New and Noteworthy Information—March 2016

Adults with a diagnosis of concussion have an increased long-term risk of suicide, particularly after concussions on weekends, according to a study published online ahead of print February 8 in the Canadian Medical Association Journal. Researchers performed a longitudinal cohort analysis of adults with a diagnosis of concussion from April 1, 1992 to March 31, 2012. Concussions that resulted in hospital admission were excluded. Investigators identified 235,110 patients with concussion, and 667 subsequent suicides occurring over a median follow-up of 9.3 years, which was three times the expected rate. Weekend concussions were associated with a one-third further increased risk of suicide, compared with weekday concussions. According to the researchers, the increased risk applied regardless of patients’ demographic characteristics, was independent of past psychiatric conditions, became accentuated with time, and exceeded the risk among military personnel.

Imaging with 3-T T2-weighted brain MRI distinguishes perivenous multiple sclerosis (MS) lesions from microangiopathic lesions, according to a study of 40 patients published online ahead of print December 10, 2015, in the Multiple Sclerosis Journal. Initially, a test cohort of 10 patients with MS and 10 patients with microangiopathic white matter lesions underwent T2-weighted brain imaging on a 3T MRI. Anonymized scans were analyzed blind to clinical data, and simple diagnostic rules were devised. These rules were applied to a validation cohort of 20 patients by a blinded observer. Within the test cohort, all patients with MS had central veins visible in more than 45% of brain lesions, while the rest had central veins visible in less than 45% of lesions. By applying diagnostic rules to the validation cohort, all remaining patients were correctly categorized.

In asymptomatic patients with severe carotid stenosis who are not at high risk for surgical complications, stenting is noninferior to endarterectomy with regard to the rates of stroke, death, or myocardial infarction at one year, according to a study published online ahead of print February 17 in the New England Journal of Medicine. Researchers compared carotid-artery stenting with embolic protection and carotid endarterectomy in 1,453 patients age 79 or younger. The rate of stroke or death within 30 days was 2.9% in the stenting group and 1.7% in the endarterectomy group. From 30 days to five years after the procedure, the rate of freedom from ipsilateral stroke was 97.8% in the stenting group and 97.3% in the endarterectomy group, and the overall survival rates were 87.1% and 89.4%, respectively.

Past exposure to marijuana is associated with worsened verbal memory, but does not appear to affect other domains of cognitive function, according to a study published online ahead of print February 1 in JAMA Internal Medicine. Researchers examined data for 5,115 African American and Caucasian men and women ages 18 to 30 at baseline. Participants were followed for 26 years to estimate cumulative exposure to marijuana. Among 3,385 participants with cognitive function measurements at the year 25 visit, 2,852 reported past marijuana use, and 392 continued to use marijuana into middle age. After excluding current users and adjusting for potential confounders, cumulative lifetime exposure to marijuana remained significantly associated with worsened verbal memory. For each five years of past exposure, verbal memory was 0.13 standardized units lower.

Frequent shifts in sleep timing may impair metabolic health among non-shift-working women of middle age, according to a study published in the February issue of Sleep. A total of 338 Caucasian, African American, and Chinese non-shift-working women ages 48 through 58 who were not taking insulin-related medications participated in the Study of Women’s Health Across the Nation Sleep Study and were examined approximately 5.39 years later. Daily diary-reported bedtimes were used to calculate four measures of sleep timing. BMI and insulin resistance were measured at two time points. In cross-sectional models, greater variability in bedtime and greater bedtime delay were associated with higher homeostatic model assessment-insulin resistance, and greater bedtime advance was associated with higher BMI. Prospectively, greater bedtime delay predicted increased homeostatic model assessment-insulin resistance.

Elderly people with high levels of depressive symptoms on several occasions over a 10-year period have substantially increased risk of coronary heart disease and stroke, according to a study published in the January issue of Journal of the American Geriatrics Society. Researchers examined 9,294 participants at baseline between 1999 and 2001, and during repeated study visits. There were 7,313 participants with an average age of 73.8, with no history of coronary heart disease, stroke, or dementia at baseline. After a median follow-up of 8.4 years, 629 first coronary heart disease or stroke events occurred. After adjustment for sociodemographic characteristics and vascular risk factors, the risk of coronary heart disease and stroke combined increased 1.15-fold per each additional study visit with high levels of depressive symptoms.

Submandibular gland needle biopsies identify phosphorylated alpha-synuclein staining in 74% of patients with early Parkinson’s disease, according to a study published in the February issue of Movement Disorders. Twenty-five patients with early Parkinson’s disease and 10 controls underwent transcutaneous needle core biopsies of the submandibular gland. Tissue was stained for phosphorylated alpha-synuclein and reviewed blind to clinical diagnosis. Only nerve element staining was considered positive. Mean age was 69.5 for the Parkinson’s disease group and 64.8 for controls, and disease duration was 2.6 years. Six people with Parkinson’s disease and one control subject had inadequate glandular tissue. Positive staining was found in 14 of 19 patients with Parkinson’s disease and two out of nine control subjects. Parkinson’s disease-positive and -negative cases did not differ clinically.

Lower cardiovascular fitness and exaggerated exercise blood pressure heart-rate responses in middle-aged adults are associated with smaller brain volume nearly two decades later, according to a study published online ahead of print February 10 in Neurology. In all, 1,094 people without dementia and cardiovascular disease underwent an exercise treadmill test at a mean age of 40. A second treadmill test and MRI scans of the brain were administered two decades later. Poor cardiovascular fitness and greater diastolic blood pressure and heart-rate response to exercise at baseline were associated with a smaller total cerebral brain volume almost two decades later in multivariable adjusted models. The effect of one standard deviation of lower fitness was equivalent to approximately one additional year of brain aging in individuals free of cardiovascular disease.

The increased risks of falling and hip fracture before the diagnosis of Parkinson’s disease may suggest the presence of clinically relevant neurodegenerative impairment years before the diagnosis of the disease, according to a study published February 2 in PLOS Medicine. Researchers compiled two nested case–control cohorts: In cohort one were individuals diagnosed with Parkinson’s disease; cohort two included individuals with an injurious fall. In cohort one, 18.0% of cases had at least one injurious fall before Parkinson’s disease diagnosis, whereas 11.5% of controls had an injurious fall. In cohort two, 0.7% of individuals with an injurious fall and 0.5% of controls were diagnosed with Parkinson’s disease during follow-up. The risk of Parkinson’s disease was increased for as long as 10 years after an injurious fall.

Increased amyloid β burden is observed in traumatic brain injury (TBI), according to a study published online ahead of print February 3 in Neurology. Patients age 11 months to 17 years with moderate to severe TBI underwent ¹¹C-Pittsburgh compound B (¹¹C-PiB)-PET, structural and diffusion MRI, and neuropsychologic examination. Healthy controls and patients with Alzheimer’s disease underwent PET and structural MRI. In TBI, fractional anisotropy was estimated and correlated with ¹¹C-PiB binding potential. Increased ¹¹C-PiB binding potential was found in TBI versus controls in the posterior cingulate cortex and cerebellum. Binding in the posterior cingulate cortex increased with decreasing fractional anisotropy of associated white matter tracts and increased with time since injury. Compared with Alzheimer’s disease, binding after TBI was lower in neocortical regions, but increased in the cerebellum.

Among participants in the Framingham Heart Study, the incidence of dementia has declined over three decades, according to a study published February 11 in the New England Journal of Medicine. In this analysis, which included 5,205 people age 60 and older, researchers used Cox proportional-hazards models adjusted for age and sex to determine the five-year incidence of dementia during each of four epochs. The five-year age- and sex-adjusted cumulative hazard rates for dementia were 3.6 per 100 persons during the first epoch, 2.8 per 100 persons during the second epoch, 2.2 per 100 persons during the third epoch, and 2.0 per 100 persons during the fourth epoch. During the second through fourth epochs, the incidence of dementia declined by 22%, 38%, and 44%, respectively, compared with the first epoch.

The FDA has approved Onzetra Xsail (sumatriptan nasal powder), formerly known as AVP-825, for the acute treatment of migraine with or without aura in adults. The approval is based on data from phase II and phase III trials, safety data from more than 300 patients, and reference data from the extensive clinical use of sumatriptan over the past 20 years. In one trial, 230 patients with migraine were randomized to self-administer either Onzetra Xsail or placebo, using the Xsail Breath Powered Delivery Device when they had moderate to severe migraine pain. A significantly greater proportion of patients on the study drug reported headache relief at 30 minutes and at every time point up to two hours post dose. Avanir Pharmaceuticals manufactures the drug.

The FDA has approved Medtronic Deep Brain Stimulation (DBS) Therapy for use in patients with Parkinson’s disease of at least four-years duration and with recent onset of motor complications, or motor complications of longer-standing duration that are not adequately controlled with medication. In 2002, the FDA initially approved Medtronic DBS Therapy for use in patients with advanced Parkinson’s disease. This new approval expands the population of patients who may benefit from this therapy. The approval is based on data from the EARLYSTIM study published in the New England Journal of Medicine in 2012.

—Kimberly Williams

Adults with a diagnosis of concussion have an increased long-term risk of suicide, particularly after concussions on weekends, according to a study published online ahead of print February 8 in the Canadian Medical Association Journal. Researchers performed a longitudinal cohort analysis of adults with a diagnosis of concussion from April 1, 1992 to March 31, 2012. Concussions that resulted in hospital admission were excluded. Investigators identified 235,110 patients with concussion, and 667 subsequent suicides occurring over a median follow-up of 9.3 years, which was three times the expected rate. Weekend concussions were associated with a one-third further increased risk of suicide, compared with weekday concussions. According to the researchers, the increased risk applied regardless of patients’ demographic characteristics, was independent of past psychiatric conditions, became accentuated with time, and exceeded the risk among military personnel.

Imaging with 3-T T2-weighted brain MRI distinguishes perivenous multiple sclerosis (MS) lesions from microangiopathic lesions, according to a study of 40 patients published online ahead of print December 10, 2015, in the Multiple Sclerosis Journal. Initially, a test cohort of 10 patients with MS and 10 patients with microangiopathic white matter lesions underwent T2-weighted brain imaging on a 3T MRI. Anonymized scans were analyzed blind to clinical data, and simple diagnostic rules were devised. These rules were applied to a validation cohort of 20 patients by a blinded observer. Within the test cohort, all patients with MS had central veins visible in more than 45% of brain lesions, while the rest had central veins visible in less than 45% of lesions. By applying diagnostic rules to the validation cohort, all remaining patients were correctly categorized.

In asymptomatic patients with severe carotid stenosis who are not at high risk for surgical complications, stenting is noninferior to endarterectomy with regard to the rates of stroke, death, or myocardial infarction at one year, according to a study published online ahead of print February 17 in the New England Journal of Medicine. Researchers compared carotid-artery stenting with embolic protection and carotid endarterectomy in 1,453 patients age 79 or younger. The rate of stroke or death within 30 days was 2.9% in the stenting group and 1.7% in the endarterectomy group. From 30 days to five years after the procedure, the rate of freedom from ipsilateral stroke was 97.8% in the stenting group and 97.3% in the endarterectomy group, and the overall survival rates were 87.1% and 89.4%, respectively.

Past exposure to marijuana is associated with worsened verbal memory, but does not appear to affect other domains of cognitive function, according to a study published online ahead of print February 1 in JAMA Internal Medicine. Researchers examined data for 5,115 African American and Caucasian men and women ages 18 to 30 at baseline. Participants were followed for 26 years to estimate cumulative exposure to marijuana. Among 3,385 participants with cognitive function measurements at the year 25 visit, 2,852 reported past marijuana use, and 392 continued to use marijuana into middle age. After excluding current users and adjusting for potential confounders, cumulative lifetime exposure to marijuana remained significantly associated with worsened verbal memory. For each five years of past exposure, verbal memory was 0.13 standardized units lower.

Frequent shifts in sleep timing may impair metabolic health among non-shift-working women of middle age, according to a study published in the February issue of Sleep. A total of 338 Caucasian, African American, and Chinese non-shift-working women ages 48 through 58 who were not taking insulin-related medications participated in the Study of Women’s Health Across the Nation Sleep Study and were examined approximately 5.39 years later. Daily diary-reported bedtimes were used to calculate four measures of sleep timing. BMI and insulin resistance were measured at two time points. In cross-sectional models, greater variability in bedtime and greater bedtime delay were associated with higher homeostatic model assessment-insulin resistance, and greater bedtime advance was associated with higher BMI. Prospectively, greater bedtime delay predicted increased homeostatic model assessment-insulin resistance.

Elderly people with high levels of depressive symptoms on several occasions over a 10-year period have substantially increased risk of coronary heart disease and stroke, according to a study published in the January issue of Journal of the American Geriatrics Society. Researchers examined 9,294 participants at baseline between 1999 and 2001, and during repeated study visits. There were 7,313 participants with an average age of 73.8, with no history of coronary heart disease, stroke, or dementia at baseline. After a median follow-up of 8.4 years, 629 first coronary heart disease or stroke events occurred. After adjustment for sociodemographic characteristics and vascular risk factors, the risk of coronary heart disease and stroke combined increased 1.15-fold per each additional study visit with high levels of depressive symptoms.

Submandibular gland needle biopsies identify phosphorylated alpha-synuclein staining in 74% of patients with early Parkinson’s disease, according to a study published in the February issue of Movement Disorders. Twenty-five patients with early Parkinson’s disease and 10 controls underwent transcutaneous needle core biopsies of the submandibular gland. Tissue was stained for phosphorylated alpha-synuclein and reviewed blind to clinical diagnosis. Only nerve element staining was considered positive. Mean age was 69.5 for the Parkinson’s disease group and 64.8 for controls, and disease duration was 2.6 years. Six people with Parkinson’s disease and one control subject had inadequate glandular tissue. Positive staining was found in 14 of 19 patients with Parkinson’s disease and two out of nine control subjects. Parkinson’s disease-positive and -negative cases did not differ clinically.

Lower cardiovascular fitness and exaggerated exercise blood pressure heart-rate responses in middle-aged adults are associated with smaller brain volume nearly two decades later, according to a study published online ahead of print February 10 in Neurology. In all, 1,094 people without dementia and cardiovascular disease underwent an exercise treadmill test at a mean age of 40. A second treadmill test and MRI scans of the brain were administered two decades later. Poor cardiovascular fitness and greater diastolic blood pressure and heart-rate response to exercise at baseline were associated with a smaller total cerebral brain volume almost two decades later in multivariable adjusted models. The effect of one standard deviation of lower fitness was equivalent to approximately one additional year of brain aging in individuals free of cardiovascular disease.

The increased risks of falling and hip fracture before the diagnosis of Parkinson’s disease may suggest the presence of clinically relevant neurodegenerative impairment years before the diagnosis of the disease, according to a study published February 2 in PLOS Medicine. Researchers compiled two nested case–control cohorts: In cohort one were individuals diagnosed with Parkinson’s disease; cohort two included individuals with an injurious fall. In cohort one, 18.0% of cases had at least one injurious fall before Parkinson’s disease diagnosis, whereas 11.5% of controls had an injurious fall. In cohort two, 0.7% of individuals with an injurious fall and 0.5% of controls were diagnosed with Parkinson’s disease during follow-up. The risk of Parkinson’s disease was increased for as long as 10 years after an injurious fall.

Increased amyloid β burden is observed in traumatic brain injury (TBI), according to a study published online ahead of print February 3 in Neurology. Patients age 11 months to 17 years with moderate to severe TBI underwent ¹¹C-Pittsburgh compound B (¹¹C-PiB)-PET, structural and diffusion MRI, and neuropsychologic examination. Healthy controls and patients with Alzheimer’s disease underwent PET and structural MRI. In TBI, fractional anisotropy was estimated and correlated with ¹¹C-PiB binding potential. Increased ¹¹C-PiB binding potential was found in TBI versus controls in the posterior cingulate cortex and cerebellum. Binding in the posterior cingulate cortex increased with decreasing fractional anisotropy of associated white matter tracts and increased with time since injury. Compared with Alzheimer’s disease, binding after TBI was lower in neocortical regions, but increased in the cerebellum.

Among participants in the Framingham Heart Study, the incidence of dementia has declined over three decades, according to a study published February 11 in the New England Journal of Medicine. In this analysis, which included 5,205 people age 60 and older, researchers used Cox proportional-hazards models adjusted for age and sex to determine the five-year incidence of dementia during each of four epochs. The five-year age- and sex-adjusted cumulative hazard rates for dementia were 3.6 per 100 persons during the first epoch, 2.8 per 100 persons during the second epoch, 2.2 per 100 persons during the third epoch, and 2.0 per 100 persons during the fourth epoch. During the second through fourth epochs, the incidence of dementia declined by 22%, 38%, and 44%, respectively, compared with the first epoch.

The FDA has approved Onzetra Xsail (sumatriptan nasal powder), formerly known as AVP-825, for the acute treatment of migraine with or without aura in adults. The approval is based on data from phase II and phase III trials, safety data from more than 300 patients, and reference data from the extensive clinical use of sumatriptan over the past 20 years. In one trial, 230 patients with migraine were randomized to self-administer either Onzetra Xsail or placebo, using the Xsail Breath Powered Delivery Device when they had moderate to severe migraine pain. A significantly greater proportion of patients on the study drug reported headache relief at 30 minutes and at every time point up to two hours post dose. Avanir Pharmaceuticals manufactures the drug.

The FDA has approved Medtronic Deep Brain Stimulation (DBS) Therapy for use in patients with Parkinson’s disease of at least four-years duration and with recent onset of motor complications, or motor complications of longer-standing duration that are not adequately controlled with medication. In 2002, the FDA initially approved Medtronic DBS Therapy for use in patients with advanced Parkinson’s disease. This new approval expands the population of patients who may benefit from this therapy. The approval is based on data from the EARLYSTIM study published in the New England Journal of Medicine in 2012.

—Kimberly Williams

Adults with a diagnosis of concussion have an increased long-term risk of suicide, particularly after concussions on weekends, according to a study published online ahead of print February 8 in the Canadian Medical Association Journal. Researchers performed a longitudinal cohort analysis of adults with a diagnosis of concussion from April 1, 1992 to March 31, 2012. Concussions that resulted in hospital admission were excluded. Investigators identified 235,110 patients with concussion, and 667 subsequent suicides occurring over a median follow-up of 9.3 years, which was three times the expected rate. Weekend concussions were associated with a one-third further increased risk of suicide, compared with weekday concussions. According to the researchers, the increased risk applied regardless of patients’ demographic characteristics, was independent of past psychiatric conditions, became accentuated with time, and exceeded the risk among military personnel.

Imaging with 3-T T2-weighted brain MRI distinguishes perivenous multiple sclerosis (MS) lesions from microangiopathic lesions, according to a study of 40 patients published online ahead of print December 10, 2015, in the Multiple Sclerosis Journal. Initially, a test cohort of 10 patients with MS and 10 patients with microangiopathic white matter lesions underwent T2-weighted brain imaging on a 3T MRI. Anonymized scans were analyzed blind to clinical data, and simple diagnostic rules were devised. These rules were applied to a validation cohort of 20 patients by a blinded observer. Within the test cohort, all patients with MS had central veins visible in more than 45% of brain lesions, while the rest had central veins visible in less than 45% of lesions. By applying diagnostic rules to the validation cohort, all remaining patients were correctly categorized.

In asymptomatic patients with severe carotid stenosis who are not at high risk for surgical complications, stenting is noninferior to endarterectomy with regard to the rates of stroke, death, or myocardial infarction at one year, according to a study published online ahead of print February 17 in the New England Journal of Medicine. Researchers compared carotid-artery stenting with embolic protection and carotid endarterectomy in 1,453 patients age 79 or younger. The rate of stroke or death within 30 days was 2.9% in the stenting group and 1.7% in the endarterectomy group. From 30 days to five years after the procedure, the rate of freedom from ipsilateral stroke was 97.8% in the stenting group and 97.3% in the endarterectomy group, and the overall survival rates were 87.1% and 89.4%, respectively.

Past exposure to marijuana is associated with worsened verbal memory, but does not appear to affect other domains of cognitive function, according to a study published online ahead of print February 1 in JAMA Internal Medicine. Researchers examined data for 5,115 African American and Caucasian men and women ages 18 to 30 at baseline. Participants were followed for 26 years to estimate cumulative exposure to marijuana. Among 3,385 participants with cognitive function measurements at the year 25 visit, 2,852 reported past marijuana use, and 392 continued to use marijuana into middle age. After excluding current users and adjusting for potential confounders, cumulative lifetime exposure to marijuana remained significantly associated with worsened verbal memory. For each five years of past exposure, verbal memory was 0.13 standardized units lower.

Frequent shifts in sleep timing may impair metabolic health among non-shift-working women of middle age, according to a study published in the February issue of Sleep. A total of 338 Caucasian, African American, and Chinese non-shift-working women ages 48 through 58 who were not taking insulin-related medications participated in the Study of Women’s Health Across the Nation Sleep Study and were examined approximately 5.39 years later. Daily diary-reported bedtimes were used to calculate four measures of sleep timing. BMI and insulin resistance were measured at two time points. In cross-sectional models, greater variability in bedtime and greater bedtime delay were associated with higher homeostatic model assessment-insulin resistance, and greater bedtime advance was associated with higher BMI. Prospectively, greater bedtime delay predicted increased homeostatic model assessment-insulin resistance.

Elderly people with high levels of depressive symptoms on several occasions over a 10-year period have substantially increased risk of coronary heart disease and stroke, according to a study published in the January issue of Journal of the American Geriatrics Society. Researchers examined 9,294 participants at baseline between 1999 and 2001, and during repeated study visits. There were 7,313 participants with an average age of 73.8, with no history of coronary heart disease, stroke, or dementia at baseline. After a median follow-up of 8.4 years, 629 first coronary heart disease or stroke events occurred. After adjustment for sociodemographic characteristics and vascular risk factors, the risk of coronary heart disease and stroke combined increased 1.15-fold per each additional study visit with high levels of depressive symptoms.

Submandibular gland needle biopsies identify phosphorylated alpha-synuclein staining in 74% of patients with early Parkinson’s disease, according to a study published in the February issue of Movement Disorders. Twenty-five patients with early Parkinson’s disease and 10 controls underwent transcutaneous needle core biopsies of the submandibular gland. Tissue was stained for phosphorylated alpha-synuclein and reviewed blind to clinical diagnosis. Only nerve element staining was considered positive. Mean age was 69.5 for the Parkinson’s disease group and 64.8 for controls, and disease duration was 2.6 years. Six people with Parkinson’s disease and one control subject had inadequate glandular tissue. Positive staining was found in 14 of 19 patients with Parkinson’s disease and two out of nine control subjects. Parkinson’s disease-positive and -negative cases did not differ clinically.

Lower cardiovascular fitness and exaggerated exercise blood pressure heart-rate responses in middle-aged adults are associated with smaller brain volume nearly two decades later, according to a study published online ahead of print February 10 in Neurology. In all, 1,094 people without dementia and cardiovascular disease underwent an exercise treadmill test at a mean age of 40. A second treadmill test and MRI scans of the brain were administered two decades later. Poor cardiovascular fitness and greater diastolic blood pressure and heart-rate response to exercise at baseline were associated with a smaller total cerebral brain volume almost two decades later in multivariable adjusted models. The effect of one standard deviation of lower fitness was equivalent to approximately one additional year of brain aging in individuals free of cardiovascular disease.

The increased risks of falling and hip fracture before the diagnosis of Parkinson’s disease may suggest the presence of clinically relevant neurodegenerative impairment years before the diagnosis of the disease, according to a study published February 2 in PLOS Medicine. Researchers compiled two nested case–control cohorts: In cohort one were individuals diagnosed with Parkinson’s disease; cohort two included individuals with an injurious fall. In cohort one, 18.0% of cases had at least one injurious fall before Parkinson’s disease diagnosis, whereas 11.5% of controls had an injurious fall. In cohort two, 0.7% of individuals with an injurious fall and 0.5% of controls were diagnosed with Parkinson’s disease during follow-up. The risk of Parkinson’s disease was increased for as long as 10 years after an injurious fall.

Increased amyloid β burden is observed in traumatic brain injury (TBI), according to a study published online ahead of print February 3 in Neurology. Patients age 11 months to 17 years with moderate to severe TBI underwent ¹¹C-Pittsburgh compound B (¹¹C-PiB)-PET, structural and diffusion MRI, and neuropsychologic examination. Healthy controls and patients with Alzheimer’s disease underwent PET and structural MRI. In TBI, fractional anisotropy was estimated and correlated with ¹¹C-PiB binding potential. Increased ¹¹C-PiB binding potential was found in TBI versus controls in the posterior cingulate cortex and cerebellum. Binding in the posterior cingulate cortex increased with decreasing fractional anisotropy of associated white matter tracts and increased with time since injury. Compared with Alzheimer’s disease, binding after TBI was lower in neocortical regions, but increased in the cerebellum.

Among participants in the Framingham Heart Study, the incidence of dementia has declined over three decades, according to a study published February 11 in the New England Journal of Medicine. In this analysis, which included 5,205 people age 60 and older, researchers used Cox proportional-hazards models adjusted for age and sex to determine the five-year incidence of dementia during each of four epochs. The five-year age- and sex-adjusted cumulative hazard rates for dementia were 3.6 per 100 persons during the first epoch, 2.8 per 100 persons during the second epoch, 2.2 per 100 persons during the third epoch, and 2.0 per 100 persons during the fourth epoch. During the second through fourth epochs, the incidence of dementia declined by 22%, 38%, and 44%, respectively, compared with the first epoch.

The FDA has approved Onzetra Xsail (sumatriptan nasal powder), formerly known as AVP-825, for the acute treatment of migraine with or without aura in adults. The approval is based on data from phase II and phase III trials, safety data from more than 300 patients, and reference data from the extensive clinical use of sumatriptan over the past 20 years. In one trial, 230 patients with migraine were randomized to self-administer either Onzetra Xsail or placebo, using the Xsail Breath Powered Delivery Device when they had moderate to severe migraine pain. A significantly greater proportion of patients on the study drug reported headache relief at 30 minutes and at every time point up to two hours post dose. Avanir Pharmaceuticals manufactures the drug.

The FDA has approved Medtronic Deep Brain Stimulation (DBS) Therapy for use in patients with Parkinson’s disease of at least four-years duration and with recent onset of motor complications, or motor complications of longer-standing duration that are not adequately controlled with medication. In 2002, the FDA initially approved Medtronic DBS Therapy for use in patients with advanced Parkinson’s disease. This new approval expands the population of patients who may benefit from this therapy. The approval is based on data from the EARLYSTIM study published in the New England Journal of Medicine in 2012.

—Kimberly Williams