New and Noteworthy Information—October 2016

Resective surgery for epilepsy is cost-effective in the medium term, according to a study published online ahead of print September 5 in Epilepsia. A prospective cohort of adult patients with surgically remediable and medically intractable partial epilepsy was followed for more than five years in 15 French centers. During the second year of follow-up, the proportion of patients who had been completely seizure-free for the previous 12 months was 69.0% among participants who underwent surgery and 12.3% in the medical group. The respective rates of seizure freedom were 76.8% and 21% during the fifth year. Direct costs became significantly lower in the surgical group during the third year after surgery as a result of decreased antiepileptic drug use. Surgery became cost-effective between nine and 10 years after surgery.  
 
The NIH Toolbox Cognitive Battery can assess important dimensions of cognition in persons with intellectual disabilities, and several tests may be useful for tracking response to interventions, according to a study published September 6 in the Journal of Neurodevelopmental Disorders. In separate pilot studies of patients with fragile X syndrome, Down syndrome, and idiopathic intellectual disabilities, researchers used the web-based NIH Toolbox Cognitive Battery to measure processing speed, executive function, episodic memory, word and letter reading, receptive vocabulary, and working memory. The test's feasibility was good to excellent for people above mental age 4 for all tests except list sorting. Test-retest stability was good to excellent. More extensive psychometric studies are needed to determine the battery's true utility as a set of outcome measures, said the researchers.  
 
Graded aerobic treadmill testing is a safe, tolerable, and clinically valuable tool that can assist in the evaluation and management of pediatric sports-related concussion, according to a study published online ahead of print September 13 in the Journal of Neurosurgery: Pediatrics. Researchers conducted a retrospective chart review of 106 pediatric patients with sports-related concussion who were referred to a multidisciplinary pediatric concussion program and underwent graded aerobic treadmill testing between October 9, 2014, and February 11, 2016. Treadmill testing confirmed physiologic recovery in 96.9% of 65 patients tested, allowing successful return to play in 93.8% of patients. Of the 41 patients with physiologic post-concussion disorder who had complete follow-up and were treated with tailored submaximal exercise, 90.2% were classified as clinically improved and 80.5% successfully returned to sporting activities.  
 
Exposure to MRI during the first trimester of pregnancy, compared with nonexposure, is not associated with increased risk of harm to the fetus or in early childhood, according to a study published September 6 in JAMA. Gadolinium MRI, however, was associated with an increased risk of rheumatologic, inflammatory, or infiltrative skin conditions, and stillbirth or neonatal death. The study included 1,424,105 deliveries. Researchers compared first-trimester MRI exposure to no MRI exposure. The adjusted relative risk of stillbirth, congenital anomalies, neoplasm, or vision or hearing loss for first-trimester MRI was not significantly higher, compared with no MRI exposure. Comparing gadolinium MRI with no MRI, the adjusted hazard ratio of any rheumatologic, inflammatory, or infiltrative skin condition for first-trimester MRI was 1.36, for an adjusted risk difference of 45.3 per 1,000 person-years.  
 
In women in the United Kingdom, higher BMI is associated with increased risk of ischemic stroke, but decreased risk of hemorrhagic stroke, according to a study published online ahead of print September 7 in Neurology. Researchers recruited 1.3 million previously stroke-free women from the UK between 1996 and 2001 and followed them by record linkage for hospital admissions and deaths. Increased BMI was associated with an increased risk of ischemic stroke, but a decreased risk of hemorrhagic stroke. The BMI-associated trends for ischemic and hemorrhagic stroke were significantly different, but were not significantly different for intracerebral hemorrhage and subarachnoid hemorrhage. Published data from prospective studies showed consistently greater BMI-associated relative risks for ischemic stroke than hemorrhagic stroke, with most evidence before this study coming from Asian populations.
 
Data confirm the relevance of complement biomarkers in mild cognitive impairment (MCI) and Alzheimer's disease, according to a study published September 6 in the Journal of Alzheimer's Disease. Results also indicate the value of multiparameter models for disease prediction and stratification. Researchers studied 292 people to measure five complement proteins and four activation products in plasma from donors with MCI, those with Alzheimer's disease, and healthy controls. Only clusterin differed significantly between control and Alzheimer's disease plasma. Overall, a model combining clusterin with relevant covariables was highly predictive of disease. Clusterin, factor I, and terminal complement complex were significantly different between individuals with MCI who had converted to dementia one year later compared with nonconverters. A model combining these three analytes with informative covariables was highly predictive of conversion.
 
Prenatal exposure to levetiracetam or topiramate may not impair a child's thinking skills, according to a study published online ahead of print August 31 in Neurology. For this cross-sectional observational study, researchers followed women enrolled in the UK Epilepsy and Pregnancy Register. The women received monotherapy levetiracetam, topiramate, or valproate, or took no therapy. Physicians conducted assessor-blinded neuropsychologic assessments of the women's children between ages 5 and 9. In the adjusted analyses, prenatal exposure to levetiracetam and topiramate were not found to be associated with reductions in children's cognitive abilities, and adverse outcomes were not associated with increasing dose. Increasing the dose of valproate was associated with poorer full-scale IQ, verbal abilities, nonverbal abilities, and expressive language ability. The evidence base for newer antiepileptic drugs is limited, said the authors.  
 
At six months, decompressive craniectomy in patients with traumatic brain injury (TBI) and refractory intracranial hypertension results in lower mortality and higher rates of vegetative state and severe disability, compared with medical care, according to a study published online ahead of print September 7 in the New England Journal of Medicine. Researchers randomly assigned 408 patients, ages 10 to 65, with TBI and refractory elevated intracranial pressure to undergo decompressive craniectomy or receive ongoing medical care. At six months, approximately 27% of patients who received a craniectomy had died, compared with 49% of patients who received medical management. Patients who survived after a craniectomy were more likely to be dependent on others for care. At 12 months, mortality was 30% among surgical patients and 52% among medical patients.
 
Contralaterally controlled functional electrical stimulation (CCFES) improves hand dexterity after stroke more than cyclic neuromuscular electrical stimulation (cNMES) does, according to a study published online ahead of print September 8 in Stroke. Researchers enrolled 80 patients with stroke and chronic moderate to severe upper extremity hemiparesis in the study. Participants were randomized to receive 10 sessions per week of CCFES- or cNMES-assisted hand-opening exercise at home, along with 20 sessions of functional task practice in the laboratory for 12 weeks. At six months post treatment, the CCFES group had an improvement of 4.6 on the Box and Block Test, compared with an improvement of 1.8 for the cNMES group. Fugl-Meyer performance and Arm Motor Abilities Test performance did not differ between groups, however.  
 
Antipsychotic use is associated with higher risk of pneumonia, regardless of the choice of drug, according to a study published online ahead of print June 11 in Chest. Researchers investigated whether incident antipsychotic use or specific antipsychotics are related to higher risk of hospitalization or death due to pneumonia in the MEDALZ cohort. The cohort includes all persons who received a clinically verified diagnosis of Alzheimer's disease in Finland from 2005 to 2011. A matched comparison cohort without Alzheimer's disease was used to compare the magnitude of risk. Antipsychotic use was associated with higher risk of pneumonia in the Alzheimer's disease cohort and with somewhat higher risk in the comparison cohort. No major differences were observed between the most commonly used antipsychotics.
 
The FDA has allowed the marketing of two Trevo clot-retrieval devices as an initial therapy to reduce paralysis, speech difficulties, and other disabilities following ischemic stroke. The agency evaluated data from a clinical trial comparing 96 randomly selected patients treated with the Trevo device and t-PA and medical management  with 249 patients who received only t-PA and medical management. Twenty-nine percent of patients treated with the Trevo device were functionally independent at three months after stroke, compared with 19% of patients who were not treated with the Trevo device. These devices should be used within six hours of symptom onset and only following treatment with a clot-dissolving drug, which needs to be given within three hours of symptom onset, said the FDA. Concentric Medical, headquartered in Mountain View, California, markets Trevo.  
 
Class I evidence suggests that for boys with Duchenne muscular dystrophy, daily use of deflazacort or prednisone is effective in preserving muscle strength over a 12-week period, according to a study published online ahead of print August 26 in Neurology. This phase III, double-blind, randomized, placebo-controlled, multicenter study evaluated the muscle strength of 196 boys ages 5 to 15 with Duchenne muscular dystrophy during a 52-week period. Participants received deflazacort, prednisone, or placebo for 12 weeks. At week 13, patients continued active treatment or switched from placebo to active treatment. All treatment groups demonstrated significant improvement in muscle strength, compared with placebo, at 12 weeks. Participants taking prednisone had significantly more weight gain than other participants at 12 weeks and at 52 weeks.  
 
The FDA has granted tentative approval to Supernus Pharmaceuticals's Supplemental New Drug Application (sNDA) requesting a label expansion for Trokendi XR (topiramate) to include prophylaxis of migraine headache in adults. The approval of the sNDA is tentative because the FDA has determined that the drug meets all of the required quality, safety, and efficacy standards for approval, but is subject to the pediatric exclusivity, which expires on March 28, 2017. Final approval may not be made effective until this exclusivity period has expired. The FDA also has granted final approval to expand the label for Trokendi XR for monotherapy treatment of partial onset seizures to include adults and pediatric patients age six and older, rather than age 10 and older. Supernus Pharmaceuticals is headquartered in Rockville, Maryland.

—Kimberly Williams

Resective surgery for epilepsy is cost-effective in the medium term, according to a study published online ahead of print September 5 in Epilepsia. A prospective cohort of adult patients with surgically remediable and medically intractable partial epilepsy was followed for more than five years in 15 French centers. During the second year of follow-up, the proportion of patients who had been completely seizure-free for the previous 12 months was 69.0% among participants who underwent surgery and 12.3% in the medical group. The respective rates of seizure freedom were 76.8% and 21% during the fifth year. Direct costs became significantly lower in the surgical group during the third year after surgery as a result of decreased antiepileptic drug use. Surgery became cost-effective between nine and 10 years after surgery.  
 
The NIH Toolbox Cognitive Battery can assess important dimensions of cognition in persons with intellectual disabilities, and several tests may be useful for tracking response to interventions, according to a study published September 6 in the Journal of Neurodevelopmental Disorders. In separate pilot studies of patients with fragile X syndrome, Down syndrome, and idiopathic intellectual disabilities, researchers used the web-based NIH Toolbox Cognitive Battery to measure processing speed, executive function, episodic memory, word and letter reading, receptive vocabulary, and working memory. The test's feasibility was good to excellent for people above mental age 4 for all tests except list sorting. Test-retest stability was good to excellent. More extensive psychometric studies are needed to determine the battery's true utility as a set of outcome measures, said the researchers.  
 
Graded aerobic treadmill testing is a safe, tolerable, and clinically valuable tool that can assist in the evaluation and management of pediatric sports-related concussion, according to a study published online ahead of print September 13 in the Journal of Neurosurgery: Pediatrics. Researchers conducted a retrospective chart review of 106 pediatric patients with sports-related concussion who were referred to a multidisciplinary pediatric concussion program and underwent graded aerobic treadmill testing between October 9, 2014, and February 11, 2016. Treadmill testing confirmed physiologic recovery in 96.9% of 65 patients tested, allowing successful return to play in 93.8% of patients. Of the 41 patients with physiologic post-concussion disorder who had complete follow-up and were treated with tailored submaximal exercise, 90.2% were classified as clinically improved and 80.5% successfully returned to sporting activities.  
 
Exposure to MRI during the first trimester of pregnancy, compared with nonexposure, is not associated with increased risk of harm to the fetus or in early childhood, according to a study published September 6 in JAMA. Gadolinium MRI, however, was associated with an increased risk of rheumatologic, inflammatory, or infiltrative skin conditions, and stillbirth or neonatal death. The study included 1,424,105 deliveries. Researchers compared first-trimester MRI exposure to no MRI exposure. The adjusted relative risk of stillbirth, congenital anomalies, neoplasm, or vision or hearing loss for first-trimester MRI was not significantly higher, compared with no MRI exposure. Comparing gadolinium MRI with no MRI, the adjusted hazard ratio of any rheumatologic, inflammatory, or infiltrative skin condition for first-trimester MRI was 1.36, for an adjusted risk difference of 45.3 per 1,000 person-years.  
 
In women in the United Kingdom, higher BMI is associated with increased risk of ischemic stroke, but decreased risk of hemorrhagic stroke, according to a study published online ahead of print September 7 in Neurology. Researchers recruited 1.3 million previously stroke-free women from the UK between 1996 and 2001 and followed them by record linkage for hospital admissions and deaths. Increased BMI was associated with an increased risk of ischemic stroke, but a decreased risk of hemorrhagic stroke. The BMI-associated trends for ischemic and hemorrhagic stroke were significantly different, but were not significantly different for intracerebral hemorrhage and subarachnoid hemorrhage. Published data from prospective studies showed consistently greater BMI-associated relative risks for ischemic stroke than hemorrhagic stroke, with most evidence before this study coming from Asian populations.
 
Data confirm the relevance of complement biomarkers in mild cognitive impairment (MCI) and Alzheimer's disease, according to a study published September 6 in the Journal of Alzheimer's Disease. Results also indicate the value of multiparameter models for disease prediction and stratification. Researchers studied 292 people to measure five complement proteins and four activation products in plasma from donors with MCI, those with Alzheimer's disease, and healthy controls. Only clusterin differed significantly between control and Alzheimer's disease plasma. Overall, a model combining clusterin with relevant covariables was highly predictive of disease. Clusterin, factor I, and terminal complement complex were significantly different between individuals with MCI who had converted to dementia one year later compared with nonconverters. A model combining these three analytes with informative covariables was highly predictive of conversion.
 
Prenatal exposure to levetiracetam or topiramate may not impair a child's thinking skills, according to a study published online ahead of print August 31 in Neurology. For this cross-sectional observational study, researchers followed women enrolled in the UK Epilepsy and Pregnancy Register. The women received monotherapy levetiracetam, topiramate, or valproate, or took no therapy. Physicians conducted assessor-blinded neuropsychologic assessments of the women's children between ages 5 and 9. In the adjusted analyses, prenatal exposure to levetiracetam and topiramate were not found to be associated with reductions in children's cognitive abilities, and adverse outcomes were not associated with increasing dose. Increasing the dose of valproate was associated with poorer full-scale IQ, verbal abilities, nonverbal abilities, and expressive language ability. The evidence base for newer antiepileptic drugs is limited, said the authors.  
 
At six months, decompressive craniectomy in patients with traumatic brain injury (TBI) and refractory intracranial hypertension results in lower mortality and higher rates of vegetative state and severe disability, compared with medical care, according to a study published online ahead of print September 7 in the New England Journal of Medicine. Researchers randomly assigned 408 patients, ages 10 to 65, with TBI and refractory elevated intracranial pressure to undergo decompressive craniectomy or receive ongoing medical care. At six months, approximately 27% of patients who received a craniectomy had died, compared with 49% of patients who received medical management. Patients who survived after a craniectomy were more likely to be dependent on others for care. At 12 months, mortality was 30% among surgical patients and 52% among medical patients.
 
Contralaterally controlled functional electrical stimulation (CCFES) improves hand dexterity after stroke more than cyclic neuromuscular electrical stimulation (cNMES) does, according to a study published online ahead of print September 8 in Stroke. Researchers enrolled 80 patients with stroke and chronic moderate to severe upper extremity hemiparesis in the study. Participants were randomized to receive 10 sessions per week of CCFES- or cNMES-assisted hand-opening exercise at home, along with 20 sessions of functional task practice in the laboratory for 12 weeks. At six months post treatment, the CCFES group had an improvement of 4.6 on the Box and Block Test, compared with an improvement of 1.8 for the cNMES group. Fugl-Meyer performance and Arm Motor Abilities Test performance did not differ between groups, however.  
 
Antipsychotic use is associated with higher risk of pneumonia, regardless of the choice of drug, according to a study published online ahead of print June 11 in Chest. Researchers investigated whether incident antipsychotic use or specific antipsychotics are related to higher risk of hospitalization or death due to pneumonia in the MEDALZ cohort. The cohort includes all persons who received a clinically verified diagnosis of Alzheimer's disease in Finland from 2005 to 2011. A matched comparison cohort without Alzheimer's disease was used to compare the magnitude of risk. Antipsychotic use was associated with higher risk of pneumonia in the Alzheimer's disease cohort and with somewhat higher risk in the comparison cohort. No major differences were observed between the most commonly used antipsychotics.
 
The FDA has allowed the marketing of two Trevo clot-retrieval devices as an initial therapy to reduce paralysis, speech difficulties, and other disabilities following ischemic stroke. The agency evaluated data from a clinical trial comparing 96 randomly selected patients treated with the Trevo device and t-PA and medical management  with 249 patients who received only t-PA and medical management. Twenty-nine percent of patients treated with the Trevo device were functionally independent at three months after stroke, compared with 19% of patients who were not treated with the Trevo device. These devices should be used within six hours of symptom onset and only following treatment with a clot-dissolving drug, which needs to be given within three hours of symptom onset, said the FDA. Concentric Medical, headquartered in Mountain View, California, markets Trevo.  
 
Class I evidence suggests that for boys with Duchenne muscular dystrophy, daily use of deflazacort or prednisone is effective in preserving muscle strength over a 12-week period, according to a study published online ahead of print August 26 in Neurology. This phase III, double-blind, randomized, placebo-controlled, multicenter study evaluated the muscle strength of 196 boys ages 5 to 15 with Duchenne muscular dystrophy during a 52-week period. Participants received deflazacort, prednisone, or placebo for 12 weeks. At week 13, patients continued active treatment or switched from placebo to active treatment. All treatment groups demonstrated significant improvement in muscle strength, compared with placebo, at 12 weeks. Participants taking prednisone had significantly more weight gain than other participants at 12 weeks and at 52 weeks.  
 
The FDA has granted tentative approval to Supernus Pharmaceuticals's Supplemental New Drug Application (sNDA) requesting a label expansion for Trokendi XR (topiramate) to include prophylaxis of migraine headache in adults. The approval of the sNDA is tentative because the FDA has determined that the drug meets all of the required quality, safety, and efficacy standards for approval, but is subject to the pediatric exclusivity, which expires on March 28, 2017. Final approval may not be made effective until this exclusivity period has expired. The FDA also has granted final approval to expand the label for Trokendi XR for monotherapy treatment of partial onset seizures to include adults and pediatric patients age six and older, rather than age 10 and older. Supernus Pharmaceuticals is headquartered in Rockville, Maryland.

—Kimberly Williams

Resective surgery for epilepsy is cost-effective in the medium term, according to a study published online ahead of print September 5 in Epilepsia. A prospective cohort of adult patients with surgically remediable and medically intractable partial epilepsy was followed for more than five years in 15 French centers. During the second year of follow-up, the proportion of patients who had been completely seizure-free for the previous 12 months was 69.0% among participants who underwent surgery and 12.3% in the medical group. The respective rates of seizure freedom were 76.8% and 21% during the fifth year. Direct costs became significantly lower in the surgical group during the third year after surgery as a result of decreased antiepileptic drug use. Surgery became cost-effective between nine and 10 years after surgery.  
 
The NIH Toolbox Cognitive Battery can assess important dimensions of cognition in persons with intellectual disabilities, and several tests may be useful for tracking response to interventions, according to a study published September 6 in the Journal of Neurodevelopmental Disorders. In separate pilot studies of patients with fragile X syndrome, Down syndrome, and idiopathic intellectual disabilities, researchers used the web-based NIH Toolbox Cognitive Battery to measure processing speed, executive function, episodic memory, word and letter reading, receptive vocabulary, and working memory. The test's feasibility was good to excellent for people above mental age 4 for all tests except list sorting. Test-retest stability was good to excellent. More extensive psychometric studies are needed to determine the battery's true utility as a set of outcome measures, said the researchers.  
 
Graded aerobic treadmill testing is a safe, tolerable, and clinically valuable tool that can assist in the evaluation and management of pediatric sports-related concussion, according to a study published online ahead of print September 13 in the Journal of Neurosurgery: Pediatrics. Researchers conducted a retrospective chart review of 106 pediatric patients with sports-related concussion who were referred to a multidisciplinary pediatric concussion program and underwent graded aerobic treadmill testing between October 9, 2014, and February 11, 2016. Treadmill testing confirmed physiologic recovery in 96.9% of 65 patients tested, allowing successful return to play in 93.8% of patients. Of the 41 patients with physiologic post-concussion disorder who had complete follow-up and were treated with tailored submaximal exercise, 90.2% were classified as clinically improved and 80.5% successfully returned to sporting activities.  
 
Exposure to MRI during the first trimester of pregnancy, compared with nonexposure, is not associated with increased risk of harm to the fetus or in early childhood, according to a study published September 6 in JAMA. Gadolinium MRI, however, was associated with an increased risk of rheumatologic, inflammatory, or infiltrative skin conditions, and stillbirth or neonatal death. The study included 1,424,105 deliveries. Researchers compared first-trimester MRI exposure to no MRI exposure. The adjusted relative risk of stillbirth, congenital anomalies, neoplasm, or vision or hearing loss for first-trimester MRI was not significantly higher, compared with no MRI exposure. Comparing gadolinium MRI with no MRI, the adjusted hazard ratio of any rheumatologic, inflammatory, or infiltrative skin condition for first-trimester MRI was 1.36, for an adjusted risk difference of 45.3 per 1,000 person-years.  
 
In women in the United Kingdom, higher BMI is associated with increased risk of ischemic stroke, but decreased risk of hemorrhagic stroke, according to a study published online ahead of print September 7 in Neurology. Researchers recruited 1.3 million previously stroke-free women from the UK between 1996 and 2001 and followed them by record linkage for hospital admissions and deaths. Increased BMI was associated with an increased risk of ischemic stroke, but a decreased risk of hemorrhagic stroke. The BMI-associated trends for ischemic and hemorrhagic stroke were significantly different, but were not significantly different for intracerebral hemorrhage and subarachnoid hemorrhage. Published data from prospective studies showed consistently greater BMI-associated relative risks for ischemic stroke than hemorrhagic stroke, with most evidence before this study coming from Asian populations.
 
Data confirm the relevance of complement biomarkers in mild cognitive impairment (MCI) and Alzheimer's disease, according to a study published September 6 in the Journal of Alzheimer's Disease. Results also indicate the value of multiparameter models for disease prediction and stratification. Researchers studied 292 people to measure five complement proteins and four activation products in plasma from donors with MCI, those with Alzheimer's disease, and healthy controls. Only clusterin differed significantly between control and Alzheimer's disease plasma. Overall, a model combining clusterin with relevant covariables was highly predictive of disease. Clusterin, factor I, and terminal complement complex were significantly different between individuals with MCI who had converted to dementia one year later compared with nonconverters. A model combining these three analytes with informative covariables was highly predictive of conversion.
 
Prenatal exposure to levetiracetam or topiramate may not impair a child's thinking skills, according to a study published online ahead of print August 31 in Neurology. For this cross-sectional observational study, researchers followed women enrolled in the UK Epilepsy and Pregnancy Register. The women received monotherapy levetiracetam, topiramate, or valproate, or took no therapy. Physicians conducted assessor-blinded neuropsychologic assessments of the women's children between ages 5 and 9. In the adjusted analyses, prenatal exposure to levetiracetam and topiramate were not found to be associated with reductions in children's cognitive abilities, and adverse outcomes were not associated with increasing dose. Increasing the dose of valproate was associated with poorer full-scale IQ, verbal abilities, nonverbal abilities, and expressive language ability. The evidence base for newer antiepileptic drugs is limited, said the authors.  
 
At six months, decompressive craniectomy in patients with traumatic brain injury (TBI) and refractory intracranial hypertension results in lower mortality and higher rates of vegetative state and severe disability, compared with medical care, according to a study published online ahead of print September 7 in the New England Journal of Medicine. Researchers randomly assigned 408 patients, ages 10 to 65, with TBI and refractory elevated intracranial pressure to undergo decompressive craniectomy or receive ongoing medical care. At six months, approximately 27% of patients who received a craniectomy had died, compared with 49% of patients who received medical management. Patients who survived after a craniectomy were more likely to be dependent on others for care. At 12 months, mortality was 30% among surgical patients and 52% among medical patients.
 
Contralaterally controlled functional electrical stimulation (CCFES) improves hand dexterity after stroke more than cyclic neuromuscular electrical stimulation (cNMES) does, according to a study published online ahead of print September 8 in Stroke. Researchers enrolled 80 patients with stroke and chronic moderate to severe upper extremity hemiparesis in the study. Participants were randomized to receive 10 sessions per week of CCFES- or cNMES-assisted hand-opening exercise at home, along with 20 sessions of functional task practice in the laboratory for 12 weeks. At six months post treatment, the CCFES group had an improvement of 4.6 on the Box and Block Test, compared with an improvement of 1.8 for the cNMES group. Fugl-Meyer performance and Arm Motor Abilities Test performance did not differ between groups, however.  
 
Antipsychotic use is associated with higher risk of pneumonia, regardless of the choice of drug, according to a study published online ahead of print June 11 in Chest. Researchers investigated whether incident antipsychotic use or specific antipsychotics are related to higher risk of hospitalization or death due to pneumonia in the MEDALZ cohort. The cohort includes all persons who received a clinically verified diagnosis of Alzheimer's disease in Finland from 2005 to 2011. A matched comparison cohort without Alzheimer's disease was used to compare the magnitude of risk. Antipsychotic use was associated with higher risk of pneumonia in the Alzheimer's disease cohort and with somewhat higher risk in the comparison cohort. No major differences were observed between the most commonly used antipsychotics.
 
The FDA has allowed the marketing of two Trevo clot-retrieval devices as an initial therapy to reduce paralysis, speech difficulties, and other disabilities following ischemic stroke. The agency evaluated data from a clinical trial comparing 96 randomly selected patients treated with the Trevo device and t-PA and medical management  with 249 patients who received only t-PA and medical management. Twenty-nine percent of patients treated with the Trevo device were functionally independent at three months after stroke, compared with 19% of patients who were not treated with the Trevo device. These devices should be used within six hours of symptom onset and only following treatment with a clot-dissolving drug, which needs to be given within three hours of symptom onset, said the FDA. Concentric Medical, headquartered in Mountain View, California, markets Trevo.  
 
Class I evidence suggests that for boys with Duchenne muscular dystrophy, daily use of deflazacort or prednisone is effective in preserving muscle strength over a 12-week period, according to a study published online ahead of print August 26 in Neurology. This phase III, double-blind, randomized, placebo-controlled, multicenter study evaluated the muscle strength of 196 boys ages 5 to 15 with Duchenne muscular dystrophy during a 52-week period. Participants received deflazacort, prednisone, or placebo for 12 weeks. At week 13, patients continued active treatment or switched from placebo to active treatment. All treatment groups demonstrated significant improvement in muscle strength, compared with placebo, at 12 weeks. Participants taking prednisone had significantly more weight gain than other participants at 12 weeks and at 52 weeks.  
 
The FDA has granted tentative approval to Supernus Pharmaceuticals's Supplemental New Drug Application (sNDA) requesting a label expansion for Trokendi XR (topiramate) to include prophylaxis of migraine headache in adults. The approval of the sNDA is tentative because the FDA has determined that the drug meets all of the required quality, safety, and efficacy standards for approval, but is subject to the pediatric exclusivity, which expires on March 28, 2017. Final approval may not be made effective until this exclusivity period has expired. The FDA also has granted final approval to expand the label for Trokendi XR for monotherapy treatment of partial onset seizures to include adults and pediatric patients age six and older, rather than age 10 and older. Supernus Pharmaceuticals is headquartered in Rockville, Maryland.

—Kimberly Williams