News for Your Practice

In February 2013, the FDA approved ospemifeme (Osphena 60 mg tablets, Shionogi Inc, Florham Park, NJ), an orally administered tissue-selective estrogen agonist/antagonist, for the treatment of dyspareunia caused by vulvar and vaginal atrophy (VVA) in menopausal women.¹ As with its pharmacologic relatives tamoxifen and raloxifene, ospemifene acts as an estrogen agonist in some tissues and an estrogen antagonist in other tissues.

In clinical trials, ospemifene has been found to reduce pain with sexual intercourse and increase vaginal mucosal maturation and vaginal pH to a greater extent than placebo.² Contraindications listed in package labeling for ospemifene include estrogen-dependent neoplasia and active or prior venous thromboembolism (VTE), stroke, or myocardial infarction.³ Although ospemifene has an estrogen-agonist impact on the endometrium, no cases of endometrial cancer were noted in clinical trials (the longest of which was 12 months).⁴ Adverse reactions most frequently reported in clinical trials were hot flushes (7.5% with ospemifene vs 2.6% with placebo), vaginal discharge (3.8% vs 0.3%, respectively), and muscle spasms (3.2% vs 0.9%, respectively).²

Women today have greater expectations regarding sexuality during their menopausal years. However, fewer menopausal women are using hormone therapy, leading to an epidemic of symptomatic VVA. Against this backdrop, new treatment options represent good news for women. Ospemifene may be of particular appeal for symptomatic women who prefer not to use estrogen vaginal cream, tablets, or the vaginal ring. However, in contrast to vaginal estrogen therapy, ospemifene increases hot flushes and may (like tamoxifen and raloxifene) increase the risk of VTE. As with vaginal estrogen, package labeling does not specifically recommend the use of progestin with ospemifene to prevent endometrial neoplasia in women with an intact uterus. However, and again, as with vaginal estrogen, endometrial monitoring should be considered in long-term users, and any vaginal bleeding occurring in users should be evaluated.

Use of vaginal or systemic estrogen is contraindicated in women with a history of breast cancer. As the package labeling indicates, “Osphena [ospemifene] 60 mg has not been adequately studied in women with breast cancer…”³ Accordingly, the FDA’s guidance is that, as with vaginal estrogen, ospemifene “…should not be used in women with known or suspected breast cancer or with a history of breast cancer.”¹

In February 2013, the FDA approved ospemifeme (Osphena 60 mg tablets, Shionogi Inc, Florham Park, NJ), an orally administered tissue-selective estrogen agonist/antagonist, for the treatment of dyspareunia caused by vulvar and vaginal atrophy (VVA) in menopausal women.¹ As with its pharmacologic relatives tamoxifen and raloxifene, ospemifene acts as an estrogen agonist in some tissues and an estrogen antagonist in other tissues.

In clinical trials, ospemifene has been found to reduce pain with sexual intercourse and increase vaginal mucosal maturation and vaginal pH to a greater extent than placebo.² Contraindications listed in package labeling for ospemifene include estrogen-dependent neoplasia and active or prior venous thromboembolism (VTE), stroke, or myocardial infarction.³ Although ospemifene has an estrogen-agonist impact on the endometrium, no cases of endometrial cancer were noted in clinical trials (the longest of which was 12 months).⁴ Adverse reactions most frequently reported in clinical trials were hot flushes (7.5% with ospemifene vs 2.6% with placebo), vaginal discharge (3.8% vs 0.3%, respectively), and muscle spasms (3.2% vs 0.9%, respectively).²

Women today have greater expectations regarding sexuality during their menopausal years. However, fewer menopausal women are using hormone therapy, leading to an epidemic of symptomatic VVA. Against this backdrop, new treatment options represent good news for women. Ospemifene may be of particular appeal for symptomatic women who prefer not to use estrogen vaginal cream, tablets, or the vaginal ring. However, in contrast to vaginal estrogen therapy, ospemifene increases hot flushes and may (like tamoxifen and raloxifene) increase the risk of VTE. As with vaginal estrogen, package labeling does not specifically recommend the use of progestin with ospemifene to prevent endometrial neoplasia in women with an intact uterus. However, and again, as with vaginal estrogen, endometrial monitoring should be considered in long-term users, and any vaginal bleeding occurring in users should be evaluated.

Use of vaginal or systemic estrogen is contraindicated in women with a history of breast cancer. As the package labeling indicates, “Osphena [ospemifene] 60 mg has not been adequately studied in women with breast cancer…”³ Accordingly, the FDA’s guidance is that, as with vaginal estrogen, ospemifene “…should not be used in women with known or suspected breast cancer or with a history of breast cancer.”¹

In February 2013, the FDA approved ospemifeme (Osphena 60 mg tablets, Shionogi Inc, Florham Park, NJ), an orally administered tissue-selective estrogen agonist/antagonist, for the treatment of dyspareunia caused by vulvar and vaginal atrophy (VVA) in menopausal women.¹ As with its pharmacologic relatives tamoxifen and raloxifene, ospemifene acts as an estrogen agonist in some tissues and an estrogen antagonist in other tissues.

In clinical trials, ospemifene has been found to reduce pain with sexual intercourse and increase vaginal mucosal maturation and vaginal pH to a greater extent than placebo.² Contraindications listed in package labeling for ospemifene include estrogen-dependent neoplasia and active or prior venous thromboembolism (VTE), stroke, or myocardial infarction.³ Although ospemifene has an estrogen-agonist impact on the endometrium, no cases of endometrial cancer were noted in clinical trials (the longest of which was 12 months).⁴ Adverse reactions most frequently reported in clinical trials were hot flushes (7.5% with ospemifene vs 2.6% with placebo), vaginal discharge (3.8% vs 0.3%, respectively), and muscle spasms (3.2% vs 0.9%, respectively).²

Women today have greater expectations regarding sexuality during their menopausal years. However, fewer menopausal women are using hormone therapy, leading to an epidemic of symptomatic VVA. Against this backdrop, new treatment options represent good news for women. Ospemifene may be of particular appeal for symptomatic women who prefer not to use estrogen vaginal cream, tablets, or the vaginal ring. However, in contrast to vaginal estrogen therapy, ospemifene increases hot flushes and may (like tamoxifen and raloxifene) increase the risk of VTE. As with vaginal estrogen, package labeling does not specifically recommend the use of progestin with ospemifene to prevent endometrial neoplasia in women with an intact uterus. However, and again, as with vaginal estrogen, endometrial monitoring should be considered in long-term users, and any vaginal bleeding occurring in users should be evaluated.

Use of vaginal or systemic estrogen is contraindicated in women with a history of breast cancer. As the package labeling indicates, “Osphena [ospemifene] 60 mg has not been adequately studied in women with breast cancer…”³ Accordingly, the FDA’s guidance is that, as with vaginal estrogen, ospemifene “…should not be used in women with known or suspected breast cancer or with a history of breast cancer.”¹

Prenatal exposure to valproate correlates with an increased risk of autism spectrum disorder and childhood autism in offspring, according to a study published in the Journal of the American Medical Association (JAMA).

Jakob Christensen, PhD, from Aarhus University Hospital in Denmark, and colleagues examined whether prenatal exposure to valproate correlates with the risk of autism in offspring in a population-base study involving 655,615 children born from 1996 through 2006 in Denmark.

Of the cohort, 5,437 were identified with autism spectrum disorder, including 2,067 with childhood autism. After 14 years of follow-up, the researchers found that the estimated absolute risk of autism spectrum disorder was 1.53%, and that of childhood autism was 0.48%. The absolute risks for the 508 children exposed to valproate were 4.42% for autism spectrum disorder (adjusted hazard ratio [aHR], 2.9) and 2.50% for childhood autism (aHR, 5.2). On restriction of the cohort to the 6,584 children born to women with epilepsy, the absolute risk of autism spectrum disorder was 2.44% for those not exposed to valproate (6,152 children) versus 4.15% for those exposed to valproate (432 children; aHR, 1.7); for childhood autism, the corresponding risks were 1.02% and 2.95% (aHR, 2.9).

“Maternal use of valproate during pregnancy was associated with a significantly increased risk of autism in the offspring, even after adjusting for parental psychiatric disease and epilepsy,” the authors write. “For women of childbearing potential who use antiepileptic medications, these findings must be balanced against the treatment benefits for women who require valproate for epilepsy control.”

One author disclosed financial ties to the pharmaceutical industry.

To read the JAMA abstract, click here.

Prenatal exposure to valproate correlates with an increased risk of autism spectrum disorder and childhood autism in offspring, according to a study published in the Journal of the American Medical Association (JAMA).

Jakob Christensen, PhD, from Aarhus University Hospital in Denmark, and colleagues examined whether prenatal exposure to valproate correlates with the risk of autism in offspring in a population-base study involving 655,615 children born from 1996 through 2006 in Denmark.

Of the cohort, 5,437 were identified with autism spectrum disorder, including 2,067 with childhood autism. After 14 years of follow-up, the researchers found that the estimated absolute risk of autism spectrum disorder was 1.53%, and that of childhood autism was 0.48%. The absolute risks for the 508 children exposed to valproate were 4.42% for autism spectrum disorder (adjusted hazard ratio [aHR], 2.9) and 2.50% for childhood autism (aHR, 5.2). On restriction of the cohort to the 6,584 children born to women with epilepsy, the absolute risk of autism spectrum disorder was 2.44% for those not exposed to valproate (6,152 children) versus 4.15% for those exposed to valproate (432 children; aHR, 1.7); for childhood autism, the corresponding risks were 1.02% and 2.95% (aHR, 2.9).

“Maternal use of valproate during pregnancy was associated with a significantly increased risk of autism in the offspring, even after adjusting for parental psychiatric disease and epilepsy,” the authors write. “For women of childbearing potential who use antiepileptic medications, these findings must be balanced against the treatment benefits for women who require valproate for epilepsy control.”

One author disclosed financial ties to the pharmaceutical industry.

To read the JAMA abstract, click here.

Prenatal exposure to valproate correlates with an increased risk of autism spectrum disorder and childhood autism in offspring, according to a study published in the Journal of the American Medical Association (JAMA).

Jakob Christensen, PhD, from Aarhus University Hospital in Denmark, and colleagues examined whether prenatal exposure to valproate correlates with the risk of autism in offspring in a population-base study involving 655,615 children born from 1996 through 2006 in Denmark.

Of the cohort, 5,437 were identified with autism spectrum disorder, including 2,067 with childhood autism. After 14 years of follow-up, the researchers found that the estimated absolute risk of autism spectrum disorder was 1.53%, and that of childhood autism was 0.48%. The absolute risks for the 508 children exposed to valproate were 4.42% for autism spectrum disorder (adjusted hazard ratio [aHR], 2.9) and 2.50% for childhood autism (aHR, 5.2). On restriction of the cohort to the 6,584 children born to women with epilepsy, the absolute risk of autism spectrum disorder was 2.44% for those not exposed to valproate (6,152 children) versus 4.15% for those exposed to valproate (432 children; aHR, 1.7); for childhood autism, the corresponding risks were 1.02% and 2.95% (aHR, 2.9).

“Maternal use of valproate during pregnancy was associated with a significantly increased risk of autism in the offspring, even after adjusting for parental psychiatric disease and epilepsy,” the authors write. “For women of childbearing potential who use antiepileptic medications, these findings must be balanced against the treatment benefits for women who require valproate for epilepsy control.”

One author disclosed financial ties to the pharmaceutical industry.

To read the JAMA abstract, click here.

Pharmaceutical sales representatives (PSRs) rarely inform primary care physicians about drug safety information during sales visits, according to research published online in the Journal of General Internal Medicine.

Barbara Mintzes, PhD, of the University of British Columbia in Vancouver, British Columbia, Canada, and colleagues conducted a prospective cohort study in Canada, France, and the United States to determine if PSRs adequately communicated safety information to primary care physicians during consecutive sales visits.

According to the researchers, 255 physicians had 1,692 drug-specific sales visits from May 2009 to June 2010. During these visits, “minimally adequate safety information” was only provided by PSRs in 1.7% of the visits, and they did not differ among the sites (range 0.9% to 3.0%). Serious adverse events were mentioned only in 5% to 6% of visits per site, despite a high proportion of the drugs promoted as having either a US Food and Drug Administration “Black Box” warning or a Canadian boxed warning. The physicians considered the quality of scientific information presented to be good or excellent in 54% of the sales visits, and they were “somewhat” or “very likely” to prescribe two-thirds of the time after the visits.

“Our results suggest a serious lack of information on harmful effects of promoted medicines,” the authors write. “Unless regulatory oversight is improved to ensure balanced information, limits to PSR-physician interactions may be the most effective way to ensure that prescribing decisions are based on adequate information on harm as well as benefit.”

To access the abstract of the article published in the Journal of General Internal Medicine, click here.

Pharmaceutical sales representatives (PSRs) rarely inform primary care physicians about drug safety information during sales visits, according to research published online in the Journal of General Internal Medicine.

Barbara Mintzes, PhD, of the University of British Columbia in Vancouver, British Columbia, Canada, and colleagues conducted a prospective cohort study in Canada, France, and the United States to determine if PSRs adequately communicated safety information to primary care physicians during consecutive sales visits.

According to the researchers, 255 physicians had 1,692 drug-specific sales visits from May 2009 to June 2010. During these visits, “minimally adequate safety information” was only provided by PSRs in 1.7% of the visits, and they did not differ among the sites (range 0.9% to 3.0%). Serious adverse events were mentioned only in 5% to 6% of visits per site, despite a high proportion of the drugs promoted as having either a US Food and Drug Administration “Black Box” warning or a Canadian boxed warning. The physicians considered the quality of scientific information presented to be good or excellent in 54% of the sales visits, and they were “somewhat” or “very likely” to prescribe two-thirds of the time after the visits.

“Our results suggest a serious lack of information on harmful effects of promoted medicines,” the authors write. “Unless regulatory oversight is improved to ensure balanced information, limits to PSR-physician interactions may be the most effective way to ensure that prescribing decisions are based on adequate information on harm as well as benefit.”

To access the abstract of the article published in the Journal of General Internal Medicine, click here.

Pharmaceutical sales representatives (PSRs) rarely inform primary care physicians about drug safety information during sales visits, according to research published online in the Journal of General Internal Medicine.

Barbara Mintzes, PhD, of the University of British Columbia in Vancouver, British Columbia, Canada, and colleagues conducted a prospective cohort study in Canada, France, and the United States to determine if PSRs adequately communicated safety information to primary care physicians during consecutive sales visits.

According to the researchers, 255 physicians had 1,692 drug-specific sales visits from May 2009 to June 2010. During these visits, “minimally adequate safety information” was only provided by PSRs in 1.7% of the visits, and they did not differ among the sites (range 0.9% to 3.0%). Serious adverse events were mentioned only in 5% to 6% of visits per site, despite a high proportion of the drugs promoted as having either a US Food and Drug Administration “Black Box” warning or a Canadian boxed warning. The physicians considered the quality of scientific information presented to be good or excellent in 54% of the sales visits, and they were “somewhat” or “very likely” to prescribe two-thirds of the time after the visits.

“Our results suggest a serious lack of information on harmful effects of promoted medicines,” the authors write. “Unless regulatory oversight is improved to ensure balanced information, limits to PSR-physician interactions may be the most effective way to ensure that prescribing decisions are based on adequate information on harm as well as benefit.”

To access the abstract of the article published in the Journal of General Internal Medicine, click here.

Diclegis (doxylamine succinate and pyridoxine hydrochloride) has been approved by the US Food and Drug Administration to treat nausea and vomiting during pregnancy.

The drug was sanctioned for pregnant women who haven’t responded to other therapies, such as eating smaller meals, eating lower-fat foods, and avoiding smells that can prompt nausea, the agency said in a media release.

Diclegis was evaluated in 261 adult women experiencing nausea and vomiting due to pregnancy who were at least 18 years of age and had been pregnant between 7 and 14 weeks. Women who took the drug had less nausea and vomiting than those who took a placebo. Studies also showed the drug didn’t pose a threat to the fetus, the FDA said.

The starting dose is two pills at bedtime, with an increase to a maximum recommended dose of four tablets daily (one in the morning, one mid-afternoon and two at bedtime) if symptoms are not adequately controlled. The most common side effect of the drug was potentially severe drowsiness. Women who take Diclegis should avoid driving or operating heavy machinery, the agency said.

The drug is marketed by the Canadian pharma firm Duchesnay, based in Quebec.

To read the FDA news release, click here.

Diclegis (doxylamine succinate and pyridoxine hydrochloride) has been approved by the US Food and Drug Administration to treat nausea and vomiting during pregnancy.

The drug was sanctioned for pregnant women who haven’t responded to other therapies, such as eating smaller meals, eating lower-fat foods, and avoiding smells that can prompt nausea, the agency said in a media release.

Diclegis was evaluated in 261 adult women experiencing nausea and vomiting due to pregnancy who were at least 18 years of age and had been pregnant between 7 and 14 weeks. Women who took the drug had less nausea and vomiting than those who took a placebo. Studies also showed the drug didn’t pose a threat to the fetus, the FDA said.

The starting dose is two pills at bedtime, with an increase to a maximum recommended dose of four tablets daily (one in the morning, one mid-afternoon and two at bedtime) if symptoms are not adequately controlled. The most common side effect of the drug was potentially severe drowsiness. Women who take Diclegis should avoid driving or operating heavy machinery, the agency said.

The drug is marketed by the Canadian pharma firm Duchesnay, based in Quebec.

To read the FDA news release, click here.

Diclegis (doxylamine succinate and pyridoxine hydrochloride) has been approved by the US Food and Drug Administration to treat nausea and vomiting during pregnancy.

The drug was sanctioned for pregnant women who haven’t responded to other therapies, such as eating smaller meals, eating lower-fat foods, and avoiding smells that can prompt nausea, the agency said in a media release.

Diclegis was evaluated in 261 adult women experiencing nausea and vomiting due to pregnancy who were at least 18 years of age and had been pregnant between 7 and 14 weeks. Women who took the drug had less nausea and vomiting than those who took a placebo. Studies also showed the drug didn’t pose a threat to the fetus, the FDA said.

The starting dose is two pills at bedtime, with an increase to a maximum recommended dose of four tablets daily (one in the morning, one mid-afternoon and two at bedtime) if symptoms are not adequately controlled. The most common side effect of the drug was potentially severe drowsiness. Women who take Diclegis should avoid driving or operating heavy machinery, the agency said.

The drug is marketed by the Canadian pharma firm Duchesnay, based in Quebec.

To read the FDA news release, click here.

A study of nearly 4,000 pairs of mothers and their children at the University of Bristol in England found no association between maternal vitamin D levels during pregnancy and the child’s bone health in later life.¹

And new guidelines from the US Preventive Services Task Force (USPSTF) recommend against supplementation of vitamin D in amounts up to 400 IU daily and calcium in amounts up to 1,000 mg daily for the primary prevention of fractures in noninstitutionalized postmenopausal women.²

Children of the 90s study is largest so far

In the largest observational study ever published on the effects of maternal vitamin D levels on children’s bone health—the Children of the 90s trial—Lawlor and colleagues assessed vitamin D levels in 3,960 pregnant women, recording data from all three trimesters. When the children of these women reached an average age of 9 years and 11 months, their bone-mineral density (BMD) was assessed using dual-energy x-ray absorptiometry (DXA). Investigators found no significant association between a mother’s vitamin D levels and her child’s BMD.¹

On average, the women’s vitamin D levels were lowest during the first trimester and increased as pregnancy progressed. As expected, levels were higher when measured during summer months and lower during winter months. And although nonwhite mothers and those who smoked during pregnancy tended to have lower vitamin D levels overall, this finding appeared to have no effect on their children’s bone health.

Earlier studies of the effects of maternal vitamin D levels on children’s bone health were inconclusive. This study by Lawlor and colleagues is more than 10 times larger than all previous studies combined.

“We believe that there is no strong evidence that pregnant women should receive vitamin D supplementation to prevent low [BMD] in their offspring, although we cannot comment on other possible effects of vitamin D in pregnant women,” said Dr. Debbie Lawlor, lead author of the study. “While excessive vitamin D intake can affect the body’s calcium balance and result in cardiac arrhythmias and muscle problems (both rare), as well as milder problems such as dry mouth and constipation, our study didn’t look at any other potential beneficial or adverse effects of vitamin D supplementation besides the association with children’s bone health.”¹

USPSTF mostly found a lack of evidence

The USPSTF commissioned two systematic evidence reviews and a meta-analysis of vitamin D supplementation with or without calcium to assess²:

• the effects of supplementation on bone health in community-dwelling adults
• the association between vitamin D and calcium levels and bone health
• any adverse effects of supplementation.

After reviewing the findings, the Task Force concluded that there is insufficient evidence to determine the true balance of benefits versus risks of supplementation of vitamin D in amounts greater than 400 IU daily and calcium in amounts greater than 1,000 mg daily among postmenopausal women in the community. It also recommended against daily supplementation with 400 IU or less of vitamin D and 1,000 mg or less of calcium in this population, as there is no evidence that this practice prevents bone fracture.

In other words, the USPSTF has no recommendation on doses of these supplements at amounts greater than 400 IU of vitamin D and 1,000 mg of calcium daily among postmenopausal women, and recommends against supplementation at lower amounts in the same population.

Both studies focused on a specific context

Both the USPSTF and Lawlor and colleagues emphasized that their investigations focused only on bone mineral density or the risk of fracture, and they acknowledged that there may be other benefits and risks of vitamin D supplementation in pregnancy—and of supplementation with vitamin D and calcium after menopause.^1,2

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

A study of nearly 4,000 pairs of mothers and their children at the University of Bristol in England found no association between maternal vitamin D levels during pregnancy and the child’s bone health in later life.¹

And new guidelines from the US Preventive Services Task Force (USPSTF) recommend against supplementation of vitamin D in amounts up to 400 IU daily and calcium in amounts up to 1,000 mg daily for the primary prevention of fractures in noninstitutionalized postmenopausal women.²

Children of the 90s study is largest so far

In the largest observational study ever published on the effects of maternal vitamin D levels on children’s bone health—the Children of the 90s trial—Lawlor and colleagues assessed vitamin D levels in 3,960 pregnant women, recording data from all three trimesters. When the children of these women reached an average age of 9 years and 11 months, their bone-mineral density (BMD) was assessed using dual-energy x-ray absorptiometry (DXA). Investigators found no significant association between a mother’s vitamin D levels and her child’s BMD.¹

On average, the women’s vitamin D levels were lowest during the first trimester and increased as pregnancy progressed. As expected, levels were higher when measured during summer months and lower during winter months. And although nonwhite mothers and those who smoked during pregnancy tended to have lower vitamin D levels overall, this finding appeared to have no effect on their children’s bone health.

Earlier studies of the effects of maternal vitamin D levels on children’s bone health were inconclusive. This study by Lawlor and colleagues is more than 10 times larger than all previous studies combined.

“We believe that there is no strong evidence that pregnant women should receive vitamin D supplementation to prevent low [BMD] in their offspring, although we cannot comment on other possible effects of vitamin D in pregnant women,” said Dr. Debbie Lawlor, lead author of the study. “While excessive vitamin D intake can affect the body’s calcium balance and result in cardiac arrhythmias and muscle problems (both rare), as well as milder problems such as dry mouth and constipation, our study didn’t look at any other potential beneficial or adverse effects of vitamin D supplementation besides the association with children’s bone health.”¹

USPSTF mostly found a lack of evidence

The USPSTF commissioned two systematic evidence reviews and a meta-analysis of vitamin D supplementation with or without calcium to assess²:

• the effects of supplementation on bone health in community-dwelling adults
• the association between vitamin D and calcium levels and bone health
• any adverse effects of supplementation.

After reviewing the findings, the Task Force concluded that there is insufficient evidence to determine the true balance of benefits versus risks of supplementation of vitamin D in amounts greater than 400 IU daily and calcium in amounts greater than 1,000 mg daily among postmenopausal women in the community. It also recommended against daily supplementation with 400 IU or less of vitamin D and 1,000 mg or less of calcium in this population, as there is no evidence that this practice prevents bone fracture.

In other words, the USPSTF has no recommendation on doses of these supplements at amounts greater than 400 IU of vitamin D and 1,000 mg of calcium daily among postmenopausal women, and recommends against supplementation at lower amounts in the same population.

Both studies focused on a specific context

Both the USPSTF and Lawlor and colleagues emphasized that their investigations focused only on bone mineral density or the risk of fracture, and they acknowledged that there may be other benefits and risks of vitamin D supplementation in pregnancy—and of supplementation with vitamin D and calcium after menopause.^1,2

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

A study of nearly 4,000 pairs of mothers and their children at the University of Bristol in England found no association between maternal vitamin D levels during pregnancy and the child’s bone health in later life.¹

And new guidelines from the US Preventive Services Task Force (USPSTF) recommend against supplementation of vitamin D in amounts up to 400 IU daily and calcium in amounts up to 1,000 mg daily for the primary prevention of fractures in noninstitutionalized postmenopausal women.²

Children of the 90s study is largest so far

In the largest observational study ever published on the effects of maternal vitamin D levels on children’s bone health—the Children of the 90s trial—Lawlor and colleagues assessed vitamin D levels in 3,960 pregnant women, recording data from all three trimesters. When the children of these women reached an average age of 9 years and 11 months, their bone-mineral density (BMD) was assessed using dual-energy x-ray absorptiometry (DXA). Investigators found no significant association between a mother’s vitamin D levels and her child’s BMD.¹

On average, the women’s vitamin D levels were lowest during the first trimester and increased as pregnancy progressed. As expected, levels were higher when measured during summer months and lower during winter months. And although nonwhite mothers and those who smoked during pregnancy tended to have lower vitamin D levels overall, this finding appeared to have no effect on their children’s bone health.

Earlier studies of the effects of maternal vitamin D levels on children’s bone health were inconclusive. This study by Lawlor and colleagues is more than 10 times larger than all previous studies combined.

“We believe that there is no strong evidence that pregnant women should receive vitamin D supplementation to prevent low [BMD] in their offspring, although we cannot comment on other possible effects of vitamin D in pregnant women,” said Dr. Debbie Lawlor, lead author of the study. “While excessive vitamin D intake can affect the body’s calcium balance and result in cardiac arrhythmias and muscle problems (both rare), as well as milder problems such as dry mouth and constipation, our study didn’t look at any other potential beneficial or adverse effects of vitamin D supplementation besides the association with children’s bone health.”¹

USPSTF mostly found a lack of evidence

The USPSTF commissioned two systematic evidence reviews and a meta-analysis of vitamin D supplementation with or without calcium to assess²:

• the effects of supplementation on bone health in community-dwelling adults
• the association between vitamin D and calcium levels and bone health
• any adverse effects of supplementation.

After reviewing the findings, the Task Force concluded that there is insufficient evidence to determine the true balance of benefits versus risks of supplementation of vitamin D in amounts greater than 400 IU daily and calcium in amounts greater than 1,000 mg daily among postmenopausal women in the community. It also recommended against daily supplementation with 400 IU or less of vitamin D and 1,000 mg or less of calcium in this population, as there is no evidence that this practice prevents bone fracture.

In other words, the USPSTF has no recommendation on doses of these supplements at amounts greater than 400 IU of vitamin D and 1,000 mg of calcium daily among postmenopausal women, and recommends against supplementation at lower amounts in the same population.

Both studies focused on a specific context

Both the USPSTF and Lawlor and colleagues emphasized that their investigations focused only on bone mineral density or the risk of fracture, and they acknowledged that there may be other benefits and risks of vitamin D supplementation in pregnancy—and of supplementation with vitamin D and calcium after menopause.^1,2

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

When the Food and Drug Administration (FDA) approved Skyla, a 13.5-mg levonorgestrel-releasing intrauterine system (LNG-IUS), early this year, it increased the number of IUDs available in the United States by one-third. The new device joins the copper IUD (ParaGard) and the 52-mg LNG-IUS (Mirena) as options for women seeking long-acting intrauterine contraception. The new device and Mirena both are manufactured by Bayer HealthCare Pharmaceuticals.

Skyla releases 14 μg of levonorgestrel daily, an amount that decreases progressively to 5 μg/day after 3 years. The device comes packaged within a sterile inserter and is approved for 3 years of use.

Approval followed a multinational Phase 3 trial

The trial involved 1,432 women 18 to 35 years old, 556 (38.8%) of whom were nulliparous. The primary efficacy endpoint used to assess contraceptive reliability was the pregnancy rate, calculated as the Pearl Index (PI). The PI estimate for the first year of use, based on the five pregnancies that occurred after the onset of treatment and within 7 days after Skyla removal or expulsion, was 0.41, with a 95% upper confidence limit of 0.96. The cumulative 3-year pregnancy rate, based on 10 pregnancies and estimated by the Kaplan-Meier method, was 0.9 per 100 women or 0.9%, with a 95% upper confidence limit of 1.7%.¹

As a point of reference, the 12-month pregnancy rate for Mirena was ≤0.2%, and it was 0.5% over 5 years.² The one-year pregnancy rate for ParaGard is 0.6% with perfect use, 0.8% with typical use.³

Of the women using Skyla, 21.9% discontinued because of an adverse event. The most common adverse reactions (occurring in ≥10% of users) were:

• changes in bleeding patterns
  
• vulvovaginitis
  
• abdominal or pelvic pain
  
• acne or seborrhea
  
• ovarian cyst
  
• headache.¹
  

Family planning expert Mitchell Creinin, MD, professor and chair of obstetrics and gynecology at the University of California, Davis, does not see any cause for concern about adverse events.

“These adverse events include anything that occurs during study. For 20% of sexually active women to have at least one episode of vulvovaginitis over 3 years is not a problem”—nor is an occasional twinge of abdominal pain, he adds.

Insertion and removal

Skyla should be inserted during the first 7 days of the menstrual cycle or immediately after a first-trimester abortion. No back-up contraception is needed if it is inserted at these times.

Postpartum insertions should take place a minimum of 6 weeks after delivery or after a second-trimester abortion to allow for complete uterine involution.

Skyla should be removed after 3 years of use, preferably during the menstrual cycle to allow for immediate insertion of a new device or initiation of an alternate method of contraception.

Bleeding patterns may change during early use

During the first 3 to 6 months of use, women may experience irregular periods and an increase in the number of bleeding days. Women also may have frequent spotting or light bleeding. Some women may experience heavy bleeding during this interval. Over time, the number of bleeding and spotting days is likely to decline, and there is a small chance that periods may stop altogether. In clinical trials, 6% of Skyla users developed amenorrhea by the end of the first year.¹ By comparison, 20% of Mirena users developed amenorrhea by the end of the first year.²

The only IUD for nulliparas?

Although Skyla is the only IUD studied in a significant number of nulliparous women during Phase 3 studies, and its labeling states specifically that it is appropriate for use in this population, the other two IUDs are also safe for nulliparas.

“The label for ParaGard includes nulliparous and parous women,” notes Dr. Creinin. “The label for Mirena does not exclude nulliparous women, and there are huge numbers of studies about its use in teens and nulliparas. The only issue for Skyla is that the data presented to the FDA included nulliparous women, so the label reflects this fact.”

What’s the bottom line?

Skyla is an option for women who may desire a smaller IUD with a shorter duration of use. Although placement of Skyla is enhanced by a new inserter, compared with Mirena and ParaGard, Dr. Creinin notes that all IUD insertions, regardless of brand, are fairly straightforward. For example, a randomized trial by Gemzell-Danielsson and colleagues found that IUD insertion was “very difficult” in only 2 of 239 (0.8%) women receiving a prototype of Skyla and 4 of 254 (1.6%) women receiving Mirena.⁴

The cost of Skyla is approximately $650 (for 3 years of use) versus roughly $850 for Mirena and ParaGard (for 5 and 10 years of use, respectively).

 

In general, if a woman specifically requests a shorter duration of efficacy, then Skyla may be appropriate for her, although any IUD can be removed at any time if a patient decides to become pregnant.

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

When the Food and Drug Administration (FDA) approved Skyla, a 13.5-mg levonorgestrel-releasing intrauterine system (LNG-IUS), early this year, it increased the number of IUDs available in the United States by one-third. The new device joins the copper IUD (ParaGard) and the 52-mg LNG-IUS (Mirena) as options for women seeking long-acting intrauterine contraception. The new device and Mirena both are manufactured by Bayer HealthCare Pharmaceuticals.

Skyla releases 14 μg of levonorgestrel daily, an amount that decreases progressively to 5 μg/day after 3 years. The device comes packaged within a sterile inserter and is approved for 3 years of use.

Approval followed a multinational Phase 3 trial

The trial involved 1,432 women 18 to 35 years old, 556 (38.8%) of whom were nulliparous. The primary efficacy endpoint used to assess contraceptive reliability was the pregnancy rate, calculated as the Pearl Index (PI). The PI estimate for the first year of use, based on the five pregnancies that occurred after the onset of treatment and within 7 days after Skyla removal or expulsion, was 0.41, with a 95% upper confidence limit of 0.96. The cumulative 3-year pregnancy rate, based on 10 pregnancies and estimated by the Kaplan-Meier method, was 0.9 per 100 women or 0.9%, with a 95% upper confidence limit of 1.7%.¹

As a point of reference, the 12-month pregnancy rate for Mirena was ≤0.2%, and it was 0.5% over 5 years.² The one-year pregnancy rate for ParaGard is 0.6% with perfect use, 0.8% with typical use.³

Of the women using Skyla, 21.9% discontinued because of an adverse event. The most common adverse reactions (occurring in ≥10% of users) were:

• changes in bleeding patterns
  
• vulvovaginitis
  
• abdominal or pelvic pain
  
• acne or seborrhea
  
• ovarian cyst
  
• headache.¹
  

Family planning expert Mitchell Creinin, MD, professor and chair of obstetrics and gynecology at the University of California, Davis, does not see any cause for concern about adverse events.

“These adverse events include anything that occurs during study. For 20% of sexually active women to have at least one episode of vulvovaginitis over 3 years is not a problem”—nor is an occasional twinge of abdominal pain, he adds.

Insertion and removal

Skyla should be inserted during the first 7 days of the menstrual cycle or immediately after a first-trimester abortion. No back-up contraception is needed if it is inserted at these times.

Postpartum insertions should take place a minimum of 6 weeks after delivery or after a second-trimester abortion to allow for complete uterine involution.

Skyla should be removed after 3 years of use, preferably during the menstrual cycle to allow for immediate insertion of a new device or initiation of an alternate method of contraception.

Bleeding patterns may change during early use

During the first 3 to 6 months of use, women may experience irregular periods and an increase in the number of bleeding days. Women also may have frequent spotting or light bleeding. Some women may experience heavy bleeding during this interval. Over time, the number of bleeding and spotting days is likely to decline, and there is a small chance that periods may stop altogether. In clinical trials, 6% of Skyla users developed amenorrhea by the end of the first year.¹ By comparison, 20% of Mirena users developed amenorrhea by the end of the first year.²

The only IUD for nulliparas?

Although Skyla is the only IUD studied in a significant number of nulliparous women during Phase 3 studies, and its labeling states specifically that it is appropriate for use in this population, the other two IUDs are also safe for nulliparas.

“The label for ParaGard includes nulliparous and parous women,” notes Dr. Creinin. “The label for Mirena does not exclude nulliparous women, and there are huge numbers of studies about its use in teens and nulliparas. The only issue for Skyla is that the data presented to the FDA included nulliparous women, so the label reflects this fact.”

What’s the bottom line?

Skyla is an option for women who may desire a smaller IUD with a shorter duration of use. Although placement of Skyla is enhanced by a new inserter, compared with Mirena and ParaGard, Dr. Creinin notes that all IUD insertions, regardless of brand, are fairly straightforward. For example, a randomized trial by Gemzell-Danielsson and colleagues found that IUD insertion was “very difficult” in only 2 of 239 (0.8%) women receiving a prototype of Skyla and 4 of 254 (1.6%) women receiving Mirena.⁴

The cost of Skyla is approximately $650 (for 3 years of use) versus roughly $850 for Mirena and ParaGard (for 5 and 10 years of use, respectively).

 

In general, if a woman specifically requests a shorter duration of efficacy, then Skyla may be appropriate for her, although any IUD can be removed at any time if a patient decides to become pregnant.

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

When the Food and Drug Administration (FDA) approved Skyla, a 13.5-mg levonorgestrel-releasing intrauterine system (LNG-IUS), early this year, it increased the number of IUDs available in the United States by one-third. The new device joins the copper IUD (ParaGard) and the 52-mg LNG-IUS (Mirena) as options for women seeking long-acting intrauterine contraception. The new device and Mirena both are manufactured by Bayer HealthCare Pharmaceuticals.

Skyla releases 14 μg of levonorgestrel daily, an amount that decreases progressively to 5 μg/day after 3 years. The device comes packaged within a sterile inserter and is approved for 3 years of use.

Approval followed a multinational Phase 3 trial

The trial involved 1,432 women 18 to 35 years old, 556 (38.8%) of whom were nulliparous. The primary efficacy endpoint used to assess contraceptive reliability was the pregnancy rate, calculated as the Pearl Index (PI). The PI estimate for the first year of use, based on the five pregnancies that occurred after the onset of treatment and within 7 days after Skyla removal or expulsion, was 0.41, with a 95% upper confidence limit of 0.96. The cumulative 3-year pregnancy rate, based on 10 pregnancies and estimated by the Kaplan-Meier method, was 0.9 per 100 women or 0.9%, with a 95% upper confidence limit of 1.7%.¹

As a point of reference, the 12-month pregnancy rate for Mirena was ≤0.2%, and it was 0.5% over 5 years.² The one-year pregnancy rate for ParaGard is 0.6% with perfect use, 0.8% with typical use.³

Of the women using Skyla, 21.9% discontinued because of an adverse event. The most common adverse reactions (occurring in ≥10% of users) were:

• changes in bleeding patterns
  
• vulvovaginitis
  
• abdominal or pelvic pain
  
• acne or seborrhea
  
• ovarian cyst
  
• headache.¹
  

Family planning expert Mitchell Creinin, MD, professor and chair of obstetrics and gynecology at the University of California, Davis, does not see any cause for concern about adverse events.

“These adverse events include anything that occurs during study. For 20% of sexually active women to have at least one episode of vulvovaginitis over 3 years is not a problem”—nor is an occasional twinge of abdominal pain, he adds.

Insertion and removal

Skyla should be inserted during the first 7 days of the menstrual cycle or immediately after a first-trimester abortion. No back-up contraception is needed if it is inserted at these times.

Postpartum insertions should take place a minimum of 6 weeks after delivery or after a second-trimester abortion to allow for complete uterine involution.

Skyla should be removed after 3 years of use, preferably during the menstrual cycle to allow for immediate insertion of a new device or initiation of an alternate method of contraception.

Bleeding patterns may change during early use

During the first 3 to 6 months of use, women may experience irregular periods and an increase in the number of bleeding days. Women also may have frequent spotting or light bleeding. Some women may experience heavy bleeding during this interval. Over time, the number of bleeding and spotting days is likely to decline, and there is a small chance that periods may stop altogether. In clinical trials, 6% of Skyla users developed amenorrhea by the end of the first year.¹ By comparison, 20% of Mirena users developed amenorrhea by the end of the first year.²

The only IUD for nulliparas?

Although Skyla is the only IUD studied in a significant number of nulliparous women during Phase 3 studies, and its labeling states specifically that it is appropriate for use in this population, the other two IUDs are also safe for nulliparas.

“The label for ParaGard includes nulliparous and parous women,” notes Dr. Creinin. “The label for Mirena does not exclude nulliparous women, and there are huge numbers of studies about its use in teens and nulliparas. The only issue for Skyla is that the data presented to the FDA included nulliparous women, so the label reflects this fact.”

What’s the bottom line?

Skyla is an option for women who may desire a smaller IUD with a shorter duration of use. Although placement of Skyla is enhanced by a new inserter, compared with Mirena and ParaGard, Dr. Creinin notes that all IUD insertions, regardless of brand, are fairly straightforward. For example, a randomized trial by Gemzell-Danielsson and colleagues found that IUD insertion was “very difficult” in only 2 of 239 (0.8%) women receiving a prototype of Skyla and 4 of 254 (1.6%) women receiving Mirena.⁴

The cost of Skyla is approximately $650 (for 3 years of use) versus roughly $850 for Mirena and ParaGard (for 5 and 10 years of use, respectively).

 

In general, if a woman specifically requests a shorter duration of efficacy, then Skyla may be appropriate for her, although any IUD can be removed at any time if a patient decides to become pregnant.

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

Postpartum anxiety is more common than depression in the days and months following delivery, and is associated with adverse maternal heath outcomes and reduced duration of breastfeeding, according to a study published online in Pediatrics.

Ian M. Paul, MD, from Penn State University in Hershey, and colleagues compared correlates of anxiety with correlates of depression among 1,123 mothers with "well" newborns born ≥34 weeks’ gestation. To assess health-care use, breastfeeding duration, anxiety, and depression, participants were interviewed in-person during the postpartum stay and by telephone surveys at 2 weeks, 2 months, and 6 months. All participants planned to breastfeed.

The researchers found that, at baseline, 17% of participants were positive on the State Trait Anxiety Inventory (STAI) and 6% were positive on the Edinburgh Postnatal Depression Survey (EPDS). There was a significant association between primiparity and a positive STAI (20% versus 15%; P = 0.02), but not a positive EPDS (4% versus 7%; P = 0.05). Cesarean delivery, reduced duration of breastfeeding, and increased maternal, but not infant, total unplanned health-care utilization within 2 weeks of delivery were all significantly associated with positive STAI scores. At each assessment through 6 months postpartum, positive STAI scores occurred more frequently than positive EPDS scores.

“Postpartum-state anxiety is a common, acute phenomenon during the maternity hospitalization that is associated with increased maternal health-care utilization after discharge and reduced breastfeeding duration,” write the authors. “State anxiety screening during the postpartum stay could improve these outcomes.”

To access the abstract, click here.

Postpartum anxiety is more common than depression in the days and months following delivery, and is associated with adverse maternal heath outcomes and reduced duration of breastfeeding, according to a study published online in Pediatrics.

Ian M. Paul, MD, from Penn State University in Hershey, and colleagues compared correlates of anxiety with correlates of depression among 1,123 mothers with "well" newborns born ≥34 weeks’ gestation. To assess health-care use, breastfeeding duration, anxiety, and depression, participants were interviewed in-person during the postpartum stay and by telephone surveys at 2 weeks, 2 months, and 6 months. All participants planned to breastfeed.

The researchers found that, at baseline, 17% of participants were positive on the State Trait Anxiety Inventory (STAI) and 6% were positive on the Edinburgh Postnatal Depression Survey (EPDS). There was a significant association between primiparity and a positive STAI (20% versus 15%; P = 0.02), but not a positive EPDS (4% versus 7%; P = 0.05). Cesarean delivery, reduced duration of breastfeeding, and increased maternal, but not infant, total unplanned health-care utilization within 2 weeks of delivery were all significantly associated with positive STAI scores. At each assessment through 6 months postpartum, positive STAI scores occurred more frequently than positive EPDS scores.

“Postpartum-state anxiety is a common, acute phenomenon during the maternity hospitalization that is associated with increased maternal health-care utilization after discharge and reduced breastfeeding duration,” write the authors. “State anxiety screening during the postpartum stay could improve these outcomes.”

To access the abstract, click here.

Postpartum anxiety is more common than depression in the days and months following delivery, and is associated with adverse maternal heath outcomes and reduced duration of breastfeeding, according to a study published online in Pediatrics.

Ian M. Paul, MD, from Penn State University in Hershey, and colleagues compared correlates of anxiety with correlates of depression among 1,123 mothers with "well" newborns born ≥34 weeks’ gestation. To assess health-care use, breastfeeding duration, anxiety, and depression, participants were interviewed in-person during the postpartum stay and by telephone surveys at 2 weeks, 2 months, and 6 months. All participants planned to breastfeed.

The researchers found that, at baseline, 17% of participants were positive on the State Trait Anxiety Inventory (STAI) and 6% were positive on the Edinburgh Postnatal Depression Survey (EPDS). There was a significant association between primiparity and a positive STAI (20% versus 15%; P = 0.02), but not a positive EPDS (4% versus 7%; P = 0.05). Cesarean delivery, reduced duration of breastfeeding, and increased maternal, but not infant, total unplanned health-care utilization within 2 weeks of delivery were all significantly associated with positive STAI scores. At each assessment through 6 months postpartum, positive STAI scores occurred more frequently than positive EPDS scores.

“Postpartum-state anxiety is a common, acute phenomenon during the maternity hospitalization that is associated with increased maternal health-care utilization after discharge and reduced breastfeeding duration,” write the authors. “State anxiety screening during the postpartum stay could improve these outcomes.”

To access the abstract, click here.

Robotic surgery is not the only, the best, or the most cost-efficient method for a minimally invasive hysterectomy, according to a statement published by the American College of Obstetricians & Gynecologists (ACOG).

James T. Breeden, M.D., ACOG’s president, released a statement to counter some of the aggressive, direct-to-consumer marketing pushing robotic surgery, saying that patients need factual information about all treatment options, including vaginal and laparoscopic hysterectomies.

ACOG says that expertise with robotic hysterectomies is still limited and, during the learning curve associated with new surgical methodologies, there can be increased complications. Adding the expensive technology for routine surgical care does not improve outcomes, studies have found. Evidence shows that vaginal hysterectomies are the least invasive and least expensive option, with laparoscopic hysterectomies coming in second on both measures. Hospitalizations and recovery times are shorter with both vaginal and laparoscopic hysterectomies, compared with traditional total abdominal hysterectomies. Robotic surgery is the most expensive option, adding an average of $2,000 per procedure without any clinical benefit, according to a recent study. Despite the expense, in 3 years, the percentage of hysterectomies performed robotically has increased from 0.5% to 10%. If robotic surgery were used for all hysterectomies, roughly one billion dollars of costs would be added to the health-care system.

“While there may be some advantages to the use of robotics in complex hysterectomies, especially for cancer operations that require extensive surgery and removal of lymph nodes, studies have shown that adding this expensive technology for routine surgical care does not improve patient outcomes,” Breeden said in a statement.

Robotic surgery is not the only, the best, or the most cost-efficient method for a minimally invasive hysterectomy, according to a statement published by the American College of Obstetricians & Gynecologists (ACOG).

James T. Breeden, M.D., ACOG’s president, released a statement to counter some of the aggressive, direct-to-consumer marketing pushing robotic surgery, saying that patients need factual information about all treatment options, including vaginal and laparoscopic hysterectomies.

ACOG says that expertise with robotic hysterectomies is still limited and, during the learning curve associated with new surgical methodologies, there can be increased complications. Adding the expensive technology for routine surgical care does not improve outcomes, studies have found. Evidence shows that vaginal hysterectomies are the least invasive and least expensive option, with laparoscopic hysterectomies coming in second on both measures. Hospitalizations and recovery times are shorter with both vaginal and laparoscopic hysterectomies, compared with traditional total abdominal hysterectomies. Robotic surgery is the most expensive option, adding an average of $2,000 per procedure without any clinical benefit, according to a recent study. Despite the expense, in 3 years, the percentage of hysterectomies performed robotically has increased from 0.5% to 10%. If robotic surgery were used for all hysterectomies, roughly one billion dollars of costs would be added to the health-care system.

“While there may be some advantages to the use of robotics in complex hysterectomies, especially for cancer operations that require extensive surgery and removal of lymph nodes, studies have shown that adding this expensive technology for routine surgical care does not improve patient outcomes,” Breeden said in a statement.

Robotic surgery is not the only, the best, or the most cost-efficient method for a minimally invasive hysterectomy, according to a statement published by the American College of Obstetricians & Gynecologists (ACOG).

James T. Breeden, M.D., ACOG’s president, released a statement to counter some of the aggressive, direct-to-consumer marketing pushing robotic surgery, saying that patients need factual information about all treatment options, including vaginal and laparoscopic hysterectomies.

ACOG says that expertise with robotic hysterectomies is still limited and, during the learning curve associated with new surgical methodologies, there can be increased complications. Adding the expensive technology for routine surgical care does not improve outcomes, studies have found. Evidence shows that vaginal hysterectomies are the least invasive and least expensive option, with laparoscopic hysterectomies coming in second on both measures. Hospitalizations and recovery times are shorter with both vaginal and laparoscopic hysterectomies, compared with traditional total abdominal hysterectomies. Robotic surgery is the most expensive option, adding an average of $2,000 per procedure without any clinical benefit, according to a recent study. Despite the expense, in 3 years, the percentage of hysterectomies performed robotically has increased from 0.5% to 10%. If robotic surgery were used for all hysterectomies, roughly one billion dollars of costs would be added to the health-care system.

“While there may be some advantages to the use of robotics in complex hysterectomies, especially for cancer operations that require extensive surgery and removal of lymph nodes, studies have shown that adding this expensive technology for routine surgical care does not improve patient outcomes,” Breeden said in a statement.

Robotically assisted hysterectomy for benign gynecologic disorders increased significantly between 2007 and 2010, according to a study published February 20, 2013, in JAMA.¹ However, compared with laparoscopic hysterectomy, the robotic procedure appears to offer little short-term benefit and is accompanied by substantially increased costs.

In the cohort study of 264,758 women who underwent hysterectomy at 441 hospitals across the United States, Wright and colleagues analyzed the use of robotically assisted hysterectomy in comparison with the abdominal and laparoscopic approaches. They also compared in-house complication rates between the three approaches.

Use of the robot for hysterectomy increased from 0.5% of all hysterectomies in 2007 to 9.5% in 2010, and laparoscopic hysterectomy increased from 24.3% to 30.5%. The rates of abdominal hysterectomy declined in hospitals, regardless of whether the robotic approach was available.

Complication rates were similar between robotically assisted hysterectomy and laparoscopic hysterectomy (5.5% vs 5.3%; relative risk [RR], 1.03; 95% confidence interval [CI], 0.86–1.24). The need for transfusion (1.4% for the robotic approach vs 1.8% for laparoscopy; RR, 0.80; 95% CI, 0.55–1.15) and the rate of discharge to a nursing facility (0.2% vs 0.3%, respectively; RR, 0.79; 95% CI, 0.35–1.76) were similar between the laparoscopic and robotically assisted approaches. However, the total cost of robotic hysterectomy was $2,189 more per case, compared with the laparoscopic approach (95% CI, $2,030–$2,389).

“Proponents of robotic surgery have argued that robotic technology allows women who otherwise would undergo laparotomy to have a minimally invasive procedure,” write Wright and colleagues. “However, there is little to support these claims, and because both laparoscopic and robotically assisted hysterectomy are associated with low complication rates, it is unclear what benefits robotically assisted hysterectomy offers.”

The investigators also point out that, unlike other procedures such as prostatectomy, for which robotic assistance is used more frequently than conventional laparoscopic approaches, laparoscopic hysterectomy is already widely available.

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

Robotically assisted hysterectomy for benign gynecologic disorders increased significantly between 2007 and 2010, according to a study published February 20, 2013, in JAMA.¹ However, compared with laparoscopic hysterectomy, the robotic procedure appears to offer little short-term benefit and is accompanied by substantially increased costs.

In the cohort study of 264,758 women who underwent hysterectomy at 441 hospitals across the United States, Wright and colleagues analyzed the use of robotically assisted hysterectomy in comparison with the abdominal and laparoscopic approaches. They also compared in-house complication rates between the three approaches.

Use of the robot for hysterectomy increased from 0.5% of all hysterectomies in 2007 to 9.5% in 2010, and laparoscopic hysterectomy increased from 24.3% to 30.5%. The rates of abdominal hysterectomy declined in hospitals, regardless of whether the robotic approach was available.

Complication rates were similar between robotically assisted hysterectomy and laparoscopic hysterectomy (5.5% vs 5.3%; relative risk [RR], 1.03; 95% confidence interval [CI], 0.86–1.24). The need for transfusion (1.4% for the robotic approach vs 1.8% for laparoscopy; RR, 0.80; 95% CI, 0.55–1.15) and the rate of discharge to a nursing facility (0.2% vs 0.3%, respectively; RR, 0.79; 95% CI, 0.35–1.76) were similar between the laparoscopic and robotically assisted approaches. However, the total cost of robotic hysterectomy was $2,189 more per case, compared with the laparoscopic approach (95% CI, $2,030–$2,389).

“Proponents of robotic surgery have argued that robotic technology allows women who otherwise would undergo laparotomy to have a minimally invasive procedure,” write Wright and colleagues. “However, there is little to support these claims, and because both laparoscopic and robotically assisted hysterectomy are associated with low complication rates, it is unclear what benefits robotically assisted hysterectomy offers.”

The investigators also point out that, unlike other procedures such as prostatectomy, for which robotic assistance is used more frequently than conventional laparoscopic approaches, laparoscopic hysterectomy is already widely available.

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

Robotically assisted hysterectomy for benign gynecologic disorders increased significantly between 2007 and 2010, according to a study published February 20, 2013, in JAMA.¹ However, compared with laparoscopic hysterectomy, the robotic procedure appears to offer little short-term benefit and is accompanied by substantially increased costs.

In the cohort study of 264,758 women who underwent hysterectomy at 441 hospitals across the United States, Wright and colleagues analyzed the use of robotically assisted hysterectomy in comparison with the abdominal and laparoscopic approaches. They also compared in-house complication rates between the three approaches.

Use of the robot for hysterectomy increased from 0.5% of all hysterectomies in 2007 to 9.5% in 2010, and laparoscopic hysterectomy increased from 24.3% to 30.5%. The rates of abdominal hysterectomy declined in hospitals, regardless of whether the robotic approach was available.

Complication rates were similar between robotically assisted hysterectomy and laparoscopic hysterectomy (5.5% vs 5.3%; relative risk [RR], 1.03; 95% confidence interval [CI], 0.86–1.24). The need for transfusion (1.4% for the robotic approach vs 1.8% for laparoscopy; RR, 0.80; 95% CI, 0.55–1.15) and the rate of discharge to a nursing facility (0.2% vs 0.3%, respectively; RR, 0.79; 95% CI, 0.35–1.76) were similar between the laparoscopic and robotically assisted approaches. However, the total cost of robotic hysterectomy was $2,189 more per case, compared with the laparoscopic approach (95% CI, $2,030–$2,389).

“Proponents of robotic surgery have argued that robotic technology allows women who otherwise would undergo laparotomy to have a minimally invasive procedure,” write Wright and colleagues. “However, there is little to support these claims, and because both laparoscopic and robotically assisted hysterectomy are associated with low complication rates, it is unclear what benefits robotically assisted hysterectomy offers.”

The investigators also point out that, unlike other procedures such as prostatectomy, for which robotic assistance is used more frequently than conventional laparoscopic approaches, laparoscopic hysterectomy is already widely available.

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