News Roundup: New and Noteworthy Information

Patients previously treated with IV immunoglobulin (IVIg) showed a reduced risk of developing Alzheimer’s disease and related disorders (ADRD), according to a study published in the July 21 Neurology. Investigators conducted a retrospective case-control analysis of medical claims for patients 65 or older from a national database. “Treated patients in the Kaplan-Meier analysis had lower ADRD incidence with an estimated 2.6% of the 847 IVIg-treated vs. 4.6% of 84,700 controls diagnosed with ADRD at 60 months after index date,” the researchers stated. Of those treated in a Cox proportional hazard model, 42% had a lower risk of being diagnosed with ADRD, and an estimated 2.8% of treated versus 4.8% of controls were diagnosed with ADRD at 60 months after index date.

Most adolescents with chronic daily headache (CDH) will experience a decline in headache frequency over time, according to a study in the July 15 online Neurology. A total of 103 adolescents (mean age, 21.6; 26 males) with CDH were followed up from 2000 to 2008. Headache frequency, presence of CDH in 2008, and Migraine Disability Assessment scores were outcome measures. Moderate or severe headache disability was reported by 28 (27.2%) subjects. Twelve (12%) participants met CDH criteria; chronic migraine was the most common subtype (n = 10, 83%). Medication overuse was noted in two (2%) patients. “Presence of migraine at baseline predicted poorer outcome of all three measures,” investigators stated. CDH onset at 13 or younger lasting at least two years and medication overuse predicted more frequent headaches or presence of CDH in 2008.

Select biomarkers may be used to predict cardiovascular events but have minimal gain in comparison to conventional risk factors, researchers reported in the July 1JAMA. A cohort of 5,067 subjects (mean age, 58; 60% women) without cardiovascular disease were followed up for a median of 12.8 years. A total of 418 cardiovascular and 230 coronary events occurred. “Models with conventional risk factors had C statistics of 0.758 and 0.760 for cardiovascular and coronary events, respectively,” the investigators stated. In backward-elimination models, C-reactive protein and N-terminal pro-B type natriuretic peptide (N-BNP) for cardiovascular events and midregional proadrenomedullin and N-BNP for coronary events were retained, which increased the C statistic by 0.007 and 0.009, respectively. “Risk classification improved in intermediate-risk individuals, mainly through the identification of those unlikely to develop events.”

Persistent cognitive impairment is a better predictor of white matter hyperintensity (WMH) volumes than baseline WMH burden, reported investigators in the July 14Neurology. Researchers observed 98 cognitively intact elderly subjects (49 with three brain MRIs and annual cognitive and neurologic assessments until persistent cognitive impairment diagnosis). Cognitive impairment risk was assessed with Cox proportional hazards survival analyses. Higher risk of persistent cognitive impairment was associated with total WMH volume (hazard ratio [HR], 1.84) and periventricular WMH volume (HR, 1.94), but not with baseline WMH volumes. “Greater periventricular WMH burden progression is associated with the development of persistent cognitive impairment, a potential precursor to Alzheimer’s or vascular dementia,” researchers stated. “Identification of factors that decrease WMH accumulation over time is needed to maintain cognitive health in our growing elderly population,” stated the authors.

Cambia, a diclofenac-based NSAID combined with potassium bicarbonate, has been approved by the FDA for the treatment of acute migraine with or without aura in adults. In clinical trials, Cambia effectively treated migraine pain, photophobia, phonophobia, and nausea. Significant onset of relief from pain was achieved within 15 to 30 minutes. Cambia is marketed by Novartis Pharma AG, headquartered in Basel, Switzerland, through a license from Kowa Pharmaceuticals America (KPA), Inc, in Montgomery, Alabama.

The FDA has approved a New Drug Application for Sumavel DosePro (sumatriptan injection), a needle-free delivery system to treat acute migraine with or without aura, and cluster headache. Sumavel DosePro provides migraine relief within 10 minutes for some patients. The system should only be used when diagnosis of migraine or cluster headaches has been established. It should not be administered to patients with cerebrovascular symptoms, peripheral vascular disease, or uncontrolled hypertension. Sumavel DosePro is marketed by Zogenix, Inc, in San Diego.

Cigarette smoking accelerates MS from a relapsing-remitting to a progressive course, according to a report in the July Archives of Neurology. Included in the study were 1,465 subjects with clinically definite MS (25% men; mean age, 42 at baseline; disease duration, 9.4 years); 780 patients (53.2%) were never-smokers, 428 (29.2%) were ex-smokers , and 257 (17.5%) were current smokers. At baseline, current smokers showed significantly worse disease than did never-smokers. “In addition, current smokers were significantly more likely to have primary progressive MS (adjusted odds ratio, 2.41),” investigators stated. “At longitudinal analysis, MS in smokers progressed from relapsing-remitting to secondary progressive disease faster than in never-smokers (hazard ratio for current smokers vs. never smokers, 2.50).” Also, T2-weighted lesion volume increased faster in smokers, while brain parenchymal fraction decreased faster.

Greater impairment and disability and higher education level are independently associated with an earlier need for symptomatic treatment in early Parkinson’s disease, according to a study that was reported in the July 13 online Archives of Neurology. Patients (n = 413) were randomized into treatment groups: creatine (n = 67), minocycline (n =66), coenzyme Q10 (n = 71), GPI-1485 (n = 71), and placebo (n = 138). The time between baseline assessment and need for the initiation of symptomatic treatment for Parkinson’s disease was the main outcome measure. Within 12 months, approximately half (48.5%) of the participants had reached end point. “Higher baseline impairment and disability, as determined by the Unified Parkinson’s Disease Rating Scale (UPDRS) III (motor section), UPDRS II (activities of daily living section, participant rating), and Modified Rankin Scale scores and level of education were independently associated with an earlier need for symptomatic treatment,” investigators stated.

Neuronal hypertrophy may reflect compensatory mechanisms that prevent cognitive impairment despite substantial Alzheimer’s disease lesions, according to a study that was published in the July 8 online issue of Neurology. Researchers termed the presence of neuritic beta-amyloid plaques and neurofibrillary tangles in the autopsied brains of subjects who were deemed cognitively normal before death as asymptomatic Alzheimer’s disease (ASYMAD). The study authors observed four subject groups—those with ASYMAD (n = 10), those with mild cognitive impairment (MCI, n = 5), those with Alzheimer’s disease (n = 10), and age-matched controls (n = 13). “A significant hypertrophy of the cell bodies (+44.9%), nuclei (+59.7%), and nucleoli (+80.2%) in the CA1 neurons was found in the ASYMAD compared with MCI,” the investigators stated. “Furthermore, significant higher idea density scores in early life were observed in controls and the ASYMAD group compared to the MCI and Alzheimer’s disease groups.”

—Laura Sassano

Patients previously treated with IV immunoglobulin (IVIg) showed a reduced risk of developing Alzheimer’s disease and related disorders (ADRD), according to a study published in the July 21 Neurology. Investigators conducted a retrospective case-control analysis of medical claims for patients 65 or older from a national database. “Treated patients in the Kaplan-Meier analysis had lower ADRD incidence with an estimated 2.6% of the 847 IVIg-treated vs. 4.6% of 84,700 controls diagnosed with ADRD at 60 months after index date,” the researchers stated. Of those treated in a Cox proportional hazard model, 42% had a lower risk of being diagnosed with ADRD, and an estimated 2.8% of treated versus 4.8% of controls were diagnosed with ADRD at 60 months after index date.

Most adolescents with chronic daily headache (CDH) will experience a decline in headache frequency over time, according to a study in the July 15 online Neurology. A total of 103 adolescents (mean age, 21.6; 26 males) with CDH were followed up from 2000 to 2008. Headache frequency, presence of CDH in 2008, and Migraine Disability Assessment scores were outcome measures. Moderate or severe headache disability was reported by 28 (27.2%) subjects. Twelve (12%) participants met CDH criteria; chronic migraine was the most common subtype (n = 10, 83%). Medication overuse was noted in two (2%) patients. “Presence of migraine at baseline predicted poorer outcome of all three measures,” investigators stated. CDH onset at 13 or younger lasting at least two years and medication overuse predicted more frequent headaches or presence of CDH in 2008.

Select biomarkers may be used to predict cardiovascular events but have minimal gain in comparison to conventional risk factors, researchers reported in the July 1JAMA. A cohort of 5,067 subjects (mean age, 58; 60% women) without cardiovascular disease were followed up for a median of 12.8 years. A total of 418 cardiovascular and 230 coronary events occurred. “Models with conventional risk factors had C statistics of 0.758 and 0.760 for cardiovascular and coronary events, respectively,” the investigators stated. In backward-elimination models, C-reactive protein and N-terminal pro-B type natriuretic peptide (N-BNP) for cardiovascular events and midregional proadrenomedullin and N-BNP for coronary events were retained, which increased the C statistic by 0.007 and 0.009, respectively. “Risk classification improved in intermediate-risk individuals, mainly through the identification of those unlikely to develop events.”

Persistent cognitive impairment is a better predictor of white matter hyperintensity (WMH) volumes than baseline WMH burden, reported investigators in the July 14Neurology. Researchers observed 98 cognitively intact elderly subjects (49 with three brain MRIs and annual cognitive and neurologic assessments until persistent cognitive impairment diagnosis). Cognitive impairment risk was assessed with Cox proportional hazards survival analyses. Higher risk of persistent cognitive impairment was associated with total WMH volume (hazard ratio [HR], 1.84) and periventricular WMH volume (HR, 1.94), but not with baseline WMH volumes. “Greater periventricular WMH burden progression is associated with the development of persistent cognitive impairment, a potential precursor to Alzheimer’s or vascular dementia,” researchers stated. “Identification of factors that decrease WMH accumulation over time is needed to maintain cognitive health in our growing elderly population,” stated the authors.

Cambia, a diclofenac-based NSAID combined with potassium bicarbonate, has been approved by the FDA for the treatment of acute migraine with or without aura in adults. In clinical trials, Cambia effectively treated migraine pain, photophobia, phonophobia, and nausea. Significant onset of relief from pain was achieved within 15 to 30 minutes. Cambia is marketed by Novartis Pharma AG, headquartered in Basel, Switzerland, through a license from Kowa Pharmaceuticals America (KPA), Inc, in Montgomery, Alabama.

The FDA has approved a New Drug Application for Sumavel DosePro (sumatriptan injection), a needle-free delivery system to treat acute migraine with or without aura, and cluster headache. Sumavel DosePro provides migraine relief within 10 minutes for some patients. The system should only be used when diagnosis of migraine or cluster headaches has been established. It should not be administered to patients with cerebrovascular symptoms, peripheral vascular disease, or uncontrolled hypertension. Sumavel DosePro is marketed by Zogenix, Inc, in San Diego.

Cigarette smoking accelerates MS from a relapsing-remitting to a progressive course, according to a report in the July Archives of Neurology. Included in the study were 1,465 subjects with clinically definite MS (25% men; mean age, 42 at baseline; disease duration, 9.4 years); 780 patients (53.2%) were never-smokers, 428 (29.2%) were ex-smokers , and 257 (17.5%) were current smokers. At baseline, current smokers showed significantly worse disease than did never-smokers. “In addition, current smokers were significantly more likely to have primary progressive MS (adjusted odds ratio, 2.41),” investigators stated. “At longitudinal analysis, MS in smokers progressed from relapsing-remitting to secondary progressive disease faster than in never-smokers (hazard ratio for current smokers vs. never smokers, 2.50).” Also, T2-weighted lesion volume increased faster in smokers, while brain parenchymal fraction decreased faster.

Greater impairment and disability and higher education level are independently associated with an earlier need for symptomatic treatment in early Parkinson’s disease, according to a study that was reported in the July 13 online Archives of Neurology. Patients (n = 413) were randomized into treatment groups: creatine (n = 67), minocycline (n =66), coenzyme Q10 (n = 71), GPI-1485 (n = 71), and placebo (n = 138). The time between baseline assessment and need for the initiation of symptomatic treatment for Parkinson’s disease was the main outcome measure. Within 12 months, approximately half (48.5%) of the participants had reached end point. “Higher baseline impairment and disability, as determined by the Unified Parkinson’s Disease Rating Scale (UPDRS) III (motor section), UPDRS II (activities of daily living section, participant rating), and Modified Rankin Scale scores and level of education were independently associated with an earlier need for symptomatic treatment,” investigators stated.

Neuronal hypertrophy may reflect compensatory mechanisms that prevent cognitive impairment despite substantial Alzheimer’s disease lesions, according to a study that was published in the July 8 online issue of Neurology. Researchers termed the presence of neuritic beta-amyloid plaques and neurofibrillary tangles in the autopsied brains of subjects who were deemed cognitively normal before death as asymptomatic Alzheimer’s disease (ASYMAD). The study authors observed four subject groups—those with ASYMAD (n = 10), those with mild cognitive impairment (MCI, n = 5), those with Alzheimer’s disease (n = 10), and age-matched controls (n = 13). “A significant hypertrophy of the cell bodies (+44.9%), nuclei (+59.7%), and nucleoli (+80.2%) in the CA1 neurons was found in the ASYMAD compared with MCI,” the investigators stated. “Furthermore, significant higher idea density scores in early life were observed in controls and the ASYMAD group compared to the MCI and Alzheimer’s disease groups.”

—Laura Sassano

Patients previously treated with IV immunoglobulin (IVIg) showed a reduced risk of developing Alzheimer’s disease and related disorders (ADRD), according to a study published in the July 21 Neurology. Investigators conducted a retrospective case-control analysis of medical claims for patients 65 or older from a national database. “Treated patients in the Kaplan-Meier analysis had lower ADRD incidence with an estimated 2.6% of the 847 IVIg-treated vs. 4.6% of 84,700 controls diagnosed with ADRD at 60 months after index date,” the researchers stated. Of those treated in a Cox proportional hazard model, 42% had a lower risk of being diagnosed with ADRD, and an estimated 2.8% of treated versus 4.8% of controls were diagnosed with ADRD at 60 months after index date.

Most adolescents with chronic daily headache (CDH) will experience a decline in headache frequency over time, according to a study in the July 15 online Neurology. A total of 103 adolescents (mean age, 21.6; 26 males) with CDH were followed up from 2000 to 2008. Headache frequency, presence of CDH in 2008, and Migraine Disability Assessment scores were outcome measures. Moderate or severe headache disability was reported by 28 (27.2%) subjects. Twelve (12%) participants met CDH criteria; chronic migraine was the most common subtype (n = 10, 83%). Medication overuse was noted in two (2%) patients. “Presence of migraine at baseline predicted poorer outcome of all three measures,” investigators stated. CDH onset at 13 or younger lasting at least two years and medication overuse predicted more frequent headaches or presence of CDH in 2008.

Select biomarkers may be used to predict cardiovascular events but have minimal gain in comparison to conventional risk factors, researchers reported in the July 1JAMA. A cohort of 5,067 subjects (mean age, 58; 60% women) without cardiovascular disease were followed up for a median of 12.8 years. A total of 418 cardiovascular and 230 coronary events occurred. “Models with conventional risk factors had C statistics of 0.758 and 0.760 for cardiovascular and coronary events, respectively,” the investigators stated. In backward-elimination models, C-reactive protein and N-terminal pro-B type natriuretic peptide (N-BNP) for cardiovascular events and midregional proadrenomedullin and N-BNP for coronary events were retained, which increased the C statistic by 0.007 and 0.009, respectively. “Risk classification improved in intermediate-risk individuals, mainly through the identification of those unlikely to develop events.”

Persistent cognitive impairment is a better predictor of white matter hyperintensity (WMH) volumes than baseline WMH burden, reported investigators in the July 14Neurology. Researchers observed 98 cognitively intact elderly subjects (49 with three brain MRIs and annual cognitive and neurologic assessments until persistent cognitive impairment diagnosis). Cognitive impairment risk was assessed with Cox proportional hazards survival analyses. Higher risk of persistent cognitive impairment was associated with total WMH volume (hazard ratio [HR], 1.84) and periventricular WMH volume (HR, 1.94), but not with baseline WMH volumes. “Greater periventricular WMH burden progression is associated with the development of persistent cognitive impairment, a potential precursor to Alzheimer’s or vascular dementia,” researchers stated. “Identification of factors that decrease WMH accumulation over time is needed to maintain cognitive health in our growing elderly population,” stated the authors.

Cambia, a diclofenac-based NSAID combined with potassium bicarbonate, has been approved by the FDA for the treatment of acute migraine with or without aura in adults. In clinical trials, Cambia effectively treated migraine pain, photophobia, phonophobia, and nausea. Significant onset of relief from pain was achieved within 15 to 30 minutes. Cambia is marketed by Novartis Pharma AG, headquartered in Basel, Switzerland, through a license from Kowa Pharmaceuticals America (KPA), Inc, in Montgomery, Alabama.

The FDA has approved a New Drug Application for Sumavel DosePro (sumatriptan injection), a needle-free delivery system to treat acute migraine with or without aura, and cluster headache. Sumavel DosePro provides migraine relief within 10 minutes for some patients. The system should only be used when diagnosis of migraine or cluster headaches has been established. It should not be administered to patients with cerebrovascular symptoms, peripheral vascular disease, or uncontrolled hypertension. Sumavel DosePro is marketed by Zogenix, Inc, in San Diego.

Cigarette smoking accelerates MS from a relapsing-remitting to a progressive course, according to a report in the July Archives of Neurology. Included in the study were 1,465 subjects with clinically definite MS (25% men; mean age, 42 at baseline; disease duration, 9.4 years); 780 patients (53.2%) were never-smokers, 428 (29.2%) were ex-smokers , and 257 (17.5%) were current smokers. At baseline, current smokers showed significantly worse disease than did never-smokers. “In addition, current smokers were significantly more likely to have primary progressive MS (adjusted odds ratio, 2.41),” investigators stated. “At longitudinal analysis, MS in smokers progressed from relapsing-remitting to secondary progressive disease faster than in never-smokers (hazard ratio for current smokers vs. never smokers, 2.50).” Also, T2-weighted lesion volume increased faster in smokers, while brain parenchymal fraction decreased faster.

Greater impairment and disability and higher education level are independently associated with an earlier need for symptomatic treatment in early Parkinson’s disease, according to a study that was reported in the July 13 online Archives of Neurology. Patients (n = 413) were randomized into treatment groups: creatine (n = 67), minocycline (n =66), coenzyme Q10 (n = 71), GPI-1485 (n = 71), and placebo (n = 138). The time between baseline assessment and need for the initiation of symptomatic treatment for Parkinson’s disease was the main outcome measure. Within 12 months, approximately half (48.5%) of the participants had reached end point. “Higher baseline impairment and disability, as determined by the Unified Parkinson’s Disease Rating Scale (UPDRS) III (motor section), UPDRS II (activities of daily living section, participant rating), and Modified Rankin Scale scores and level of education were independently associated with an earlier need for symptomatic treatment,” investigators stated.

Neuronal hypertrophy may reflect compensatory mechanisms that prevent cognitive impairment despite substantial Alzheimer’s disease lesions, according to a study that was published in the July 8 online issue of Neurology. Researchers termed the presence of neuritic beta-amyloid plaques and neurofibrillary tangles in the autopsied brains of subjects who were deemed cognitively normal before death as asymptomatic Alzheimer’s disease (ASYMAD). The study authors observed four subject groups—those with ASYMAD (n = 10), those with mild cognitive impairment (MCI, n = 5), those with Alzheimer’s disease (n = 10), and age-matched controls (n = 13). “A significant hypertrophy of the cell bodies (+44.9%), nuclei (+59.7%), and nucleoli (+80.2%) in the CA1 neurons was found in the ASYMAD compared with MCI,” the investigators stated. “Furthermore, significant higher idea density scores in early life were observed in controls and the ASYMAD group compared to the MCI and Alzheimer’s disease groups.”

—Laura Sassano