Research has confirmed what many people know from experience: that paid sick days can make the workplace healthier. In 1 study, researchers found universal access to paid sick days (PSD) reduced influenza in the workplace by 6%.  To drill down on the influence PSD access has on decisions to stay home from work, or to stay home with a child who has flu or influenza-like-illness, researchers from University of Pittsburgh analyzed data from the 2009 Medical Expenditure Panel Survey for 12,901 households and 12,044 employees. They chose the 2009 survey because the numbers of influenza-like-illness and influenza cases were likely to have been higher due to the 2009 H1N1 pandemic.

Of the workers surveyed, 64% had access to PSD. Access was associated significantly with gender, race/ethnicity, income, education, and number of employees in the workplace. In the group of 4,911 employees who had children, 68% had PSD.

The study highlighted some subgroups that face barriers to following CDC recommendations, such as staying home for up to 24 hours after symptoms subside. Hispanics, for instance, were significantly less likely to stay home when ill, but this was not necessarily an ethnic difference, the researchers say. Rather, they suggest, it may have had more to do with job security and workplace culture. They cite a survey done during the 2009 H1N1 pandemic, in which Hispanics reported fewer resources at work than non-Hispanic whites, including paid sick leave, job security, and ability to work from home.

Women tend to be the main caregivers for children. In this study, women had a higher prevalence of staying home for a child’s illness than men, even after the researchers controlled for PSD access. Yet, in a different survey women also were more likely to report for work when ill, or when a child was ill. The researchers called this “presenteeism.”

The researchers underscore the importance of PSD laws in reducing the economic burden of healthy behavior in families. They note that in 2015, 35% of employees did not have access to PSD, and those employees were usually people with low income. Only 34% of those in the lowest-income group had access to PSD, compared with 89% in the highest income groups.

Source:

Piper K, Youk A, James AE, III, Kumar S. PLoS ONE. 2017;12(2): e0170698.

doi:10.1371/journal.pone.0170698

Research has confirmed what many people know from experience: that paid sick days can make the workplace healthier. In 1 study, researchers found universal access to paid sick days (PSD) reduced influenza in the workplace by 6%.  To drill down on the influence PSD access has on decisions to stay home from work, or to stay home with a child who has flu or influenza-like-illness, researchers from University of Pittsburgh analyzed data from the 2009 Medical Expenditure Panel Survey for 12,901 households and 12,044 employees. They chose the 2009 survey because the numbers of influenza-like-illness and influenza cases were likely to have been higher due to the 2009 H1N1 pandemic.

Of the workers surveyed, 64% had access to PSD. Access was associated significantly with gender, race/ethnicity, income, education, and number of employees in the workplace. In the group of 4,911 employees who had children, 68% had PSD.

The study highlighted some subgroups that face barriers to following CDC recommendations, such as staying home for up to 24 hours after symptoms subside. Hispanics, for instance, were significantly less likely to stay home when ill, but this was not necessarily an ethnic difference, the researchers say. Rather, they suggest, it may have had more to do with job security and workplace culture. They cite a survey done during the 2009 H1N1 pandemic, in which Hispanics reported fewer resources at work than non-Hispanic whites, including paid sick leave, job security, and ability to work from home.

Women tend to be the main caregivers for children. In this study, women had a higher prevalence of staying home for a child’s illness than men, even after the researchers controlled for PSD access. Yet, in a different survey women also were more likely to report for work when ill, or when a child was ill. The researchers called this “presenteeism.”

The researchers underscore the importance of PSD laws in reducing the economic burden of healthy behavior in families. They note that in 2015, 35% of employees did not have access to PSD, and those employees were usually people with low income. Only 34% of those in the lowest-income group had access to PSD, compared with 89% in the highest income groups.

Source:

Piper K, Youk A, James AE, III, Kumar S. PLoS ONE. 2017;12(2): e0170698.

doi:10.1371/journal.pone.0170698

Research has confirmed what many people know from experience: that paid sick days can make the workplace healthier. In 1 study, researchers found universal access to paid sick days (PSD) reduced influenza in the workplace by 6%.  To drill down on the influence PSD access has on decisions to stay home from work, or to stay home with a child who has flu or influenza-like-illness, researchers from University of Pittsburgh analyzed data from the 2009 Medical Expenditure Panel Survey for 12,901 households and 12,044 employees. They chose the 2009 survey because the numbers of influenza-like-illness and influenza cases were likely to have been higher due to the 2009 H1N1 pandemic.

Of the workers surveyed, 64% had access to PSD. Access was associated significantly with gender, race/ethnicity, income, education, and number of employees in the workplace. In the group of 4,911 employees who had children, 68% had PSD.

The study highlighted some subgroups that face barriers to following CDC recommendations, such as staying home for up to 24 hours after symptoms subside. Hispanics, for instance, were significantly less likely to stay home when ill, but this was not necessarily an ethnic difference, the researchers say. Rather, they suggest, it may have had more to do with job security and workplace culture. They cite a survey done during the 2009 H1N1 pandemic, in which Hispanics reported fewer resources at work than non-Hispanic whites, including paid sick leave, job security, and ability to work from home.

Women tend to be the main caregivers for children. In this study, women had a higher prevalence of staying home for a child’s illness than men, even after the researchers controlled for PSD access. Yet, in a different survey women also were more likely to report for work when ill, or when a child was ill. The researchers called this “presenteeism.”

The researchers underscore the importance of PSD laws in reducing the economic burden of healthy behavior in families. They note that in 2015, 35% of employees did not have access to PSD, and those employees were usually people with low income. Only 34% of those in the lowest-income group had access to PSD, compared with 89% in the highest income groups.

Source:

Piper K, Youk A, James AE, III, Kumar S. PLoS ONE. 2017;12(2): e0170698.

doi:10.1371/journal.pone.0170698

ANSWER

The radiograph shows an oval hyperdensity within the right mid lung, presumably the known lung mass. Of note, however, is an approximate 50% pneumothorax of the right lung. It is creating mild tension, indicated by the slightly displaced trachea. There is also evidence of subcutaneous air in the right lateral chest.

These findings likely result from a complication of the aforementioned biopsy. The patient underwent chest tube placement and was admitted for further treatment. 

ANSWER

The radiograph shows an oval hyperdensity within the right mid lung, presumably the known lung mass. Of note, however, is an approximate 50% pneumothorax of the right lung. It is creating mild tension, indicated by the slightly displaced trachea. There is also evidence of subcutaneous air in the right lateral chest.

These findings likely result from a complication of the aforementioned biopsy. The patient underwent chest tube placement and was admitted for further treatment. 

ANSWER

The radiograph shows an oval hyperdensity within the right mid lung, presumably the known lung mass. Of note, however, is an approximate 50% pneumothorax of the right lung. It is creating mild tension, indicated by the slightly displaced trachea. There is also evidence of subcutaneous air in the right lateral chest.

These findings likely result from a complication of the aforementioned biopsy. The patient underwent chest tube placement and was admitted for further treatment. 

Photo courtesy of CDC

ORLANDO, FL—New research shows that patients who received inpatient palliative care while undergoing hematopoietic stem cell transplant (HSCT) experienced significant improvements in quality of life (QOL), decreases in depression, and reductions in symptom burden compared to patients who received transplant care alone.

Areej R. El-Jawahri, MD, of Harvard Medical School in Boston, Massachusetts, presented these results at the 2017 BMT Tandem Meetings (abstract 49).

She noted that palliative care is rarely used for patients with hematologic malignancies, “in part, because of misperceptions equating palliative care with just end-of-life care.”

So Dr El-Jawahri and her colleagues decided to evaluate palliative care in patients with hematologic malignancies who were scheduled to undergo HSCT.

The researchers enrolled 160 patients on the trial. Eighty-one were randomized to receive inpatient palliative care integrated with transplant care (intervention arm), and 79 were randomized to transplant care alone (control).

The latter group could request palliative care consultations, but only 2 patients did so, Dr El-Jawahri pointed out.

Patients receiving the intervention had at least twice-weekly visits with a palliative care clinician throughout their hospitalization.

“Importantly, palliative care only followed patients during their transplant hospitalization,” Dr El-Jawahri noted. “This was purely an inpatient palliative care intervention.”

Palliative care focused primarily on managing patients’ symptoms, establishing rapport with patients and families, and helping them cope with their illness. The predominant symptoms addressed included pain, nausea, diarrhea, constipation, insomnia, fatigue, depression, and anxiety.

Researchers assessed QOL, symptom burden, and mood at baseline, during hospitalization (Week 2), and at 3 and 6 months using well-validated scales.

They assessed QOL using the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) scale, mood using the Hospital Anxiety and Depression Scale (HADS) and Patient Health Questionnaire (PHQ-9), and symptom burden using the Edmonton Symptom Assessment Scale (ESAS).

They also measured post-traumatic stress (PTSD) at baseline as well as 3 and 6 months after HSCT using the PTSD checklist.

The primary endpoint of the study was patient-reported QOL at Week 2 of hospitalization. Researchers chose Week 2 because studies have shown the highest symptom burden and QOL deterioration during that period.

Demographics

Patients were a mean age of 57, and a little more than half were female. Most were white, had a college degree or higher, and were married.

Their diagnoses included, for the control and intervention arms, respectively: acute lymphoblastic leukemia (9%, 5%), acute myeloid leukemia/myelodysplastic syndromes (30%, 30%), myelofibrosis/chronic myeloid leukemia (9%, 10%), lymphoma (33%, 23%), and multiple myeloma (19%, 33%).

Results

At baseline, patients in each group had comparable QOL and mood scores.

However, at Week 2, after ANCOVA adjustment for baseline scores, patients in the intervention arm had a clinically and statistically significant effect of the intervention in all areas measured except for the PHQ-9 depression score.

In particular, the HADS depression and anxiety scores were significantly improved, at P=0.008 and P<0.001, respectively, compared to control.

At 3 months, the FACT-BMT (P=0.048), HADS-Depression (P=0.002), PHQ-9-Depression (P=0.002), and  PTSD symptom (P=0.002) scores were significantly improved in the intervention group.

And at 6 months, the HADS-Depression assessment (P=0.024), the PHQ-9-Depression assessment (P=0.027), and the PTSD symptom assessment (P=0.013) remained significantly improved. However, there were no significant differences in anxiety between the 2 groups.

The researchers concluded that a relatively brief inpatient care intervention led to “remarkable sustained improvements” in depression and post-traumatic stress symptoms at 3 and 6 months after HSCT.

“This is the first study showing the benefits of palliative care for patients with hematologic malignancies undergoing stem cell transplant,” Dr El-Jawahri said.

“It’s also the first study showing the benefits of palliative care for patients with cancer pursuing curative therapy and extends the potential benefit of palliative care in a population of patients with serious illness. [T]he significant part of what palliative care does is helping patients and families cope with serious and potentially life-threatening illness.”

The researchers recommend future studies to evaluate the impact of early integration of palliative care for this patient population.

Photo courtesy of CDC

ORLANDO, FL—New research shows that patients who received inpatient palliative care while undergoing hematopoietic stem cell transplant (HSCT) experienced significant improvements in quality of life (QOL), decreases in depression, and reductions in symptom burden compared to patients who received transplant care alone.

Areej R. El-Jawahri, MD, of Harvard Medical School in Boston, Massachusetts, presented these results at the 2017 BMT Tandem Meetings (abstract 49).

She noted that palliative care is rarely used for patients with hematologic malignancies, “in part, because of misperceptions equating palliative care with just end-of-life care.”

So Dr El-Jawahri and her colleagues decided to evaluate palliative care in patients with hematologic malignancies who were scheduled to undergo HSCT.

The researchers enrolled 160 patients on the trial. Eighty-one were randomized to receive inpatient palliative care integrated with transplant care (intervention arm), and 79 were randomized to transplant care alone (control).

The latter group could request palliative care consultations, but only 2 patients did so, Dr El-Jawahri pointed out.

Patients receiving the intervention had at least twice-weekly visits with a palliative care clinician throughout their hospitalization.

“Importantly, palliative care only followed patients during their transplant hospitalization,” Dr El-Jawahri noted. “This was purely an inpatient palliative care intervention.”

Palliative care focused primarily on managing patients’ symptoms, establishing rapport with patients and families, and helping them cope with their illness. The predominant symptoms addressed included pain, nausea, diarrhea, constipation, insomnia, fatigue, depression, and anxiety.

Researchers assessed QOL, symptom burden, and mood at baseline, during hospitalization (Week 2), and at 3 and 6 months using well-validated scales.

They assessed QOL using the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) scale, mood using the Hospital Anxiety and Depression Scale (HADS) and Patient Health Questionnaire (PHQ-9), and symptom burden using the Edmonton Symptom Assessment Scale (ESAS).

They also measured post-traumatic stress (PTSD) at baseline as well as 3 and 6 months after HSCT using the PTSD checklist.

The primary endpoint of the study was patient-reported QOL at Week 2 of hospitalization. Researchers chose Week 2 because studies have shown the highest symptom burden and QOL deterioration during that period.

Demographics

Patients were a mean age of 57, and a little more than half were female. Most were white, had a college degree or higher, and were married.

Their diagnoses included, for the control and intervention arms, respectively: acute lymphoblastic leukemia (9%, 5%), acute myeloid leukemia/myelodysplastic syndromes (30%, 30%), myelofibrosis/chronic myeloid leukemia (9%, 10%), lymphoma (33%, 23%), and multiple myeloma (19%, 33%).

Results

At baseline, patients in each group had comparable QOL and mood scores.

However, at Week 2, after ANCOVA adjustment for baseline scores, patients in the intervention arm had a clinically and statistically significant effect of the intervention in all areas measured except for the PHQ-9 depression score.

In particular, the HADS depression and anxiety scores were significantly improved, at P=0.008 and P<0.001, respectively, compared to control.

At 3 months, the FACT-BMT (P=0.048), HADS-Depression (P=0.002), PHQ-9-Depression (P=0.002), and  PTSD symptom (P=0.002) scores were significantly improved in the intervention group.

And at 6 months, the HADS-Depression assessment (P=0.024), the PHQ-9-Depression assessment (P=0.027), and the PTSD symptom assessment (P=0.013) remained significantly improved. However, there were no significant differences in anxiety between the 2 groups.

The researchers concluded that a relatively brief inpatient care intervention led to “remarkable sustained improvements” in depression and post-traumatic stress symptoms at 3 and 6 months after HSCT.

“This is the first study showing the benefits of palliative care for patients with hematologic malignancies undergoing stem cell transplant,” Dr El-Jawahri said.

“It’s also the first study showing the benefits of palliative care for patients with cancer pursuing curative therapy and extends the potential benefit of palliative care in a population of patients with serious illness. [T]he significant part of what palliative care does is helping patients and families cope with serious and potentially life-threatening illness.”

The researchers recommend future studies to evaluate the impact of early integration of palliative care for this patient population.

Photo courtesy of CDC

ORLANDO, FL—New research shows that patients who received inpatient palliative care while undergoing hematopoietic stem cell transplant (HSCT) experienced significant improvements in quality of life (QOL), decreases in depression, and reductions in symptom burden compared to patients who received transplant care alone.

Areej R. El-Jawahri, MD, of Harvard Medical School in Boston, Massachusetts, presented these results at the 2017 BMT Tandem Meetings (abstract 49).

She noted that palliative care is rarely used for patients with hematologic malignancies, “in part, because of misperceptions equating palliative care with just end-of-life care.”

So Dr El-Jawahri and her colleagues decided to evaluate palliative care in patients with hematologic malignancies who were scheduled to undergo HSCT.

The researchers enrolled 160 patients on the trial. Eighty-one were randomized to receive inpatient palliative care integrated with transplant care (intervention arm), and 79 were randomized to transplant care alone (control).

The latter group could request palliative care consultations, but only 2 patients did so, Dr El-Jawahri pointed out.

Patients receiving the intervention had at least twice-weekly visits with a palliative care clinician throughout their hospitalization.

“Importantly, palliative care only followed patients during their transplant hospitalization,” Dr El-Jawahri noted. “This was purely an inpatient palliative care intervention.”

Palliative care focused primarily on managing patients’ symptoms, establishing rapport with patients and families, and helping them cope with their illness. The predominant symptoms addressed included pain, nausea, diarrhea, constipation, insomnia, fatigue, depression, and anxiety.

Researchers assessed QOL, symptom burden, and mood at baseline, during hospitalization (Week 2), and at 3 and 6 months using well-validated scales.

They assessed QOL using the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) scale, mood using the Hospital Anxiety and Depression Scale (HADS) and Patient Health Questionnaire (PHQ-9), and symptom burden using the Edmonton Symptom Assessment Scale (ESAS).

They also measured post-traumatic stress (PTSD) at baseline as well as 3 and 6 months after HSCT using the PTSD checklist.

The primary endpoint of the study was patient-reported QOL at Week 2 of hospitalization. Researchers chose Week 2 because studies have shown the highest symptom burden and QOL deterioration during that period.

Demographics

Patients were a mean age of 57, and a little more than half were female. Most were white, had a college degree or higher, and were married.

Their diagnoses included, for the control and intervention arms, respectively: acute lymphoblastic leukemia (9%, 5%), acute myeloid leukemia/myelodysplastic syndromes (30%, 30%), myelofibrosis/chronic myeloid leukemia (9%, 10%), lymphoma (33%, 23%), and multiple myeloma (19%, 33%).

Results

At baseline, patients in each group had comparable QOL and mood scores.

However, at Week 2, after ANCOVA adjustment for baseline scores, patients in the intervention arm had a clinically and statistically significant effect of the intervention in all areas measured except for the PHQ-9 depression score.

In particular, the HADS depression and anxiety scores were significantly improved, at P=0.008 and P<0.001, respectively, compared to control.

At 3 months, the FACT-BMT (P=0.048), HADS-Depression (P=0.002), PHQ-9-Depression (P=0.002), and  PTSD symptom (P=0.002) scores were significantly improved in the intervention group.

And at 6 months, the HADS-Depression assessment (P=0.024), the PHQ-9-Depression assessment (P=0.027), and the PTSD symptom assessment (P=0.013) remained significantly improved. However, there were no significant differences in anxiety between the 2 groups.

The researchers concluded that a relatively brief inpatient care intervention led to “remarkable sustained improvements” in depression and post-traumatic stress symptoms at 3 and 6 months after HSCT.

“This is the first study showing the benefits of palliative care for patients with hematologic malignancies undergoing stem cell transplant,” Dr El-Jawahri said.

“It’s also the first study showing the benefits of palliative care for patients with cancer pursuing curative therapy and extends the potential benefit of palliative care in a population of patients with serious illness. [T]he significant part of what palliative care does is helping patients and families cope with serious and potentially life-threatening illness.”

The researchers recommend future studies to evaluate the impact of early integration of palliative care for this patient population.

Photo by Rhoda Baer

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for the antiemetic agent rolapitant (Varuby) as a treatment for adults with cancer.

The drug is intended to be used in combination with other antiemetic agents to prevent delayed nausea and vomiting associated with highly and moderately emetogenic chemotherapy.

The CHMP’s recommendation regarding rolapitant has been forwarded to the European Commission, which is expected to make a decision about the drug within 2 months.

If the commission authorizes marketing of rolapitant, the drug will be available as 90 mg film-coated tablets.

The applicant for rolapitant is Tesaro UK Limited.

Rolapitant clinical trials

Results from three phase 3 trials suggested that rolapitant (at 180 mg) in combination with a 5-HT3 receptor antagonist and dexamethasone was more effective than the 5-HT3 receptor antagonist and dexamethasone on their own (active control).

The 3-drug combination demonstrated a significant reduction in episodes of vomiting or use of rescue medication during the 25- to 120-hour period following administration of highly emetogenic and moderately emetogenic chemotherapy regimens.

In addition, patients who received rolapitant reported experiencing less nausea that interfered with normal daily life and fewer episodes of vomiting or retching over multiple cycles of chemotherapy.

Highly emetogenic chemotherapy

The clinical profile of rolapitant in cisplatin-based, highly emetogenic chemotherapy (HEC) was confirmed in two phase 3 studies: HEC1 and HEC2. Results from these trials were published in The Lancet Oncology in August 2015.

Both trials met their primary endpoint of complete response (CR) and demonstrated statistical superiority of the rolapitant combination compared to active control.

In HEC1, 264 patients received the rolapitant combination, and 262 received active control. The proportion of patients achieving a CR was 72.7% and 58.4%, respectively (P<0.001).

In HEC2, 271 patients received the rolapitant combination, and 273 received active control. The proportion of patients achieving a CR was 70.1% and 61.9%, respectively (P=0.043).

The most common adverse events (in the rolapitant and control groups, respectively) were neutropenia (9% and 8%), hiccups (5% and 4%), and abdominal pain (3% and 2%).

Moderately emetogenic chemotherapy

Researchers conducted another phase 3 trial to compare the rolapitant combination with active control in 1332 patients receiving moderately emetogenic chemotherapy. Results from this trial were also published in The Lancet Oncology in August 2015.

This trial met its primary endpoint of CR and demonstrated statistical superiority of the rolapitant combination compared to active control. The proportion of patients achieving a CR was 71.3% and 61.6%, respectively (P<0.001).

The most common adverse events (in the rolapitant and control groups, respectively) were decreased appetite (9% and 7%), neutropenia (7% and 6%), dizziness (6% and 4%), dyspepsia (4% and 2%), urinary tract infection (4% and 3%), stomatitis (4% and 2%), and anemia (3% and 2%).

Photo by Rhoda Baer

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for the antiemetic agent rolapitant (Varuby) as a treatment for adults with cancer.

The drug is intended to be used in combination with other antiemetic agents to prevent delayed nausea and vomiting associated with highly and moderately emetogenic chemotherapy.

The CHMP’s recommendation regarding rolapitant has been forwarded to the European Commission, which is expected to make a decision about the drug within 2 months.

If the commission authorizes marketing of rolapitant, the drug will be available as 90 mg film-coated tablets.

The applicant for rolapitant is Tesaro UK Limited.

Rolapitant clinical trials

Results from three phase 3 trials suggested that rolapitant (at 180 mg) in combination with a 5-HT3 receptor antagonist and dexamethasone was more effective than the 5-HT3 receptor antagonist and dexamethasone on their own (active control).

The 3-drug combination demonstrated a significant reduction in episodes of vomiting or use of rescue medication during the 25- to 120-hour period following administration of highly emetogenic and moderately emetogenic chemotherapy regimens.

In addition, patients who received rolapitant reported experiencing less nausea that interfered with normal daily life and fewer episodes of vomiting or retching over multiple cycles of chemotherapy.

Highly emetogenic chemotherapy

The clinical profile of rolapitant in cisplatin-based, highly emetogenic chemotherapy (HEC) was confirmed in two phase 3 studies: HEC1 and HEC2. Results from these trials were published in The Lancet Oncology in August 2015.

Both trials met their primary endpoint of complete response (CR) and demonstrated statistical superiority of the rolapitant combination compared to active control.

In HEC1, 264 patients received the rolapitant combination, and 262 received active control. The proportion of patients achieving a CR was 72.7% and 58.4%, respectively (P<0.001).

In HEC2, 271 patients received the rolapitant combination, and 273 received active control. The proportion of patients achieving a CR was 70.1% and 61.9%, respectively (P=0.043).

The most common adverse events (in the rolapitant and control groups, respectively) were neutropenia (9% and 8%), hiccups (5% and 4%), and abdominal pain (3% and 2%).

Moderately emetogenic chemotherapy

Researchers conducted another phase 3 trial to compare the rolapitant combination with active control in 1332 patients receiving moderately emetogenic chemotherapy. Results from this trial were also published in The Lancet Oncology in August 2015.

This trial met its primary endpoint of CR and demonstrated statistical superiority of the rolapitant combination compared to active control. The proportion of patients achieving a CR was 71.3% and 61.6%, respectively (P<0.001).

The most common adverse events (in the rolapitant and control groups, respectively) were decreased appetite (9% and 7%), neutropenia (7% and 6%), dizziness (6% and 4%), dyspepsia (4% and 2%), urinary tract infection (4% and 3%), stomatitis (4% and 2%), and anemia (3% and 2%).

Photo by Rhoda Baer

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for the antiemetic agent rolapitant (Varuby) as a treatment for adults with cancer.

The drug is intended to be used in combination with other antiemetic agents to prevent delayed nausea and vomiting associated with highly and moderately emetogenic chemotherapy.

The CHMP’s recommendation regarding rolapitant has been forwarded to the European Commission, which is expected to make a decision about the drug within 2 months.

If the commission authorizes marketing of rolapitant, the drug will be available as 90 mg film-coated tablets.

The applicant for rolapitant is Tesaro UK Limited.

Rolapitant clinical trials

Results from three phase 3 trials suggested that rolapitant (at 180 mg) in combination with a 5-HT3 receptor antagonist and dexamethasone was more effective than the 5-HT3 receptor antagonist and dexamethasone on their own (active control).

The 3-drug combination demonstrated a significant reduction in episodes of vomiting or use of rescue medication during the 25- to 120-hour period following administration of highly emetogenic and moderately emetogenic chemotherapy regimens.

In addition, patients who received rolapitant reported experiencing less nausea that interfered with normal daily life and fewer episodes of vomiting or retching over multiple cycles of chemotherapy.

Highly emetogenic chemotherapy

The clinical profile of rolapitant in cisplatin-based, highly emetogenic chemotherapy (HEC) was confirmed in two phase 3 studies: HEC1 and HEC2. Results from these trials were published in The Lancet Oncology in August 2015.

Both trials met their primary endpoint of complete response (CR) and demonstrated statistical superiority of the rolapitant combination compared to active control.

In HEC1, 264 patients received the rolapitant combination, and 262 received active control. The proportion of patients achieving a CR was 72.7% and 58.4%, respectively (P<0.001).

In HEC2, 271 patients received the rolapitant combination, and 273 received active control. The proportion of patients achieving a CR was 70.1% and 61.9%, respectively (P=0.043).

The most common adverse events (in the rolapitant and control groups, respectively) were neutropenia (9% and 8%), hiccups (5% and 4%), and abdominal pain (3% and 2%).

Moderately emetogenic chemotherapy

Researchers conducted another phase 3 trial to compare the rolapitant combination with active control in 1332 patients receiving moderately emetogenic chemotherapy. Results from this trial were also published in The Lancet Oncology in August 2015.

This trial met its primary endpoint of CR and demonstrated statistical superiority of the rolapitant combination compared to active control. The proportion of patients achieving a CR was 71.3% and 61.6%, respectively (P<0.001).

The most common adverse events (in the rolapitant and control groups, respectively) were decreased appetite (9% and 7%), neutropenia (7% and 6%), dizziness (6% and 4%), dyspepsia (4% and 2%), urinary tract infection (4% and 3%), stomatitis (4% and 2%), and anemia (3% and 2%).

Dermatology News will be on site later this week at the annual meeting of the American Academy of Dermatology in Orlando. Look for the latest news in medical, surgical, and aesthetic dermatology starting Friday, March 3. The late-breaker sessions are on Saturday and Sunday March 4 and 5.

The late-breaking research session on clinical trials on March 4 will highlight:

• 16-week results from two phase III studies of certolizumab for chronic plaque psoriasis.
• Phase III results on the long-term management of moderate to severe atopic dermatitis (AD) with dupilumab plus topical corticosteroids.

Additional late breakers focus on pediatric, procedural, and pathology studies:

• Data from the Pediatric Eczema Elective Registry, on racial/ethnic disparities in health care utilization and school attendance among children with AD.
• Results of a prospective study evaluating the efficacy and systemic absorption of topical timolol for infantile hemangioma.
• Results of a randomized, placebo-controlled, double-blind study of oral tranexamic acid for treating moderate to severe melasma.
• The efficacy of adjuvant treatment with the long-pulsed 1064nm Nd:YAG Laser for toe onychomycosis.
• Risk factors associated with a recent change in the size, shape or color of moles among participants in the AAD SPOTme® Program (2009-2010).
• A survey-based study on the management of longitudinal melanonychia among attending and resident dermatologists.

[email protected]

Dermatology News will be on site later this week at the annual meeting of the American Academy of Dermatology in Orlando. Look for the latest news in medical, surgical, and aesthetic dermatology starting Friday, March 3. The late-breaker sessions are on Saturday and Sunday March 4 and 5.

The late-breaking research session on clinical trials on March 4 will highlight:

• 16-week results from two phase III studies of certolizumab for chronic plaque psoriasis.
• Phase III results on the long-term management of moderate to severe atopic dermatitis (AD) with dupilumab plus topical corticosteroids.

Additional late breakers focus on pediatric, procedural, and pathology studies:

• Data from the Pediatric Eczema Elective Registry, on racial/ethnic disparities in health care utilization and school attendance among children with AD.
• Results of a prospective study evaluating the efficacy and systemic absorption of topical timolol for infantile hemangioma.
• Results of a randomized, placebo-controlled, double-blind study of oral tranexamic acid for treating moderate to severe melasma.
• The efficacy of adjuvant treatment with the long-pulsed 1064nm Nd:YAG Laser for toe onychomycosis.
• Risk factors associated with a recent change in the size, shape or color of moles among participants in the AAD SPOTme® Program (2009-2010).
• A survey-based study on the management of longitudinal melanonychia among attending and resident dermatologists.

[email protected]

Dermatology News will be on site later this week at the annual meeting of the American Academy of Dermatology in Orlando. Look for the latest news in medical, surgical, and aesthetic dermatology starting Friday, March 3. The late-breaker sessions are on Saturday and Sunday March 4 and 5.

The late-breaking research session on clinical trials on March 4 will highlight:

• 16-week results from two phase III studies of certolizumab for chronic plaque psoriasis.
• Phase III results on the long-term management of moderate to severe atopic dermatitis (AD) with dupilumab plus topical corticosteroids.

Additional late breakers focus on pediatric, procedural, and pathology studies:

• Data from the Pediatric Eczema Elective Registry, on racial/ethnic disparities in health care utilization and school attendance among children with AD.
• Results of a prospective study evaluating the efficacy and systemic absorption of topical timolol for infantile hemangioma.
• Results of a randomized, placebo-controlled, double-blind study of oral tranexamic acid for treating moderate to severe melasma.
• The efficacy of adjuvant treatment with the long-pulsed 1064nm Nd:YAG Laser for toe onychomycosis.
• Risk factors associated with a recent change in the size, shape or color of moles among participants in the AAD SPOTme® Program (2009-2010).
• A survey-based study on the management of longitudinal melanonychia among attending and resident dermatologists.

[email protected]

Dermatology News editorial advisor Adam Friedman, MD, provided the following recommendations for navigating the upcoming American Academy of Dermatology annual meeting, at the Orange County Convention Center in Orlando, March 3-6:
 

Don’t spread yourself too thin

Who’s ready to be overwhelmed by the almost 500 session options at the annual AAD meeting? It’s that time again, so here is my advice on how to stay on track during this circus. First, download the AAD mobile app. This makes life a lot easier when trying to find your room or search for an ongoing session. The paper program is so 2008. The AAD has created various tracks to enable dermatologists of varying stages in career or clinical foci to easily go after their interests. Follow those bread crumbs.

My general advice when deciding what to attend at this meeting is pick two or three specific topics or skills you want to expand upon or develop and go after sessions pertaining to them. Don’t spread yourself too thin as learning a little about a lot won’t strengthen your knowledge base. 

Residents: Look at practice-based sessions

For residents, there are multiple professional development and board prep courses available. At this stage in your career, it’s important to acquire practical tips on topics from contract negotiation to speaker training as many of these skills are beyond the scope of residency training. Whether you are preparing for the in-training exam or the boards, programs such as “Boards Blitz” (S049) and “Conquer the Boards: An Experiential Review” (C006) will help you along the way. If you want practical career-building advice, hit up “Boards and Beyond” (F116) and “Careers in Academic Dermatology” (D004).

Get scorched in Orlando

Interested in what’s hot right now in dermatology? Look no further. There are multiple “Hot Topics” sessions scheduled throughout the meeting, with the main event on Saturday from 1 p.m. to 4 p.m. (S024) led by none other than AAD presidential candidate Kenneth J. Tomecki, MD. Other Hot Topic sessions include: “Hot Topics in Acute and Inpatient Pediatric Dermatology” (F007), “Hot Topics in Translational Dermatology” (U065), and “FDA Hot Topics: The Evolving Regulatory Landscape” (F005).

What about playing catch up on this year’s hottest publications? Check out “New Medical Dermatology Literature that Changed my Approach to Practice” (U025) with legendary academician Warren Heymann, MD. Not to be missed!
 

Dr. Friedman is director of the residency program and director of translational research in the department of dermatology, George Washington University, Washington.

[email protected]

Dermatology News editorial advisor Adam Friedman, MD, provided the following recommendations for navigating the upcoming American Academy of Dermatology annual meeting, at the Orange County Convention Center in Orlando, March 3-6:
 

Don’t spread yourself too thin

Who’s ready to be overwhelmed by the almost 500 session options at the annual AAD meeting? It’s that time again, so here is my advice on how to stay on track during this circus. First, download the AAD mobile app. This makes life a lot easier when trying to find your room or search for an ongoing session. The paper program is so 2008. The AAD has created various tracks to enable dermatologists of varying stages in career or clinical foci to easily go after their interests. Follow those bread crumbs.

My general advice when deciding what to attend at this meeting is pick two or three specific topics or skills you want to expand upon or develop and go after sessions pertaining to them. Don’t spread yourself too thin as learning a little about a lot won’t strengthen your knowledge base. 

Residents: Look at practice-based sessions

For residents, there are multiple professional development and board prep courses available. At this stage in your career, it’s important to acquire practical tips on topics from contract negotiation to speaker training as many of these skills are beyond the scope of residency training. Whether you are preparing for the in-training exam or the boards, programs such as “Boards Blitz” (S049) and “Conquer the Boards: An Experiential Review” (C006) will help you along the way. If you want practical career-building advice, hit up “Boards and Beyond” (F116) and “Careers in Academic Dermatology” (D004).

Get scorched in Orlando

Interested in what’s hot right now in dermatology? Look no further. There are multiple “Hot Topics” sessions scheduled throughout the meeting, with the main event on Saturday from 1 p.m. to 4 p.m. (S024) led by none other than AAD presidential candidate Kenneth J. Tomecki, MD. Other Hot Topic sessions include: “Hot Topics in Acute and Inpatient Pediatric Dermatology” (F007), “Hot Topics in Translational Dermatology” (U065), and “FDA Hot Topics: The Evolving Regulatory Landscape” (F005).

What about playing catch up on this year’s hottest publications? Check out “New Medical Dermatology Literature that Changed my Approach to Practice” (U025) with legendary academician Warren Heymann, MD. Not to be missed!
 

Dr. Friedman is director of the residency program and director of translational research in the department of dermatology, George Washington University, Washington.

[email protected]

Dermatology News editorial advisor Adam Friedman, MD, provided the following recommendations for navigating the upcoming American Academy of Dermatology annual meeting, at the Orange County Convention Center in Orlando, March 3-6:
 

Don’t spread yourself too thin

Who’s ready to be overwhelmed by the almost 500 session options at the annual AAD meeting? It’s that time again, so here is my advice on how to stay on track during this circus. First, download the AAD mobile app. This makes life a lot easier when trying to find your room or search for an ongoing session. The paper program is so 2008. The AAD has created various tracks to enable dermatologists of varying stages in career or clinical foci to easily go after their interests. Follow those bread crumbs.

My general advice when deciding what to attend at this meeting is pick two or three specific topics or skills you want to expand upon or develop and go after sessions pertaining to them. Don’t spread yourself too thin as learning a little about a lot won’t strengthen your knowledge base. 

Residents: Look at practice-based sessions

For residents, there are multiple professional development and board prep courses available. At this stage in your career, it’s important to acquire practical tips on topics from contract negotiation to speaker training as many of these skills are beyond the scope of residency training. Whether you are preparing for the in-training exam or the boards, programs such as “Boards Blitz” (S049) and “Conquer the Boards: An Experiential Review” (C006) will help you along the way. If you want practical career-building advice, hit up “Boards and Beyond” (F116) and “Careers in Academic Dermatology” (D004).

Get scorched in Orlando

Interested in what’s hot right now in dermatology? Look no further. There are multiple “Hot Topics” sessions scheduled throughout the meeting, with the main event on Saturday from 1 p.m. to 4 p.m. (S024) led by none other than AAD presidential candidate Kenneth J. Tomecki, MD. Other Hot Topic sessions include: “Hot Topics in Acute and Inpatient Pediatric Dermatology” (F007), “Hot Topics in Translational Dermatology” (U065), and “FDA Hot Topics: The Evolving Regulatory Landscape” (F005).

What about playing catch up on this year’s hottest publications? Check out “New Medical Dermatology Literature that Changed my Approach to Practice” (U025) with legendary academician Warren Heymann, MD. Not to be missed!
 

Dr. Friedman is director of the residency program and director of translational research in the department of dermatology, George Washington University, Washington.

[email protected]

LAS VEGAS – A multisite trial that implemented a protocol for use of intravenous hydralazine or labetalol together with magnesium sulfate for critically high blood pressures in pregnancy saw maternal eclampsia rates fall by 46% and severe maternal morbidity fall by 17%, as the protocol compliance rate rose to almost 90% of deliveries by study’s end.

Hypertensive disorders of pregnancy (HDP) are seen in up to 10% of all births and are collectively a major cause of severe maternal morbidity, according to Laurence E. Shields, MD, a perinatologist at Marian Regional Medical Center, Santa Maria, Calif. Eclampsia, seen as a complication of HDP, can have a set of disastrous maternal neurologic, cognitive, and cardiac sequelae, he added.

Recently, both state and national guidelines have called for more attention to and aggressive treatment of critically elevated blood pressure in pregnant women, Dr. Shields said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

As part of a global pregnancy complications assessment and treatment algorithm termed the Maternal Early Warning Tool (MEWT), Dignity Health, which owns Dr. Shields’ home institution, put in place a protocol to manage hypertension in pregnancy.

For pregnant women with sustained blood pressures greater than 160 mm Hg systolic and/or 110 mm Hg diastolic, the protocol calls for intravenous hydralazine or labetalol together with magnesium sulfate. The protocol also calls for “appropriate labs” to be ordered, and permits oral medication if the patient does not have intravenous access.

These steps were taken regardless of the type of hypertension the patient had, Dr. Shields said. Patients with HDP who were treated with antihypertensives were also scheduled for postpartum follow-up within 7 days of delivery.

Originally, the MEWT trial had included a total of 29 perinatal centers, 6 of which instituted the blood pressure management protocol (“trial hospitals”). Dr. Shields said that for the present study, “we wanted to determine if we could replicate the reduction in the rate of eclampsia that we noted in the 6 MEWT trial sites after initiating similar hypertension treatment recommendations in the 23 non-MEWT sites.” He and his colleagues also wanted to determine whether using the hypertension protocol would reduce severe maternal morbidity.

Compliance with the three metrics of antihypertensive administration and magnesium sulfate administration for critical blood pressure elevations and early follow-up was assessed with an “all or none” judgment.

The study was broken into three broad phases. First, recommendations were distributed to all hospitals without monitoring compliance. Eight months later, the researchers conducted a retrospective assessment of institutional compliance with the protocol. They also monitored eclampsia rates and the incidence of severe maternal mortality, using Centers for Disease Control and Prevention (CDC) criteria. Finally, after 6 months of retrospective monitoring, a prospective assessment of compliance, rates of eclampsia, and incidence of severe maternal mortality was conducted, and the results were compared with the preintervention figures.

For data analysis, protocol compliance was assessed as a primary outcome measure, but also broken down so investigators could track rates of appropriate blood pressure medication administration and appropriate treatment with magnesium sulfate. Eclampsia and severe maternal morbidity rates were the other two outcome measures.

Delivery volume at the hospitals ranged from 150 to 5,000 per year. Hispanic patients made up 42% of the study population; white and Asian patients each made up 23%; 7% were African American, and the remainder identified as “other.”

Over the study period, compliance with all three metrics rose from a baseline of 50.5%, to a midpoint rate of 73.4%, to a final rate of 88.5%. The number of deliveries was approximately the same in all time periods.

There was an overall 10.5% increase in magnesium sulfate use, with the proportion of patients being appropriately treated with magnesium sulfate rising from 85.4% at baseline to 96.2% by the end of the trial (P less than .01).

Significantly more patients were appropriately treated with blood pressure medications by the trial’s end as well; just 56.9% of patients received appropriate hypertensive medication at baseline, but that grew to 90.1% by study’s end (P less than .01). This represented a 33.2% increase in the appropriate use of antihypertensives, Dr. Shields said.

Labetalol use increased from 44% of patients treated at baseline to 64% by the end of the study (P less than .01). Hydralazine use decreased from 39% to 26% (P less than .01), and fewer oral agents were used by the end of the study (17% compared with 10%; P less than .02).

This shift was accompanied by a decrease in eclampsia rates, with overall rates per 1,000 births decreasing from 1.15 to 0.62 by the end of the study (–46%; P = .02). Severe maternal morbidity also fell from 2.4 per 100 births to 2.0 per 1,000 patients (–16.8%; P less than .01).

About 40% of the reduction in eclampsia rates could be attributed to the improved magnesium sulfate administration rates, Dr. Shields said. “This finding would suggest that the combination of blood pressure treatment and magnesium sulfate produced a synergistic effect on the reduction of eclampsia.”

“Compliance with state and national recommendations for treatment of critically elevated blood pressures is poor without monitoring,” Dr. Shields said. But with education and monitoring, physician and nurse behavior can be modified in a relatively short time period, he said.

Dr. Shields did not report financial disclosure information.

[email protected]

On Twitter @karioakes

LAS VEGAS – A multisite trial that implemented a protocol for use of intravenous hydralazine or labetalol together with magnesium sulfate for critically high blood pressures in pregnancy saw maternal eclampsia rates fall by 46% and severe maternal morbidity fall by 17%, as the protocol compliance rate rose to almost 90% of deliveries by study’s end.

Hypertensive disorders of pregnancy (HDP) are seen in up to 10% of all births and are collectively a major cause of severe maternal morbidity, according to Laurence E. Shields, MD, a perinatologist at Marian Regional Medical Center, Santa Maria, Calif. Eclampsia, seen as a complication of HDP, can have a set of disastrous maternal neurologic, cognitive, and cardiac sequelae, he added.

Recently, both state and national guidelines have called for more attention to and aggressive treatment of critically elevated blood pressure in pregnant women, Dr. Shields said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

As part of a global pregnancy complications assessment and treatment algorithm termed the Maternal Early Warning Tool (MEWT), Dignity Health, which owns Dr. Shields’ home institution, put in place a protocol to manage hypertension in pregnancy.

For pregnant women with sustained blood pressures greater than 160 mm Hg systolic and/or 110 mm Hg diastolic, the protocol calls for intravenous hydralazine or labetalol together with magnesium sulfate. The protocol also calls for “appropriate labs” to be ordered, and permits oral medication if the patient does not have intravenous access.

These steps were taken regardless of the type of hypertension the patient had, Dr. Shields said. Patients with HDP who were treated with antihypertensives were also scheduled for postpartum follow-up within 7 days of delivery.

Originally, the MEWT trial had included a total of 29 perinatal centers, 6 of which instituted the blood pressure management protocol (“trial hospitals”). Dr. Shields said that for the present study, “we wanted to determine if we could replicate the reduction in the rate of eclampsia that we noted in the 6 MEWT trial sites after initiating similar hypertension treatment recommendations in the 23 non-MEWT sites.” He and his colleagues also wanted to determine whether using the hypertension protocol would reduce severe maternal morbidity.

Compliance with the three metrics of antihypertensive administration and magnesium sulfate administration for critical blood pressure elevations and early follow-up was assessed with an “all or none” judgment.

The study was broken into three broad phases. First, recommendations were distributed to all hospitals without monitoring compliance. Eight months later, the researchers conducted a retrospective assessment of institutional compliance with the protocol. They also monitored eclampsia rates and the incidence of severe maternal mortality, using Centers for Disease Control and Prevention (CDC) criteria. Finally, after 6 months of retrospective monitoring, a prospective assessment of compliance, rates of eclampsia, and incidence of severe maternal mortality was conducted, and the results were compared with the preintervention figures.

For data analysis, protocol compliance was assessed as a primary outcome measure, but also broken down so investigators could track rates of appropriate blood pressure medication administration and appropriate treatment with magnesium sulfate. Eclampsia and severe maternal morbidity rates were the other two outcome measures.

Delivery volume at the hospitals ranged from 150 to 5,000 per year. Hispanic patients made up 42% of the study population; white and Asian patients each made up 23%; 7% were African American, and the remainder identified as “other.”

Over the study period, compliance with all three metrics rose from a baseline of 50.5%, to a midpoint rate of 73.4%, to a final rate of 88.5%. The number of deliveries was approximately the same in all time periods.

There was an overall 10.5% increase in magnesium sulfate use, with the proportion of patients being appropriately treated with magnesium sulfate rising from 85.4% at baseline to 96.2% by the end of the trial (P less than .01).

Significantly more patients were appropriately treated with blood pressure medications by the trial’s end as well; just 56.9% of patients received appropriate hypertensive medication at baseline, but that grew to 90.1% by study’s end (P less than .01). This represented a 33.2% increase in the appropriate use of antihypertensives, Dr. Shields said.

Labetalol use increased from 44% of patients treated at baseline to 64% by the end of the study (P less than .01). Hydralazine use decreased from 39% to 26% (P less than .01), and fewer oral agents were used by the end of the study (17% compared with 10%; P less than .02).

This shift was accompanied by a decrease in eclampsia rates, with overall rates per 1,000 births decreasing from 1.15 to 0.62 by the end of the study (–46%; P = .02). Severe maternal morbidity also fell from 2.4 per 100 births to 2.0 per 1,000 patients (–16.8%; P less than .01).

About 40% of the reduction in eclampsia rates could be attributed to the improved magnesium sulfate administration rates, Dr. Shields said. “This finding would suggest that the combination of blood pressure treatment and magnesium sulfate produced a synergistic effect on the reduction of eclampsia.”

“Compliance with state and national recommendations for treatment of critically elevated blood pressures is poor without monitoring,” Dr. Shields said. But with education and monitoring, physician and nurse behavior can be modified in a relatively short time period, he said.

Dr. Shields did not report financial disclosure information.

[email protected]

On Twitter @karioakes

LAS VEGAS – A multisite trial that implemented a protocol for use of intravenous hydralazine or labetalol together with magnesium sulfate for critically high blood pressures in pregnancy saw maternal eclampsia rates fall by 46% and severe maternal morbidity fall by 17%, as the protocol compliance rate rose to almost 90% of deliveries by study’s end.

Hypertensive disorders of pregnancy (HDP) are seen in up to 10% of all births and are collectively a major cause of severe maternal morbidity, according to Laurence E. Shields, MD, a perinatologist at Marian Regional Medical Center, Santa Maria, Calif. Eclampsia, seen as a complication of HDP, can have a set of disastrous maternal neurologic, cognitive, and cardiac sequelae, he added.

Recently, both state and national guidelines have called for more attention to and aggressive treatment of critically elevated blood pressure in pregnant women, Dr. Shields said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

As part of a global pregnancy complications assessment and treatment algorithm termed the Maternal Early Warning Tool (MEWT), Dignity Health, which owns Dr. Shields’ home institution, put in place a protocol to manage hypertension in pregnancy.

For pregnant women with sustained blood pressures greater than 160 mm Hg systolic and/or 110 mm Hg diastolic, the protocol calls for intravenous hydralazine or labetalol together with magnesium sulfate. The protocol also calls for “appropriate labs” to be ordered, and permits oral medication if the patient does not have intravenous access.

These steps were taken regardless of the type of hypertension the patient had, Dr. Shields said. Patients with HDP who were treated with antihypertensives were also scheduled for postpartum follow-up within 7 days of delivery.

Originally, the MEWT trial had included a total of 29 perinatal centers, 6 of which instituted the blood pressure management protocol (“trial hospitals”). Dr. Shields said that for the present study, “we wanted to determine if we could replicate the reduction in the rate of eclampsia that we noted in the 6 MEWT trial sites after initiating similar hypertension treatment recommendations in the 23 non-MEWT sites.” He and his colleagues also wanted to determine whether using the hypertension protocol would reduce severe maternal morbidity.

Compliance with the three metrics of antihypertensive administration and magnesium sulfate administration for critical blood pressure elevations and early follow-up was assessed with an “all or none” judgment.

The study was broken into three broad phases. First, recommendations were distributed to all hospitals without monitoring compliance. Eight months later, the researchers conducted a retrospective assessment of institutional compliance with the protocol. They also monitored eclampsia rates and the incidence of severe maternal mortality, using Centers for Disease Control and Prevention (CDC) criteria. Finally, after 6 months of retrospective monitoring, a prospective assessment of compliance, rates of eclampsia, and incidence of severe maternal mortality was conducted, and the results were compared with the preintervention figures.

For data analysis, protocol compliance was assessed as a primary outcome measure, but also broken down so investigators could track rates of appropriate blood pressure medication administration and appropriate treatment with magnesium sulfate. Eclampsia and severe maternal morbidity rates were the other two outcome measures.

Delivery volume at the hospitals ranged from 150 to 5,000 per year. Hispanic patients made up 42% of the study population; white and Asian patients each made up 23%; 7% were African American, and the remainder identified as “other.”

Over the study period, compliance with all three metrics rose from a baseline of 50.5%, to a midpoint rate of 73.4%, to a final rate of 88.5%. The number of deliveries was approximately the same in all time periods.

There was an overall 10.5% increase in magnesium sulfate use, with the proportion of patients being appropriately treated with magnesium sulfate rising from 85.4% at baseline to 96.2% by the end of the trial (P less than .01).

Significantly more patients were appropriately treated with blood pressure medications by the trial’s end as well; just 56.9% of patients received appropriate hypertensive medication at baseline, but that grew to 90.1% by study’s end (P less than .01). This represented a 33.2% increase in the appropriate use of antihypertensives, Dr. Shields said.

Labetalol use increased from 44% of patients treated at baseline to 64% by the end of the study (P less than .01). Hydralazine use decreased from 39% to 26% (P less than .01), and fewer oral agents were used by the end of the study (17% compared with 10%; P less than .02).

This shift was accompanied by a decrease in eclampsia rates, with overall rates per 1,000 births decreasing from 1.15 to 0.62 by the end of the study (–46%; P = .02). Severe maternal morbidity also fell from 2.4 per 100 births to 2.0 per 1,000 patients (–16.8%; P less than .01).

About 40% of the reduction in eclampsia rates could be attributed to the improved magnesium sulfate administration rates, Dr. Shields said. “This finding would suggest that the combination of blood pressure treatment and magnesium sulfate produced a synergistic effect on the reduction of eclampsia.”

“Compliance with state and national recommendations for treatment of critically elevated blood pressures is poor without monitoring,” Dr. Shields said. But with education and monitoring, physician and nurse behavior can be modified in a relatively short time period, he said.

Dr. Shields did not report financial disclosure information.

[email protected]

On Twitter @karioakes

LAS VEGAS – A monofilament suture led to substantially fewer wound complications than a braided suture for closing nonemergency cesarean incisions in a head-to-head trial with 520 evaluable women.

Cesarean incision closure with a braided, polyglactin 910 suture (Vicryl) led to 65% more wound complications than the monofilament poliglecaprone 25 suture (Monocryl), Arin M. Buresch, MD, said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

[email protected]

On Twitter @mitchelzoler

LAS VEGAS – A monofilament suture led to substantially fewer wound complications than a braided suture for closing nonemergency cesarean incisions in a head-to-head trial with 520 evaluable women.

Cesarean incision closure with a braided, polyglactin 910 suture (Vicryl) led to 65% more wound complications than the monofilament poliglecaprone 25 suture (Monocryl), Arin M. Buresch, MD, said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

[email protected]

On Twitter @mitchelzoler

LAS VEGAS – A monofilament suture led to substantially fewer wound complications than a braided suture for closing nonemergency cesarean incisions in a head-to-head trial with 520 evaluable women.

Cesarean incision closure with a braided, polyglactin 910 suture (Vicryl) led to 65% more wound complications than the monofilament poliglecaprone 25 suture (Monocryl), Arin M. Buresch, MD, said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

[email protected]

On Twitter @mitchelzoler

Expect a chilling effect on future health care consolidations after two health insurance megamergers were blocked by federal courts, analysts say.

A federal judge barred a merger between Aetna and Humana on Jan. 23, followed by a Feb. 8 decision that blocked Anthem and Cigna from consolidating. Both rulings called the deals anticompetitive.

Ruling positive and negative for providers

Anthem’s proposed $54 billion merger with Cigna would have been the largest insurer consolidation in history. The merger, along with Aetna’s $37 billion plan to purchase Humana, would have reduced the number of major U.S. health insurers from five to three, reshaping the industry. The Department of Justice and a number of states immediately opposed the mergers, arguing the consolidations would significantly reduce competition to the detriment of patients. Judges ultimately agreed.

Anthem banking on new administration

Since the rulings, Aetna and Humana have chosen not to appeal and have mutually ended their merger agreement. Cigna is seeking to terminate its agreement with Anthem, but Anthem is fighting the dissolution. The insurance giant is looking toward the Trump administration to potentially turn the case around.

To enforce the termination, Cigna is suing Anthem in the Delaware Court of Chancery seeking a declaratory judgment that Cigna has lawfully terminated the contract, according to an announcement by Cigna. Anthem, meanwhile, is seeking a temporary restraining order to enjoin Cigna from terminating its contract.

“Anthem believes there is still sufficient time and a viable path forward potentially to complete the transaction that will save millions of Americans more than $2 billion in annual medical costs and deliver significant value to shareholders,” according to a company statement. “In addition to filing this lawsuit, Anthem is pursuing an expedited appeal of the District Court’s decision and is committed to completing this value-creating merger either through a successful appeal or through settlement with the new leadership at the Department of Justice.”

Part of that new leadership could include Makan Delrahim, a former Anthem lobbyist now serving as deputy White House counsel. He is rumored to be a top contender to lead the DOJ’s antitrust division.

Records also show that Indiana insurance regulators were supportive of the Anthem-Cigna deal while Vice President Pence was governor of Indiana and that Anthem contributed $100,000 to President Trump’s inaugural committee, according to Senate lobbying reports.

“A lot of folks are talking about the possibility that Trump will appoint people at both the FTC and DOJ antitrust devision [who] are Republicans and tend to be more business friendly, which would mean that maybe some of these mergers would be more likely to make it and less likely to be challenged,” he said.

On the other hand, a couple of leadership changes will not likely reverse the country’s historic antitrust enforcement, Mr. Dahlquist said.

“I don’t believe you’re going to see a systemic shift in the antitrust enforcement policy of this country,” he said. “Even one change at the top is not going to [create] upheaval within the ranks at the FTC and DOJ. The government is on a winning streak; I think that’s going to continue in the short term.”

Frontline Medical News/Alicia Gallegos

[email protected]

On Twitter @legal_med

Expect a chilling effect on future health care consolidations after two health insurance megamergers were blocked by federal courts, analysts say.

A federal judge barred a merger between Aetna and Humana on Jan. 23, followed by a Feb. 8 decision that blocked Anthem and Cigna from consolidating. Both rulings called the deals anticompetitive.

Ruling positive and negative for providers

Anthem’s proposed $54 billion merger with Cigna would have been the largest insurer consolidation in history. The merger, along with Aetna’s $37 billion plan to purchase Humana, would have reduced the number of major U.S. health insurers from five to three, reshaping the industry. The Department of Justice and a number of states immediately opposed the mergers, arguing the consolidations would significantly reduce competition to the detriment of patients. Judges ultimately agreed.

Anthem banking on new administration

Since the rulings, Aetna and Humana have chosen not to appeal and have mutually ended their merger agreement. Cigna is seeking to terminate its agreement with Anthem, but Anthem is fighting the dissolution. The insurance giant is looking toward the Trump administration to potentially turn the case around.

To enforce the termination, Cigna is suing Anthem in the Delaware Court of Chancery seeking a declaratory judgment that Cigna has lawfully terminated the contract, according to an announcement by Cigna. Anthem, meanwhile, is seeking a temporary restraining order to enjoin Cigna from terminating its contract.

“Anthem believes there is still sufficient time and a viable path forward potentially to complete the transaction that will save millions of Americans more than $2 billion in annual medical costs and deliver significant value to shareholders,” according to a company statement. “In addition to filing this lawsuit, Anthem is pursuing an expedited appeal of the District Court’s decision and is committed to completing this value-creating merger either through a successful appeal or through settlement with the new leadership at the Department of Justice.”

Part of that new leadership could include Makan Delrahim, a former Anthem lobbyist now serving as deputy White House counsel. He is rumored to be a top contender to lead the DOJ’s antitrust division.

Records also show that Indiana insurance regulators were supportive of the Anthem-Cigna deal while Vice President Pence was governor of Indiana and that Anthem contributed $100,000 to President Trump’s inaugural committee, according to Senate lobbying reports.

“A lot of folks are talking about the possibility that Trump will appoint people at both the FTC and DOJ antitrust devision [who] are Republicans and tend to be more business friendly, which would mean that maybe some of these mergers would be more likely to make it and less likely to be challenged,” he said.

On the other hand, a couple of leadership changes will not likely reverse the country’s historic antitrust enforcement, Mr. Dahlquist said.

“I don’t believe you’re going to see a systemic shift in the antitrust enforcement policy of this country,” he said. “Even one change at the top is not going to [create] upheaval within the ranks at the FTC and DOJ. The government is on a winning streak; I think that’s going to continue in the short term.”

Frontline Medical News/Alicia Gallegos

[email protected]

On Twitter @legal_med

Expect a chilling effect on future health care consolidations after two health insurance megamergers were blocked by federal courts, analysts say.

A federal judge barred a merger between Aetna and Humana on Jan. 23, followed by a Feb. 8 decision that blocked Anthem and Cigna from consolidating. Both rulings called the deals anticompetitive.

Ruling positive and negative for providers

Anthem’s proposed $54 billion merger with Cigna would have been the largest insurer consolidation in history. The merger, along with Aetna’s $37 billion plan to purchase Humana, would have reduced the number of major U.S. health insurers from five to three, reshaping the industry. The Department of Justice and a number of states immediately opposed the mergers, arguing the consolidations would significantly reduce competition to the detriment of patients. Judges ultimately agreed.

Anthem banking on new administration

Since the rulings, Aetna and Humana have chosen not to appeal and have mutually ended their merger agreement. Cigna is seeking to terminate its agreement with Anthem, but Anthem is fighting the dissolution. The insurance giant is looking toward the Trump administration to potentially turn the case around.

To enforce the termination, Cigna is suing Anthem in the Delaware Court of Chancery seeking a declaratory judgment that Cigna has lawfully terminated the contract, according to an announcement by Cigna. Anthem, meanwhile, is seeking a temporary restraining order to enjoin Cigna from terminating its contract.

“Anthem believes there is still sufficient time and a viable path forward potentially to complete the transaction that will save millions of Americans more than $2 billion in annual medical costs and deliver significant value to shareholders,” according to a company statement. “In addition to filing this lawsuit, Anthem is pursuing an expedited appeal of the District Court’s decision and is committed to completing this value-creating merger either through a successful appeal or through settlement with the new leadership at the Department of Justice.”

Part of that new leadership could include Makan Delrahim, a former Anthem lobbyist now serving as deputy White House counsel. He is rumored to be a top contender to lead the DOJ’s antitrust division.

Records also show that Indiana insurance regulators were supportive of the Anthem-Cigna deal while Vice President Pence was governor of Indiana and that Anthem contributed $100,000 to President Trump’s inaugural committee, according to Senate lobbying reports.

“A lot of folks are talking about the possibility that Trump will appoint people at both the FTC and DOJ antitrust devision [who] are Republicans and tend to be more business friendly, which would mean that maybe some of these mergers would be more likely to make it and less likely to be challenged,” he said.

On the other hand, a couple of leadership changes will not likely reverse the country’s historic antitrust enforcement, Mr. Dahlquist said.

“I don’t believe you’re going to see a systemic shift in the antitrust enforcement policy of this country,” he said. “Even one change at the top is not going to [create] upheaval within the ranks at the FTC and DOJ. The government is on a winning streak; I think that’s going to continue in the short term.”

Frontline Medical News/Alicia Gallegos

[email protected]

On Twitter @legal_med

HOUSTON – Acute hemostatic treatment with a clotting protein didn’t improve either short- or long-term outcomes in patients with intracerebral hemorrhage (ICH), according to findings from twin studies.

When given to patients who displayed a high-risk imaging marker suggestive of active bleeding, recombinant activated blood coagulation factor VII (rFVII) didn’t significantly reduce 24-hour hemorrhage volume or improve 90-day stroke outcomes, relative to placebo, David Gladstone, MD, said at the International Stroke Conference sponsored by the American Heart Association.

This isn’t the first time rFVII has been investigated as an acute treatment for ICH, said Dr. Gladstone, director of the Sunnybrook Regional Stroke Prevention Clinic and the Rapid Transient Ischemic Attack Clinic, Toronto. In the large phase III FAST trial, rFVII reduced growth of the hematoma but did not improve survival or functional outcome in an unselected population.

[email protected]

On Twitter @alz_gal

HOUSTON – Acute hemostatic treatment with a clotting protein didn’t improve either short- or long-term outcomes in patients with intracerebral hemorrhage (ICH), according to findings from twin studies.

When given to patients who displayed a high-risk imaging marker suggestive of active bleeding, recombinant activated blood coagulation factor VII (rFVII) didn’t significantly reduce 24-hour hemorrhage volume or improve 90-day stroke outcomes, relative to placebo, David Gladstone, MD, said at the International Stroke Conference sponsored by the American Heart Association.

This isn’t the first time rFVII has been investigated as an acute treatment for ICH, said Dr. Gladstone, director of the Sunnybrook Regional Stroke Prevention Clinic and the Rapid Transient Ischemic Attack Clinic, Toronto. In the large phase III FAST trial, rFVII reduced growth of the hematoma but did not improve survival or functional outcome in an unselected population.

[email protected]

On Twitter @alz_gal

HOUSTON – Acute hemostatic treatment with a clotting protein didn’t improve either short- or long-term outcomes in patients with intracerebral hemorrhage (ICH), according to findings from twin studies.

When given to patients who displayed a high-risk imaging marker suggestive of active bleeding, recombinant activated blood coagulation factor VII (rFVII) didn’t significantly reduce 24-hour hemorrhage volume or improve 90-day stroke outcomes, relative to placebo, David Gladstone, MD, said at the International Stroke Conference sponsored by the American Heart Association.

This isn’t the first time rFVII has been investigated as an acute treatment for ICH, said Dr. Gladstone, director of the Sunnybrook Regional Stroke Prevention Clinic and the Rapid Transient Ischemic Attack Clinic, Toronto. In the large phase III FAST trial, rFVII reduced growth of the hematoma but did not improve survival or functional outcome in an unselected population.

[email protected]

On Twitter @alz_gal