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.