology (ABOG) announced in September that, with a few exceptions, gynecologists could lose their board certification if they treated men, gynecologists were forced to stop treating male patients. This decision has now been altered, and gynecologists are now allowed to treat male patients for sexually transmitted diseases (STDs) and to screen men for anal cancer.¹

Experts in anal cancer and patient advocacy groups lobbied ABOG to revise their position based on gynecologists’ long-standing tradition of treating men and women for STDs. Anal cancer is usually caused by human papillomavirus. Although rare, the incidence of anal cancer is increasing, especially among those infected with human immunodeficiency virus.¹

ABOG’s new statement reads²:

     To remain certified by ABOG the care of male patients is prohibited except in the
     following circumstances:

• active government service
• evaluation of fertility
• genetic counseling and testing of a couple
• evaluation and management of sexually transmitted infections
• administration of immunizations
• management of transgender conditions
• emergency, pandemic, humanitarian or disaster response care
• family planning services, not to include vasectomy
• newborn circumcision  
• completion of ACGME-accredited training and certification in other specialties.   

Mark H. Einstein, MD, professor in the Department of Obstetrics and Gynecology and Women’s Health at Montefiore Medical Center in Bronx, New York, and author of “Update on Cervical Disease” (OBG Management, May 2013), was forced to discontinue seeing male patients. He commented,  “Cool heads have prevailed. This is the best decision for our patients.”¹

We want to hear from you. Tell us what you think!

When the American Board of Obstetrics and Gynecology (ABOG) announced in September that, with a few exceptions, gynecologists could lose their board certification if they treated men, gynecologists were forced to stop treating male patients. This decision has now been altered, and gynecologists are now allowed to treat male patients for sexually transmitted diseases (STDs) and to screen men for anal cancer.¹

Experts in anal cancer and patient advocacy groups lobbied ABOG to revise their position based on gynecologists’ long-standing tradition of treating men and women for STDs. Anal cancer is usually caused by human papillomavirus. Although rare, the incidence of anal cancer is increasing, especially among those infected with human immunodeficiency virus.¹

ABOG’s new statement reads²:

     To remain certified by ABOG the care of male patients is prohibited except in the
     following circumstances:

• active government service
• evaluation of fertility
• genetic counseling and testing of a couple
• evaluation and management of sexually transmitted infections
• administration of immunizations
• management of transgender conditions
• emergency, pandemic, humanitarian or disaster response care
• family planning services, not to include vasectomy
• newborn circumcision  
• completion of ACGME-accredited training and certification in other specialties.   

Mark H. Einstein, MD, professor in the Department of Obstetrics and Gynecology and Women’s Health at Montefiore Medical Center in Bronx, New York, and author of “Update on Cervical Disease” (OBG Management, May 2013), was forced to discontinue seeing male patients. He commented,  “Cool heads have prevailed. This is the best decision for our patients.”¹

We want to hear from you. Tell us what you think!

When the American Board of Obstetrics and Gynecology (ABOG) announced in September that, with a few exceptions, gynecologists could lose their board certification if they treated men, gynecologists were forced to stop treating male patients. This decision has now been altered, and gynecologists are now allowed to treat male patients for sexually transmitted diseases (STDs) and to screen men for anal cancer.¹

Experts in anal cancer and patient advocacy groups lobbied ABOG to revise their position based on gynecologists’ long-standing tradition of treating men and women for STDs. Anal cancer is usually caused by human papillomavirus. Although rare, the incidence of anal cancer is increasing, especially among those infected with human immunodeficiency virus.¹

ABOG’s new statement reads²:

     To remain certified by ABOG the care of male patients is prohibited except in the
     following circumstances:

• active government service
• evaluation of fertility
• genetic counseling and testing of a couple
• evaluation and management of sexually transmitted infections
• administration of immunizations
• management of transgender conditions
• emergency, pandemic, humanitarian or disaster response care
• family planning services, not to include vasectomy
• newborn circumcision  
• completion of ACGME-accredited training and certification in other specialties.   

Mark H. Einstein, MD, professor in the Department of Obstetrics and Gynecology and Women’s Health at Montefiore Medical Center in Bronx, New York, and author of “Update on Cervical Disease” (OBG Management, May 2013), was forced to discontinue seeing male patients. He commented,  “Cool heads have prevailed. This is the best decision for our patients.”¹

We want to hear from you. Tell us what you think!

Use of the robot has skyrocketed in recent years, with 84% of reproductive and gynecologic surgeons reporting access to the technology less than 10 years after its approval for gynecologic surgery by the US Food and Drug Administration. This and other findings from a survey of members of the American Society for Reproductive Medicine (ASRM) and AAGL were presented in a poster at the 42nd AAGL Global Congress in Washington, DC.¹

Access to robotic assistance was highest among surgeons based in academic centers (93%) and lowest among those in private practice (77%), but remained high overall (84%).

Related article: The robot is gaining ground in gynecologic surgery.
Should you be using it? (An expert roundtable; April 2013)

Other findings of the survey:

• 85% of residents and fellows reported robotic training, with the greatest exposure to training reported in American Congress of Obstetricians and Gynecologists (ACOG) Districts IV (96%) and VI (100%) and less exposure in District I (72%). District IV comprises the District of Columbia, Georgia, Maryland, North Carolina, South Carolina, Virginia, West Virginia, Puerto Rico, and the West Indies. District VI comprises Illinois, Iowa, Minnesota, Nebraska, North Dakota, South Dakota, Wisconsin, Manitoba, and Saskatchewan. And District I comprises the Atlantic provinces (New Brunswick, Newfoundland, Nova Scotia, Prince Edward Island), Connecticut, Maine, Massachusetts, New Hampshire, Quebec, Rhode Island, and Vermont.
  
  
• Sixty-one percent of surgeons had earned or were planning to earn credentials in robotic surgery, with no difference between districts or types of practice. The figure did vary by subspecialty, however, with 100% of gynecologic oncologists reporting having earned or planning to earn credentials, compared with 79% of minimally invasive gynecologic surgeons, 77% of urogynecologists, 67% of ObGyns, 46% of gynecologists (no obstetric practice), and 44% of reproductive endocrinologists and infertility specialists.
  
  
• Some surgeons declined to use the robot. Surgeons who had access to a robot but who chose not to earn privileges gave the following reasons: high cost, 20%; increased time in the operating room (OR), 18%; need for additional training, 10%; additional OR time unavailable, 8%; cost of training, 4%; safety issues, 1%; and possible need for additional ports, 1%. There was greater concern about cost and increased operative time among private practitioners (24% and 25%, respectively) than academic physicians (13% and 15%, respectively).

A link to the online survey was emailed to all members of ASRM and AAGL in June 2012, with 561 practicing gynecologic laparoscopic surgeons and 138 residents and fellows responding, for a response rate of 15%.

Overall, investigators identified no single overriding barrier to use of the robot.

Most surgeons are satisfied with the energy sources they now use
The same survey included questions about surgeons’ attitudes toward various energy sources, including monopolar, bipolar, ultrasonic, laser, and other forms of energy. It found that 94% and 93% of respondents were satisfied or very satisfied with the primary energy source they currently used in the management of endometriosis and myomectomy, respectively. Seventy-nine percent reported having used a CO₂ laser.

For the surgical management of endometriosis, practicing surgeons preferred:

• monopolar energy, 33%
• bipolar energy, 22%
• ultrasonic devices, 21%
• laser energy, 12%
• other energy source, 9%.

For myomectomy, practicing surgeons preferred:

• monopolar energy, 43%
• bipolar energy, 21%
• ultrasonic devices, 14%
• laser energy, 2%
• other energy source, 12%.

For colpotomy, practicing surgeons preferred:

• monopolar energy, 35%
• bipolar energy, 17%
• ultrasonic devices, 19%
• other energy source, 10%.

Among residents and fellows, the preference was greatest for monopolar energy for endometriosis, myomectomy, and colpotomy (44%, 41%, and 41%, respectively).

As for complications, practicing surgeons reported 78 related to endometriosis surgery and 73 related to myomectomy. The most common sites of complications were the bladder, ureter, and bowel. Unanticipated bleeding was also common.

Use of the robot has skyrocketed in recent years, with 84% of reproductive and gynecologic surgeons reporting access to the technology less than 10 years after its approval for gynecologic surgery by the US Food and Drug Administration. This and other findings from a survey of members of the American Society for Reproductive Medicine (ASRM) and AAGL were presented in a poster at the 42nd AAGL Global Congress in Washington, DC.¹

Access to robotic assistance was highest among surgeons based in academic centers (93%) and lowest among those in private practice (77%), but remained high overall (84%).

Related article: The robot is gaining ground in gynecologic surgery.
Should you be using it? (An expert roundtable; April 2013)

Other findings of the survey:

• 85% of residents and fellows reported robotic training, with the greatest exposure to training reported in American Congress of Obstetricians and Gynecologists (ACOG) Districts IV (96%) and VI (100%) and less exposure in District I (72%). District IV comprises the District of Columbia, Georgia, Maryland, North Carolina, South Carolina, Virginia, West Virginia, Puerto Rico, and the West Indies. District VI comprises Illinois, Iowa, Minnesota, Nebraska, North Dakota, South Dakota, Wisconsin, Manitoba, and Saskatchewan. And District I comprises the Atlantic provinces (New Brunswick, Newfoundland, Nova Scotia, Prince Edward Island), Connecticut, Maine, Massachusetts, New Hampshire, Quebec, Rhode Island, and Vermont.
  
  
• Sixty-one percent of surgeons had earned or were planning to earn credentials in robotic surgery, with no difference between districts or types of practice. The figure did vary by subspecialty, however, with 100% of gynecologic oncologists reporting having earned or planning to earn credentials, compared with 79% of minimally invasive gynecologic surgeons, 77% of urogynecologists, 67% of ObGyns, 46% of gynecologists (no obstetric practice), and 44% of reproductive endocrinologists and infertility specialists.
  
  
• Some surgeons declined to use the robot. Surgeons who had access to a robot but who chose not to earn privileges gave the following reasons: high cost, 20%; increased time in the operating room (OR), 18%; need for additional training, 10%; additional OR time unavailable, 8%; cost of training, 4%; safety issues, 1%; and possible need for additional ports, 1%. There was greater concern about cost and increased operative time among private practitioners (24% and 25%, respectively) than academic physicians (13% and 15%, respectively).

A link to the online survey was emailed to all members of ASRM and AAGL in June 2012, with 561 practicing gynecologic laparoscopic surgeons and 138 residents and fellows responding, for a response rate of 15%.

Overall, investigators identified no single overriding barrier to use of the robot.

Most surgeons are satisfied with the energy sources they now use
The same survey included questions about surgeons’ attitudes toward various energy sources, including monopolar, bipolar, ultrasonic, laser, and other forms of energy. It found that 94% and 93% of respondents were satisfied or very satisfied with the primary energy source they currently used in the management of endometriosis and myomectomy, respectively. Seventy-nine percent reported having used a CO₂ laser.

For the surgical management of endometriosis, practicing surgeons preferred:

• monopolar energy, 33%
• bipolar energy, 22%
• ultrasonic devices, 21%
• laser energy, 12%
• other energy source, 9%.

For myomectomy, practicing surgeons preferred:

• monopolar energy, 43%
• bipolar energy, 21%
• ultrasonic devices, 14%
• laser energy, 2%
• other energy source, 12%.

For colpotomy, practicing surgeons preferred:

• monopolar energy, 35%
• bipolar energy, 17%
• ultrasonic devices, 19%
• other energy source, 10%.

Among residents and fellows, the preference was greatest for monopolar energy for endometriosis, myomectomy, and colpotomy (44%, 41%, and 41%, respectively).

As for complications, practicing surgeons reported 78 related to endometriosis surgery and 73 related to myomectomy. The most common sites of complications were the bladder, ureter, and bowel. Unanticipated bleeding was also common.

Use of the robot has skyrocketed in recent years, with 84% of reproductive and gynecologic surgeons reporting access to the technology less than 10 years after its approval for gynecologic surgery by the US Food and Drug Administration. This and other findings from a survey of members of the American Society for Reproductive Medicine (ASRM) and AAGL were presented in a poster at the 42nd AAGL Global Congress in Washington, DC.¹

Access to robotic assistance was highest among surgeons based in academic centers (93%) and lowest among those in private practice (77%), but remained high overall (84%).

Related article: The robot is gaining ground in gynecologic surgery.
Should you be using it? (An expert roundtable; April 2013)

Other findings of the survey:

• 85% of residents and fellows reported robotic training, with the greatest exposure to training reported in American Congress of Obstetricians and Gynecologists (ACOG) Districts IV (96%) and VI (100%) and less exposure in District I (72%). District IV comprises the District of Columbia, Georgia, Maryland, North Carolina, South Carolina, Virginia, West Virginia, Puerto Rico, and the West Indies. District VI comprises Illinois, Iowa, Minnesota, Nebraska, North Dakota, South Dakota, Wisconsin, Manitoba, and Saskatchewan. And District I comprises the Atlantic provinces (New Brunswick, Newfoundland, Nova Scotia, Prince Edward Island), Connecticut, Maine, Massachusetts, New Hampshire, Quebec, Rhode Island, and Vermont.
  
  
• Sixty-one percent of surgeons had earned or were planning to earn credentials in robotic surgery, with no difference between districts or types of practice. The figure did vary by subspecialty, however, with 100% of gynecologic oncologists reporting having earned or planning to earn credentials, compared with 79% of minimally invasive gynecologic surgeons, 77% of urogynecologists, 67% of ObGyns, 46% of gynecologists (no obstetric practice), and 44% of reproductive endocrinologists and infertility specialists.
  
  
• Some surgeons declined to use the robot. Surgeons who had access to a robot but who chose not to earn privileges gave the following reasons: high cost, 20%; increased time in the operating room (OR), 18%; need for additional training, 10%; additional OR time unavailable, 8%; cost of training, 4%; safety issues, 1%; and possible need for additional ports, 1%. There was greater concern about cost and increased operative time among private practitioners (24% and 25%, respectively) than academic physicians (13% and 15%, respectively).

A link to the online survey was emailed to all members of ASRM and AAGL in June 2012, with 561 practicing gynecologic laparoscopic surgeons and 138 residents and fellows responding, for a response rate of 15%.

Overall, investigators identified no single overriding barrier to use of the robot.

Most surgeons are satisfied with the energy sources they now use
The same survey included questions about surgeons’ attitudes toward various energy sources, including monopolar, bipolar, ultrasonic, laser, and other forms of energy. It found that 94% and 93% of respondents were satisfied or very satisfied with the primary energy source they currently used in the management of endometriosis and myomectomy, respectively. Seventy-nine percent reported having used a CO₂ laser.

For the surgical management of endometriosis, practicing surgeons preferred:

• monopolar energy, 33%
• bipolar energy, 22%
• ultrasonic devices, 21%
• laser energy, 12%
• other energy source, 9%.

For myomectomy, practicing surgeons preferred:

• monopolar energy, 43%
• bipolar energy, 21%
• ultrasonic devices, 14%
• laser energy, 2%
• other energy source, 12%.

For colpotomy, practicing surgeons preferred:

• monopolar energy, 35%
• bipolar energy, 17%
• ultrasonic devices, 19%
• other energy source, 10%.

Among residents and fellows, the preference was greatest for monopolar energy for endometriosis, myomectomy, and colpotomy (44%, 41%, and 41%, respectively).

As for complications, practicing surgeons reported 78 related to endometriosis surgery and 73 related to myomectomy. The most common sites of complications were the bladder, ureter, and bowel. Unanticipated bleeding was also common.

Although more physicians today are employed by hospitals than in the past, the overwhelming majority of doctors still work in private practices, according to 2012 data from the Physician Practice Benchmark Study (PPBS) conducted by the American Medical Association (AMA).¹

The survey shows that 53.2% of physicians were self-employed in 2012, and 60% were operating in practices wholly owned by physicians. Only 23% of physicians worked in practices that were partially or fully owned by a hospital, and only 5.6% were directly employed by a hospital.¹

The AMA estimates that 18.4% of physicians worked in solo practices in 2012, a decline of about 6% from the previous AMA survey in 2207/2008.¹ In 1983, 40.5% of physicians were in solo practice.¹

“To paraphrase Mark Twain, the reports of the death of private practice medicine have been greatly exaggerated,” said AMA President Ardis Dee Hoven, MD, in presenting the figures.¹

And AMA investigators Carol C. Kane, PhD, and David W. Emmons, PhD, who authored the report, noted: “After a 5-year gap in physician-level data, the 2012 PPBS offers an update on the status of physician practice arrangements, and allows for a nationally representative response to the numerous articles of the past several years that have highlighted a surge in the employment of physicians by hospitals and the ‘death’ of private practice.”¹

Details of the survey
Like earlier AMA surveys, the PPBS involved a nationally representative random sample of physicians who had completed residency, practiced at least 20 hours per week, and were not employed by the federal government.

Unlike earlier AMA surveys, which targeted AMA members, the 2012 PPBS utilized the Epocrates Honors market research panel rather than the AMA Masterfile. The reason for this switch: declining participation rates for surveys utilizing the Masterfile.

Another distinction: Earlier surveys failed to ask specifically whether the respondent’s practice was owned by its physician members or by a larger entity, such as a hospital. They also overlooked the organizational structure of practices. The 2012 survey addressed both issues.

The PPBS went to 14,750 physicians. Of these, 3,466 physicians responded, a response rate of 28%.¹

FINDINGS ON THE STRUCTURE OF PRACTICE

Ownership status
In 2012, 53.2% of physicians fully or partly owned their practice (a decline of 8.0% since 2007/2008), 41.8% were employed, and 5.0% were independent contractors.¹

Younger physicians were less likely to own their practice than older physicians were. Among physicians under age 40, the ownership rate was 43.3%, compared with 60.0% among doctors aged 55 years or older.¹

Women, too, were less likely to own their practice (38.7% vs 59.6% for men).¹

Type of practice
The most common type of practice setting was the single-specialty practice, reported by 45.5% of physicians. Women were less likely to report single-specialty practice than men (39.7% vs 48.0%).¹

Among ObGyns, single-specialty practice was reported by 52.7% of respondents.¹

Multispecialty practice was reported by 22.1% of respondents. Among ObGyns, that figure was 17.9%.¹

Solo practice was reported by 18.4% of respondents but varied significantly by age. Among physicians under age 40, only 10% reported solo practice, compared with 25.3% of physicians aged 55 or older. Among women, solo practice was reported by 21.0%, compared with 17.3% among men. Among all ObGyns (men and women), 20.6% reported solo practice.¹

Only 5.6% of physicians reported direct hospital employment. Among ObGyns, the figure was 2.3%.¹

Size of the practice
Sixty percent of respondents (in all practice settings) reported working in a practice with fewer than 10 physicians. Sixteen percent reported working in a practice with 10 to 24 physicians, 7.1% in practices with 25 to 49 physicians, and 12.2% in practices with more than 50 physicians. Hospital employees were not asked about the number of physicians in their practice setting.

Among physicians in single-specialty practices, 39.0% reported that their practice included no more than four physicians, compared with 5.3% who reported a practice of at least 50 physicians.¹

Among physicians in multispecialty practice, only 9.9% reported having no more than four physicians, compared with 35.5% reporting at least 50 physicians.¹

Hospital ownership
Twenty-three percent of all respondents reported working in a practice that was at least partially owned by a hospital. Of these physicians, 14.7% worked in practices fully owned by a hospital.

Physicians who worked in a single-specialty practice were more likely to report physician ownership of that practice (71.8%) than were doctors in multi-specialty practice (36.9%). And physicians in small practices (single- or multispecialty) were more likely to report physician ownership than physicians in large practices: 72% of physicians in groups of two to four reported physician ownership, compared with 45.6% of physicians in groups of 50 or more. Physicians in large practices (≥50 members) also were more likely to report ownership by a not-for-profit foundation.¹

After exploring the issue of hospital ownership from several different angles, Kane and Emmons found that the association between increasing practice size and hospital ownership did not persist. Rather, they found that the “wider scope of practice in multispecialty groups, not practice size, drives hospital ownership.” They theorized that hospitals are more likely to buy primary care practices to gain a strong referral base, and this theory was borne out by the data, which showed that primary care physicians are more likely to report hospital ownership.¹

RELATED ARTICLE: Is private ObGyn practice on its way out? Lucia DiVenere, MA (October 2011)

Two final comments
Kane and Emmons point out that their analysis doesn’t “capture relationships that are short of full employment” and, therefore, may underestimate “the degree of integration between physicians and hospitals.”1

Although the decline in solo practice may have been accelerated by reform measures in recent years, the shift was “already well underway in the early 1990s,” Kane and Emmons observed.¹

Although more physicians today are employed by hospitals than in the past, the overwhelming majority of doctors still work in private practices, according to 2012 data from the Physician Practice Benchmark Study (PPBS) conducted by the American Medical Association (AMA).¹

The survey shows that 53.2% of physicians were self-employed in 2012, and 60% were operating in practices wholly owned by physicians. Only 23% of physicians worked in practices that were partially or fully owned by a hospital, and only 5.6% were directly employed by a hospital.¹

The AMA estimates that 18.4% of physicians worked in solo practices in 2012, a decline of about 6% from the previous AMA survey in 2207/2008.¹ In 1983, 40.5% of physicians were in solo practice.¹

“To paraphrase Mark Twain, the reports of the death of private practice medicine have been greatly exaggerated,” said AMA President Ardis Dee Hoven, MD, in presenting the figures.¹

And AMA investigators Carol C. Kane, PhD, and David W. Emmons, PhD, who authored the report, noted: “After a 5-year gap in physician-level data, the 2012 PPBS offers an update on the status of physician practice arrangements, and allows for a nationally representative response to the numerous articles of the past several years that have highlighted a surge in the employment of physicians by hospitals and the ‘death’ of private practice.”¹

Details of the survey
Like earlier AMA surveys, the PPBS involved a nationally representative random sample of physicians who had completed residency, practiced at least 20 hours per week, and were not employed by the federal government.

Unlike earlier AMA surveys, which targeted AMA members, the 2012 PPBS utilized the Epocrates Honors market research panel rather than the AMA Masterfile. The reason for this switch: declining participation rates for surveys utilizing the Masterfile.

Another distinction: Earlier surveys failed to ask specifically whether the respondent’s practice was owned by its physician members or by a larger entity, such as a hospital. They also overlooked the organizational structure of practices. The 2012 survey addressed both issues.

The PPBS went to 14,750 physicians. Of these, 3,466 physicians responded, a response rate of 28%.¹

FINDINGS ON THE STRUCTURE OF PRACTICE

Ownership status
In 2012, 53.2% of physicians fully or partly owned their practice (a decline of 8.0% since 2007/2008), 41.8% were employed, and 5.0% were independent contractors.¹

Younger physicians were less likely to own their practice than older physicians were. Among physicians under age 40, the ownership rate was 43.3%, compared with 60.0% among doctors aged 55 years or older.¹

Women, too, were less likely to own their practice (38.7% vs 59.6% for men).¹

Type of practice
The most common type of practice setting was the single-specialty practice, reported by 45.5% of physicians. Women were less likely to report single-specialty practice than men (39.7% vs 48.0%).¹

Among ObGyns, single-specialty practice was reported by 52.7% of respondents.¹

Multispecialty practice was reported by 22.1% of respondents. Among ObGyns, that figure was 17.9%.¹

Solo practice was reported by 18.4% of respondents but varied significantly by age. Among physicians under age 40, only 10% reported solo practice, compared with 25.3% of physicians aged 55 or older. Among women, solo practice was reported by 21.0%, compared with 17.3% among men. Among all ObGyns (men and women), 20.6% reported solo practice.¹

Only 5.6% of physicians reported direct hospital employment. Among ObGyns, the figure was 2.3%.¹

Size of the practice
Sixty percent of respondents (in all practice settings) reported working in a practice with fewer than 10 physicians. Sixteen percent reported working in a practice with 10 to 24 physicians, 7.1% in practices with 25 to 49 physicians, and 12.2% in practices with more than 50 physicians. Hospital employees were not asked about the number of physicians in their practice setting.

Among physicians in single-specialty practices, 39.0% reported that their practice included no more than four physicians, compared with 5.3% who reported a practice of at least 50 physicians.¹

Among physicians in multispecialty practice, only 9.9% reported having no more than four physicians, compared with 35.5% reporting at least 50 physicians.¹

Hospital ownership
Twenty-three percent of all respondents reported working in a practice that was at least partially owned by a hospital. Of these physicians, 14.7% worked in practices fully owned by a hospital.

Physicians who worked in a single-specialty practice were more likely to report physician ownership of that practice (71.8%) than were doctors in multi-specialty practice (36.9%). And physicians in small practices (single- or multispecialty) were more likely to report physician ownership than physicians in large practices: 72% of physicians in groups of two to four reported physician ownership, compared with 45.6% of physicians in groups of 50 or more. Physicians in large practices (≥50 members) also were more likely to report ownership by a not-for-profit foundation.¹

After exploring the issue of hospital ownership from several different angles, Kane and Emmons found that the association between increasing practice size and hospital ownership did not persist. Rather, they found that the “wider scope of practice in multispecialty groups, not practice size, drives hospital ownership.” They theorized that hospitals are more likely to buy primary care practices to gain a strong referral base, and this theory was borne out by the data, which showed that primary care physicians are more likely to report hospital ownership.¹

RELATED ARTICLE: Is private ObGyn practice on its way out? Lucia DiVenere, MA (October 2011)

Two final comments
Kane and Emmons point out that their analysis doesn’t “capture relationships that are short of full employment” and, therefore, may underestimate “the degree of integration between physicians and hospitals.”1

Although the decline in solo practice may have been accelerated by reform measures in recent years, the shift was “already well underway in the early 1990s,” Kane and Emmons observed.¹

Although more physicians today are employed by hospitals than in the past, the overwhelming majority of doctors still work in private practices, according to 2012 data from the Physician Practice Benchmark Study (PPBS) conducted by the American Medical Association (AMA).¹

The survey shows that 53.2% of physicians were self-employed in 2012, and 60% were operating in practices wholly owned by physicians. Only 23% of physicians worked in practices that were partially or fully owned by a hospital, and only 5.6% were directly employed by a hospital.¹

The AMA estimates that 18.4% of physicians worked in solo practices in 2012, a decline of about 6% from the previous AMA survey in 2207/2008.¹ In 1983, 40.5% of physicians were in solo practice.¹

“To paraphrase Mark Twain, the reports of the death of private practice medicine have been greatly exaggerated,” said AMA President Ardis Dee Hoven, MD, in presenting the figures.¹

And AMA investigators Carol C. Kane, PhD, and David W. Emmons, PhD, who authored the report, noted: “After a 5-year gap in physician-level data, the 2012 PPBS offers an update on the status of physician practice arrangements, and allows for a nationally representative response to the numerous articles of the past several years that have highlighted a surge in the employment of physicians by hospitals and the ‘death’ of private practice.”¹

Details of the survey
Like earlier AMA surveys, the PPBS involved a nationally representative random sample of physicians who had completed residency, practiced at least 20 hours per week, and were not employed by the federal government.

Unlike earlier AMA surveys, which targeted AMA members, the 2012 PPBS utilized the Epocrates Honors market research panel rather than the AMA Masterfile. The reason for this switch: declining participation rates for surveys utilizing the Masterfile.

Another distinction: Earlier surveys failed to ask specifically whether the respondent’s practice was owned by its physician members or by a larger entity, such as a hospital. They also overlooked the organizational structure of practices. The 2012 survey addressed both issues.

The PPBS went to 14,750 physicians. Of these, 3,466 physicians responded, a response rate of 28%.¹

FINDINGS ON THE STRUCTURE OF PRACTICE

Ownership status
In 2012, 53.2% of physicians fully or partly owned their practice (a decline of 8.0% since 2007/2008), 41.8% were employed, and 5.0% were independent contractors.¹

Younger physicians were less likely to own their practice than older physicians were. Among physicians under age 40, the ownership rate was 43.3%, compared with 60.0% among doctors aged 55 years or older.¹

Women, too, were less likely to own their practice (38.7% vs 59.6% for men).¹

Type of practice
The most common type of practice setting was the single-specialty practice, reported by 45.5% of physicians. Women were less likely to report single-specialty practice than men (39.7% vs 48.0%).¹

Among ObGyns, single-specialty practice was reported by 52.7% of respondents.¹

Multispecialty practice was reported by 22.1% of respondents. Among ObGyns, that figure was 17.9%.¹

Solo practice was reported by 18.4% of respondents but varied significantly by age. Among physicians under age 40, only 10% reported solo practice, compared with 25.3% of physicians aged 55 or older. Among women, solo practice was reported by 21.0%, compared with 17.3% among men. Among all ObGyns (men and women), 20.6% reported solo practice.¹

Only 5.6% of physicians reported direct hospital employment. Among ObGyns, the figure was 2.3%.¹

Size of the practice
Sixty percent of respondents (in all practice settings) reported working in a practice with fewer than 10 physicians. Sixteen percent reported working in a practice with 10 to 24 physicians, 7.1% in practices with 25 to 49 physicians, and 12.2% in practices with more than 50 physicians. Hospital employees were not asked about the number of physicians in their practice setting.

Among physicians in single-specialty practices, 39.0% reported that their practice included no more than four physicians, compared with 5.3% who reported a practice of at least 50 physicians.¹

Among physicians in multispecialty practice, only 9.9% reported having no more than four physicians, compared with 35.5% reporting at least 50 physicians.¹

Hospital ownership
Twenty-three percent of all respondents reported working in a practice that was at least partially owned by a hospital. Of these physicians, 14.7% worked in practices fully owned by a hospital.

Physicians who worked in a single-specialty practice were more likely to report physician ownership of that practice (71.8%) than were doctors in multi-specialty practice (36.9%). And physicians in small practices (single- or multispecialty) were more likely to report physician ownership than physicians in large practices: 72% of physicians in groups of two to four reported physician ownership, compared with 45.6% of physicians in groups of 50 or more. Physicians in large practices (≥50 members) also were more likely to report ownership by a not-for-profit foundation.¹

After exploring the issue of hospital ownership from several different angles, Kane and Emmons found that the association between increasing practice size and hospital ownership did not persist. Rather, they found that the “wider scope of practice in multispecialty groups, not practice size, drives hospital ownership.” They theorized that hospitals are more likely to buy primary care practices to gain a strong referral base, and this theory was borne out by the data, which showed that primary care physicians are more likely to report hospital ownership.¹

RELATED ARTICLE: Is private ObGyn practice on its way out? Lucia DiVenere, MA (October 2011)

Two final comments
Kane and Emmons point out that their analysis doesn’t “capture relationships that are short of full employment” and, therefore, may underestimate “the degree of integration between physicians and hospitals.”1

Although the decline in solo practice may have been accelerated by reform measures in recent years, the shift was “already well underway in the early 1990s,” Kane and Emmons observed.¹

Clinicians should engage in shared, informed decision-making with women who are at increased risk for breast cancer about medications to reduce their risk. For women who are at increased risk for breast cancer and at low risk for adverse medication effects, clinicians should offer to prescribe risk-reducing medications, such as tamoxifen or raloxifene, recommends the US Preventive Services Task Force (USPSTF).

RELATED ARTICLE: Update on Breast Health Mark Pearlman, MD, and Jennifer Griffin Miller, MD, MPH (March 2013)

Tamoxifen and raloxifene
These agents are selective estrogen receptor (ER) modulators and have been shown to reduce the incidence of invasive, ER-positive breast cancer in several randomized, controlled trials. Tamoxifen has been approved by the US Food and Drug Administration (FDA) for this use in women aged 35 years or older, and raloxifene has been FDA-approved for this use in postmenopausal women.

RELATED ARTICLE: Osteoporosis treatment and breast cancer prevention: Two goals, one treatment? Robert L. Barbieri, MD (Editorial, November 2013)

A systematic review of clinical trials found that tamoxifen and raloxifene reduced the incidence of invasive breast cancer by 7 to 9 events per 1000 women over 5 years. Tamoxifen was found to reduce the incidence of breast cancer more than raloxifene. Tamoxifen also reduces the incidence of invasive breast cancer in premenopausal women who are at increased risk for the disease.

USPSTF-defined high risk
Women with an estimated 5-year risk for breast cancer of 3% or more are likely to benefit from treatment with tamoxifen or raloxifene. For women with no increased risk for breast cancer, the USPSTF found that the benefit of treatment with tamoxifen or raloxifene is limited (small). The USPSTF recommends against the routine use of medications, such as tamoxifen or raloxifene, for risk reduction of primary breast cancer in women who are not at increased risk for breast cancer.

The usual daily doses for tamoxifen and raloxifene are 20 mg and 60 mg, respectively, for 5 years. Tamoxifen is not recommended for use in combination with hormone therapy or hormonal contraception or in women who are pregnant, those who may become pregnant, or breastfeeding mothers.

RELATED ARTICLE: What is the gynecologist's role in the care of BRCA previvors? Robert L. Barbieri, MD (Editorial, September 2013)

Potential harms from tamoxifen and raloxifene
Tamoxifen and raloxifene increase risk for venous thromboembolic events (VTEs) by 4 to 7 events per 1000 women over 5 years; tamoxifen increases risk more than raloxifene. The USPSTF found that potential harms from thromboembolic events are small to moderate, with increased potential for harms in older women. Neither tamoxifen nor raloxifene should be used in women who have a history of thromboembolic events (deep venous thrombosis, pulmonary embolus, stroke, or transient ischemic attack).

Tamoxifen, but not raloxifene, has been found to increase risk for endometrial cancer (4 more cases per 1000 women). Potential harms from tamoxifen-related endometrial cancer are small to moderate and depend on hysterectomy status and age. The potential risks for tamoxifen-related harms are higher in women older than age 50 and in women with a uterus. Tamoxifen may also increase the incidence of cataracts.

Vasomotor symptoms are a common adverse effect of both tamoxifen and raloxifene. These symptoms may affect a patient's quality of life and willingness to use or adhere to the medications.

The final recommendation statement was published online in the Annals of Internal Medicine September 24, 2013, and is available on the USPSTF Web site.

Clinicians should engage in shared, informed decision-making with women who are at increased risk for breast cancer about medications to reduce their risk. For women who are at increased risk for breast cancer and at low risk for adverse medication effects, clinicians should offer to prescribe risk-reducing medications, such as tamoxifen or raloxifene, recommends the US Preventive Services Task Force (USPSTF).

RELATED ARTICLE: Update on Breast Health Mark Pearlman, MD, and Jennifer Griffin Miller, MD, MPH (March 2013)

Tamoxifen and raloxifene
These agents are selective estrogen receptor (ER) modulators and have been shown to reduce the incidence of invasive, ER-positive breast cancer in several randomized, controlled trials. Tamoxifen has been approved by the US Food and Drug Administration (FDA) for this use in women aged 35 years or older, and raloxifene has been FDA-approved for this use in postmenopausal women.

RELATED ARTICLE: Osteoporosis treatment and breast cancer prevention: Two goals, one treatment? Robert L. Barbieri, MD (Editorial, November 2013)

A systematic review of clinical trials found that tamoxifen and raloxifene reduced the incidence of invasive breast cancer by 7 to 9 events per 1000 women over 5 years. Tamoxifen was found to reduce the incidence of breast cancer more than raloxifene. Tamoxifen also reduces the incidence of invasive breast cancer in premenopausal women who are at increased risk for the disease.

USPSTF-defined high risk
Women with an estimated 5-year risk for breast cancer of 3% or more are likely to benefit from treatment with tamoxifen or raloxifene. For women with no increased risk for breast cancer, the USPSTF found that the benefit of treatment with tamoxifen or raloxifene is limited (small). The USPSTF recommends against the routine use of medications, such as tamoxifen or raloxifene, for risk reduction of primary breast cancer in women who are not at increased risk for breast cancer.

The usual daily doses for tamoxifen and raloxifene are 20 mg and 60 mg, respectively, for 5 years. Tamoxifen is not recommended for use in combination with hormone therapy or hormonal contraception or in women who are pregnant, those who may become pregnant, or breastfeeding mothers.

RELATED ARTICLE: What is the gynecologist's role in the care of BRCA previvors? Robert L. Barbieri, MD (Editorial, September 2013)

Potential harms from tamoxifen and raloxifene
Tamoxifen and raloxifene increase risk for venous thromboembolic events (VTEs) by 4 to 7 events per 1000 women over 5 years; tamoxifen increases risk more than raloxifene. The USPSTF found that potential harms from thromboembolic events are small to moderate, with increased potential for harms in older women. Neither tamoxifen nor raloxifene should be used in women who have a history of thromboembolic events (deep venous thrombosis, pulmonary embolus, stroke, or transient ischemic attack).

Tamoxifen, but not raloxifene, has been found to increase risk for endometrial cancer (4 more cases per 1000 women). Potential harms from tamoxifen-related endometrial cancer are small to moderate and depend on hysterectomy status and age. The potential risks for tamoxifen-related harms are higher in women older than age 50 and in women with a uterus. Tamoxifen may also increase the incidence of cataracts.

Vasomotor symptoms are a common adverse effect of both tamoxifen and raloxifene. These symptoms may affect a patient's quality of life and willingness to use or adhere to the medications.

The final recommendation statement was published online in the Annals of Internal Medicine September 24, 2013, and is available on the USPSTF Web site.

Clinicians should engage in shared, informed decision-making with women who are at increased risk for breast cancer about medications to reduce their risk. For women who are at increased risk for breast cancer and at low risk for adverse medication effects, clinicians should offer to prescribe risk-reducing medications, such as tamoxifen or raloxifene, recommends the US Preventive Services Task Force (USPSTF).

RELATED ARTICLE: Update on Breast Health Mark Pearlman, MD, and Jennifer Griffin Miller, MD, MPH (March 2013)

Tamoxifen and raloxifene
These agents are selective estrogen receptor (ER) modulators and have been shown to reduce the incidence of invasive, ER-positive breast cancer in several randomized, controlled trials. Tamoxifen has been approved by the US Food and Drug Administration (FDA) for this use in women aged 35 years or older, and raloxifene has been FDA-approved for this use in postmenopausal women.

RELATED ARTICLE: Osteoporosis treatment and breast cancer prevention: Two goals, one treatment? Robert L. Barbieri, MD (Editorial, November 2013)

A systematic review of clinical trials found that tamoxifen and raloxifene reduced the incidence of invasive breast cancer by 7 to 9 events per 1000 women over 5 years. Tamoxifen was found to reduce the incidence of breast cancer more than raloxifene. Tamoxifen also reduces the incidence of invasive breast cancer in premenopausal women who are at increased risk for the disease.

USPSTF-defined high risk
Women with an estimated 5-year risk for breast cancer of 3% or more are likely to benefit from treatment with tamoxifen or raloxifene. For women with no increased risk for breast cancer, the USPSTF found that the benefit of treatment with tamoxifen or raloxifene is limited (small). The USPSTF recommends against the routine use of medications, such as tamoxifen or raloxifene, for risk reduction of primary breast cancer in women who are not at increased risk for breast cancer.

The usual daily doses for tamoxifen and raloxifene are 20 mg and 60 mg, respectively, for 5 years. Tamoxifen is not recommended for use in combination with hormone therapy or hormonal contraception or in women who are pregnant, those who may become pregnant, or breastfeeding mothers.

RELATED ARTICLE: What is the gynecologist's role in the care of BRCA previvors? Robert L. Barbieri, MD (Editorial, September 2013)

Potential harms from tamoxifen and raloxifene
Tamoxifen and raloxifene increase risk for venous thromboembolic events (VTEs) by 4 to 7 events per 1000 women over 5 years; tamoxifen increases risk more than raloxifene. The USPSTF found that potential harms from thromboembolic events are small to moderate, with increased potential for harms in older women. Neither tamoxifen nor raloxifene should be used in women who have a history of thromboembolic events (deep venous thrombosis, pulmonary embolus, stroke, or transient ischemic attack).

Tamoxifen, but not raloxifene, has been found to increase risk for endometrial cancer (4 more cases per 1000 women). Potential harms from tamoxifen-related endometrial cancer are small to moderate and depend on hysterectomy status and age. The potential risks for tamoxifen-related harms are higher in women older than age 50 and in women with a uterus. Tamoxifen may also increase the incidence of cataracts.

Vasomotor symptoms are a common adverse effect of both tamoxifen and raloxifene. These symptoms may affect a patient's quality of life and willingness to use or adhere to the medications.

The final recommendation statement was published online in the Annals of Internal Medicine September 24, 2013, and is available on the USPSTF Web site.

A conjugated estrogen/bazedoxifene formulation (Duavee) was approved by the FDA in early October to treat moderate-to-severe menopausal vasomotor symptoms and prevent menopausal osteoporosis in women with an intact uterus.

“Endometrial safety studies up to 1 year in length suggest that the SERM (bazedoxifene) component of this combination formulation prevents the elevated risk of endometrial hyperplasia associated with estrogen-alone treatment,” said Andrew M. Kaunitz, MD.

“[The new drug] is an alternative to hormone therapy in women with a uterus who are experiencing bothersome vasomotor symptoms in menopause,” concluded JoAnn V. Pinkerton, MD, in a NAMS presentation entitled, “Beyond hormone therapy: Innovative options for treatment of hot flashes.” To hear Dr. Pinkerton describe how much relief from their symptoms (specifically hot flash frequency and severity) patients can expect, as well as advice on patient selection, click on the audio player below.  

“In clinical trials, the most commonly reported side effects [of Duavee] included muscle spasms, nausea, diarrhea, upset stomach, abdominal pain, throat pain, dizziness, and neck pain,” Dr. Kaunitz reported.

The manufacturer’s (Pfizer) Web site indicates that Duavee will be available in the first quarter of 2014. 

A conjugated estrogen/bazedoxifene formulation (Duavee) was approved by the FDA in early October to treat moderate-to-severe menopausal vasomotor symptoms and prevent menopausal osteoporosis in women with an intact uterus.

“Endometrial safety studies up to 1 year in length suggest that the SERM (bazedoxifene) component of this combination formulation prevents the elevated risk of endometrial hyperplasia associated with estrogen-alone treatment,” said Andrew M. Kaunitz, MD.

“[The new drug] is an alternative to hormone therapy in women with a uterus who are experiencing bothersome vasomotor symptoms in menopause,” concluded JoAnn V. Pinkerton, MD, in a NAMS presentation entitled, “Beyond hormone therapy: Innovative options for treatment of hot flashes.” To hear Dr. Pinkerton describe how much relief from their symptoms (specifically hot flash frequency and severity) patients can expect, as well as advice on patient selection, click on the audio player below.  

“In clinical trials, the most commonly reported side effects [of Duavee] included muscle spasms, nausea, diarrhea, upset stomach, abdominal pain, throat pain, dizziness, and neck pain,” Dr. Kaunitz reported.

The manufacturer’s (Pfizer) Web site indicates that Duavee will be available in the first quarter of 2014. 

A conjugated estrogen/bazedoxifene formulation (Duavee) was approved by the FDA in early October to treat moderate-to-severe menopausal vasomotor symptoms and prevent menopausal osteoporosis in women with an intact uterus.

“Endometrial safety studies up to 1 year in length suggest that the SERM (bazedoxifene) component of this combination formulation prevents the elevated risk of endometrial hyperplasia associated with estrogen-alone treatment,” said Andrew M. Kaunitz, MD.

“[The new drug] is an alternative to hormone therapy in women with a uterus who are experiencing bothersome vasomotor symptoms in menopause,” concluded JoAnn V. Pinkerton, MD, in a NAMS presentation entitled, “Beyond hormone therapy: Innovative options for treatment of hot flashes.” To hear Dr. Pinkerton describe how much relief from their symptoms (specifically hot flash frequency and severity) patients can expect, as well as advice on patient selection, click on the audio player below.  

“In clinical trials, the most commonly reported side effects [of Duavee] included muscle spasms, nausea, diarrhea, upset stomach, abdominal pain, throat pain, dizziness, and neck pain,” Dr. Kaunitz reported.

The manufacturer’s (Pfizer) Web site indicates that Duavee will be available in the first quarter of 2014. 

“Since the 2002 publication of initial findings of the [Women’s Health Initiative], women and clinicians have been much more interested in nonhormonal treatment options for moderate to severe vasomotor symptoms,” said Andrew M. Kauntiz, MD, at NAMS 2013.

“Because of this interest, we have seen extensive trials of SSRIs [selective serotonin reuptake inhibitors] and SNRIs [selective norepinephrin reuptake inhibitors] for the treatment of bothersome hot flashes. We recognize that these agents do have efficacy greater than placebo in the treatment of these distressing symptoms among menopausal women. However, a concern among women and their providers has been that SSRIs and SNRIs can cause unwanted weight gain as well as sexual side effects,” Dr. Kaunitz said.

Low-dose mesylate salt of paroxetine (Brisdelle), an SSRI, was FDA-approved in June 2013 as 7.5-mg paroxetine tablets—the first nonhormonal treatment for moderate to severe vasomotor symptoms associated with menopause.

Dr. Kaunitz and colleagues pooled the data from two Phase 3 randomized, double-blind, placebo-controlled trials that demonstrated reduced frequency and severity of vasomotor symptoms and favorable tolerability with the 7.5-mg paroxetine formulation.

They found no clinically meaningful or statistically significant changes from baseline in weight or sexual function among the paroxetine group (median weight 74.5 kg) versus placebo (75.8 kg). The median body mass index (BMI) was 27.9 kg/m² among women using paroxetine versus 28.2 kg/m² in the placebo group. The Arizona Sexual Experience Scale (ASEX) score was 59% in the paroxetine group versus 58% in the placebo group.

In addition, no significant difference between treatment groups was observed in the proportion of patients who had a gain in body weight of 7% or greater at weeks 4, 12, or 24. The rates of adverse events suggestive of sexual dysfunction were low and were similar in both treatment groups.

“What’s encouraging with our clinical trial findings is that it is the first nonhormonal treatment for menopausal vasomotor symptoms and does not cause weight gain or sexual side effects," said Dr. Kaunitz.

Listen to Dr. Kaunitz’s round-up of this new drug:

“Since the 2002 publication of initial findings of the [Women’s Health Initiative], women and clinicians have been much more interested in nonhormonal treatment options for moderate to severe vasomotor symptoms,” said Andrew M. Kauntiz, MD, at NAMS 2013.

“Because of this interest, we have seen extensive trials of SSRIs [selective serotonin reuptake inhibitors] and SNRIs [selective norepinephrin reuptake inhibitors] for the treatment of bothersome hot flashes. We recognize that these agents do have efficacy greater than placebo in the treatment of these distressing symptoms among menopausal women. However, a concern among women and their providers has been that SSRIs and SNRIs can cause unwanted weight gain as well as sexual side effects,” Dr. Kaunitz said.

Low-dose mesylate salt of paroxetine (Brisdelle), an SSRI, was FDA-approved in June 2013 as 7.5-mg paroxetine tablets—the first nonhormonal treatment for moderate to severe vasomotor symptoms associated with menopause.

Dr. Kaunitz and colleagues pooled the data from two Phase 3 randomized, double-blind, placebo-controlled trials that demonstrated reduced frequency and severity of vasomotor symptoms and favorable tolerability with the 7.5-mg paroxetine formulation.

They found no clinically meaningful or statistically significant changes from baseline in weight or sexual function among the paroxetine group (median weight 74.5 kg) versus placebo (75.8 kg). The median body mass index (BMI) was 27.9 kg/m² among women using paroxetine versus 28.2 kg/m² in the placebo group. The Arizona Sexual Experience Scale (ASEX) score was 59% in the paroxetine group versus 58% in the placebo group.

In addition, no significant difference between treatment groups was observed in the proportion of patients who had a gain in body weight of 7% or greater at weeks 4, 12, or 24. The rates of adverse events suggestive of sexual dysfunction were low and were similar in both treatment groups.

“What’s encouraging with our clinical trial findings is that it is the first nonhormonal treatment for menopausal vasomotor symptoms and does not cause weight gain or sexual side effects," said Dr. Kaunitz.

Listen to Dr. Kaunitz’s round-up of this new drug:

“Since the 2002 publication of initial findings of the [Women’s Health Initiative], women and clinicians have been much more interested in nonhormonal treatment options for moderate to severe vasomotor symptoms,” said Andrew M. Kauntiz, MD, at NAMS 2013.

“Because of this interest, we have seen extensive trials of SSRIs [selective serotonin reuptake inhibitors] and SNRIs [selective norepinephrin reuptake inhibitors] for the treatment of bothersome hot flashes. We recognize that these agents do have efficacy greater than placebo in the treatment of these distressing symptoms among menopausal women. However, a concern among women and their providers has been that SSRIs and SNRIs can cause unwanted weight gain as well as sexual side effects,” Dr. Kaunitz said.

Low-dose mesylate salt of paroxetine (Brisdelle), an SSRI, was FDA-approved in June 2013 as 7.5-mg paroxetine tablets—the first nonhormonal treatment for moderate to severe vasomotor symptoms associated with menopause.

Dr. Kaunitz and colleagues pooled the data from two Phase 3 randomized, double-blind, placebo-controlled trials that demonstrated reduced frequency and severity of vasomotor symptoms and favorable tolerability with the 7.5-mg paroxetine formulation.

They found no clinically meaningful or statistically significant changes from baseline in weight or sexual function among the paroxetine group (median weight 74.5 kg) versus placebo (75.8 kg). The median body mass index (BMI) was 27.9 kg/m² among women using paroxetine versus 28.2 kg/m² in the placebo group. The Arizona Sexual Experience Scale (ASEX) score was 59% in the paroxetine group versus 58% in the placebo group.

In addition, no significant difference between treatment groups was observed in the proportion of patients who had a gain in body weight of 7% or greater at weeks 4, 12, or 24. The rates of adverse events suggestive of sexual dysfunction were low and were similar in both treatment groups.

“What’s encouraging with our clinical trial findings is that it is the first nonhormonal treatment for menopausal vasomotor symptoms and does not cause weight gain or sexual side effects," said Dr. Kaunitz.

Listen to Dr. Kaunitz’s round-up of this new drug: