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Can a Fatty Diet Increase Relapse Risk in Children With MS?
In children with multiple sclerosis (MS), high energy intake from fat, especially saturated fat, may increase the hazard of relapse, while vegetable intake may be independently protective, according to a study published online ahead of print October 9 in the Journal of Neurology, Neurosurgery & Psychiatry. A total of 219 patients with pediatric relapsing-remitting MS or clinically isolated syndrome with disease onset before age 18 and duration of less than four years were enrolled in a multicenter study that was completed at 11 pediatric MS centers. Investigators used the Block Kids Food Screener to examine dietary intake during the week before enrollment. Each 10% increase in energy intake from fat increased the hazard of relapse by 56%, and each 10% increase in saturated fat tripled this hazard.
Azary S, Schreiner T, Graves J, et al. Contribution of dietary intake to relapse rate in early paediatric multiple sclerosis. J Neurol Neurosurg Psychiatry. 2017 Oct 9 [Epub ahead of print].
Cooling Reduces Risk of Epilepsy After Perinatal Asphyxia
Administering therapeutic hypothermia to babies with perinatal asphyxia can reduce their risk of epilepsy in childhood, according to a study published online ahead of print September 29 in Epilepsia. From 2006 to 2013, 151 infants with perinatal asphyxia underwent 72 hours of cooling. Clinical and amplitude-integrated EEG with single-channel EEG-verified neonatal seizures were treated with antiepileptic drugs (AEDs). MRI was assessed using a severity score that ranged from 0 to 11. One hundred thirty-four children were assessed at 18–24 months. Babies born after 2007 who received therapeutic hypothermia had a lower rate of epilepsy than those born before this method was introduced. At two years, 6% of the children had epilepsy, and 2% were receiving AEDs. Before therapeutic hypothermia was introduced, the rate of death or moderate or severe disability was about 66%.
Liu X, Jary S, Cowan F, Thoresen M. Reduced infancy and childhood epilepsy following hypothermia-treated neonatal encephalopathy. Epilepsia. 2017 Sep 29 [Epub ahead of print].
Risk Factors Are Increasing in People With Stroke
The prevalence of hypertension, diabetes, dyslipidemia, smoking, and drug abuse in acute ischemic stroke increased between 2004 and 2014, according to a study published online ahead of print October 11 in Neurology. Researchers used the National Inpatient Sample to identify 922,451 adult hospitalizations for ischemic stroke. In all, 92.5% of patients with stroke had one or more risk factors. Age- and sex-adjusted prevalence of hypertension, diabetes, dyslipidemia, smoking, and drug abuse were 79%, 34%, 47%, 15%, and 2%, respectively. The prevalence of carotid stenosis, chronic renal failure, and coronary artery disease were 13%, 12%, and 27%, respectively. Risk factor prevalence varied by age, race, and sex. The prevalence of hypertension, diabetes, dyslipidemia, smoking, and drug abuse increased annually by 1.4%, 2%, 7%, 5%, and 7%, respectively.
Otite FO, Liaw N, Khandelwal P, et al. Increasing prevalence of vascular risk factors in patients with stroke: a call to action. Neurology. 2017 Oct 11 [Epub ahead of print].
Transcranial Direct-Current Stimulation for MS-Related Fatigue
People with multiple sclerosis (MS) who undergo a noninvasive form of electrical brain stimulation have significantly reduced fatigue, according to a study published online ahead of print September 1 in the Multiple Sclerosis Journal. Twenty-seven people with MS were randomized to receive transcranial direct-current stimulation or a placebo while playing a cognitive training game that targets processing speed and working memory. After 20 sessions, participants reported their level of fatigue using the Patient-Reported Outcomes Measurement Information System. Higher numbers correlated with greater fatigue. The researchers reported a statistically significant reduction in the group that underwent transcranial direct-current stimulation, compared with the placebo group. Intervention participants had a 5.6-point drop in fatigue on average, while control participants had a 0.9-point increase in fatigue.
Charvet LE, Dobbs B, Shaw MT, et al. Remotely supervised transcranial direct current stimulation for the treatment of fatigue in multiple sclerosis: results from a randomized, sham-controlled trial. Mult Scler. 2017 Sep 1 [Epub ahead of print].
New Genetic Risk Variants for RLS Identified
Thirteen previously unknown genetic risk variants for restless legs syndrome (RLS) have been identified, according to a study published in the November issue of Lancet Neurology. Researchers combined three genome-wide association studies’ datasets with diagnosis data collected from 2003 to 2017. The latter data came from interviews and questionnaires and included 15,126 cases and 95,725 controls. Significant genome-wide signals were tested for replication in an independent genome-wide association study of 30,770 cases and 286,913 controls. Investigators identified and replicated 13 new risk loci for RLS and confirmed six previously identified risk loci. MEIS1 was confirmed as the strongest genetic risk factor for RLS. Gene prioritization, enrichment, and genetic correlation analyses showed that identified pathways were related to neurodevelopment and highlighted genes linked to axon guidance, synapse formation, and neuronal specification.
Schormair B, Zhao C, Bell S, et al. Identification of novel risk loci for restless legs syndrome in genome-wide association studies in individuals of European ancestry: a meta-analysis. Lancet Neurol. 2017;16(11):898-907.
High Blood Pressure Associated With Increased Dementia Risk in Women
Hypertension is more common in men, but is only associated with dementia risk in women, according to a study published online ahead of print October 4 in Neurology. Researchers evaluated 5,646 members of a diverse integrated health care delivery system who had clinical examinations and health survey data from 1964 to 1973 (mean age, 32.7) and 1978 to 1985 (mean age, 44.3) and were members as of January 1, 1996 (mean age, 59.8). A total of 532 people were diagnosed with dementia. Mid-adulthood (circa age 44) hypertension was associated with 65% increased dementia risk among women, but not among men. Onset of hypertension in mid-adulthood predicted 73% higher dementia risk in women, compared with stable normotension. There was no evidence that hypertension or changes in hypertension increased dementia risk among men.
Gilsanz P, Mayeda ER, Glymour MM, et al. Female sex, early-onset hypertension, and risk of dementia. Neurology. 2017 Oct 4 [Epub ahead of print].
A Risk Factor for Major Bleeding During Treatment With NOACs
Among patients taking non-vitamin K oral anticoagulants (NOACs) for nonvalvular atrial fibrillation, concurrent use of amiodarone, fluconazole, rifampin, and phenytoin, compared with the use of NOACs alone, is associated with increased risk of major bleeding, according to a study published October 3 in JAMA. Researchers retrospectively examined data for 91,330 patients with nonvalvular atrial fibrillation who received at least one NOAC prescription of dabigatran, rivaroxaban, or apixaban from 2012 through 2016. They analyzed the bleeding risk associated with the concurrent use of 12 commonly prescribed medications. A total of 4,770 major bleeding events occurred. The incidence rate of major bleeding was significantly lower for concurrent use of atorvastatin, digoxin, and erythromycin or clarithromycin. Physicians prescribing NOACs should consider the potential risks associated with concomitant use of other drugs, the researchers said.
Chang SH, Chou IJ, Yeh YH, et al. Association between use of non-vitamin K oral anticoagulants with and without concurrent medications and risk of major bleeding in nonvalvular atrial fibrillation. JAMA. 2017;318(13):1250-1259.
Discontinuing Aspirin Therapy May Increase Cardiovascular Risk
In long-term users, discontinuation of low-dose aspirin in the absence of major surgery or bleeding is associated with a greater-than-30% increased risk of cardiovascular events, according to a study published September 26 in Circulation. Researchers performed a cohort study of 601,527 participants taking low-dose aspirin for heart attack and stroke prevention between 2005 and 2009. Participants were older than 40, cancer-free, and had an adherence rate of 80% or greater during the first year of treatment. During a median of 3.0 years of follow-up, 62,690 cardiovascular events were reported. Patients who discontinued aspirin had a higher rate of cardiovascular events than those who continued (multivariable-adjusted hazard ratio, 1.37), corresponding to an additional cardiovascular event observed per year in one of every 74 patients who discontinued aspirin.
Sundström J, Hedberg J, Thuresson M, et al. Low-dose aspirin discontinuation and risk of cardiovascular events: a Swedish nationwide, population-based cohort study. Circulation. 2017;136(13):1183-1192.
FDA Approves 80-mg Ingrezza Capsule for Tardive Dyskinesia
The FDA has approved an 80-mg capsule of Ingrezza (valbenazine) for the treatment of adults with tardive dyskinesia. In clinical studies, Ingrezza 80 mg provided significant, rapid, and meaningful improvement in tardive dyskinesia severity, compared with placebo, at six weeks. Results were seen as early as two weeks, and continued reductions were observed through 48 weeks of treatment. The drug was FDA-approved in April and has been available as 40-mg capsules. Neurocrine Biosciences markets Ingrezza.
FDA Approves Generic Version of Copaxone
The FDA has approved Mylan’s glatiramer acetate injection 40 mg/mL for thrice-weekly injection. The drug is a substitutable generic version of Teva’s Copaxone 40 mg/mL. The agency also approved Mylan’s glatiramer acetate injection 20 mg/mL for once-daily injection, a substitutable generic version of Teva’s Copaxone 20 mg/mL. Both products are indicated for the treatment of patients with relapsing forms of multiple sclerosis. As part of its applications, Mylan submitted side-by-side analyses demonstrating that its glatiramer acetate injections have the same active ingredient, dosage form, route of administration, and strength as their branded counterpart.
FDA Approves Gocovri for Dyskinesia in Parkinson’s Disease
The FDA has approved Gocovri (amantadine) extended-release capsules for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy with or without concomitant dopaminergic medications. Gocovri, previously granted orphan drug status by the FDA, is the first medicine approved by the FDA for this indication. Gocovri is a high-dose (274 mg) formulation of amantadine (equivalent to 340 mg of amantadine HCl) taken once-daily at bedtime that delivers consistently high levels of amantadine from the morning and throughout the day. Adamas Pharmaceuticals markets the drug.
FDA Has Approved Lyrica CR for Two Indications
The FDA has approved Lyrica CR (pregabalin) extended-release tablets CV as once-daily therapy for the management of neuropathic pain associated with diabetic peripheral neuropathy and the management of postherpetic neuralgia. The efficacy and safety of Lyrica CR in postherpetic neuralgia was established in a randomized placebo-controlled clinical trial conducted in 801 patients with postherpetic neuralgia who entered single-blind treatment with Lyrica CR. In the study, 73.6% of patients in the Lyrica CR group achieved at least 50% improvement in pain intensity, compared with 54.6% in the placebo group. The postherpetic neuralgia data also supported the diabetic peripheral neuropathy indication. Pfizer markets Lyrica CR.
—Kimberly Williams
Can a Fatty Diet Increase Relapse Risk in Children With MS?
In children with multiple sclerosis (MS), high energy intake from fat, especially saturated fat, may increase the hazard of relapse, while vegetable intake may be independently protective, according to a study published online ahead of print October 9 in the Journal of Neurology, Neurosurgery & Psychiatry. A total of 219 patients with pediatric relapsing-remitting MS or clinically isolated syndrome with disease onset before age 18 and duration of less than four years were enrolled in a multicenter study that was completed at 11 pediatric MS centers. Investigators used the Block Kids Food Screener to examine dietary intake during the week before enrollment. Each 10% increase in energy intake from fat increased the hazard of relapse by 56%, and each 10% increase in saturated fat tripled this hazard.
Azary S, Schreiner T, Graves J, et al. Contribution of dietary intake to relapse rate in early paediatric multiple sclerosis. J Neurol Neurosurg Psychiatry. 2017 Oct 9 [Epub ahead of print].
Cooling Reduces Risk of Epilepsy After Perinatal Asphyxia
Administering therapeutic hypothermia to babies with perinatal asphyxia can reduce their risk of epilepsy in childhood, according to a study published online ahead of print September 29 in Epilepsia. From 2006 to 2013, 151 infants with perinatal asphyxia underwent 72 hours of cooling. Clinical and amplitude-integrated EEG with single-channel EEG-verified neonatal seizures were treated with antiepileptic drugs (AEDs). MRI was assessed using a severity score that ranged from 0 to 11. One hundred thirty-four children were assessed at 18–24 months. Babies born after 2007 who received therapeutic hypothermia had a lower rate of epilepsy than those born before this method was introduced. At two years, 6% of the children had epilepsy, and 2% were receiving AEDs. Before therapeutic hypothermia was introduced, the rate of death or moderate or severe disability was about 66%.
Liu X, Jary S, Cowan F, Thoresen M. Reduced infancy and childhood epilepsy following hypothermia-treated neonatal encephalopathy. Epilepsia. 2017 Sep 29 [Epub ahead of print].
Risk Factors Are Increasing in People With Stroke
The prevalence of hypertension, diabetes, dyslipidemia, smoking, and drug abuse in acute ischemic stroke increased between 2004 and 2014, according to a study published online ahead of print October 11 in Neurology. Researchers used the National Inpatient Sample to identify 922,451 adult hospitalizations for ischemic stroke. In all, 92.5% of patients with stroke had one or more risk factors. Age- and sex-adjusted prevalence of hypertension, diabetes, dyslipidemia, smoking, and drug abuse were 79%, 34%, 47%, 15%, and 2%, respectively. The prevalence of carotid stenosis, chronic renal failure, and coronary artery disease were 13%, 12%, and 27%, respectively. Risk factor prevalence varied by age, race, and sex. The prevalence of hypertension, diabetes, dyslipidemia, smoking, and drug abuse increased annually by 1.4%, 2%, 7%, 5%, and 7%, respectively.
Otite FO, Liaw N, Khandelwal P, et al. Increasing prevalence of vascular risk factors in patients with stroke: a call to action. Neurology. 2017 Oct 11 [Epub ahead of print].
Transcranial Direct-Current Stimulation for MS-Related Fatigue
People with multiple sclerosis (MS) who undergo a noninvasive form of electrical brain stimulation have significantly reduced fatigue, according to a study published online ahead of print September 1 in the Multiple Sclerosis Journal. Twenty-seven people with MS were randomized to receive transcranial direct-current stimulation or a placebo while playing a cognitive training game that targets processing speed and working memory. After 20 sessions, participants reported their level of fatigue using the Patient-Reported Outcomes Measurement Information System. Higher numbers correlated with greater fatigue. The researchers reported a statistically significant reduction in the group that underwent transcranial direct-current stimulation, compared with the placebo group. Intervention participants had a 5.6-point drop in fatigue on average, while control participants had a 0.9-point increase in fatigue.
Charvet LE, Dobbs B, Shaw MT, et al. Remotely supervised transcranial direct current stimulation for the treatment of fatigue in multiple sclerosis: results from a randomized, sham-controlled trial. Mult Scler. 2017 Sep 1 [Epub ahead of print].
New Genetic Risk Variants for RLS Identified
Thirteen previously unknown genetic risk variants for restless legs syndrome (RLS) have been identified, according to a study published in the November issue of Lancet Neurology. Researchers combined three genome-wide association studies’ datasets with diagnosis data collected from 2003 to 2017. The latter data came from interviews and questionnaires and included 15,126 cases and 95,725 controls. Significant genome-wide signals were tested for replication in an independent genome-wide association study of 30,770 cases and 286,913 controls. Investigators identified and replicated 13 new risk loci for RLS and confirmed six previously identified risk loci. MEIS1 was confirmed as the strongest genetic risk factor for RLS. Gene prioritization, enrichment, and genetic correlation analyses showed that identified pathways were related to neurodevelopment and highlighted genes linked to axon guidance, synapse formation, and neuronal specification.
Schormair B, Zhao C, Bell S, et al. Identification of novel risk loci for restless legs syndrome in genome-wide association studies in individuals of European ancestry: a meta-analysis. Lancet Neurol. 2017;16(11):898-907.
High Blood Pressure Associated With Increased Dementia Risk in Women
Hypertension is more common in men, but is only associated with dementia risk in women, according to a study published online ahead of print October 4 in Neurology. Researchers evaluated 5,646 members of a diverse integrated health care delivery system who had clinical examinations and health survey data from 1964 to 1973 (mean age, 32.7) and 1978 to 1985 (mean age, 44.3) and were members as of January 1, 1996 (mean age, 59.8). A total of 532 people were diagnosed with dementia. Mid-adulthood (circa age 44) hypertension was associated with 65% increased dementia risk among women, but not among men. Onset of hypertension in mid-adulthood predicted 73% higher dementia risk in women, compared with stable normotension. There was no evidence that hypertension or changes in hypertension increased dementia risk among men.
Gilsanz P, Mayeda ER, Glymour MM, et al. Female sex, early-onset hypertension, and risk of dementia. Neurology. 2017 Oct 4 [Epub ahead of print].
A Risk Factor for Major Bleeding During Treatment With NOACs
Among patients taking non-vitamin K oral anticoagulants (NOACs) for nonvalvular atrial fibrillation, concurrent use of amiodarone, fluconazole, rifampin, and phenytoin, compared with the use of NOACs alone, is associated with increased risk of major bleeding, according to a study published October 3 in JAMA. Researchers retrospectively examined data for 91,330 patients with nonvalvular atrial fibrillation who received at least one NOAC prescription of dabigatran, rivaroxaban, or apixaban from 2012 through 2016. They analyzed the bleeding risk associated with the concurrent use of 12 commonly prescribed medications. A total of 4,770 major bleeding events occurred. The incidence rate of major bleeding was significantly lower for concurrent use of atorvastatin, digoxin, and erythromycin or clarithromycin. Physicians prescribing NOACs should consider the potential risks associated with concomitant use of other drugs, the researchers said.
Chang SH, Chou IJ, Yeh YH, et al. Association between use of non-vitamin K oral anticoagulants with and without concurrent medications and risk of major bleeding in nonvalvular atrial fibrillation. JAMA. 2017;318(13):1250-1259.
Discontinuing Aspirin Therapy May Increase Cardiovascular Risk
In long-term users, discontinuation of low-dose aspirin in the absence of major surgery or bleeding is associated with a greater-than-30% increased risk of cardiovascular events, according to a study published September 26 in Circulation. Researchers performed a cohort study of 601,527 participants taking low-dose aspirin for heart attack and stroke prevention between 2005 and 2009. Participants were older than 40, cancer-free, and had an adherence rate of 80% or greater during the first year of treatment. During a median of 3.0 years of follow-up, 62,690 cardiovascular events were reported. Patients who discontinued aspirin had a higher rate of cardiovascular events than those who continued (multivariable-adjusted hazard ratio, 1.37), corresponding to an additional cardiovascular event observed per year in one of every 74 patients who discontinued aspirin.
Sundström J, Hedberg J, Thuresson M, et al. Low-dose aspirin discontinuation and risk of cardiovascular events: a Swedish nationwide, population-based cohort study. Circulation. 2017;136(13):1183-1192.
FDA Approves 80-mg Ingrezza Capsule for Tardive Dyskinesia
The FDA has approved an 80-mg capsule of Ingrezza (valbenazine) for the treatment of adults with tardive dyskinesia. In clinical studies, Ingrezza 80 mg provided significant, rapid, and meaningful improvement in tardive dyskinesia severity, compared with placebo, at six weeks. Results were seen as early as two weeks, and continued reductions were observed through 48 weeks of treatment. The drug was FDA-approved in April and has been available as 40-mg capsules. Neurocrine Biosciences markets Ingrezza.
FDA Approves Generic Version of Copaxone
The FDA has approved Mylan’s glatiramer acetate injection 40 mg/mL for thrice-weekly injection. The drug is a substitutable generic version of Teva’s Copaxone 40 mg/mL. The agency also approved Mylan’s glatiramer acetate injection 20 mg/mL for once-daily injection, a substitutable generic version of Teva’s Copaxone 20 mg/mL. Both products are indicated for the treatment of patients with relapsing forms of multiple sclerosis. As part of its applications, Mylan submitted side-by-side analyses demonstrating that its glatiramer acetate injections have the same active ingredient, dosage form, route of administration, and strength as their branded counterpart.
FDA Approves Gocovri for Dyskinesia in Parkinson’s Disease
The FDA has approved Gocovri (amantadine) extended-release capsules for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy with or without concomitant dopaminergic medications. Gocovri, previously granted orphan drug status by the FDA, is the first medicine approved by the FDA for this indication. Gocovri is a high-dose (274 mg) formulation of amantadine (equivalent to 340 mg of amantadine HCl) taken once-daily at bedtime that delivers consistently high levels of amantadine from the morning and throughout the day. Adamas Pharmaceuticals markets the drug.
FDA Has Approved Lyrica CR for Two Indications
The FDA has approved Lyrica CR (pregabalin) extended-release tablets CV as once-daily therapy for the management of neuropathic pain associated with diabetic peripheral neuropathy and the management of postherpetic neuralgia. The efficacy and safety of Lyrica CR in postherpetic neuralgia was established in a randomized placebo-controlled clinical trial conducted in 801 patients with postherpetic neuralgia who entered single-blind treatment with Lyrica CR. In the study, 73.6% of patients in the Lyrica CR group achieved at least 50% improvement in pain intensity, compared with 54.6% in the placebo group. The postherpetic neuralgia data also supported the diabetic peripheral neuropathy indication. Pfizer markets Lyrica CR.
—Kimberly Williams
Can a Fatty Diet Increase Relapse Risk in Children With MS?
In children with multiple sclerosis (MS), high energy intake from fat, especially saturated fat, may increase the hazard of relapse, while vegetable intake may be independently protective, according to a study published online ahead of print October 9 in the Journal of Neurology, Neurosurgery & Psychiatry. A total of 219 patients with pediatric relapsing-remitting MS or clinically isolated syndrome with disease onset before age 18 and duration of less than four years were enrolled in a multicenter study that was completed at 11 pediatric MS centers. Investigators used the Block Kids Food Screener to examine dietary intake during the week before enrollment. Each 10% increase in energy intake from fat increased the hazard of relapse by 56%, and each 10% increase in saturated fat tripled this hazard.
Azary S, Schreiner T, Graves J, et al. Contribution of dietary intake to relapse rate in early paediatric multiple sclerosis. J Neurol Neurosurg Psychiatry. 2017 Oct 9 [Epub ahead of print].
Cooling Reduces Risk of Epilepsy After Perinatal Asphyxia
Administering therapeutic hypothermia to babies with perinatal asphyxia can reduce their risk of epilepsy in childhood, according to a study published online ahead of print September 29 in Epilepsia. From 2006 to 2013, 151 infants with perinatal asphyxia underwent 72 hours of cooling. Clinical and amplitude-integrated EEG with single-channel EEG-verified neonatal seizures were treated with antiepileptic drugs (AEDs). MRI was assessed using a severity score that ranged from 0 to 11. One hundred thirty-four children were assessed at 18–24 months. Babies born after 2007 who received therapeutic hypothermia had a lower rate of epilepsy than those born before this method was introduced. At two years, 6% of the children had epilepsy, and 2% were receiving AEDs. Before therapeutic hypothermia was introduced, the rate of death or moderate or severe disability was about 66%.
Liu X, Jary S, Cowan F, Thoresen M. Reduced infancy and childhood epilepsy following hypothermia-treated neonatal encephalopathy. Epilepsia. 2017 Sep 29 [Epub ahead of print].
Risk Factors Are Increasing in People With Stroke
The prevalence of hypertension, diabetes, dyslipidemia, smoking, and drug abuse in acute ischemic stroke increased between 2004 and 2014, according to a study published online ahead of print October 11 in Neurology. Researchers used the National Inpatient Sample to identify 922,451 adult hospitalizations for ischemic stroke. In all, 92.5% of patients with stroke had one or more risk factors. Age- and sex-adjusted prevalence of hypertension, diabetes, dyslipidemia, smoking, and drug abuse were 79%, 34%, 47%, 15%, and 2%, respectively. The prevalence of carotid stenosis, chronic renal failure, and coronary artery disease were 13%, 12%, and 27%, respectively. Risk factor prevalence varied by age, race, and sex. The prevalence of hypertension, diabetes, dyslipidemia, smoking, and drug abuse increased annually by 1.4%, 2%, 7%, 5%, and 7%, respectively.
Otite FO, Liaw N, Khandelwal P, et al. Increasing prevalence of vascular risk factors in patients with stroke: a call to action. Neurology. 2017 Oct 11 [Epub ahead of print].
Transcranial Direct-Current Stimulation for MS-Related Fatigue
People with multiple sclerosis (MS) who undergo a noninvasive form of electrical brain stimulation have significantly reduced fatigue, according to a study published online ahead of print September 1 in the Multiple Sclerosis Journal. Twenty-seven people with MS were randomized to receive transcranial direct-current stimulation or a placebo while playing a cognitive training game that targets processing speed and working memory. After 20 sessions, participants reported their level of fatigue using the Patient-Reported Outcomes Measurement Information System. Higher numbers correlated with greater fatigue. The researchers reported a statistically significant reduction in the group that underwent transcranial direct-current stimulation, compared with the placebo group. Intervention participants had a 5.6-point drop in fatigue on average, while control participants had a 0.9-point increase in fatigue.
Charvet LE, Dobbs B, Shaw MT, et al. Remotely supervised transcranial direct current stimulation for the treatment of fatigue in multiple sclerosis: results from a randomized, sham-controlled trial. Mult Scler. 2017 Sep 1 [Epub ahead of print].
New Genetic Risk Variants for RLS Identified
Thirteen previously unknown genetic risk variants for restless legs syndrome (RLS) have been identified, according to a study published in the November issue of Lancet Neurology. Researchers combined three genome-wide association studies’ datasets with diagnosis data collected from 2003 to 2017. The latter data came from interviews and questionnaires and included 15,126 cases and 95,725 controls. Significant genome-wide signals were tested for replication in an independent genome-wide association study of 30,770 cases and 286,913 controls. Investigators identified and replicated 13 new risk loci for RLS and confirmed six previously identified risk loci. MEIS1 was confirmed as the strongest genetic risk factor for RLS. Gene prioritization, enrichment, and genetic correlation analyses showed that identified pathways were related to neurodevelopment and highlighted genes linked to axon guidance, synapse formation, and neuronal specification.
Schormair B, Zhao C, Bell S, et al. Identification of novel risk loci for restless legs syndrome in genome-wide association studies in individuals of European ancestry: a meta-analysis. Lancet Neurol. 2017;16(11):898-907.
High Blood Pressure Associated With Increased Dementia Risk in Women
Hypertension is more common in men, but is only associated with dementia risk in women, according to a study published online ahead of print October 4 in Neurology. Researchers evaluated 5,646 members of a diverse integrated health care delivery system who had clinical examinations and health survey data from 1964 to 1973 (mean age, 32.7) and 1978 to 1985 (mean age, 44.3) and were members as of January 1, 1996 (mean age, 59.8). A total of 532 people were diagnosed with dementia. Mid-adulthood (circa age 44) hypertension was associated with 65% increased dementia risk among women, but not among men. Onset of hypertension in mid-adulthood predicted 73% higher dementia risk in women, compared with stable normotension. There was no evidence that hypertension or changes in hypertension increased dementia risk among men.
Gilsanz P, Mayeda ER, Glymour MM, et al. Female sex, early-onset hypertension, and risk of dementia. Neurology. 2017 Oct 4 [Epub ahead of print].
A Risk Factor for Major Bleeding During Treatment With NOACs
Among patients taking non-vitamin K oral anticoagulants (NOACs) for nonvalvular atrial fibrillation, concurrent use of amiodarone, fluconazole, rifampin, and phenytoin, compared with the use of NOACs alone, is associated with increased risk of major bleeding, according to a study published October 3 in JAMA. Researchers retrospectively examined data for 91,330 patients with nonvalvular atrial fibrillation who received at least one NOAC prescription of dabigatran, rivaroxaban, or apixaban from 2012 through 2016. They analyzed the bleeding risk associated with the concurrent use of 12 commonly prescribed medications. A total of 4,770 major bleeding events occurred. The incidence rate of major bleeding was significantly lower for concurrent use of atorvastatin, digoxin, and erythromycin or clarithromycin. Physicians prescribing NOACs should consider the potential risks associated with concomitant use of other drugs, the researchers said.
Chang SH, Chou IJ, Yeh YH, et al. Association between use of non-vitamin K oral anticoagulants with and without concurrent medications and risk of major bleeding in nonvalvular atrial fibrillation. JAMA. 2017;318(13):1250-1259.
Discontinuing Aspirin Therapy May Increase Cardiovascular Risk
In long-term users, discontinuation of low-dose aspirin in the absence of major surgery or bleeding is associated with a greater-than-30% increased risk of cardiovascular events, according to a study published September 26 in Circulation. Researchers performed a cohort study of 601,527 participants taking low-dose aspirin for heart attack and stroke prevention between 2005 and 2009. Participants were older than 40, cancer-free, and had an adherence rate of 80% or greater during the first year of treatment. During a median of 3.0 years of follow-up, 62,690 cardiovascular events were reported. Patients who discontinued aspirin had a higher rate of cardiovascular events than those who continued (multivariable-adjusted hazard ratio, 1.37), corresponding to an additional cardiovascular event observed per year in one of every 74 patients who discontinued aspirin.
Sundström J, Hedberg J, Thuresson M, et al. Low-dose aspirin discontinuation and risk of cardiovascular events: a Swedish nationwide, population-based cohort study. Circulation. 2017;136(13):1183-1192.
FDA Approves 80-mg Ingrezza Capsule for Tardive Dyskinesia
The FDA has approved an 80-mg capsule of Ingrezza (valbenazine) for the treatment of adults with tardive dyskinesia. In clinical studies, Ingrezza 80 mg provided significant, rapid, and meaningful improvement in tardive dyskinesia severity, compared with placebo, at six weeks. Results were seen as early as two weeks, and continued reductions were observed through 48 weeks of treatment. The drug was FDA-approved in April and has been available as 40-mg capsules. Neurocrine Biosciences markets Ingrezza.
FDA Approves Generic Version of Copaxone
The FDA has approved Mylan’s glatiramer acetate injection 40 mg/mL for thrice-weekly injection. The drug is a substitutable generic version of Teva’s Copaxone 40 mg/mL. The agency also approved Mylan’s glatiramer acetate injection 20 mg/mL for once-daily injection, a substitutable generic version of Teva’s Copaxone 20 mg/mL. Both products are indicated for the treatment of patients with relapsing forms of multiple sclerosis. As part of its applications, Mylan submitted side-by-side analyses demonstrating that its glatiramer acetate injections have the same active ingredient, dosage form, route of administration, and strength as their branded counterpart.
FDA Approves Gocovri for Dyskinesia in Parkinson’s Disease
The FDA has approved Gocovri (amantadine) extended-release capsules for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy with or without concomitant dopaminergic medications. Gocovri, previously granted orphan drug status by the FDA, is the first medicine approved by the FDA for this indication. Gocovri is a high-dose (274 mg) formulation of amantadine (equivalent to 340 mg of amantadine HCl) taken once-daily at bedtime that delivers consistently high levels of amantadine from the morning and throughout the day. Adamas Pharmaceuticals markets the drug.
FDA Has Approved Lyrica CR for Two Indications
The FDA has approved Lyrica CR (pregabalin) extended-release tablets CV as once-daily therapy for the management of neuropathic pain associated with diabetic peripheral neuropathy and the management of postherpetic neuralgia. The efficacy and safety of Lyrica CR in postherpetic neuralgia was established in a randomized placebo-controlled clinical trial conducted in 801 patients with postherpetic neuralgia who entered single-blind treatment with Lyrica CR. In the study, 73.6% of patients in the Lyrica CR group achieved at least 50% improvement in pain intensity, compared with 54.6% in the placebo group. The postherpetic neuralgia data also supported the diabetic peripheral neuropathy indication. Pfizer markets Lyrica CR.
—Kimberly Williams
