Kerri Wachter

Major Finding: Of the 30 women who underwent modified panniculectomy at the time of cesarean section, there was one operative site infection that required readmission. In contrast, in the control group there were seven late wound complications and three readmissions. The difference in late wound complications was significant.

Data Source: A chart review during 2004 that included 30 morbidly obese patients who underwent incidental panniculectomy during cesarean section and a control group of 29 morbidly obese women who underwent a cesarean section without a panniculectomy.

Disclosures: Dr. Miranda-Seijo reported that he had no relevant financial disclosures.

WASHINGTON – Modified panniculectomy at the time of cesarean section may be a useful adjunct for decreasing postoperative morbidity in morbidly obese patients, based on results of a small case series.

“We found that women who underwent panniculectomy at the time of cesarean section were less likely to have significant wound complications than controls that did not undergo panniculectomy,” Dr. Pedro Miranda-Seijo said in a poster presentation at the meeting.

He and his coinvestigators conducted a chart review during 2004 that included 30 morbidly obese patients who underwent incidental panniculectomy during cesarean section and a control group of 29 morbidly obese women who underwent a cesarean section without a panniculectomy.

The definition of morbidly obese was a body mass index (BMI) of greater than 42 kg/m

“The decision to perform a panniculectomy was made originally by me before starting surgery, at which time I would obtain informed consent,” Dr. Miranda-Seijo said in an interview.

“After I'd done the first 10 or 15 cases, the residents and other attending began trying to schedule elective cases on morbidly obese patients on days that I would be available; often I would see these patients during their antepartum visit and discuss the procedure with them,” said Dr. Miranda-Seijo, who is an obstetrician at Denver Health and Hospitals.

“I am the only attending that does these procedures; [patients] understand that if they come in labor and I'm not available, they would not be getting a panniculectomy,” he said.

Also “when a morbidly obese patient who is in labor needs a cesarean section, if I'm available, I often get called to do it,” he commented.

“If the indication is urgent but not emergent – say failure to descend or secondary arrest of dilation – and I will be available in a few hours, the case is often held for me to do when I arrive,” he said.

Notably, the women in this series who underwent panniculectomy had significantly greater BMIs – a mean of 54 vs. 49 kg/m

Of the 30 women who underwent modified panniculectomy at the time of cesarean section, there was one operative site infection that required readmission.

In contrast, in the control group there were seven late wound complications and three readmissions.

The difference in late wound complications was significant.

There was a nonsignificant difference in operative time, with a mean of 66 minutes with a panniculectomy compared with 63 minutes for cesarean section alone.

Panniculectomy did not significantly increase blood loss.

“The extra time needed to infiltrate the skin, remove the pannus, and [close] the large incision is offset by the greater speed achieved in accessing the uterus, delivering the baby, and closing the uterus and fascia, due to better exposure and easier access,” he commented.

Several questions were raised by the study: Does the removal of so much adipose tissue have an effect on glucose tolerance, and could this procedure be used by patients as a starting point to initiate healthier lifestyle changes?

Additional research will be needed to provide answers, Dr. Miranda-Seijo said.

Modified panniculectomy at the time of cesarean section on morbidly obese patients did not significantly increase blood loss.

Source Photos courtesy Dr. Pedro Miranda-Seijo

Women who underwent panniculectomy at the time of c-section were less likely to have significant wound infections than those who did not have the procedure.

Major Finding: Of the 30 women who underwent modified panniculectomy at the time of cesarean section, there was one operative site infection that required readmission. In contrast, in the control group there were seven late wound complications and three readmissions. The difference in late wound complications was significant.

Data Source: A chart review during 2004 that included 30 morbidly obese patients who underwent incidental panniculectomy during cesarean section and a control group of 29 morbidly obese women who underwent a cesarean section without a panniculectomy.

Disclosures: Dr. Miranda-Seijo reported that he had no relevant financial disclosures.

WASHINGTON – Modified panniculectomy at the time of cesarean section may be a useful adjunct for decreasing postoperative morbidity in morbidly obese patients, based on results of a small case series.

“We found that women who underwent panniculectomy at the time of cesarean section were less likely to have significant wound complications than controls that did not undergo panniculectomy,” Dr. Pedro Miranda-Seijo said in a poster presentation at the meeting.

He and his coinvestigators conducted a chart review during 2004 that included 30 morbidly obese patients who underwent incidental panniculectomy during cesarean section and a control group of 29 morbidly obese women who underwent a cesarean section without a panniculectomy.

The definition of morbidly obese was a body mass index (BMI) of greater than 42 kg/m

“The decision to perform a panniculectomy was made originally by me before starting surgery, at which time I would obtain informed consent,” Dr. Miranda-Seijo said in an interview.

“After I'd done the first 10 or 15 cases, the residents and other attending began trying to schedule elective cases on morbidly obese patients on days that I would be available; often I would see these patients during their antepartum visit and discuss the procedure with them,” said Dr. Miranda-Seijo, who is an obstetrician at Denver Health and Hospitals.

“I am the only attending that does these procedures; [patients] understand that if they come in labor and I'm not available, they would not be getting a panniculectomy,” he said.

Also “when a morbidly obese patient who is in labor needs a cesarean section, if I'm available, I often get called to do it,” he commented.

“If the indication is urgent but not emergent – say failure to descend or secondary arrest of dilation – and I will be available in a few hours, the case is often held for me to do when I arrive,” he said.

Notably, the women in this series who underwent panniculectomy had significantly greater BMIs – a mean of 54 vs. 49 kg/m

Of the 30 women who underwent modified panniculectomy at the time of cesarean section, there was one operative site infection that required readmission.

In contrast, in the control group there were seven late wound complications and three readmissions.

The difference in late wound complications was significant.

There was a nonsignificant difference in operative time, with a mean of 66 minutes with a panniculectomy compared with 63 minutes for cesarean section alone.

Panniculectomy did not significantly increase blood loss.

“The extra time needed to infiltrate the skin, remove the pannus, and [close] the large incision is offset by the greater speed achieved in accessing the uterus, delivering the baby, and closing the uterus and fascia, due to better exposure and easier access,” he commented.

Several questions were raised by the study: Does the removal of so much adipose tissue have an effect on glucose tolerance, and could this procedure be used by patients as a starting point to initiate healthier lifestyle changes?

Additional research will be needed to provide answers, Dr. Miranda-Seijo said.

Modified panniculectomy at the time of cesarean section on morbidly obese patients did not significantly increase blood loss.

Source Photos courtesy Dr. Pedro Miranda-Seijo

Women who underwent panniculectomy at the time of c-section were less likely to have significant wound infections than those who did not have the procedure.

Major Finding: Of the 30 women who underwent modified panniculectomy at the time of cesarean section, there was one operative site infection that required readmission. In contrast, in the control group there were seven late wound complications and three readmissions. The difference in late wound complications was significant.

Data Source: A chart review during 2004 that included 30 morbidly obese patients who underwent incidental panniculectomy during cesarean section and a control group of 29 morbidly obese women who underwent a cesarean section without a panniculectomy.

Disclosures: Dr. Miranda-Seijo reported that he had no relevant financial disclosures.

WASHINGTON – Modified panniculectomy at the time of cesarean section may be a useful adjunct for decreasing postoperative morbidity in morbidly obese patients, based on results of a small case series.

“We found that women who underwent panniculectomy at the time of cesarean section were less likely to have significant wound complications than controls that did not undergo panniculectomy,” Dr. Pedro Miranda-Seijo said in a poster presentation at the meeting.

He and his coinvestigators conducted a chart review during 2004 that included 30 morbidly obese patients who underwent incidental panniculectomy during cesarean section and a control group of 29 morbidly obese women who underwent a cesarean section without a panniculectomy.

The definition of morbidly obese was a body mass index (BMI) of greater than 42 kg/m

“The decision to perform a panniculectomy was made originally by me before starting surgery, at which time I would obtain informed consent,” Dr. Miranda-Seijo said in an interview.

“After I'd done the first 10 or 15 cases, the residents and other attending began trying to schedule elective cases on morbidly obese patients on days that I would be available; often I would see these patients during their antepartum visit and discuss the procedure with them,” said Dr. Miranda-Seijo, who is an obstetrician at Denver Health and Hospitals.

“I am the only attending that does these procedures; [patients] understand that if they come in labor and I'm not available, they would not be getting a panniculectomy,” he said.

Also “when a morbidly obese patient who is in labor needs a cesarean section, if I'm available, I often get called to do it,” he commented.

“If the indication is urgent but not emergent – say failure to descend or secondary arrest of dilation – and I will be available in a few hours, the case is often held for me to do when I arrive,” he said.

Notably, the women in this series who underwent panniculectomy had significantly greater BMIs – a mean of 54 vs. 49 kg/m

Of the 30 women who underwent modified panniculectomy at the time of cesarean section, there was one operative site infection that required readmission.

In contrast, in the control group there were seven late wound complications and three readmissions.

The difference in late wound complications was significant.

There was a nonsignificant difference in operative time, with a mean of 66 minutes with a panniculectomy compared with 63 minutes for cesarean section alone.

Panniculectomy did not significantly increase blood loss.

“The extra time needed to infiltrate the skin, remove the pannus, and [close] the large incision is offset by the greater speed achieved in accessing the uterus, delivering the baby, and closing the uterus and fascia, due to better exposure and easier access,” he commented.

Several questions were raised by the study: Does the removal of so much adipose tissue have an effect on glucose tolerance, and could this procedure be used by patients as a starting point to initiate healthier lifestyle changes?

Additional research will be needed to provide answers, Dr. Miranda-Seijo said.

Modified panniculectomy at the time of cesarean section on morbidly obese patients did not significantly increase blood loss.

Source Photos courtesy Dr. Pedro Miranda-Seijo

Women who underwent panniculectomy at the time of c-section were less likely to have significant wound infections than those who did not have the procedure.

BOSTON – Healthy individuals do not need to be screened for vitamin D deficiency, according to guidelines from the Endocrine Society.

“That's an important message. So we're recommending screening for those at risk for vitamin D deficiency – those who are obese, African Americans, pregnant and lactating women, patients with malabsorption syndromes, and a whole list that we have provided in the guidelines,” lead author Dr. Michael F. Holick said at the meeting.

Dr. Holick headed a task force appointed by the clinical guidelines subcommittee of the Endocrine Society to formulate evidence-based recommendations on vitamin D deficiency. The subcommittee deemed vitamin D deficiency a priority area in need of practice guidelines.

The task force recommended that those at risk for vitamin D deficiency be screened by measuring serum 25-hydroxyvitamin D levels using a reliable assay. Causes of vitamin D deficiency include obesity, fat malabsorption syndromes, bariatric surgery, nephrotic syndrome, a wide range of medications (anticonvulsants and anti-HIV/AIDS drugs), chronic granuloma-forming disorders, some lymphomas, and primary hyperthyroidism.

The guidelines were released at the meeting and will be published in the July issue of the Journal of Clinical Endocrinology & Metabolism (doi: 10.1210/jc.2011–0385).

The guidelines provide long-awaited recommendations on vitamin D intake and the diagnosis and treatment of vitamin D deficiency.

Physicians have struggled for years to delineate how much vitamin D is necessary for different clinical groups, how to measure it, and how best to supplement deficiencies.

The task force commissioned two systematic reviews of the literature to inform its key recommendations and followed the approach recommended by GRADE, an international group with expertise in development and implementation of evidence-based guidelines.

“All available evidence suggests that children and adults should maintain a blood level of 25(OH)D above 20 ng/mL to prevent rickets and osteomalacia, respectively. However, to maximize vitamin D's effect on calcium, bone, and muscle metabolism, the 25(OH)D blood level should be above 30 ng/mL,” the group wrote.

In the new guidelines, vitamin D deficiency is defined as a 25(OH)D concentration less than 20 ng/mL (50 nmol/L). The task force suggests:

▸ Infants aged 0–1 year require at least 400 IU/day (IU = 25 ng) of vitamin D to maximize bone health.

▸ Children 1 year and older require at least 600 IU/day.

▸ Adults aged 19–50 years require at least 600 IU/day.

▸ Adults aged 50–70 years require at least 600 IU/day.

▸ Adults 70 years and older require 800 IU/day.

▸ Pregnant and lactating women require at least 600 IU/day.

The task force also recommends that obese children and adults and children and adults on certain medications (anticonvulsant medications, glucocorticoids, antifungals such as ketoconazole, and medications for AIDS) be given at least 2-3 times more vitamin D for their age group to satisfy their bodies' vitamin D requirements. Either vitamin D₂ or vitamin D₃ can be used for the treatment and prevention of vitamin D deficiency.

The group recommends that adults who are vitamin D deficient be treated with 50,000 IU of vitamin D₂ or vitamin D₃ once a week for 8 weeks or its equivalent of 6,000 IU of vitamin D₂ or vitamin D₃ daily to achieve a blood level of 25(OH)D greater than 30 ng/mL.

This should be followed by maintenance therapy of 1,500-2,000 IU/day.

The task force also recommends vitamin D supplementation for fall prevention. “We know that there is sufficient evidence to give vitamin D for fall prevention. It's well documented that vitamin D is very important for muscle strength,” said Dr. Holick, professor of medicine, physiology and biophysics at Boston University.

However, the group does not recommend prescribing vitamin D supplementation beyond recommended daily needs for the purpose of preventing cardiovascular disease or death or improving quality of life, because there is insufficient evidence.

The task force noted that most individuals do not get adequate vitamin D for a number of reasons. In particular, “there needs to be an appreciation that unprotected sun exposure is the major source of vitamin D for both children and adults and that in the absence of sun exposure it is difficult, if not impossible, to obtain an adequate amount of vitamin D from dietary sources without supplementation to satisfy the body's requirement. Concerns about melanoma and other types of skin cancer necessitate avoidance of excessive exposure to midday sun,” they wrote.

The guidelines are cosponsored by the Canadian Society of Endocrinology and Metabolism and the National Osteoporosis Foundation.

All but one of the authors reported having significant financial relationships with pharmaceutical companies, medical organizations and/or food industry groups.

BOSTON – Healthy individuals do not need to be screened for vitamin D deficiency, according to guidelines from the Endocrine Society.

“That's an important message. So we're recommending screening for those at risk for vitamin D deficiency – those who are obese, African Americans, pregnant and lactating women, patients with malabsorption syndromes, and a whole list that we have provided in the guidelines,” lead author Dr. Michael F. Holick said at the meeting.

Dr. Holick headed a task force appointed by the clinical guidelines subcommittee of the Endocrine Society to formulate evidence-based recommendations on vitamin D deficiency. The subcommittee deemed vitamin D deficiency a priority area in need of practice guidelines.

The task force recommended that those at risk for vitamin D deficiency be screened by measuring serum 25-hydroxyvitamin D levels using a reliable assay. Causes of vitamin D deficiency include obesity, fat malabsorption syndromes, bariatric surgery, nephrotic syndrome, a wide range of medications (anticonvulsants and anti-HIV/AIDS drugs), chronic granuloma-forming disorders, some lymphomas, and primary hyperthyroidism.

The guidelines were released at the meeting and will be published in the July issue of the Journal of Clinical Endocrinology & Metabolism (doi: 10.1210/jc.2011–0385).

The guidelines provide long-awaited recommendations on vitamin D intake and the diagnosis and treatment of vitamin D deficiency.

Physicians have struggled for years to delineate how much vitamin D is necessary for different clinical groups, how to measure it, and how best to supplement deficiencies.

The task force commissioned two systematic reviews of the literature to inform its key recommendations and followed the approach recommended by GRADE, an international group with expertise in development and implementation of evidence-based guidelines.

“All available evidence suggests that children and adults should maintain a blood level of 25(OH)D above 20 ng/mL to prevent rickets and osteomalacia, respectively. However, to maximize vitamin D's effect on calcium, bone, and muscle metabolism, the 25(OH)D blood level should be above 30 ng/mL,” the group wrote.

In the new guidelines, vitamin D deficiency is defined as a 25(OH)D concentration less than 20 ng/mL (50 nmol/L). The task force suggests:

▸ Infants aged 0–1 year require at least 400 IU/day (IU = 25 ng) of vitamin D to maximize bone health.

▸ Children 1 year and older require at least 600 IU/day.

▸ Adults aged 19–50 years require at least 600 IU/day.

▸ Adults aged 50–70 years require at least 600 IU/day.

▸ Adults 70 years and older require 800 IU/day.

▸ Pregnant and lactating women require at least 600 IU/day.

The task force also recommends that obese children and adults and children and adults on certain medications (anticonvulsant medications, glucocorticoids, antifungals such as ketoconazole, and medications for AIDS) be given at least 2-3 times more vitamin D for their age group to satisfy their bodies' vitamin D requirements. Either vitamin D₂ or vitamin D₃ can be used for the treatment and prevention of vitamin D deficiency.

The group recommends that adults who are vitamin D deficient be treated with 50,000 IU of vitamin D₂ or vitamin D₃ once a week for 8 weeks or its equivalent of 6,000 IU of vitamin D₂ or vitamin D₃ daily to achieve a blood level of 25(OH)D greater than 30 ng/mL.

This should be followed by maintenance therapy of 1,500-2,000 IU/day.

The task force also recommends vitamin D supplementation for fall prevention. “We know that there is sufficient evidence to give vitamin D for fall prevention. It's well documented that vitamin D is very important for muscle strength,” said Dr. Holick, professor of medicine, physiology and biophysics at Boston University.

However, the group does not recommend prescribing vitamin D supplementation beyond recommended daily needs for the purpose of preventing cardiovascular disease or death or improving quality of life, because there is insufficient evidence.

The task force noted that most individuals do not get adequate vitamin D for a number of reasons. In particular, “there needs to be an appreciation that unprotected sun exposure is the major source of vitamin D for both children and adults and that in the absence of sun exposure it is difficult, if not impossible, to obtain an adequate amount of vitamin D from dietary sources without supplementation to satisfy the body's requirement. Concerns about melanoma and other types of skin cancer necessitate avoidance of excessive exposure to midday sun,” they wrote.

The guidelines are cosponsored by the Canadian Society of Endocrinology and Metabolism and the National Osteoporosis Foundation.

All but one of the authors reported having significant financial relationships with pharmaceutical companies, medical organizations and/or food industry groups.

BOSTON – Healthy individuals do not need to be screened for vitamin D deficiency, according to guidelines from the Endocrine Society.

“That's an important message. So we're recommending screening for those at risk for vitamin D deficiency – those who are obese, African Americans, pregnant and lactating women, patients with malabsorption syndromes, and a whole list that we have provided in the guidelines,” lead author Dr. Michael F. Holick said at the meeting.

Dr. Holick headed a task force appointed by the clinical guidelines subcommittee of the Endocrine Society to formulate evidence-based recommendations on vitamin D deficiency. The subcommittee deemed vitamin D deficiency a priority area in need of practice guidelines.

The task force recommended that those at risk for vitamin D deficiency be screened by measuring serum 25-hydroxyvitamin D levels using a reliable assay. Causes of vitamin D deficiency include obesity, fat malabsorption syndromes, bariatric surgery, nephrotic syndrome, a wide range of medications (anticonvulsants and anti-HIV/AIDS drugs), chronic granuloma-forming disorders, some lymphomas, and primary hyperthyroidism.

The guidelines were released at the meeting and will be published in the July issue of the Journal of Clinical Endocrinology & Metabolism (doi: 10.1210/jc.2011–0385).

The guidelines provide long-awaited recommendations on vitamin D intake and the diagnosis and treatment of vitamin D deficiency.

Physicians have struggled for years to delineate how much vitamin D is necessary for different clinical groups, how to measure it, and how best to supplement deficiencies.

The task force commissioned two systematic reviews of the literature to inform its key recommendations and followed the approach recommended by GRADE, an international group with expertise in development and implementation of evidence-based guidelines.

“All available evidence suggests that children and adults should maintain a blood level of 25(OH)D above 20 ng/mL to prevent rickets and osteomalacia, respectively. However, to maximize vitamin D's effect on calcium, bone, and muscle metabolism, the 25(OH)D blood level should be above 30 ng/mL,” the group wrote.

In the new guidelines, vitamin D deficiency is defined as a 25(OH)D concentration less than 20 ng/mL (50 nmol/L). The task force suggests:

▸ Infants aged 0–1 year require at least 400 IU/day (IU = 25 ng) of vitamin D to maximize bone health.

▸ Children 1 year and older require at least 600 IU/day.

▸ Adults aged 19–50 years require at least 600 IU/day.

▸ Adults aged 50–70 years require at least 600 IU/day.

▸ Adults 70 years and older require 800 IU/day.

▸ Pregnant and lactating women require at least 600 IU/day.

The task force also recommends that obese children and adults and children and adults on certain medications (anticonvulsant medications, glucocorticoids, antifungals such as ketoconazole, and medications for AIDS) be given at least 2-3 times more vitamin D for their age group to satisfy their bodies' vitamin D requirements. Either vitamin D₂ or vitamin D₃ can be used for the treatment and prevention of vitamin D deficiency.

The group recommends that adults who are vitamin D deficient be treated with 50,000 IU of vitamin D₂ or vitamin D₃ once a week for 8 weeks or its equivalent of 6,000 IU of vitamin D₂ or vitamin D₃ daily to achieve a blood level of 25(OH)D greater than 30 ng/mL.

This should be followed by maintenance therapy of 1,500-2,000 IU/day.

The task force also recommends vitamin D supplementation for fall prevention. “We know that there is sufficient evidence to give vitamin D for fall prevention. It's well documented that vitamin D is very important for muscle strength,” said Dr. Holick, professor of medicine, physiology and biophysics at Boston University.

However, the group does not recommend prescribing vitamin D supplementation beyond recommended daily needs for the purpose of preventing cardiovascular disease or death or improving quality of life, because there is insufficient evidence.

The task force noted that most individuals do not get adequate vitamin D for a number of reasons. In particular, “there needs to be an appreciation that unprotected sun exposure is the major source of vitamin D for both children and adults and that in the absence of sun exposure it is difficult, if not impossible, to obtain an adequate amount of vitamin D from dietary sources without supplementation to satisfy the body's requirement. Concerns about melanoma and other types of skin cancer necessitate avoidance of excessive exposure to midday sun,” they wrote.

The guidelines are cosponsored by the Canadian Society of Endocrinology and Metabolism and the National Osteoporosis Foundation.

All but one of the authors reported having significant financial relationships with pharmaceutical companies, medical organizations and/or food industry groups.

WASHINGTON – Bundling criteria for elective induction would result in better outcomes and reduced costs if favorable cervix were added as a criterion, according to the results of a prospective trial.

"Among women achieving elective induction bundle criteria, favorable cervix is associated with significantly better outcomes and costs," said Tiffany Kenny, R.N., of Summa Health System in Akron, Ohio. "It’s not a novel finding that outcomes are better when the cervix is favorable. However, this study indicates that the current bundle is missing this key component and does not adequately guarantee cost or quality."

The elective induction bundle includes four criteria: a gestational age of at least 39 weeks, a normal fetal status at the start, pelvic exam documented prior to the start, and recognition and management of uterine tachysystole.

The investigators included all women at one institution who had delivered from October 2009 to October 2010 and had an elective induction. Data were collected prospectively for all 180 women, and all underwent quality bundling, which included a bundle audit, related education, and peer review, Ms. Kenny said at the annual meeting of the American College of Obstetricians and Gynecologists.

The study patients were divided into two groups – those achieving bundle criteria and those who did not. Those who achieved bundling criteria were then grouped by favorable cervix on admission. A favorable cervix was defined as a Bishop score greater than 6, determined by hospital admission exam by a physician or certified nurse midwife before the start of the induction.

At the end of the study period, a control group (prebundling) was retrospectively abstracted using the same methods, and included all women who had delivered from January 2005 to December 2007 and met the inclusion criteria.

Among the prebundling control group of 473 women, none achieved bundling. Of the 180 women included in the study group, 96% achieved bundling.

The two primary end points were cesarean delivery rate and rates of special or intensive care required. The cesarean delivery rate was 21% for women in the prebundling group and 12% with bundling, a significant difference. Women in the study group also had significantly less maternal blood loss and shorter lengths of stay. However, there were no differences in the rates of special or intensive care required – around 5.5%.

"Those who achieved bundle criteria did not always have favorable outcomes," Ms. Kenny said. "When bundle achievers were grouped by Bishop score, those with a poor Bishop score had higher rates of cesarean, more neonates to special care, longer lengths of labor, and higher rates of cesarean for dystocia and poor fetal heart rate pattern."

Among women in the study group, those with a Bishop score greater than 6 – considered a favorable cervix – had a 4% cesarean rate, compared with 19% for women who had a Bishop score of 6 or less, which was a significant difference. In addition, women with a Bishop score greater than 6 were significantly less likely to have a neonate requiring special or intensive care – 1% vs. 10% for women with a Bishop score of 6 or less.

In addition, "bundle achiever dyads with a poor Bishop score were significantly more costly than those with a Bishop score greater than 6, particularly if delivered vaginally."

Among vaginal delivery dyads, the net loss was $341 for those with a Bishop score greater than 6 vs. a net loss of $1,706 for those with a Bishop score of 6 or less. Likewise, among cesarean delivery dyads, the net loss was $2,166 for those with a Bishop score greater than 6 vs. a net loss of $6,342 for those with a Bishop score of 6 or less.

"Overall, the study cohort totaled a net income loss of over $270,000 for the hospital," said Ms. Kenny. "Elective induction was identified as the top drain to our department. The financial concerns of elective inductions will further intensify with health care reform, as reimbursement will soon be based on quality and cost – transitioning from fee-for-service to value-based care."

"Our findings also suggest that education and peer review interventions are not sufficient. Hard stops at the point of scheduling may be required," she said.

The investigators reported that they had no relevant financial disclosures.

WASHINGTON – Bundling criteria for elective induction would result in better outcomes and reduced costs if favorable cervix were added as a criterion, according to the results of a prospective trial.

"Among women achieving elective induction bundle criteria, favorable cervix is associated with significantly better outcomes and costs," said Tiffany Kenny, R.N., of Summa Health System in Akron, Ohio. "It’s not a novel finding that outcomes are better when the cervix is favorable. However, this study indicates that the current bundle is missing this key component and does not adequately guarantee cost or quality."

The elective induction bundle includes four criteria: a gestational age of at least 39 weeks, a normal fetal status at the start, pelvic exam documented prior to the start, and recognition and management of uterine tachysystole.

The investigators included all women at one institution who had delivered from October 2009 to October 2010 and had an elective induction. Data were collected prospectively for all 180 women, and all underwent quality bundling, which included a bundle audit, related education, and peer review, Ms. Kenny said at the annual meeting of the American College of Obstetricians and Gynecologists.

The study patients were divided into two groups – those achieving bundle criteria and those who did not. Those who achieved bundling criteria were then grouped by favorable cervix on admission. A favorable cervix was defined as a Bishop score greater than 6, determined by hospital admission exam by a physician or certified nurse midwife before the start of the induction.

At the end of the study period, a control group (prebundling) was retrospectively abstracted using the same methods, and included all women who had delivered from January 2005 to December 2007 and met the inclusion criteria.

Among the prebundling control group of 473 women, none achieved bundling. Of the 180 women included in the study group, 96% achieved bundling.

The two primary end points were cesarean delivery rate and rates of special or intensive care required. The cesarean delivery rate was 21% for women in the prebundling group and 12% with bundling, a significant difference. Women in the study group also had significantly less maternal blood loss and shorter lengths of stay. However, there were no differences in the rates of special or intensive care required – around 5.5%.

"Those who achieved bundle criteria did not always have favorable outcomes," Ms. Kenny said. "When bundle achievers were grouped by Bishop score, those with a poor Bishop score had higher rates of cesarean, more neonates to special care, longer lengths of labor, and higher rates of cesarean for dystocia and poor fetal heart rate pattern."

Among women in the study group, those with a Bishop score greater than 6 – considered a favorable cervix – had a 4% cesarean rate, compared with 19% for women who had a Bishop score of 6 or less, which was a significant difference. In addition, women with a Bishop score greater than 6 were significantly less likely to have a neonate requiring special or intensive care – 1% vs. 10% for women with a Bishop score of 6 or less.

In addition, "bundle achiever dyads with a poor Bishop score were significantly more costly than those with a Bishop score greater than 6, particularly if delivered vaginally."

Among vaginal delivery dyads, the net loss was $341 for those with a Bishop score greater than 6 vs. a net loss of $1,706 for those with a Bishop score of 6 or less. Likewise, among cesarean delivery dyads, the net loss was $2,166 for those with a Bishop score greater than 6 vs. a net loss of $6,342 for those with a Bishop score of 6 or less.

"Overall, the study cohort totaled a net income loss of over $270,000 for the hospital," said Ms. Kenny. "Elective induction was identified as the top drain to our department. The financial concerns of elective inductions will further intensify with health care reform, as reimbursement will soon be based on quality and cost – transitioning from fee-for-service to value-based care."

"Our findings also suggest that education and peer review interventions are not sufficient. Hard stops at the point of scheduling may be required," she said.

The investigators reported that they had no relevant financial disclosures.

WASHINGTON – Bundling criteria for elective induction would result in better outcomes and reduced costs if favorable cervix were added as a criterion, according to the results of a prospective trial.

"Among women achieving elective induction bundle criteria, favorable cervix is associated with significantly better outcomes and costs," said Tiffany Kenny, R.N., of Summa Health System in Akron, Ohio. "It’s not a novel finding that outcomes are better when the cervix is favorable. However, this study indicates that the current bundle is missing this key component and does not adequately guarantee cost or quality."

The elective induction bundle includes four criteria: a gestational age of at least 39 weeks, a normal fetal status at the start, pelvic exam documented prior to the start, and recognition and management of uterine tachysystole.

The investigators included all women at one institution who had delivered from October 2009 to October 2010 and had an elective induction. Data were collected prospectively for all 180 women, and all underwent quality bundling, which included a bundle audit, related education, and peer review, Ms. Kenny said at the annual meeting of the American College of Obstetricians and Gynecologists.

The study patients were divided into two groups – those achieving bundle criteria and those who did not. Those who achieved bundling criteria were then grouped by favorable cervix on admission. A favorable cervix was defined as a Bishop score greater than 6, determined by hospital admission exam by a physician or certified nurse midwife before the start of the induction.

At the end of the study period, a control group (prebundling) was retrospectively abstracted using the same methods, and included all women who had delivered from January 2005 to December 2007 and met the inclusion criteria.

Among the prebundling control group of 473 women, none achieved bundling. Of the 180 women included in the study group, 96% achieved bundling.

The two primary end points were cesarean delivery rate and rates of special or intensive care required. The cesarean delivery rate was 21% for women in the prebundling group and 12% with bundling, a significant difference. Women in the study group also had significantly less maternal blood loss and shorter lengths of stay. However, there were no differences in the rates of special or intensive care required – around 5.5%.

"Those who achieved bundle criteria did not always have favorable outcomes," Ms. Kenny said. "When bundle achievers were grouped by Bishop score, those with a poor Bishop score had higher rates of cesarean, more neonates to special care, longer lengths of labor, and higher rates of cesarean for dystocia and poor fetal heart rate pattern."

Among women in the study group, those with a Bishop score greater than 6 – considered a favorable cervix – had a 4% cesarean rate, compared with 19% for women who had a Bishop score of 6 or less, which was a significant difference. In addition, women with a Bishop score greater than 6 were significantly less likely to have a neonate requiring special or intensive care – 1% vs. 10% for women with a Bishop score of 6 or less.

In addition, "bundle achiever dyads with a poor Bishop score were significantly more costly than those with a Bishop score greater than 6, particularly if delivered vaginally."

Among vaginal delivery dyads, the net loss was $341 for those with a Bishop score greater than 6 vs. a net loss of $1,706 for those with a Bishop score of 6 or less. Likewise, among cesarean delivery dyads, the net loss was $2,166 for those with a Bishop score greater than 6 vs. a net loss of $6,342 for those with a Bishop score of 6 or less.

"Overall, the study cohort totaled a net income loss of over $270,000 for the hospital," said Ms. Kenny. "Elective induction was identified as the top drain to our department. The financial concerns of elective inductions will further intensify with health care reform, as reimbursement will soon be based on quality and cost – transitioning from fee-for-service to value-based care."

"Our findings also suggest that education and peer review interventions are not sufficient. Hard stops at the point of scheduling may be required," she said.

The investigators reported that they had no relevant financial disclosures.

The oral tyrosine kinase inhibitor sunitinib (Sutent) was approved May 20 for treatment of patients with metastatic pancreatic neuroendocrine tumors, according to the Food and Drug Administration.

Approval of sunitinib (Sutent, Pfizer) for the indication follows closely the May 5 approval of everolimus (Afinitor) for the treatment of advanced pancreatic neuroendocrine tumors. The two approvals mark the first new treatments in roughly 30 years for advanced pancreatic neuroendocrine tumors. There are an estimated 1,000 new cases of the tumor in the United States each year.

According to the FDA, the most commonly reported side effects of sunitinib include diarrhea, nausea, vomiting, fatigue, anorexia, high blood pressure, energy loss (asthenia), abdominal pain, changes in hair color, inflammation of the mouth (stomatitis), and a decrease in infection-fighting white blood cells (neutropenia).

Sutent is also FDA approved to treat patients with late-stage kidney cancer (metastatic renal cell carcinoma) and to treat patients with gastrointestinal stromal tumor or GIST.

In April, the FDA’s Oncologic Drug Advisory Committee voted 8-2 that the sunitinib’s risk-benefit profile was favorable for patients with this rare cancer. Their recommendation was based on the published results of a planned trial of 171 patients randomized to either 37.5 mg/day of oral sunitinib or placebo. Sunitinib doubled median progression-free survival for patients with advanced pancreatic neuroendocrine tumors from 5.5 months to 11.4 months. The probability of progression-free survival at 6 months was 71% in the sunitinib group and 43% in the placebo group (N. Engl. J. Med. 2011;364:501-13).

The trial was halted after randomization of 154 patients, when a data and safety monitoring committee found a greater number of serious adverse events and deaths in the placebo group. There were 9 deaths in the sunitinib group (10%) vs. 21 deaths in the placebo group (25%). The hazard ratio for death was 0.41 (P = .02) in favor of sunitinib. Eight patients on sunitinib had confirmed tumor responses (two complete responses and six partial responses) for an objective response rate of 9.3%.

At the committee meeting, members of the ODAC and the FDA expressed concerns that early termination of the study could have overestimated the magnitude of the treatment difference on progression-free survival, the primary end point of the study.

The oral tyrosine kinase inhibitor sunitinib (Sutent) was approved May 20 for treatment of patients with metastatic pancreatic neuroendocrine tumors, according to the Food and Drug Administration.

Approval of sunitinib (Sutent, Pfizer) for the indication follows closely the May 5 approval of everolimus (Afinitor) for the treatment of advanced pancreatic neuroendocrine tumors. The two approvals mark the first new treatments in roughly 30 years for advanced pancreatic neuroendocrine tumors. There are an estimated 1,000 new cases of the tumor in the United States each year.

According to the FDA, the most commonly reported side effects of sunitinib include diarrhea, nausea, vomiting, fatigue, anorexia, high blood pressure, energy loss (asthenia), abdominal pain, changes in hair color, inflammation of the mouth (stomatitis), and a decrease in infection-fighting white blood cells (neutropenia).

Sutent is also FDA approved to treat patients with late-stage kidney cancer (metastatic renal cell carcinoma) and to treat patients with gastrointestinal stromal tumor or GIST.

In April, the FDA’s Oncologic Drug Advisory Committee voted 8-2 that the sunitinib’s risk-benefit profile was favorable for patients with this rare cancer. Their recommendation was based on the published results of a planned trial of 171 patients randomized to either 37.5 mg/day of oral sunitinib or placebo. Sunitinib doubled median progression-free survival for patients with advanced pancreatic neuroendocrine tumors from 5.5 months to 11.4 months. The probability of progression-free survival at 6 months was 71% in the sunitinib group and 43% in the placebo group (N. Engl. J. Med. 2011;364:501-13).

The trial was halted after randomization of 154 patients, when a data and safety monitoring committee found a greater number of serious adverse events and deaths in the placebo group. There were 9 deaths in the sunitinib group (10%) vs. 21 deaths in the placebo group (25%). The hazard ratio for death was 0.41 (P = .02) in favor of sunitinib. Eight patients on sunitinib had confirmed tumor responses (two complete responses and six partial responses) for an objective response rate of 9.3%.

At the committee meeting, members of the ODAC and the FDA expressed concerns that early termination of the study could have overestimated the magnitude of the treatment difference on progression-free survival, the primary end point of the study.

The oral tyrosine kinase inhibitor sunitinib (Sutent) was approved May 20 for treatment of patients with metastatic pancreatic neuroendocrine tumors, according to the Food and Drug Administration.

Approval of sunitinib (Sutent, Pfizer) for the indication follows closely the May 5 approval of everolimus (Afinitor) for the treatment of advanced pancreatic neuroendocrine tumors. The two approvals mark the first new treatments in roughly 30 years for advanced pancreatic neuroendocrine tumors. There are an estimated 1,000 new cases of the tumor in the United States each year.

According to the FDA, the most commonly reported side effects of sunitinib include diarrhea, nausea, vomiting, fatigue, anorexia, high blood pressure, energy loss (asthenia), abdominal pain, changes in hair color, inflammation of the mouth (stomatitis), and a decrease in infection-fighting white blood cells (neutropenia).

Sutent is also FDA approved to treat patients with late-stage kidney cancer (metastatic renal cell carcinoma) and to treat patients with gastrointestinal stromal tumor or GIST.

In April, the FDA’s Oncologic Drug Advisory Committee voted 8-2 that the sunitinib’s risk-benefit profile was favorable for patients with this rare cancer. Their recommendation was based on the published results of a planned trial of 171 patients randomized to either 37.5 mg/day of oral sunitinib or placebo. Sunitinib doubled median progression-free survival for patients with advanced pancreatic neuroendocrine tumors from 5.5 months to 11.4 months. The probability of progression-free survival at 6 months was 71% in the sunitinib group and 43% in the placebo group (N. Engl. J. Med. 2011;364:501-13).

The trial was halted after randomization of 154 patients, when a data and safety monitoring committee found a greater number of serious adverse events and deaths in the placebo group. There were 9 deaths in the sunitinib group (10%) vs. 21 deaths in the placebo group (25%). The hazard ratio for death was 0.41 (P = .02) in favor of sunitinib. Eight patients on sunitinib had confirmed tumor responses (two complete responses and six partial responses) for an objective response rate of 9.3%.

At the committee meeting, members of the ODAC and the FDA expressed concerns that early termination of the study could have overestimated the magnitude of the treatment difference on progression-free survival, the primary end point of the study.

The oral tyrosine kinase inhibitor sunitinib (Sutent) was approved May 20 for treatment of patients with metastatic pancreatic neuroendocrine tumors, according to the Food and Drug Administration.

Approval of sunitinib (Sutent, Pfizer) for the indication follows closely the May 5 approval of everolimus (Afinitor) for the treatment of advanced pancreatic neuroendocrine tumors. The two approvals mark the first new treatments in roughly 30 years for advanced pancreatic neuroendocrine tumors. There are an estimated 1,000 new cases of the tumor in the United States each year.

According to the FDA, the most commonly reported side effects of sunitinib include diarrhea, nausea, vomiting, fatigue, anorexia, high blood pressure, energy loss (asthenia), abdominal pain, changes in hair color, inflammation of the mouth (stomatitis), and a decrease in infection-fighting white blood cells (neutropenia).

Sutent is also FDA approved to treat patients with late-stage kidney cancer (metastatic renal cell carcinoma) and to treat patients with gastrointestinal stromal tumor or GIST.

In April, the FDA’s Oncologic Drug Advisory Committee voted 8-2 that the sunitinib’s risk-benefit profile was favorable for patients with this rare cancer. Their recommendation was based on the published results of a planned trial of 171 patients randomized to either 37.5 mg/day of oral sunitinib or placebo. Sunitinib doubled median progression-free survival for patients with advanced pancreatic neuroendocrine tumors from 5.5 months to 11.4 months. The probability of progression-free survival at 6 months was 71% in the sunitinib group and 43% in the placebo group (N. Engl. J. Med. 2011;364:501-13).

The trial was halted after randomization of 154 patients, when a data and safety monitoring committee found a greater number of serious adverse events and deaths in the placebo group. There were 9 deaths in the sunitinib group (10%) vs. 21 deaths in the placebo group (25%). The hazard ratio for death was 0.41 (P = .02) in favor of sunitinib. Eight patients on sunitinib had confirmed tumor responses (two complete responses and six partial responses) for an objective response rate of 9.3%.

At the committee meeting, members of the ODAC and the FDA expressed concerns that early termination of the study could have overestimated the magnitude of the treatment difference on progression-free survival, the primary end point of the study.

The oral tyrosine kinase inhibitor sunitinib (Sutent) was approved May 20 for treatment of patients with metastatic pancreatic neuroendocrine tumors, according to the Food and Drug Administration.

Approval of sunitinib (Sutent, Pfizer) for the indication follows closely the May 5 approval of everolimus (Afinitor) for the treatment of advanced pancreatic neuroendocrine tumors. The two approvals mark the first new treatments in roughly 30 years for advanced pancreatic neuroendocrine tumors. There are an estimated 1,000 new cases of the tumor in the United States each year.

According to the FDA, the most commonly reported side effects of sunitinib include diarrhea, nausea, vomiting, fatigue, anorexia, high blood pressure, energy loss (asthenia), abdominal pain, changes in hair color, inflammation of the mouth (stomatitis), and a decrease in infection-fighting white blood cells (neutropenia).

Sutent is also FDA approved to treat patients with late-stage kidney cancer (metastatic renal cell carcinoma) and to treat patients with gastrointestinal stromal tumor or GIST.

In April, the FDA’s Oncologic Drug Advisory Committee voted 8-2 that the sunitinib’s risk-benefit profile was favorable for patients with this rare cancer. Their recommendation was based on the published results of a planned trial of 171 patients randomized to either 37.5 mg/day of oral sunitinib or placebo. Sunitinib doubled median progression-free survival for patients with advanced pancreatic neuroendocrine tumors from 5.5 months to 11.4 months. The probability of progression-free survival at 6 months was 71% in the sunitinib group and 43% in the placebo group (N. Engl. J. Med. 2011;364:501-13).

The trial was halted after randomization of 154 patients, when a data and safety monitoring committee found a greater number of serious adverse events and deaths in the placebo group. There were 9 deaths in the sunitinib group (10%) vs. 21 deaths in the placebo group (25%). The hazard ratio for death was 0.41 (P = .02) in favor of sunitinib. Eight patients on sunitinib had confirmed tumor responses (two complete responses and six partial responses) for an objective response rate of 9.3%.

At the committee meeting, members of the ODAC and the FDA expressed concerns that early termination of the study could have overestimated the magnitude of the treatment difference on progression-free survival, the primary end point of the study.

The oral tyrosine kinase inhibitor sunitinib (Sutent) was approved May 20 for treatment of patients with metastatic pancreatic neuroendocrine tumors, according to the Food and Drug Administration.

Approval of sunitinib (Sutent, Pfizer) for the indication follows closely the May 5 approval of everolimus (Afinitor) for the treatment of advanced pancreatic neuroendocrine tumors. The two approvals mark the first new treatments in roughly 30 years for advanced pancreatic neuroendocrine tumors. There are an estimated 1,000 new cases of the tumor in the United States each year.

According to the FDA, the most commonly reported side effects of sunitinib include diarrhea, nausea, vomiting, fatigue, anorexia, high blood pressure, energy loss (asthenia), abdominal pain, changes in hair color, inflammation of the mouth (stomatitis), and a decrease in infection-fighting white blood cells (neutropenia).

Sutent is also FDA approved to treat patients with late-stage kidney cancer (metastatic renal cell carcinoma) and to treat patients with gastrointestinal stromal tumor or GIST.

In April, the FDA’s Oncologic Drug Advisory Committee voted 8-2 that the sunitinib’s risk-benefit profile was favorable for patients with this rare cancer. Their recommendation was based on the published results of a planned trial of 171 patients randomized to either 37.5 mg/day of oral sunitinib or placebo. Sunitinib doubled median progression-free survival for patients with advanced pancreatic neuroendocrine tumors from 5.5 months to 11.4 months. The probability of progression-free survival at 6 months was 71% in the sunitinib group and 43% in the placebo group (N. Engl. J. Med. 2011;364:501-13).

The trial was halted after randomization of 154 patients, when a data and safety monitoring committee found a greater number of serious adverse events and deaths in the placebo group. There were 9 deaths in the sunitinib group (10%) vs. 21 deaths in the placebo group (25%). The hazard ratio for death was 0.41 (P = .02) in favor of sunitinib. Eight patients on sunitinib had confirmed tumor responses (two complete responses and six partial responses) for an objective response rate of 9.3%.

At the committee meeting, members of the ODAC and the FDA expressed concerns that early termination of the study could have overestimated the magnitude of the treatment difference on progression-free survival, the primary end point of the study.

The oral tyrosine kinase inhibitor sunitinib (Sutent) was approved May 20 for treatment of patients with metastatic pancreatic neuroendocrine tumors, according to the Food and Drug Administration.

Approval of sunitinib (Sutent, Pfizer) for the indication follows closely the May 5 approval of everolimus (Afinitor) for the treatment of advanced pancreatic neuroendocrine tumors. The two approvals mark the first new treatments in roughly 30 years for advanced pancreatic neuroendocrine tumors. There are an estimated 1,000 new cases of the tumor in the United States each year.

According to the FDA, the most commonly reported side effects of sunitinib include diarrhea, nausea, vomiting, fatigue, anorexia, high blood pressure, energy loss (asthenia), abdominal pain, changes in hair color, inflammation of the mouth (stomatitis), and a decrease in infection-fighting white blood cells (neutropenia).

Sutent is also FDA approved to treat patients with late-stage kidney cancer (metastatic renal cell carcinoma) and to treat patients with gastrointestinal stromal tumor or GIST.

In April, the FDA’s Oncologic Drug Advisory Committee voted 8-2 that the sunitinib’s risk-benefit profile was favorable for patients with this rare cancer. Their recommendation was based on the published results of a planned trial of 171 patients randomized to either 37.5 mg/day of oral sunitinib or placebo. Sunitinib doubled median progression-free survival for patients with advanced pancreatic neuroendocrine tumors from 5.5 months to 11.4 months. The probability of progression-free survival at 6 months was 71% in the sunitinib group and 43% in the placebo group (N. Engl. J. Med. 2011;364:501-13).

The trial was halted after randomization of 154 patients, when a data and safety monitoring committee found a greater number of serious adverse events and deaths in the placebo group. There were 9 deaths in the sunitinib group (10%) vs. 21 deaths in the placebo group (25%). The hazard ratio for death was 0.41 (P = .02) in favor of sunitinib. Eight patients on sunitinib had confirmed tumor responses (two complete responses and six partial responses) for an objective response rate of 9.3%.

At the committee meeting, members of the ODAC and the FDA expressed concerns that early termination of the study could have overestimated the magnitude of the treatment difference on progression-free survival, the primary end point of the study.

The oral tyrosine kinase inhibitor sunitinib (Sutent) was approved May 20 for treatment of patients with metastatic pancreatic neuroendocrine tumors, according to the Food and Drug Administration.

Approval of sunitinib (Sutent, Pfizer) for the indication follows closely the May 5 approval of everolimus (Afinitor) for the treatment of advanced pancreatic neuroendocrine tumors. The two approvals mark the first new treatments in roughly 30 years for advanced pancreatic neuroendocrine tumors. There are an estimated 1,000 new cases of the tumor in the United States each year.

According to the FDA, the most commonly reported side effects of sunitinib include diarrhea, nausea, vomiting, fatigue, anorexia, high blood pressure, energy loss (asthenia), abdominal pain, changes in hair color, inflammation of the mouth (stomatitis), and a decrease in infection-fighting white blood cells (neutropenia).

Sutent is also FDA approved to treat patients with late-stage kidney cancer (metastatic renal cell carcinoma) and to treat patients with gastrointestinal stromal tumor or GIST.

In April, the FDA’s Oncologic Drug Advisory Committee voted 8-2 that the sunitinib’s risk-benefit profile was favorable for patients with this rare cancer. Their recommendation was based on the published results of a planned trial of 171 patients randomized to either 37.5 mg/day of oral sunitinib or placebo. Sunitinib doubled median progression-free survival for patients with advanced pancreatic neuroendocrine tumors from 5.5 months to 11.4 months. The probability of progression-free survival at 6 months was 71% in the sunitinib group and 43% in the placebo group (N. Engl. J. Med. 2011;364:501-13).

The trial was halted after randomization of 154 patients, when a data and safety monitoring committee found a greater number of serious adverse events and deaths in the placebo group. There were 9 deaths in the sunitinib group (10%) vs. 21 deaths in the placebo group (25%). The hazard ratio for death was 0.41 (P = .02) in favor of sunitinib. Eight patients on sunitinib had confirmed tumor responses (two complete responses and six partial responses) for an objective response rate of 9.3%.

At the committee meeting, members of the ODAC and the FDA expressed concerns that early termination of the study could have overestimated the magnitude of the treatment difference on progression-free survival, the primary end point of the study.

The oral tyrosine kinase inhibitor sunitinib (Sutent) was approved May 20 for treatment of patients with metastatic pancreatic neuroendocrine tumors, according to the Food and Drug Administration.

Approval of sunitinib (Sutent, Pfizer) for the indication follows closely the May 5 approval of everolimus (Afinitor) for the treatment of advanced pancreatic neuroendocrine tumors. The two approvals mark the first new treatments in roughly 30 years for advanced pancreatic neuroendocrine tumors. There are an estimated 1,000 new cases of the tumor in the United States each year.

According to the FDA, the most commonly reported side effects of sunitinib include diarrhea, nausea, vomiting, fatigue, anorexia, high blood pressure, energy loss (asthenia), abdominal pain, changes in hair color, inflammation of the mouth (stomatitis), and a decrease in infection-fighting white blood cells (neutropenia).

Sutent is also FDA approved to treat patients with late-stage kidney cancer (metastatic renal cell carcinoma) and to treat patients with gastrointestinal stromal tumor or GIST.

In April, the FDA’s Oncologic Drug Advisory Committee voted 8-2 that the sunitinib’s risk-benefit profile was favorable for patients with this rare cancer. Their recommendation was based on the published results of a planned trial of 171 patients randomized to either 37.5 mg/day of oral sunitinib or placebo. Sunitinib doubled median progression-free survival for patients with advanced pancreatic neuroendocrine tumors from 5.5 months to 11.4 months. The probability of progression-free survival at 6 months was 71% in the sunitinib group and 43% in the placebo group (N. Engl. J. Med. 2011;364:501-13).

The trial was halted after randomization of 154 patients, when a data and safety monitoring committee found a greater number of serious adverse events and deaths in the placebo group. There were 9 deaths in the sunitinib group (10%) vs. 21 deaths in the placebo group (25%). The hazard ratio for death was 0.41 (P = .02) in favor of sunitinib. Eight patients on sunitinib had confirmed tumor responses (two complete responses and six partial responses) for an objective response rate of 9.3%.

At the committee meeting, members of the ODAC and the FDA expressed concerns that early termination of the study could have overestimated the magnitude of the treatment difference on progression-free survival, the primary end point of the study.

Rilpivirine has been approved for the treatment of HIV-1 infection, in combination with other antiretroviral drugs, in treatment-naive adults, according to a statement by the Food and Drug Administration.

The May 20 decision adds an alternative option to the armamentarium of highly active antiretroviral therapies intended to suppress the viral load in the blood.

The approval is based in part on 48-week safety and effectiveness data from two phase III trials involving a total of 1,368 adult patients with HIV infection. In the two trials, rilpivirine was compared with efavirenz, which is also approved for the treatment of HIV infection. Both are non-nucleoside reverse transcriptase inhibitors, which block HIV viral replication. In the study, both agents were given in combination with other antiretroviral therapies, according to the statement.

Rilpivirine was as effective as efavirenz in lowering viral load. After 48 weeks of treatment, 83% and 80% of each group, respectively, had undetectable levels of HIV in their blood. However, fewer patients stopped taking rilpivirine due to side effects that included depression, insomnia, headache, and rash, according to the FDA statement.

Rilpivirine (Edurant) is manufactured by Tibotec Therapeutics, a division of Centocor Ortho Biotech Inc.

Rilpivirine has been approved for the treatment of HIV-1 infection, in combination with other antiretroviral drugs, in treatment-naive adults, according to a statement by the Food and Drug Administration.

The May 20 decision adds an alternative option to the armamentarium of highly active antiretroviral therapies intended to suppress the viral load in the blood.

The approval is based in part on 48-week safety and effectiveness data from two phase III trials involving a total of 1,368 adult patients with HIV infection. In the two trials, rilpivirine was compared with efavirenz, which is also approved for the treatment of HIV infection. Both are non-nucleoside reverse transcriptase inhibitors, which block HIV viral replication. In the study, both agents were given in combination with other antiretroviral therapies, according to the statement.

Rilpivirine was as effective as efavirenz in lowering viral load. After 48 weeks of treatment, 83% and 80% of each group, respectively, had undetectable levels of HIV in their blood. However, fewer patients stopped taking rilpivirine due to side effects that included depression, insomnia, headache, and rash, according to the FDA statement.

Rilpivirine (Edurant) is manufactured by Tibotec Therapeutics, a division of Centocor Ortho Biotech Inc.

Rilpivirine has been approved for the treatment of HIV-1 infection, in combination with other antiretroviral drugs, in treatment-naive adults, according to a statement by the Food and Drug Administration.

The May 20 decision adds an alternative option to the armamentarium of highly active antiretroviral therapies intended to suppress the viral load in the blood.

The approval is based in part on 48-week safety and effectiveness data from two phase III trials involving a total of 1,368 adult patients with HIV infection. In the two trials, rilpivirine was compared with efavirenz, which is also approved for the treatment of HIV infection. Both are non-nucleoside reverse transcriptase inhibitors, which block HIV viral replication. In the study, both agents were given in combination with other antiretroviral therapies, according to the statement.

Rilpivirine was as effective as efavirenz in lowering viral load. After 48 weeks of treatment, 83% and 80% of each group, respectively, had undetectable levels of HIV in their blood. However, fewer patients stopped taking rilpivirine due to side effects that included depression, insomnia, headache, and rash, according to the FDA statement.

Rilpivirine (Edurant) is manufactured by Tibotec Therapeutics, a division of Centocor Ortho Biotech Inc.

Rilpivirine has been approved for the treatment of HIV-1 infection, in combination with other antiretroviral drugs, in treatment-naive adults, according to a statement by the Food and Drug Administration.

The May 20 decision adds an alternative option to the armamentarium of highly active antiretroviral therapies intended to suppress the viral load in the blood.

The approval is based in part on 48-week safety and effectiveness data from two phase III trials involving a total of 1,368 adult patients with HIV infection. In the two trials, rilpivirine was compared with efavirenz, which is also approved for the treatment of HIV infection. Both are non-nucleoside reverse transcriptase inhibitors, which block HIV viral replication. In the study, both agents were given in combination with other antiretroviral therapies, according to the statement.

Rilpivirine was as effective as efavirenz in lowering viral load. After 48 weeks of treatment, 83% and 80% of each group, respectively, had undetectable levels of HIV in their blood. However, fewer patients stopped taking rilpivirine due to side effects that included depression, insomnia, headache, and rash, according to the FDA statement.

Rilpivirine (Edurant) is manufactured by Tibotec Therapeutics, a division of Centocor Ortho Biotech Inc.

Rilpivirine has been approved for the treatment of HIV-1 infection, in combination with other antiretroviral drugs, in treatment-naive adults, according to a statement by the Food and Drug Administration.

The May 20 decision adds an alternative option to the armamentarium of highly active antiretroviral therapies intended to suppress the viral load in the blood.

The approval is based in part on 48-week safety and effectiveness data from two phase III trials involving a total of 1,368 adult patients with HIV infection. In the two trials, rilpivirine was compared with efavirenz, which is also approved for the treatment of HIV infection. Both are non-nucleoside reverse transcriptase inhibitors, which block HIV viral replication. In the study, both agents were given in combination with other antiretroviral therapies, according to the statement.

Rilpivirine was as effective as efavirenz in lowering viral load. After 48 weeks of treatment, 83% and 80% of each group, respectively, had undetectable levels of HIV in their blood. However, fewer patients stopped taking rilpivirine due to side effects that included depression, insomnia, headache, and rash, according to the FDA statement.

Rilpivirine (Edurant) is manufactured by Tibotec Therapeutics, a division of Centocor Ortho Biotech Inc.

Rilpivirine has been approved for the treatment of HIV-1 infection, in combination with other antiretroviral drugs, in treatment-naive adults, according to a statement by the Food and Drug Administration.

The May 20 decision adds an alternative option to the armamentarium of highly active antiretroviral therapies intended to suppress the viral load in the blood.

The approval is based in part on 48-week safety and effectiveness data from two phase III trials involving a total of 1,368 adult patients with HIV infection. In the two trials, rilpivirine was compared with efavirenz, which is also approved for the treatment of HIV infection. Both are non-nucleoside reverse transcriptase inhibitors, which block HIV viral replication. In the study, both agents were given in combination with other antiretroviral therapies, according to the statement.

Rilpivirine was as effective as efavirenz in lowering viral load. After 48 weeks of treatment, 83% and 80% of each group, respectively, had undetectable levels of HIV in their blood. However, fewer patients stopped taking rilpivirine due to side effects that included depression, insomnia, headache, and rash, according to the FDA statement.

Rilpivirine (Edurant) is manufactured by Tibotec Therapeutics, a division of Centocor Ortho Biotech Inc.

Rilpivirine has been approved for the treatment of HIV-1 infection, in combination with other antiretroviral drugs, in treatment-naive adults, according to a statement by the Food and Drug Administration.

The May 20 decision adds an alternative option to the armamentarium of highly active antiretroviral therapies intended to suppress the viral load in the blood.

The approval is based in part on 48-week safety and effectiveness data from two phase III trials involving a total of 1,368 adult patients with HIV infection. In the two trials, rilpivirine was compared with efavirenz, which is also approved for the treatment of HIV infection. Both are non-nucleoside reverse transcriptase inhibitors, which block HIV viral replication. In the study, both agents were given in combination with other antiretroviral therapies, according to the statement.

Rilpivirine was as effective as efavirenz in lowering viral load. After 48 weeks of treatment, 83% and 80% of each group, respectively, had undetectable levels of HIV in their blood. However, fewer patients stopped taking rilpivirine due to side effects that included depression, insomnia, headache, and rash, according to the FDA statement.

Rilpivirine (Edurant) is manufactured by Tibotec Therapeutics, a division of Centocor Ortho Biotech Inc.

Rilpivirine has been approved for the treatment of HIV-1 infection, in combination with other antiretroviral drugs, in treatment-naive adults, according to a statement by the Food and Drug Administration.

The May 20 decision adds an alternative option to the armamentarium of highly active antiretroviral therapies intended to suppress the viral load in the blood.

The approval is based in part on 48-week safety and effectiveness data from two phase III trials involving a total of 1,368 adult patients with HIV infection. In the two trials, rilpivirine was compared with efavirenz, which is also approved for the treatment of HIV infection. Both are non-nucleoside reverse transcriptase inhibitors, which block HIV viral replication. In the study, both agents were given in combination with other antiretroviral therapies, according to the statement.

Rilpivirine was as effective as efavirenz in lowering viral load. After 48 weeks of treatment, 83% and 80% of each group, respectively, had undetectable levels of HIV in their blood. However, fewer patients stopped taking rilpivirine due to side effects that included depression, insomnia, headache, and rash, according to the FDA statement.

Rilpivirine (Edurant) is manufactured by Tibotec Therapeutics, a division of Centocor Ortho Biotech Inc.

Rilpivirine has been approved for the treatment of HIV-1 infection, in combination with other antiretroviral drugs, in treatment-naive adults, according to a statement by the Food and Drug Administration.

The May 20 decision adds an alternative option to the armamentarium of highly active antiretroviral therapies intended to suppress the viral load in the blood.

The approval is based in part on 48-week safety and effectiveness data from two phase III trials involving a total of 1,368 adult patients with HIV infection. In the two trials, rilpivirine was compared with efavirenz, which is also approved for the treatment of HIV infection. Both are non-nucleoside reverse transcriptase inhibitors, which block HIV viral replication. In the study, both agents were given in combination with other antiretroviral therapies, according to the statement.

Rilpivirine was as effective as efavirenz in lowering viral load. After 48 weeks of treatment, 83% and 80% of each group, respectively, had undetectable levels of HIV in their blood. However, fewer patients stopped taking rilpivirine due to side effects that included depression, insomnia, headache, and rash, according to the FDA statement.

Rilpivirine (Edurant) is manufactured by Tibotec Therapeutics, a division of Centocor Ortho Biotech Inc.