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Lucas Franki is an associate editor for MDedge News, and has been with the company since 2014. He has a BA in English from Penn State University and is an Eagle Scout.
FDA begins priority review of cemiplimab for advanced cutaneous squamous cell carcinoma
The Food and Drug Administration will conduct a priority review of cemiplimab for the treatment of locally advanced and metastatic cutaneous squamous cell carcinoma (SCC), the companies developing the treatment announced on April 30.
Cemiplimab, a human monoclonal antibody being developed by Regeneron Pharmaceuticals and Sanofi, targets the checkpoint inhibitor programmed cell death protein-1 (PD-1). The drug was previously granted Breakthrough Therapy status by the FDA in September 2017.
No safety and efficacy data are available for cemiplimab at this time.
Find the full press release on the Regeneron website.
The Food and Drug Administration will conduct a priority review of cemiplimab for the treatment of locally advanced and metastatic cutaneous squamous cell carcinoma (SCC), the companies developing the treatment announced on April 30.
Cemiplimab, a human monoclonal antibody being developed by Regeneron Pharmaceuticals and Sanofi, targets the checkpoint inhibitor programmed cell death protein-1 (PD-1). The drug was previously granted Breakthrough Therapy status by the FDA in September 2017.
No safety and efficacy data are available for cemiplimab at this time.
Find the full press release on the Regeneron website.
The Food and Drug Administration will conduct a priority review of cemiplimab for the treatment of locally advanced and metastatic cutaneous squamous cell carcinoma (SCC), the companies developing the treatment announced on April 30.
Cemiplimab, a human monoclonal antibody being developed by Regeneron Pharmaceuticals and Sanofi, targets the checkpoint inhibitor programmed cell death protein-1 (PD-1). The drug was previously granted Breakthrough Therapy status by the FDA in September 2017.
No safety and efficacy data are available for cemiplimab at this time.
Find the full press release on the Regeneron website.
Preterm intervention underused in at-risk women
A significant number of woman who delivered ahead of term and were already considered at risk for spontaneous preterm birth did not receive any sort of intervention to prevent the preterm birth, according to Yu Yang Feng and associates.
For the retrospective study, the researchers analyzed the medical records of 31 women who had been admitted to a primary, secondary, or tertiary prenatal care center and who had a history of spontaneous singleton preterm birth and/or cervical shortening before 24 weeks of gestation. Of the 23 women who were referred to a prenatal care center before reaching a gestational age of 24 weeks, only 13 were offered an intervention and only 12 received progesterone or cerclage as an intervention, while none received pessary. One of the 13 was offered and declined progesterone.
Of the 12 women who received an intervention before 24 weeks’ gestational age, 8 received progesterone, 2 received elective cerclage, and 2 received rescue cerclage. An additional woman who was referred to a prenatal care center after 24 weeks received progesterone, the only one in that group to receive an intervention.
Most of the women in the study were referred to a prenatal care center by their family physician, although two were referred by their midwife, one was referred by a nurse practitioner and fertility specialist, and three started their care with an obstetrician.
“Our findings that less than one in three women with a previous preterm birth or current short cervix received progesterone attest to the importance of improving knowledge translation with the latest evidence to encourage referral in time and use of this intervention for the prevention of preterm birth,” the study investigators concluded.
Find the full study in the Journal of Obstetrics and Gynaecology Canada (2018 Jan. doi: 10.1016/j.jogc.2017.08.036).
A significant number of woman who delivered ahead of term and were already considered at risk for spontaneous preterm birth did not receive any sort of intervention to prevent the preterm birth, according to Yu Yang Feng and associates.
For the retrospective study, the researchers analyzed the medical records of 31 women who had been admitted to a primary, secondary, or tertiary prenatal care center and who had a history of spontaneous singleton preterm birth and/or cervical shortening before 24 weeks of gestation. Of the 23 women who were referred to a prenatal care center before reaching a gestational age of 24 weeks, only 13 were offered an intervention and only 12 received progesterone or cerclage as an intervention, while none received pessary. One of the 13 was offered and declined progesterone.
Of the 12 women who received an intervention before 24 weeks’ gestational age, 8 received progesterone, 2 received elective cerclage, and 2 received rescue cerclage. An additional woman who was referred to a prenatal care center after 24 weeks received progesterone, the only one in that group to receive an intervention.
Most of the women in the study were referred to a prenatal care center by their family physician, although two were referred by their midwife, one was referred by a nurse practitioner and fertility specialist, and three started their care with an obstetrician.
“Our findings that less than one in three women with a previous preterm birth or current short cervix received progesterone attest to the importance of improving knowledge translation with the latest evidence to encourage referral in time and use of this intervention for the prevention of preterm birth,” the study investigators concluded.
Find the full study in the Journal of Obstetrics and Gynaecology Canada (2018 Jan. doi: 10.1016/j.jogc.2017.08.036).
A significant number of woman who delivered ahead of term and were already considered at risk for spontaneous preterm birth did not receive any sort of intervention to prevent the preterm birth, according to Yu Yang Feng and associates.
For the retrospective study, the researchers analyzed the medical records of 31 women who had been admitted to a primary, secondary, or tertiary prenatal care center and who had a history of spontaneous singleton preterm birth and/or cervical shortening before 24 weeks of gestation. Of the 23 women who were referred to a prenatal care center before reaching a gestational age of 24 weeks, only 13 were offered an intervention and only 12 received progesterone or cerclage as an intervention, while none received pessary. One of the 13 was offered and declined progesterone.
Of the 12 women who received an intervention before 24 weeks’ gestational age, 8 received progesterone, 2 received elective cerclage, and 2 received rescue cerclage. An additional woman who was referred to a prenatal care center after 24 weeks received progesterone, the only one in that group to receive an intervention.
Most of the women in the study were referred to a prenatal care center by their family physician, although two were referred by their midwife, one was referred by a nurse practitioner and fertility specialist, and three started their care with an obstetrician.
“Our findings that less than one in three women with a previous preterm birth or current short cervix received progesterone attest to the importance of improving knowledge translation with the latest evidence to encourage referral in time and use of this intervention for the prevention of preterm birth,” the study investigators concluded.
Find the full study in the Journal of Obstetrics and Gynaecology Canada (2018 Jan. doi: 10.1016/j.jogc.2017.08.036).
FROM THE JOURNAL OF OBSTETRICS AND GYNAECOLOGY CANADA
Successive antiepileptic drug treatments offer diminished chances for seizure freedom
despite the wide availability of a variety of new antiepileptic drugs, according to Zhibin Chen, PhD, and his associates
The study included a total of 1,795 patients who were treated at the epilepsy unit of the Western Infirmary in Glasgow, Scotland, from July 1, 1982, to Oct. 31, 2012, and followed until Oct. 31, 2014, or until their deaths. They had a median follow-up of 11 years. Of this group, 1,144 patients were seizure free for a year or longer, including 816 who achieved seizure freedom after the first antiepileptic drug and 212 after receiving their second antiepileptic drug.
The odds ratio for each successive antiepileptic drug regimen’s failing if the first regimen failed was 1.73. The first antiepileptic drug regimen offered about a 50% probability of seizure freedom for 1 year or longer, but the probability of success was only 12% with the second regimen and 4% with the third. Attempts after the third regimen all had a probability of seizure freedom of around or below 1%. Patients who had a greater number of seizures prior to treatment, reported recreational drug use, or had first-degree relatives with a history of seizure were significantly less likely to achieve seizure freedom in a multivariate regression analysis.
“A paradigm shift in treatment and research strategies is needed to improve the long-term outcomes of newly diagnosed epilepsy. Patients with drug-resistant epilepsy should be considered early for nonpharmacological therapies, such as resective surgery and brain stimulation techniques,” the study investigators wrote.
SOURCE: Chen Z et al. JAMA Neurol. 2017 Dec 26. doi: 10.1001/jamaneurol.2017.3949
despite the wide availability of a variety of new antiepileptic drugs, according to Zhibin Chen, PhD, and his associates
The study included a total of 1,795 patients who were treated at the epilepsy unit of the Western Infirmary in Glasgow, Scotland, from July 1, 1982, to Oct. 31, 2012, and followed until Oct. 31, 2014, or until their deaths. They had a median follow-up of 11 years. Of this group, 1,144 patients were seizure free for a year or longer, including 816 who achieved seizure freedom after the first antiepileptic drug and 212 after receiving their second antiepileptic drug.
The odds ratio for each successive antiepileptic drug regimen’s failing if the first regimen failed was 1.73. The first antiepileptic drug regimen offered about a 50% probability of seizure freedom for 1 year or longer, but the probability of success was only 12% with the second regimen and 4% with the third. Attempts after the third regimen all had a probability of seizure freedom of around or below 1%. Patients who had a greater number of seizures prior to treatment, reported recreational drug use, or had first-degree relatives with a history of seizure were significantly less likely to achieve seizure freedom in a multivariate regression analysis.
“A paradigm shift in treatment and research strategies is needed to improve the long-term outcomes of newly diagnosed epilepsy. Patients with drug-resistant epilepsy should be considered early for nonpharmacological therapies, such as resective surgery and brain stimulation techniques,” the study investigators wrote.
SOURCE: Chen Z et al. JAMA Neurol. 2017 Dec 26. doi: 10.1001/jamaneurol.2017.3949
despite the wide availability of a variety of new antiepileptic drugs, according to Zhibin Chen, PhD, and his associates
The study included a total of 1,795 patients who were treated at the epilepsy unit of the Western Infirmary in Glasgow, Scotland, from July 1, 1982, to Oct. 31, 2012, and followed until Oct. 31, 2014, or until their deaths. They had a median follow-up of 11 years. Of this group, 1,144 patients were seizure free for a year or longer, including 816 who achieved seizure freedom after the first antiepileptic drug and 212 after receiving their second antiepileptic drug.
The odds ratio for each successive antiepileptic drug regimen’s failing if the first regimen failed was 1.73. The first antiepileptic drug regimen offered about a 50% probability of seizure freedom for 1 year or longer, but the probability of success was only 12% with the second regimen and 4% with the third. Attempts after the third regimen all had a probability of seizure freedom of around or below 1%. Patients who had a greater number of seizures prior to treatment, reported recreational drug use, or had first-degree relatives with a history of seizure were significantly less likely to achieve seizure freedom in a multivariate regression analysis.
“A paradigm shift in treatment and research strategies is needed to improve the long-term outcomes of newly diagnosed epilepsy. Patients with drug-resistant epilepsy should be considered early for nonpharmacological therapies, such as resective surgery and brain stimulation techniques,” the study investigators wrote.
SOURCE: Chen Z et al. JAMA Neurol. 2017 Dec 26. doi: 10.1001/jamaneurol.2017.3949
FROM JAMA NEUROLOGY
Review: Common gastrointestinal conditions in people living with HIV/AIDS
The two most common gastrointestinal conditions reported by people living with HIV/AIDS are diarrhea and nausea, according to Vincent Hall, PhD.
Diarrhea has been reported in up to 60% of people living with HIV/AIDS, and is generally classified as being infectious or noninfectious. While infectious causes of diarrhea, such as bacteria, fungi, viruses, and protozoa, have declined, noninfectious causes have increased. Common causes of noninfectious diarrhea include HIV enteropathy, diarrhea associated with highly active antiretroviral therapy (HAART), autonomic neuropathy, and chronic pancreatitis.
Prior to the development of HAART, nausea in people living with HIV/AIDS was usually caused by opportunistic infections; however, this has changed. Nausea can come from medication side effects, overlapping drug interactions, and from opportunistic infections in patients with poor immune health. The most common side effect of ART is nausea, and nausea is also the most common cause of ART discontinuation.
“It has been noted that HIV infection can be considered a disease of the GI tract because it is a significant target of infection and because of the side effects HAART can have on the GI system. Therefore, it is important that clinicians have an understanding of the causes of diarrhea and nausea and vomiting in people living with HIV/AIDS and educate patients about potential side effects and treatment options,” Mr. Hall concluded.
Find the full review in Critical Care Nursing Clinics of North America (doi: 10.1016/j.cnc.2017.10.009).
The two most common gastrointestinal conditions reported by people living with HIV/AIDS are diarrhea and nausea, according to Vincent Hall, PhD.
Diarrhea has been reported in up to 60% of people living with HIV/AIDS, and is generally classified as being infectious or noninfectious. While infectious causes of diarrhea, such as bacteria, fungi, viruses, and protozoa, have declined, noninfectious causes have increased. Common causes of noninfectious diarrhea include HIV enteropathy, diarrhea associated with highly active antiretroviral therapy (HAART), autonomic neuropathy, and chronic pancreatitis.
Prior to the development of HAART, nausea in people living with HIV/AIDS was usually caused by opportunistic infections; however, this has changed. Nausea can come from medication side effects, overlapping drug interactions, and from opportunistic infections in patients with poor immune health. The most common side effect of ART is nausea, and nausea is also the most common cause of ART discontinuation.
“It has been noted that HIV infection can be considered a disease of the GI tract because it is a significant target of infection and because of the side effects HAART can have on the GI system. Therefore, it is important that clinicians have an understanding of the causes of diarrhea and nausea and vomiting in people living with HIV/AIDS and educate patients about potential side effects and treatment options,” Mr. Hall concluded.
Find the full review in Critical Care Nursing Clinics of North America (doi: 10.1016/j.cnc.2017.10.009).
The two most common gastrointestinal conditions reported by people living with HIV/AIDS are diarrhea and nausea, according to Vincent Hall, PhD.
Diarrhea has been reported in up to 60% of people living with HIV/AIDS, and is generally classified as being infectious or noninfectious. While infectious causes of diarrhea, such as bacteria, fungi, viruses, and protozoa, have declined, noninfectious causes have increased. Common causes of noninfectious diarrhea include HIV enteropathy, diarrhea associated with highly active antiretroviral therapy (HAART), autonomic neuropathy, and chronic pancreatitis.
Prior to the development of HAART, nausea in people living with HIV/AIDS was usually caused by opportunistic infections; however, this has changed. Nausea can come from medication side effects, overlapping drug interactions, and from opportunistic infections in patients with poor immune health. The most common side effect of ART is nausea, and nausea is also the most common cause of ART discontinuation.
“It has been noted that HIV infection can be considered a disease of the GI tract because it is a significant target of infection and because of the side effects HAART can have on the GI system. Therefore, it is important that clinicians have an understanding of the causes of diarrhea and nausea and vomiting in people living with HIV/AIDS and educate patients about potential side effects and treatment options,” Mr. Hall concluded.
Find the full review in Critical Care Nursing Clinics of North America (doi: 10.1016/j.cnc.2017.10.009).
FROM CRITICAL CARE NURSING CLINICS OF NORTH AMERICA
CMV colitis mortality rates similar in both immunocompetent and immunocompromised patients
Cytomegalovirus (CMV) colitis has mortality rates similar in immunocompetent patients to that in immunocompromised patients, according to Puo-Hsien Le, MD, and associates.
In a retrospective study, the investigators analyzed data from 42 immunocompetent patients and 27 patients who were immunocompromised because of HIV infection, solid organ or bone marrow transplantation, immunosuppressive drug use, chemotherapeutic agent use within 6 months, or other reasons. In-hospital mortality was 26.2% in immunocompetent patients and 25.9% in immunocompromised patients.
While diarrhea and melena were the first presenting symptom in a similar number of patients, immunocompetent patients were more likely to present with melena while immunocompromised patients were more likely to present with diarrhea. The number of days until diagnosis was the only independent predictor of in-hospital mortality according to the analysis, with patients who were diagnosed within 9 days of admittance having a significantly higher survival rate.
“Contrary to data published up to this point, we found that CMV colitis was not rare and that it could be fatal in immunocompetent hosts, especially those patients with advanced age, specific comorbidities associated with immune dysfunction, critical illness, or IBD. ... Being alert to the different presentations can greatly help make an accurate early diagnosis and materially improve survival for CMV colitis patients,” the investigators concluded.
Find the full study in Therapeutics and Clinical Risk Management (doi: 10.2147/TCRM.S151180).
Cytomegalovirus (CMV) colitis has mortality rates similar in immunocompetent patients to that in immunocompromised patients, according to Puo-Hsien Le, MD, and associates.
In a retrospective study, the investigators analyzed data from 42 immunocompetent patients and 27 patients who were immunocompromised because of HIV infection, solid organ or bone marrow transplantation, immunosuppressive drug use, chemotherapeutic agent use within 6 months, or other reasons. In-hospital mortality was 26.2% in immunocompetent patients and 25.9% in immunocompromised patients.
While diarrhea and melena were the first presenting symptom in a similar number of patients, immunocompetent patients were more likely to present with melena while immunocompromised patients were more likely to present with diarrhea. The number of days until diagnosis was the only independent predictor of in-hospital mortality according to the analysis, with patients who were diagnosed within 9 days of admittance having a significantly higher survival rate.
“Contrary to data published up to this point, we found that CMV colitis was not rare and that it could be fatal in immunocompetent hosts, especially those patients with advanced age, specific comorbidities associated with immune dysfunction, critical illness, or IBD. ... Being alert to the different presentations can greatly help make an accurate early diagnosis and materially improve survival for CMV colitis patients,” the investigators concluded.
Find the full study in Therapeutics and Clinical Risk Management (doi: 10.2147/TCRM.S151180).
Cytomegalovirus (CMV) colitis has mortality rates similar in immunocompetent patients to that in immunocompromised patients, according to Puo-Hsien Le, MD, and associates.
In a retrospective study, the investigators analyzed data from 42 immunocompetent patients and 27 patients who were immunocompromised because of HIV infection, solid organ or bone marrow transplantation, immunosuppressive drug use, chemotherapeutic agent use within 6 months, or other reasons. In-hospital mortality was 26.2% in immunocompetent patients and 25.9% in immunocompromised patients.
While diarrhea and melena were the first presenting symptom in a similar number of patients, immunocompetent patients were more likely to present with melena while immunocompromised patients were more likely to present with diarrhea. The number of days until diagnosis was the only independent predictor of in-hospital mortality according to the analysis, with patients who were diagnosed within 9 days of admittance having a significantly higher survival rate.
“Contrary to data published up to this point, we found that CMV colitis was not rare and that it could be fatal in immunocompetent hosts, especially those patients with advanced age, specific comorbidities associated with immune dysfunction, critical illness, or IBD. ... Being alert to the different presentations can greatly help make an accurate early diagnosis and materially improve survival for CMV colitis patients,” the investigators concluded.
Find the full study in Therapeutics and Clinical Risk Management (doi: 10.2147/TCRM.S151180).
FROM THERAPEUTICS AND CLINICAL RISK MANAGEMENT
Clinical Trial: The Checklist to Prevent MRSA Surgical Site Infections
who are undergoing or have undergone cardiac surgery or total joint arthroplasty.
The Department of Veteran Affairs has previously implemented the VA MRSA Prevention Initiative, which successfully reduced patient-to-patient MRSA transmission; however, this initiative does not prevent most MRSA surgical site infections, which are spread differently. The VA has developed a new checklist which will be tested in this study aimed at reducing MRSA surgical site infections (SSIs), and will be implemented at 10 VA medical centers.
The primary outcome measure is superficial and deep/organ space MRSA infections within 90 days of operation. Secondary outcome measures include superficial and deep/organ space MRSA infections within 1 year of operation, presurgical bundle and individual bundle components compliance for 30 days prior to operation, length of postoperative stay, all-cause mortality 1 year after surgery, readmission within 90 days of surgery, and mupirocin and chlorhexidine resistance 30 days presurgery to 90 days postsurgery.
The study will end in April 2019. More than 10,000 people are expected to be included in the final analysis.
Find more information on the study page at Clinicaltrials.gov.
who are undergoing or have undergone cardiac surgery or total joint arthroplasty.
The Department of Veteran Affairs has previously implemented the VA MRSA Prevention Initiative, which successfully reduced patient-to-patient MRSA transmission; however, this initiative does not prevent most MRSA surgical site infections, which are spread differently. The VA has developed a new checklist which will be tested in this study aimed at reducing MRSA surgical site infections (SSIs), and will be implemented at 10 VA medical centers.
The primary outcome measure is superficial and deep/organ space MRSA infections within 90 days of operation. Secondary outcome measures include superficial and deep/organ space MRSA infections within 1 year of operation, presurgical bundle and individual bundle components compliance for 30 days prior to operation, length of postoperative stay, all-cause mortality 1 year after surgery, readmission within 90 days of surgery, and mupirocin and chlorhexidine resistance 30 days presurgery to 90 days postsurgery.
The study will end in April 2019. More than 10,000 people are expected to be included in the final analysis.
Find more information on the study page at Clinicaltrials.gov.
who are undergoing or have undergone cardiac surgery or total joint arthroplasty.
The Department of Veteran Affairs has previously implemented the VA MRSA Prevention Initiative, which successfully reduced patient-to-patient MRSA transmission; however, this initiative does not prevent most MRSA surgical site infections, which are spread differently. The VA has developed a new checklist which will be tested in this study aimed at reducing MRSA surgical site infections (SSIs), and will be implemented at 10 VA medical centers.
The primary outcome measure is superficial and deep/organ space MRSA infections within 90 days of operation. Secondary outcome measures include superficial and deep/organ space MRSA infections within 1 year of operation, presurgical bundle and individual bundle components compliance for 30 days prior to operation, length of postoperative stay, all-cause mortality 1 year after surgery, readmission within 90 days of surgery, and mupirocin and chlorhexidine resistance 30 days presurgery to 90 days postsurgery.
The study will end in April 2019. More than 10,000 people are expected to be included in the final analysis.
Find more information on the study page at Clinicaltrials.gov.
FROM CLINICALTRIALS.GOV
Denosumab indication now includes multiple myeloma, Amgen announces
The Food and Drug Administration has expanded the indications for denosumab (Xgeva), previously indicated for the prevention of skeletal-related events in patients with bone metastases from solid tumors, to include patients with multiple myeloma, according to a press release from Amgen, the manufacturer of Xgeva.
“Up to 40% of [multiple myeloma] patients remain untreated for the prevention of bone complications, and the percentage is highest among patients with renal impairment at the time of diagnosis. Denosumab, which is not cleared through the kidneys, offers multiple myeloma patients bone protection with a convenient subcutaneous administration, providing patients with a novel treatment option,” Dr. Noopur Raje, director of the Center for Multiple Myeloma, Massachusetts General Hospital Cancer Center, Boston, said in the press release.
Adverse events in multiple myeloma patients were broadly similar to the known safety profile of denosumab. The most common adverse events were diarrhea, nausea, anemia, back pain, thrombocytopenia, peripheral edema, hypocalcemia, upper respiratory tract infection, rash, and headache. The most common adverse event resulting in discontinuation of treatment was osteonecrosis of the jaw.
Find the full press release on the Amgen website.
The Food and Drug Administration has expanded the indications for denosumab (Xgeva), previously indicated for the prevention of skeletal-related events in patients with bone metastases from solid tumors, to include patients with multiple myeloma, according to a press release from Amgen, the manufacturer of Xgeva.
“Up to 40% of [multiple myeloma] patients remain untreated for the prevention of bone complications, and the percentage is highest among patients with renal impairment at the time of diagnosis. Denosumab, which is not cleared through the kidneys, offers multiple myeloma patients bone protection with a convenient subcutaneous administration, providing patients with a novel treatment option,” Dr. Noopur Raje, director of the Center for Multiple Myeloma, Massachusetts General Hospital Cancer Center, Boston, said in the press release.
Adverse events in multiple myeloma patients were broadly similar to the known safety profile of denosumab. The most common adverse events were diarrhea, nausea, anemia, back pain, thrombocytopenia, peripheral edema, hypocalcemia, upper respiratory tract infection, rash, and headache. The most common adverse event resulting in discontinuation of treatment was osteonecrosis of the jaw.
Find the full press release on the Amgen website.
The Food and Drug Administration has expanded the indications for denosumab (Xgeva), previously indicated for the prevention of skeletal-related events in patients with bone metastases from solid tumors, to include patients with multiple myeloma, according to a press release from Amgen, the manufacturer of Xgeva.
“Up to 40% of [multiple myeloma] patients remain untreated for the prevention of bone complications, and the percentage is highest among patients with renal impairment at the time of diagnosis. Denosumab, which is not cleared through the kidneys, offers multiple myeloma patients bone protection with a convenient subcutaneous administration, providing patients with a novel treatment option,” Dr. Noopur Raje, director of the Center for Multiple Myeloma, Massachusetts General Hospital Cancer Center, Boston, said in the press release.
Adverse events in multiple myeloma patients were broadly similar to the known safety profile of denosumab. The most common adverse events were diarrhea, nausea, anemia, back pain, thrombocytopenia, peripheral edema, hypocalcemia, upper respiratory tract infection, rash, and headache. The most common adverse event resulting in discontinuation of treatment was osteonecrosis of the jaw.
Find the full press release on the Amgen website.
Thrombectomy shines in presence of a clinical deficit and imaging mismatch
, according to Raul G. Nogueira, MD, and his DAWN trial coinvestigators.
A total of 206 patients who had experienced occlusion of the intracranial internal carotid artery or proximal middle cerebral artery in the past 6-24 hours were included in the study – 107 receiving thrombectomy with the Trevo device plus standard care and 99 receiving standard care alone. After 90 days of treatment, the mean utility-weighted modified Rankin scale score for patients who received thrombectomy was 5.5, compared with 3.4 in the control group. The rate of functional independence was 49% in the thrombectomy group and 13% in the control group.
“Further studies are needed to establish the prevalence of patients who would be eligible for thrombectomy among the entire population of patients with ischemic stroke. Further studies are also needed to determine whether late thrombectomy has a benefit when more widely available imaging techniques are used to estimate the infarct volume at presentation, such as assessment of the extent of hypodensity on non–contrast-enhanced CT,” the investigators noted.
SOURCE: Nogueira R et al. N Engl J Med. 2018;378:11-21
, according to Raul G. Nogueira, MD, and his DAWN trial coinvestigators.
A total of 206 patients who had experienced occlusion of the intracranial internal carotid artery or proximal middle cerebral artery in the past 6-24 hours were included in the study – 107 receiving thrombectomy with the Trevo device plus standard care and 99 receiving standard care alone. After 90 days of treatment, the mean utility-weighted modified Rankin scale score for patients who received thrombectomy was 5.5, compared with 3.4 in the control group. The rate of functional independence was 49% in the thrombectomy group and 13% in the control group.
“Further studies are needed to establish the prevalence of patients who would be eligible for thrombectomy among the entire population of patients with ischemic stroke. Further studies are also needed to determine whether late thrombectomy has a benefit when more widely available imaging techniques are used to estimate the infarct volume at presentation, such as assessment of the extent of hypodensity on non–contrast-enhanced CT,” the investigators noted.
SOURCE: Nogueira R et al. N Engl J Med. 2018;378:11-21
, according to Raul G. Nogueira, MD, and his DAWN trial coinvestigators.
A total of 206 patients who had experienced occlusion of the intracranial internal carotid artery or proximal middle cerebral artery in the past 6-24 hours were included in the study – 107 receiving thrombectomy with the Trevo device plus standard care and 99 receiving standard care alone. After 90 days of treatment, the mean utility-weighted modified Rankin scale score for patients who received thrombectomy was 5.5, compared with 3.4 in the control group. The rate of functional independence was 49% in the thrombectomy group and 13% in the control group.
“Further studies are needed to establish the prevalence of patients who would be eligible for thrombectomy among the entire population of patients with ischemic stroke. Further studies are also needed to determine whether late thrombectomy has a benefit when more widely available imaging techniques are used to estimate the infarct volume at presentation, such as assessment of the extent of hypodensity on non–contrast-enhanced CT,” the investigators noted.
SOURCE: Nogueira R et al. N Engl J Med. 2018;378:11-21
FROM NEW ENGLAND JOURNAL OF MEDICINE
U.S. autism rates edge up from 2014-2016
The prevalence of autism spectrum disorder (ASD) in U.S. children and adolescents climbed to 2.41% from 2014 to 2016, Guifeng Xu, MD, and her associates, wrote in a research letter. However, the increased prevalence of ASD over the 3-year period was not statistically significant.
Males were far more likely to be diagnosed with ASD than females, with respective prevalence rates of 3.54% and 1.22%, from 2014 to 2016.
using data from the Autism and Developmental Disabilities Monitoring Network. The ADDM reported a rate of 1.46%, compared with the NHIS rate of 2.41%. Differences in study design and participant characteristics are likely the cause of this difference; the ADDM is conducted at specific sites, while the NHIS is considered to be a nationally representative sample.
“Changes in nonetiologic factors (such as diagnostic criteria, public awareness, and referral), as well as in etiologic factors (including genetic and environmental risk factors), have been postulated to account for the previously observed increase in ASD prevalence,” concluded Dr. Xu, of the department of epidemiology at the University of Iowa, Iowa City, and her associates. “Continued monitoring of the prevalence and investigation of changes in risk factors are warranted.”
Find the full research letter in JAMA (2018;319[1]:81-2. doi: 10.1001/jama.2017.17812).
The prevalence of autism spectrum disorder (ASD) in U.S. children and adolescents climbed to 2.41% from 2014 to 2016, Guifeng Xu, MD, and her associates, wrote in a research letter. However, the increased prevalence of ASD over the 3-year period was not statistically significant.
Males were far more likely to be diagnosed with ASD than females, with respective prevalence rates of 3.54% and 1.22%, from 2014 to 2016.
using data from the Autism and Developmental Disabilities Monitoring Network. The ADDM reported a rate of 1.46%, compared with the NHIS rate of 2.41%. Differences in study design and participant characteristics are likely the cause of this difference; the ADDM is conducted at specific sites, while the NHIS is considered to be a nationally representative sample.
“Changes in nonetiologic factors (such as diagnostic criteria, public awareness, and referral), as well as in etiologic factors (including genetic and environmental risk factors), have been postulated to account for the previously observed increase in ASD prevalence,” concluded Dr. Xu, of the department of epidemiology at the University of Iowa, Iowa City, and her associates. “Continued monitoring of the prevalence and investigation of changes in risk factors are warranted.”
Find the full research letter in JAMA (2018;319[1]:81-2. doi: 10.1001/jama.2017.17812).
The prevalence of autism spectrum disorder (ASD) in U.S. children and adolescents climbed to 2.41% from 2014 to 2016, Guifeng Xu, MD, and her associates, wrote in a research letter. However, the increased prevalence of ASD over the 3-year period was not statistically significant.
Males were far more likely to be diagnosed with ASD than females, with respective prevalence rates of 3.54% and 1.22%, from 2014 to 2016.
using data from the Autism and Developmental Disabilities Monitoring Network. The ADDM reported a rate of 1.46%, compared with the NHIS rate of 2.41%. Differences in study design and participant characteristics are likely the cause of this difference; the ADDM is conducted at specific sites, while the NHIS is considered to be a nationally representative sample.
“Changes in nonetiologic factors (such as diagnostic criteria, public awareness, and referral), as well as in etiologic factors (including genetic and environmental risk factors), have been postulated to account for the previously observed increase in ASD prevalence,” concluded Dr. Xu, of the department of epidemiology at the University of Iowa, Iowa City, and her associates. “Continued monitoring of the prevalence and investigation of changes in risk factors are warranted.”
Find the full research letter in JAMA (2018;319[1]:81-2. doi: 10.1001/jama.2017.17812).
FROM JAMA
Pertuzumab approved for HER2-positive breast cancer
, according to the Food and Drug Administration.
The approval was based on results from the APHINITY trial, which included 4,804 patients who had HER2-positive early breast cancers that were excised prior to the study. After a median follow-up period of 45.4 months, an invasive disease event occurred in 7.1% of all patients who received pertuzumab (Perjeta) and in 8.7% of patients who received placebo. In patients with hormone receptor–negative disease, invasive events occurred in 8.2% of the pertuzumab group and in 10.6% of the placebo group. In patients with node-positive disease, the invasive event rate was 9.2% in the pertuzumab group and 12.1% in the placebo group.
“The initial pertuzumab dose is 840 mg administered as a 60-minute intravenous infusion, followed every 3 weeks thereafter by 420 mg administered as a 30- to 60-minute intravenous infusion,” the FDA said in the statement.
Find the full statement on the FDA website.
, according to the Food and Drug Administration.
The approval was based on results from the APHINITY trial, which included 4,804 patients who had HER2-positive early breast cancers that were excised prior to the study. After a median follow-up period of 45.4 months, an invasive disease event occurred in 7.1% of all patients who received pertuzumab (Perjeta) and in 8.7% of patients who received placebo. In patients with hormone receptor–negative disease, invasive events occurred in 8.2% of the pertuzumab group and in 10.6% of the placebo group. In patients with node-positive disease, the invasive event rate was 9.2% in the pertuzumab group and 12.1% in the placebo group.
“The initial pertuzumab dose is 840 mg administered as a 60-minute intravenous infusion, followed every 3 weeks thereafter by 420 mg administered as a 30- to 60-minute intravenous infusion,” the FDA said in the statement.
Find the full statement on the FDA website.
, according to the Food and Drug Administration.
The approval was based on results from the APHINITY trial, which included 4,804 patients who had HER2-positive early breast cancers that were excised prior to the study. After a median follow-up period of 45.4 months, an invasive disease event occurred in 7.1% of all patients who received pertuzumab (Perjeta) and in 8.7% of patients who received placebo. In patients with hormone receptor–negative disease, invasive events occurred in 8.2% of the pertuzumab group and in 10.6% of the placebo group. In patients with node-positive disease, the invasive event rate was 9.2% in the pertuzumab group and 12.1% in the placebo group.
“The initial pertuzumab dose is 840 mg administered as a 60-minute intravenous infusion, followed every 3 weeks thereafter by 420 mg administered as a 30- to 60-minute intravenous infusion,” the FDA said in the statement.
Find the full statement on the FDA website.